E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 110 CONGRESS, FIRST SESSION

Vol. 153 WASHINGTON, TUESDAY, MAY 1, 2007 No. 70 Senate The Senate met at 10 a.m. and was Senator from the State of Ohio, to perform PERFORMANCE OF THE MEDIA called to order by the Honorable the duties of the Chair. Mr. BENNETT. Mr. President, my SHERROD BROWN, a Senator from the ROBERT C. BYRD, President pro tempore. theme today has to do with our friends State of Ohio. in the media, or the fourth estate as Mr. BROWN thereupon assumed the they like to call themselves. There are chair as Acting President pro tempore. PRAYER two items I wish to call to the atten- The Chaplain, Dr. Barry C. Black, of- f tion of the Senate and anyone else who fered the following prayer: RECOGNITION OF THE ACTING might be listening with respect to the Let us pray. MAJORITY LEADER performance of the media. The first one O God, our rock, fortress, and deliv- The ACTING PRESIDENT pro tem- is highlighted in an editorial that ap- erer, we trust You to strengthen us pore. The acting majority leader is rec- peared this morning in the Wall Street today. ognized. Journal entitled ‘‘Frist’s Vindication.’’ Empower our Senators with humility All of us in this Chamber know Sen- f to listen, wisdom to understand, cour- ator FRIST. We know him as a man of age to attempt, and power to obey. ORDER OF PROCEDURE integrity, intelligence, and grace. He May they devote themselves to the Ms. STABENOW. Mr. President, I presided over the Senate as the major- honorable, the noble, and the good. now ask unanimous consent that when ity leader for 4 years. He has a long Keep them from self-indulgence, men- the Senate resumes S. 1082 this morn- history as a humanitarian, as a sci- tal lethargy, and negative expectations ing, it be for debate only until 12:30 entist, as a skilled doctor who pio- as You guide their hearts and minds in p.m., with no amendments in order neered procedures in the process of the knowledge of Your love. Purify during that time, with the time equal- heart and lung transplants. their ambitions so that they may set ly divided and controlled between the We also know him as the target of their hearts only on that which pleases two leaders or their designees. media attack for insider trading, and You. May they find even in problems The ACTING PRESIDENT pro tem- we know groups that are self-anointed opportunities to discover Your power. pore. Is there objection? as watchdogs of the public conscious- We pray in Your great Name. Amen. Without objection, it is so ordered. ness that picked that up and kept the drumbeat alive. Our friends in the f f media also kept the drumbeat alive PLEDGE OF ALLEGIANCE RESERVATION OF LEADER TIME saying, over and over again, Dr. Frist The ACTING PRESIDENT pro tem- was a hypocrite, Dr. Frist engaged in The Honorable SHERROD BROWN led the Pledge of Allegiance, as follows: pore. Under the previous order, the insider trading, Dr. Frist used his posi- I pledge allegiance to the Flag of the leadership time is reserved. tion to enrich himself while he was United States of America, and to the Repub- f here in the Senate. lic for which it stands, one nation under God, Well, the Securities and Exchange indivisible, with liberty and justice for all. MORNING BUSINESS Commission was sufficiently aroused The ACTING PRESIDENT pro tem- by those attacks that they entered into f pore. Under the previous order, there an investigation of Dr. Frist’s activi- APPOINTMENT OF ACTING will now be a period for the transaction ties with respect to his stock. That in- PRESIDENT PRO TEMPORE of morning business for up to 60 min- vestigation is now closed. I did not re- utes, with Senators permitted to speak The PRESIDING OFFICER. The alize the investigation was closed be- for up to 10 minutes each, with the clerk will please read a communication cause there has been no hue and cry first half of the time under the control to the Senate from the President pro whatsoever in the media. There has of the Republicans and the second half been no mention that came to my at- tempore (Mr. BYRD). of the time under the control of the The assistant legislative clerk read tention in the media, until I picked up majority. the following letter: this morning’s Wall Street Journal and The Senator from Utah is recognized. saw this editorial. U.S. SENATE, Mr. BENNETT. Mr. President, I ask I would like to quote from it. Under PRESIDENT PRO TEMPORE, unanimous consent that I be allowed to Washington, DC, May 1, 2007. the title ‘‘Frist’s Vindication’’ and the To the Senate: speak for up to 15 minutes. subhead ‘‘So much for that ‘insider Under the provisions of rule I, paragraph 3, The ACTING PRESIDENT pro tem- trading’ smear,’’ here is what it says: of the Standing Rules of the Senate, I hereby pore. Without objection, it is so or- When insider-trading allegations against appoint the Honorable SHERROD BROWN, a dered. former Senate Majority Leader Bill Frist

∑ This ‘‘bullet’’ symbol identifies statements or insertions which are not spoken by a Member of the Senate on the floor.

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VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00001 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.000 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5316 CONGRESSIONAL RECORD — SENATE May 1, 2007 surfaced back in 2005, they were splashed on and those self-appointed leaders of eth- China is the nation of the future. We the pages of major newspapers from coast to ics who are quick to criticize but slow have heard in the media statements coast. Now that Dr. Frist has been vindi- to apologize. about the 20th century being the Amer- cated, the silence is instructive. Is anybody Now, Mr. President, the next issue I ican century; the 21st century is going out there? would like to raise with respect to the to be the Chinese century. It goes on to describe the allegations media has to do with the hysteria over Well, let me put up another chart against Dr. Frist. I shall not repeat America’s trade deficit with China. I that I think will demonstrate that them. Basically, it says he used his po- have some charts I would like to put up might be a little bit premature. sition in the Senate to get insider in- to show some historical evidence with Let’s look at the size of the two formation and started selling his stock respect to this issue. economies. The size of the economy is in HCA in advance of a drop in the Let’s talk about China and the trade measured in gross domestic product. stock that occurred because of earn- deficit and the rise of China. This chart The gross domestic product of the ings reports. has two lines on it, one in red, which is United States in 2000 was $9.8 trillion. The editorial says: American exports to China, and one in The gross domestic product in China in Thanks in part to his meticulous email ar- blue, which is American imports from 2000 was $1.2 trillion. This is the begin- chives, Dr. Frist was able to show that he China. ning of the Chinese century? The Chi- had begun the process of selling his HCA Let’s go back to 1975, before people nese are starting off pretty far behind stock in April of 2005, months before he was were all excited about China and how alleged to have received the inside whispers. in this race if they are going to turn China was destroying us in the age of the 21st century into the Chinese cen- It goes on to discuss the groups that globalization, how China’s cheap labor tury. They are at $1.2 trillion and we attacked him. Again quoting: was taking all of our jobs, and we were are at $9.8 trillion. We have sprinted For years he was harassed by such liberal flooded with Chinese imports. We no- into what the media is calling the Chi- lobbies as Public Citizen, and Citizens for tice on the chart there was a gap be- nese century now for the first 6 years. Responsibility and Ethics in Washington, which alleged conflicts of interest. These tween American exports to China and Where are we? These statistics are groups objected even to those stocks he held American imports from China. No one for the first 5 years, the first 5 percent. in the blind trust he had created to avoid the felt that gap was ready to threaten and In that period of time, our annual GDP appearance of a conflict of interest. Yet destroy the American economy. No one growth has been 3.2 percent. The Chi- when he sold those stocks, with a possible got excited about it. All right. nese has been 10 percent. Those are the eye on higher office, he was pilloried for You go to 1990, and you find that nei- numbers that say they are going to doing what the ethicists had asked him to do ther line has moved up very much, but overtake us. Ten percent is clearly bet- all along. the gap remains virtually the same. ter than 3 percent. The editorial indicates that while Now, the Chinese economy started to I would make this one footnote with this absolution is a relief to Dr. Frist, take off and we started to buy things respect to the 10 percent. I am a little ‘‘it’s impossible to undo the damage to from them, and at the same time we suspect of these numbers because the his political career. Despite flimsy evi- started to sell things to them. Both Chinese released their annual figures dence, the media storm cast a shadow lines started moving up. We saw, yes, on December 31 of the same year. We over his office, derailing any thought imports from China were going up, but don’t know our annual figures for of a Presidential bid this year. The exports to China were going up. By months afterwards. Then, when more Nashville heart surgeon chose instead 2002, 2003, both were up significantly data comes in, we revise them upward to ‘take a sabbatical from public life.’’’ over where they had been in 1975. But or downward, based on additional infor- A great deal was made out of this. the gap remained roughly the same. All mation. Somehow they know on New The editorial quotes American Univer- right. Year’s Eve exactly how they have done sity professor James Thurber as saying Interestingly enough, as we get to- during the year. If they were a corpora- that Dr. Frist ‘‘came in like Jimmy ward 2005 and so on, there are moments tion required to report to the SEC, Stewart and was leaving like Martha when the gap disappears, when our there would be some investigations Stewart.’’ That is a great line. That sales to China were greater than our about the possibility of ‘‘cooking the gets headlines. The press loves things imports from China. Why would that books.’’ I think they make the deter- of that kind. be? It would be because the improving mination of where they want the num- Now that it is clear he behaved in an Chinese economy now has enough ber to be and then report it thusly, ei- absolutely ethical way—documented money to buy American goods. They ther too high or too low for whatever everything he did, turned over all of want to buy our airplanes. Boeing does their political purposes might be. his e-mails—and has been completely well in China. The last time I was in So all right, let’s take these numbers cleared, after 18 months of careful ex- China, I met with the manager of Gen- at their face value. These numbers amination by the Securities and Ex- eral Motors in China. General Motors mean from 2000 to 2005 the Chinese change Commission, we hear nothing was having a very bad year in the GDP grew from $1.2 trillion to $2.2 tril- in the press, we hear nothing in the United States, but they were having a lion, a $1 trillion increase. That is not way of an apology from Public Citizen good year in China. They were making a slouchy thing to do. That is clearly a or Citizens for Responsibility and Eth- money in China. They were selling tremendously impressive perform- ics in Washington. Maybe ethics does Buicks and other automobiles in China. ance—almost doubling a $1 trillion in- not apply to them when it comes to The red line started to move up, and, crease. How about the United States. apologizing for smears against legiti- as I say, at one point they actually We are just limping along at 3 percent, mate and responsible public servants. crossed the blue line. OK, the blue line 3.2 percent, but we went from $9.8 tril- Maybe we will now hear that Dr. Thur- opened up again, not as great as the lion to $12.4 trillion. ber has something else to say besides gap back in 1975, but it began to open In other words, they went up $1 tril- his quick quip about Dr. Frist being up. Once again, we saw the gap closed. lion, and we went up $3 trillion. How is the same as Martha Stewart as she Sales to China reached the same level that possible if they are growing an- went to jail. But I doubt we will hear as purchases from China. And then it other 10 percent, and we are only grow- any of that. I doubt the press will even opened up again. It appears if we want ing at 3 percent? It is because they are notice. I doubt there will be a sidebar to project from this period on into the starting from a very low base. Those anywhere. future that the pattern of our import- who say the 21st century will be the I am grateful to the Wall Street ing slightly more from China than we Chinese century and the Americans are Journal for pointing this out to us, and sell to China is likely to continue. through need to pay attention to what I appreciate the opportunity on the I doubt this historic demonstration the real numbers are. floor of the Senate to speak on behalf of facts comports with the way the If we are going to have a game and of a man whom I consider a friend, I media is talking about China. They are we start out the game with one team think whom all of us consider a respon- telling us China is going to overtake having almost 10 times as many points sible Senator, a devoted leader. He de- us. They are telling us China is going as the other, and then add on to that serves better at the hands of the press to destroy us. They are telling us on a percentage basis rather than an

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00002 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.001 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5317 absolute basis, we see in terms of the cles that are awaiting $3.1 billion in security plan to back up Iraqi forces in gap between the size of the American spending in this appropriations bill to Baghdad to implement the clear hold- GDP and the Chinese GDP the gap is get those to the Marines and Army in and-build strategy that GEN David actually widening rather than shrink- Iraq, something that has proven, in the Petraeus is the architect of as part of ing. Yes, they can have a higher rate of hands of the Marines, to be very resist- our counterinsurgency measures is growth, but their higher rate of growth ant to the improvised explosive de- only halfway deployed. Only half of the is on a much lower base. Our growth on vices. They save lives. That is one ex- troops that are a part of this so-called a higher base is unprecedented in world ample, one concrete example of funding surge are on the ground. While we are history. for equipment that is being held up be- seeing some progress, we are also see- My message today is we need to hold cause Congress continues to dither and ing some increased violence and, unfor- the media accountable as well as all of play political games now 85 days after tunately, deaths as a result of meeting the others. We have had two examples the President has requested this fund- the enemy in places where previously I have highlighted this morning where ing for our troops. The bill that will— they were safe and secure because we the media has misled us: the first with after this so-called signing ceremony could not even go into places such as respect to one of our respected and be- and after this reading of the bill after Sadar City, which was controlled by loved colleagues, Dr. Frist, where he it has passed rather than before it was Moqtada al-Sadr, the radical Shiite was smeared and then when he was vin- passed exercise—be sent to the Presi- cleric who has since left to go to dicated, that fact was ignored. The sec- dent and he will veto it is simply unac- Tehran. He has left the country be- ond has to do with telling us where the ceptable. Why? For two reasons. cause he is afraid of the American and world is going. For whatever reasons, First of all, because it imposes arbi- Iraqi military forces joining together. there are those who are constantly trary timelines on our generals in Iraq, He has instructed the Shiite militias, panicked about China and its impact including GEN David Petraeus, who one of the major causes of death squads on the United States who need to pay was confirmed unanimously by the and violence and ethnic cleansing in attention to the reality of the num- Senate, who was here last week to ex- Iraq, to lay down their arms. What is bers. plain the progress that is being made there not to like about that kind of Mr. President, I yield the floor. in places such as Al Anbar Province, progress? Yet Congress, thousands of The ACTING PRESIDENT pro tem- west of Iraq, which has been controlled miles away in the safety and comfort pore. The Senator from Texas is recog- by al-Qaida for some time now, and we of the Senate Chamber and our offices, nized. are finally starting to see some real, is undermining the good efforts that f concrete improvements being made are going forward in Iraq. there. We are seeing the local sheiks While no one believes success is as- IRAQ offering troops to supplement Iraqi po- sured, we know, in the words of Gen- Mr. CORNYN. Mr. President, today is lice officers and the Iraqi Army to eral Petraeus: an important yet a sad day for our Na- fight al-Qaida—the same organization The mission is hard, but it is not hopeless. tion because it represents the 85th day that killed 3,000 Americans on Sep- The only thing that would make it that our fighting men and women in tember 11—right in Iraq. That is good hopeless is if Congress continues to un- uniform have been waiting for emer- news. dermine General Petraeus and our gency aid from the Congress. Yet they We are beginning to see some real se- troops who are in harm’s way. It bog- have been left waiting because of polit- curity measures going forward. So why gles my mind that we have that sort of ical gamesmanship and political the- we would have Congress tie the hands mindset in Washington, DC because of ater in Washington, DC. The latest is of General Petraeus and these success- some rabid, antiwar, left-leaning reported in the Congressional Quar- ful efforts in Al Anbar Province, west groups that insist we ought to simply terly today, an article I have here in of Baghdad, controlled by al-Qaida, and tuck our tail and run. They haven’t my hand—actually the date is April 30, why Congress would want to tie the come up with an adequate explanation 2007, 10:45 p.m., entitled: ‘‘President’s hands of our military leaders at a time as to what they think would happen if Veto Dependent on House Speaker’s when we are seeing some real improve- we were to leave precipitously, as some Signature.’’ The report is that Con- ment there is, frankly, beyond me. of them suggest. gresswoman PELOSI wanted time to Why would we simply give up when we I happen to believe that notwith- personally read the emergency supple- are beginning to see some light at the standing the fact that Darfur, where mental bill and to sign it before send- end of the tunnel? 400,000 people at last count have died as ing it to Pennsylvania Avenue. I would Then, of course, there is the second a result of terrible violence there, have thought that Congresswoman matter of providing porkbarrel spend- would pale compared to the ethnic PELOSI and Members of Congress would ing in order to secure the votes of some cleansing and the violence that would have read legislation before they voted Members of the House for this bill that follow if America were to betray our on it, not afterwards. they would not support on the merits. Iraqi allies and would leave precipi- Also, in today’s edition of The Hill, It is completely demeaning to our tously. It would also create a regional there is a story that says: troops and the nobility of their sac- conflict where Sunni majority nations Congressional leaders today will put an ex- rifice, not to mention the sacrifice of would come in and try to stave off the clamation point on their political showdown the military families who wait anx- Shiites from Iran for helping them and with President Bush on Iraq spending, stag- iously hoping their loved one will re- trying to prevent them from killing ing a signing event to send their Iraq supple- turn from the fight only to be told that the Sunni minority there. mental bill to the White House. Congress is causing unnecessary delays The Democratic leadership has not I don’t think this is Congress’s finest in this spending—85 days now—putting helped the situation in Iraq with their hour, and I think it is an embarrass- arbitrary timelines on the troops, mak- recent pronouncements either. Demo- ment that when our troops are waiting ing it harder for them to succeed, deny- cratic leadership in recent floor state- on an emergency spending bill to pro- ing them the equipment necessary for ments has suggested that if the Presi- vide them essential equipment, we are their very safety, while Congress en- dent vetoes this bill, then he will be staging signing ceremonies and going gages in more porkbarrel spending in the one endangering the troops. They through political kabuki theater just order to secure a political consensus further stated they hope the President to demonstrate on the part of some for this ill-considered piece of legisla- would realize that with his pen in hand their disagreement on the present tion. he can honor soldiers, honor his coun- strategy in Baghdad and in Iraq. I The bill, on its way to the President try, and bring an end to this war. think it is inappropriate and irrespon- after this kabuki theater, substitutes To that I say baloney. That is sheer sible. congressional mandates for the consid- fantasy that by cutting and running, I know one of our colleagues here has ered judgments of our military leaders. by neglecting our allies in Iraq, by ne- talked about, for example, the MRAP This bill assumes and forces the failure glecting the improvements we have vehicles, the so-called Mine Resistant of a new strategy, which is only half- been able to make, by recruiting tribal Ambush Prevented V-shaped hull vehi- way implemented. The new Baghdad sheiks to help us in fighting al-Qaida,

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00003 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.003 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5318 CONGRESSIONAL RECORD — SENATE May 1, 2007 that somehow, by giving up on that, we I submit our colleagues who have have now been in Iraq for nearly 50 are going to bring an end to the vio- said General Petraeus said there is no months, longer than the United States lence and the death in Iraq. To the con- military solution in Iraq are not listen- was in World War II. trary, we would create a failed state ing to what he is saying, because what Four years ago today, President Bush where al-Qaida, the very same people he has said is that improving our secu- declared mission accomplished. Yet who hit this country on September 11, rity situation is necessary but not suf- U.S. troop fatalities are up 33 percent 2001, could reorganize, train, and re- ficient. It is not a question of whether since the President’s escalation of the cruit, and export future terrorist at- we are going to do the security part or war in January. tacks to the United States. the political reconciliation part. One Four years ago today, President Bush I am chilled by comments made a few must precede the other. It makes com- declared mission accomplished. Yet months ago when I attended a cere- mon sense that it is hard to sit down today, Iraqi civilian casualties are esti- mony where the Deputy Secretary of and work out your differences around a mated to be in the tens or even hun- Defense spoke. conference table in a political debate, dreds of thousands. It is impossible to He asked rhetorically: or an attempt at reconciliation, if peo- know how many have been killed in Iraq, but the United Nations estimates Do you know why al-Qaida killed 3,000 peo- ple are driving automobile-borne im- ple on September 11, 2001, in New York and provised explosive devices or people are that 35,000 civilians have been killed. Washington, DC? walking into the Parliament in a sui- Four years ago today, President Bush cide vest. So security must precede the declared mission accomplished. Yet Then he answered his own question. today oil production in Iraq is still 15 He said: political reconciliation that we all rec- ognize is so absolutely important. That percent lower than it was before the Because they could not kill 30,000, because war. they could not kill 3 million. is what General Petraeus is saying. That is what we have to accomplish. Four years ago today, President Bush His point is if they had the kind of We have some hopeful signs in Iraq declared mission accomplished. Yet biological, chemical, or nuclear weap- now, for the first time in a long time, Baghdad is only getting 6 hours of elec- ons they are seeking, they would have as a result of this new strategy that is tricity a day, significantly less than killed thousands—perhaps hundreds of only about half way implemented. But before the war. thousands more innocent Americans. if we are going to succeed, it won’t be Four years ago today, President Bush And they will do that at will if they because our commanders have had declared mission accomplished. Yet the are provided that sort of weaponry. their hands tied by arbitrary deadlines Special Inspector General for Iraq Re- So it is sheer naivete on the part of in Washington, DC. It won’t be because construction just put out a new report those who say all we need to do is leave of the political theater going on here 85 detailing how projects the administra- and somehow these people will go days after the President had requested tion declared a ‘‘success’’ are actually away. They will not go away and they the emergency spending included in failing and no longer operating. will visit us here again with deadly re- this bill for necessary equipment for Frankly, it reminds me of all the sults. our troops. other ways we were misled by this ad- With General Petraeus back from The leadership should sign this legis- ministration. Let us remember what Iraq for the first time last week since lation and get it to the President so he this administration told us about this he assumed command of U.S. forces, can veto it and we can get down to the war. Let us remember the Iraq myths. and the emergency supplemental, I serious business of providing for our Remember the unfound weapons of hope, reaching the President later troops. mass destruction; remember the miss- today, it is appropriate to reflect on I yield the floor. ing mobile weapons labs; remember the the majority leader’s statement, where The ACTING PRESIDENT pro tem- yellowcake uranium in Africa; remem- he said we have ‘‘lost the war.’’ pore. The minority’s time has expired. ber Saddam’s nonexistent vast stock- Two weeks ago, the Senate Armed The Senator from New Jersey is rec- piles of chemical weapons; remember Services Committee heard testimony ognized. when Secretary Rumsfeld told us that from GEN Barry McCaffrey, a proven f ‘‘we know where the weapons of mass destruction are;’’ remember the non- combat commander from the first gulf IRAQ war, and a recognized expert on the existent link between al-Qaida and tactical, operational, and strategic sit- Mr. MENENDEZ. Mr. President, 4 Saddam; remember the claims that uation in Iraq. I will quote for a mo- years ago today, President Bush landed Iraqi oil and other countries, not the ment from his statement. He said: on the U.S.S. Abraham Lincoln in his United States taxpayer, would pay for flight suit. The banner behind him the cost of reconstruction; remember The consequences of failure in Iraq will be proudly said, ‘‘Mission accomplished.’’ a disaster to the American people and our al- when the administration told us the lies if we cannot achieve our objective to President Bush announced to the war would cost only between $50 billion create a stable, law-based state at peace with world, and to the American people, and $60 billion; remember when Paul its neighbors. . . . We have 150,000 U.S. that ‘‘major combat operations in Iraq Wolfowitz said ‘‘it seems outlandish’’ troops battling in Iraq and 22,000 fighting have ended. In the battle of Iraq, the to think we would need several hun- bravely in Afghanistan. United States and our allies have pre- dred thousand troops in Iraq; and re- These are the finest, most courageous mili- vailed.’’ member when President Bush told us tary men and women we have ever fielded in I can think of almost no greater act on May 1, 2003, that ‘‘major combat op- battle. Their commanders—who have almost of hubris, arrogance, and denial than erations in Iraq have ended.’’ without exception at company, battalion, This is the same administration that and brigade level served multiple combat the declaration of mission accom- tours—are the most capable leaders that I plished in Iraq 4 years ago. It is truly now comes to this Congress and says: have encountered in my many years of stunning how false that statement was. Trust us. This is the same administra- watching our Armed Forces with admiration. Four years ago today, President Bush tion that says: Trust us, our new esca- He goes on to say: declared mission accomplished. Yet, lation plan will work. This is the same since that time, 3,000 U.S. troops have administration that tells this Congress Our new leadership team in Iraq—our bril- and the American people to be patient, liant new commander, General David been killed in Iraq. Over 104 American Petraeus, and the equally experienced Am- troops died in April alone, making it to give their ‘‘new’’ plan to escalate bassador Ryan Crocker—are launched on a the deadliest month since last Decem- the war time to work. new approach to use political reconciliation, ber. Yet their new plan is more of the new methods and equipment to strengthen Four years ago today, President Bush same. To quote one of the witnesses the Iraqi security forces and enhanced U.S. declared mission accomplished. Yet we who testified before the Senate Foreign combat protective power to stabilize the sit- have now spent over $450 billion on the Relations Committee: uation. We must give them time and space. war in Iraq. This war is costing us al- This plan is just stay-the-course plus 20,000 That is exactly what we are trying to most 10 times what the Bush adminis- troops. do, to provide the basic security Gen- tration initially said it would. That is what they thought then when eral Petraeus said is necessary, but not Four years ago today, President Bush the witness testified, but eventually it sufficient, to solve the problem. declared mission accomplished. Yet we has been a lot more than 20,000 troops.

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00004 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.004 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5319 Well, the American people and this times that more than 100 servicemem- Vetoing the supplemental sends the Congress have run out of patience. This bers were killed in 1 month since the message to the Iraqis that they do not administration has run out of credi- start of the war. have to take responsibility and that bility to ask for more time or another Violence outside of Baghdad is on the our troops will be in Iraq indefinitely. chance, when all we are largely doing rise, with more than twice the number But staying in Iraq isn’t in the na- is staying the course. Frankly, I find it of American troops killed in the past 5 tional interest or national security of insulting that this administration months in Diyala Province than were the United States. thinks this Congress would simply go killed all of last year. Our troops are caught in the middle along with their escalation plan with- In terms of civilians, over 1,500 Iraqis of a civil war they cannot solve. Keep- out question. were killed between February 14 and ing more troops there will only put Why should we support President April 12. That is almost 500 more peo- them directly in the middle of an Iraqi Bush’s escalation—a plan with bench- ple than were killed during the pre- fight. Keeping our troops there is try- marks but no real consequences? As I vious 2 months. ing to solve a political problem with a have said time and time again, bench- Frankly, I don’t believe the Presi- military solution. Staying in Iraq actu- marks without consequences are sim- dent’s escalation plan is working. So I ally keeps the Iraqis from taking re- ply aspirations. We have seen countless say to the President: The era of blank sponsibility for their actions. misguided plans from this administra- checks is over and the time of congres- Frankly, what we hear from the tion, but the Iraqis have never been sional oversight has begun. other side doesn’t make sense. They The President would largely want us held accountable. talk about victory, but what is the def- to send him a blank check. We have We were told by the end of 2006 a pro- inition of ‘‘victory’’? Is that the vic- spent 10 times more than we were told vincial election law would be approved. tory we have heard is around the cor- we would spend on this war, and there But that benchmark has not been met. ner? They talk about benchmarks for is no end in sight in terms of lives and We were told that Iraqis would approve the Iraqis, but they set no con- national treasure. That is why this a law for de-Baathification. But that sequences. Senate and the House sent the Presi- benchmark has not been met. Four years after the President de- dent an Iraq spending bill with a re- We were told that Iraqis would create clared ‘‘mission accomplished,’’ 4 years sponsible timeline for withdrawing our a law to help restrain sectarian mili- and over 3,000 Americans lives later, 4 troops from Iraq. I believe the Presi- tias. But that benchmark, too, has not years and over $450 billion later, 4 dent is making a serious mistake with been met. years with no new plan for Iraq, just We were told the Iraqis would estab- his plan to veto the bill. Some on the other side of the aisle more of the same, 4 years after the lish a law to regulate the oil industry like to point out that the President is President declared ‘‘mission accom- and share revenues, which is one of the the Commander in Chief. I remind my plished,’’ I ask: How many more lives critical elements to be able to achieve friends the Constitution puts the Con- must we lose and how much more reconciliation in Iraq, the sharing of gress in charge of appropriating funds. money must we spend? the nation’s national resources. But The Constitution, in article I, section I close by asking: When will this ad- that benchmark has not been met. 8, provides what scholars call the ministration finally understand that We were told that, by March, the power of the purse, and it says: ‘‘The ‘‘mission accomplished’’ was a myth of Iraqi Government was supposed to hold Congress’’—the Congress—‘‘shall have their own imagination, born of delu- a referendum on constitutional amend- Power To lay and collect Taxes, Du- sion and denial, yet another terrible ments. But that benchmark has not ties, Imposts and Excises, to pay the mistake in a series of tragic errors? been met. Debts and provide for the common When will we finally hear the words Time and again, the Iraqi Govern- Defence and general Welfare of the ‘‘major combat in Iraq has ended’’ and ment has fallen short; and time and United States.’’ Congress has the power know they are true? again, this administration has looked and the right and the obligation to I yield the floor. the other way—basing their plans on make sure we spend the taxpayers’ The PRESIDING OFFICER (Mr. the hope that the Iraqis will step up. money wisely. WHITEHOUSE). The Senator from Ohio. Continuing this failed policy in Iraq In a recent editorial, Leon Panetta, a Mr. BROWN. Mr. President, 4 years based on the mere hope that things will member of the Iraq Study Group, re- ago today, as Senator MENENDEZ said, improve is not good enough. The bro- minded us the President has stated the the President landed on an aircraft car- ken promises must stop. goal of our involvement is for Iraq to rier, amid a flurry of pomp and cir- It also seems to me the President is be able to ‘‘govern itself, sustain itself, cumstance, and declared, ‘‘Mission ac- once again out of touch about our defend itself.’’ complished.’’ progress on the ground and his esca- In order for us to get to that point, Since that day, much has happened. lation plan. The President said last we need to hold Iraqis accountable for Since that day, 3,000 brave American week: meeting the benchmarks they helped soldiers and marines have died in Iraq. The direction of the fight is beginning to set. The emergency supplemental bill This war has gone on, since that day, shift . . . and so far the operation is meeting that passed the House and the Senate longer than World War II. Since that expectations. does just that, by including a plan to day, the United Nations has estimated This is very much like ‘‘mission ac- redeploy U.S. forces in relation to that 35,000 Iraqi civilians have been complished.’’ Yet, last Monday, an at- progress made by the Iraqi Government killed. Since that day, U.S. taxpayers tack carried out by a suicide bomber in achieving security and diplomatic have spent $450 billion on the war in near Baqubah killed 9 soldiers and benchmarks. Iraq. wounded 20 others. The explosion was Leon Panetta also said: To get an understanding of what $450 one of the deadliest single ground at- The worst mistake now would be to pro- billion is, if we spent $500 every second tacks on American forces since the vide money for the war without sending the of every minute of every hour of every start of the war. Iraqis any message at all about their respon- day, it would take 29 years to spend the Two weeks ago, five different bombs sibility for reforms. Both the President and $450 billion we have spent in Iraq. exploded in Baghdad, killing at least the Congress at the very least must make Now, 4 years later, our troops in Iraq the Iraqi Government understand that future 171 people. These attacks mark the financial and military support is going to de- are stuck in the middle of a civil war. deadliest day in the capital city since pend on Baghdad’s making substantial Too many of our brave soldiers do not the new security plan was implemented progress toward the milestones Prime Min- have the body armor they need, in 2 months ago. ister Nuri al-Maliki has publicly committed spite of the imploring of so many of us In fact, almost four coalition soldiers to. to the administration to do what they have been killed per day in the past The Iraq supplemental sends a strong need to do to protect our soldiers. Now month—the highest rate since January message to the Iraqis that it is their thousands of Guard men and women of 2005. As I pointed out before, over 100 responsibility to take control of their face early and extended redeployment. soldiers were killed in April, including own country and that our involvement Four years later, the will of the peo- 9 killed over the weekend, 1 of only 6 in Iraq is not indefinite. ple resonates in townhalls and in

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00005 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.006 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5320 CONGRESSIONAL RECORD — SENATE May 1, 2007 churches, in back yards and in living tected vehicles; $4.8 billion in military CWO Keith Yoakum, 41, died on February rooms across this country. Their mes- construction for BRAC, the Base Clos- 2, in Taji, Iraq, when his helicopter crashed. sage is clear: Mr. President, redeploy ing Commission; and the VA, which has Chief Warrant Officer Four Yoakum was as- signed to A Company, 1st Battalion, 227th our troops out of Iraq. been underfunded by $2 billion in the Aviation Regiment, 1st Cavalry Division, Up to now, however, the President President’s budget, under this bill Fort Hood, TX. He was from Hemet, CA. has refused to hear the calls of millions would get $1.7 billion immediately, SGM Joseph J. Ellis, 40, died February 7, of Americans. He has refused to listen more than the President’s VA proposal, while conducting combat operations in Al to voters last fall who demanded a dif- and will do better in the next budget. Anbar Province, Iraq. Sergeant Major Ellis ferent course in Iraq. He has refused to It includes $100 million for VA mental was assigned to Battalion Landing Team 2nd listen to the Iraq Study Group, which Battalion, 4th Marine Regiment, 15th Marine health services. Expeditionary Unit, Special Operations Ca- recommended the redeployment of our It is absolutely outrageous that this pable, I Marine Expeditionary Force, Camp troops out of Iraq. He has refused to Congress—the House and Senate—and Pendleton, CA. listen to his own generals who have im- this President send our men and SGT James R. Tijerina, 26, died February plored him, in many cases, to dis- women off to war, not equipping them 7, when the helicopter he was flying in engage from this civil war. He has re- with the right body armor, not giving crashed while supporting combat operations fused to listen to Congress. in Al Anbar Province, Iraq. Sergeant them the Mine Resistant Ambush Pro- Tijerina was assigned to Marine Medium The supplemental on its way to the tected vehicles we know how to build Helicopter Squadron 364, Marine Aircraft White House echoes what many of us in in this country, and then when they re- Group 39, 3rd Marine Aircraft Wing, I Marine Congress and military families across turn home, not giving tens of thou- Expeditionary Force, Camp Pendleton, CA. this great country have been saying: sands of soldiers and marines the SGT Travis D. Pfister, 27, died February 7, We need a new direction for Iraq. health care they deserve. when the helicopter he was flying in crashed We take a backseat to no one in sup- while supporting combat operations in Al In addition to what we do to restore Anbar Province, Iraq. Sergeant Pfister was porting the brave men and women that spending and take care of our vet- assigned to Marine Medium Helicopter fighting in Iraq. That is why so many erans when they return home, this Squadron 364, Marine Aircraft Group 39, 3rd of us have pushed this administration, emergency legislation has over $1 bil- Marine Aircraft Wing, I Marine Expedi- pushed the civilian leadership in the lion for Katrina relief, $13 million for tionary Force, Camp Pendleton, CA. Pentagon and in the White House to mine safety because of the increase in CPT Jennifer J. Harris, 28, died February 7, equip our soldiers with proper body when the helicopter she was flying in deaths in mines in places such as Penn- crashed while supporting combat operations armor. sylvania and West Virginia, $625 mil- in Al Anbar Province, Iraq. She was assigned We take a backseat to no one in sup- lion for the pandemic flu response, to Marine Medium Helicopter Squadron 364, porting the families of our soldiers something we absolutely need to be Marine Aircraft Group 39, 3rd Marine Air- overseas. That is why so many of us in prepared for, and $400 million for en- craft Wing, I Marine Expeditionary Force, this Chamber have pushed to help these ergy assistance for the low-income el- Camp Pendleton, CA. 1LT Jared M. Landaker, 25, died February support groups that have formed all derly. over the country for soldiers and help- 7, when the helicopter he was flying in Please, Mr. President, before you de- crashed while supporting combat operations ing them reintegrate back into their cide to veto this bill, read this legisla- in Al Anbar Province, Iraq. First Lieutenant jobs, back with their families and their tion. Don’t turn your back on millions Landaker was assigned to Marine Medium society when they return home from of Americans, don’t turn your back on Helicopter Squadron 364, Marine Aircraft Iraq. your military advisers and the military Group 39, 3rd Marine Aircraft Wing, I Marine But more of the same is not a plan experts, don’t turn your back on our Expeditionary Force, Camp Pendleton, CA. for our troops and will not end the war He was from Big Bear City, CA. soldiers. Sign this legislation. SGT Robert B. Thrasher, 23, died on Feb- in Iraq. This war has made our country f ruary 11, in Baghdad, Iraq, when his dis- and our world less safe. Congress will mounted patrol received small arms fire. continue to fight for our Nation’s mili- HONORING OUR ARMED FORCES Sergeant Thrasher was assigned to D Com- tary by working to see that they have Mrs. BOXER. Mr. President, I rise pany, 2nd Battalion, 12th Cavalry Regiment, the resources and the support they today to speak about the issue of Iraq, 1st Cavalry Division, Fort Bliss, TX. He was need and the leadership they deserve. from Folsom, CA. to call on the President to sign the PVT Clarence T. Spencer, 24, died Feb- This legislation fully funds and sup- supplemental appropriations bill, the ruary 4, in Balad, Iraq, of wounds suffered ports our troops, while establishing emergency bill that we will be sending when his unit came in contact with the conditions that will bring our troops him, and also to pay tribute to 43 enemy using small arms fire in Baqubah, home. It provides desperately needed young Americans who have been killed Iraq. Private Spencer was assigned to the 1st funding to the Veterans’ Administra- in Iraq from my State since January Battalion, 12th Cavalry Regiment, 3rd Bri- tion, something this administration gade, 1st Cavalry Division, Fort Hood, TX. 30, 2007. This brings to 720 the number He was from San Diego, CA. and previous Republican Congresses of soldiers who were either from Cali- SP Dennis L. Sellen, Jr., 20, died on Feb- have woefully underfunded. It provides fornia or based in California who have ruary 11, in Umm Qasr, Iraq, of noncombat desperately needed funding to the Vet- been killed while serving our country related injuries. Specialist Sellen was as- erans’ Administration to help care for in Iraq. This represents 22 percent of signed to Headquarters and Headquarters the hundreds of thousands of new vet- all U.S. deaths in Iraq. Company, 1st Battalion, 185th Infantry Regi- erans created by this war. I ask unanimous consent to have ment, Army National Guard, Fresno, CA. He If the President will not take respon- was from Newhall, CA. printed in the RECORD their names, SP Ronnie G. Madore Jr., 34, died February sibility for his failures in his conduct their ages, the circumstances of their 14, in Baqubah, Iraq, when an improvised ex- of this war, then Congress will. If the death. plosive device detonated near his vehicle. President will not lead our troops There being no objection, the mate- Specialist Madore was assigned to the 1st home, then Congress will. We owe it to rial was ordered to be printed in the Battalion, 12th Cavalry Regiment, 3rd Bri- our soldiers, to our sailors, to our air- RECORD, as follows: gade, 1st Cavalry Division, Fort Hood, TX. He was from San Diego, CA. men, airwomen, and to our marines, SGT Alejandro Carrillo, 22, died January and we owe it to their families. SGT Carl L. Seigart, 32, died February 14, 30, while conducting combat operations in Al in Baqubah, Iraq, when an improvised explo- Instead of threatening a veto, the Anbar Province, Iraq. Sergeant Carrillo was sive device detonated near his vehicle. Ser- President should listen to the military assigned to Combat Logistics Battalion 7, geant Seigart was assigned to the 1st Bat- leaders, listen to the American people, Combat Logistics Regiment 1, 1st Marine Lo- talion, 12th Cavalry Regiment, 3rd Brigade, and work with Congress to change the gistics Group, I Marine Expeditionary Force, 1st Cavalry Division, Fort Hood, TX. He was course in Iraq. Twentynine Palms, CA. He was from Los An- from San Luis Obispo, CA. Vetoing this legislation would deny geles, CA. LCpl Brian A. Escalante, 25, died February funding our military and our veterans CPL Richard O. Quill III, 22, died February 17, while conducting combat operations in Al 1, from a nonhostile cause in Al Anbar Prov- Anbar Province, Iraq. Lance Corporal desperately need: $99 billion in emer- ince, Iraq. Corporal Quill was assigned to 2nd Escalante was assigned to 3rd Battalion, 4th gency Department of Defense spending, Battalion, 4th Marine Regiment, 1st Marine Marine Regiment, 1st Marine Division, I Ma- more than the President’s budget; $3 Division, I Marine Expeditionary Force, rine Expeditionary Force, Twentynine billion for Mine Resistant Ambush Pro- Camp Pendleton, CA. Palms, CA.

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00006 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.010 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5321 SGT Clinton W. Ahlquist, 23, died February arms fire. Private First Class Garcia was as- 1LT Shaun M. Blue, 25, died April 16, while 20, while conducting combat operations in Al signed to C Company, 1st Battalion, 26th In- conducting combat operations in Al Anbar Anbar Province, Iraq. Sergeant Ahlquist was fantry Regiment, 1st Infantry Division, Province, Iraq. First Lieutenant Blue was as- assigned to 2nd Battalion, 4th Marine Regi- Schweinfurt, Germany. He was from Bakers- signed to 2nd Battalion, 7th Marine Regi- ment, 1st Marine Division, I Marine Expedi- field, CA. ment, 1st Marine Division, I Marine Expedi- tionary Force, Camp Pendleton, CA. LCpl Steven M. Chavez, 20, died March 14, tionary Force, Twentynine Palms, CA. LCpl Blake H. Howey, 20, died February 18, from a nonhostile incident in Al Anbar Prov- LCpl Jesse D. Delatorre, 29, died April 16, while conducting combat operations in Al ince, Iraq. Lance Corporal Chavez was as- from wounds suffered while conducting com- Anbar Province, Iraq. Lance Corporal Howey signed to 2nd Battalion, 4th Marine Regi- bat operations in Al Anbar Province, Iraq. was assigned to 2nd Battalion, 7th Marine ment, 1st Marine Division, I Marine Expedi- Lance Corporal Delatorre was assigned to Regiment, 1st Marine Division, I Marine Ex- tionary Force, Camp Pendleton, CA. 2nd Battalion, 7th Marine Regiment, 1st Ma- peditionary Force, Twentynine Palms, CA. LCpl Harry H. Timberman, 20, died March rine Division, I Marine Expeditionary Force, He was from Glendora, CA. 17, from wounds received while conducting Twentynine Palms, CA. SP Louis G. Kim, 19, died on February 20, combat operations in Al Anbar Province, PFC Steven J. Walberg, 18, died April 15, in in Ar Ramadi, Iraq, when he received small Iraq. Lance Corporal Timberman was as- Baghdad, Iraq, of wounds sustained from arms fire. Specialist Kim was assigned to B signed to 2nd Battalion, 7th Marine Regi- enemy small arms fire. Private First Class Company, 1st Battalion, 26th Infantry Regi- ment, 1st Marine Division, I Marine Expedi- Walberg was assigned to the 1st Squadron, ment, 1st Infantry Division, Schweinfurt, tionary Force, Twentynine Palms, CA. 4th Cavalry Regiment, 4th Infantry Brigade Germany. He was from West Covina, CA. SGT John E. Allen, 25, died on March 17, in Combat Team, 1st Infantry Division, Fort PFC Rowan D. Walter, 25, died February 23, Baghdad, Iraq, of injuries sustained when an Riley, KS. He was from Paradise, CA. of injuries suffered when an improvised ex- improvised explosive device detonated near SGT Mario K. De Leon, 26, died April 16, in plosive device detonated near his vehicle his military vehicle. Sergeant Allen was as- Baghdad, Iraq, of wounds sustained from during combat operations in Ramadi, Iraq, signed to the 2nd Battalion, 12th Cavalry enemy small arms fire. Sergeant De Leon on February 22. Private First Class Walter Regiment, 1st Cavalry Division, Fort Bliss, was assigned to the 1st Battalion, 18th Infan- was assigned to the 1st Battalion, 9th Infan- TX. He was from Palmdale, CA. try Regiment, 2nd Brigade Combat Team, 1st try Regiment, 2nd Brigade Combat Team, SSG Darrell R. Griffin Jr., 36, died on Infantry Division, Schweinfurt, Germany. He 2nd Infantry Division, Fort Carson, CO. He March, 21, in Balad, Iraq, from wounds suf- was from San Francisco, CA. was from Winnetka, CA. fered when his unit came in contact with PFC Jason M. Morales, 20, died April 18, in SGT Richard A. Soukenka, 30, died on Feb- small arms fire during combat operations. Baghdad, Iraq, of injuries sustained when his ruary 27, in Baghdad, Iraq, when an impro- Staff Sergeant Griffin was assigned to the unit came in contact with enemy forces vised explosive device detonated near his 2nd Battalion, 3rd Infantry Regiment, 3rd using small arms fire. Private First Class military vehicle. Sergeant Soukenka was as- Stryker Brigade Combat Team, 2nd Infantry Morales was assigned to the 1st Battalion, signed to the 2nd Brigade Special Troops Division, Fort Lewis, WA. He was from Al- 28th Infantry Regiment, 4th Brigade Combat Battalion, 10th Mountain Division, Fort hambra, CA. Team, 1st Infantry Division, Fort Riley, KS. Drum, NY. He was from Oceanside, CA. LCpl Daniel R. Olsen, 20, died April 2, while He was from La Puente, CA. SSG Dustin M. Gould, 28, died March 2, conducting combat operations in Al Anbar CPL Michael M. Rojas, 21, died on April 18, while conducting combat operations in Al Province, Iraq. Lance Corporal Olsen was as- in Taji, Iraq, when an improvised explosive Anbar Province, Iraq. Staff Sergeant Gould signed to 2nd Battalion, 7th Marine Regi- device detonated near his military vehicle. was assigned to 7th Engineer Support Bat- ment, 1st Marine Division, I Marine Expedi- Corporal Rojas was assigned to C Battery, talion, 1st Marine Logistics Group, I Marine tionary Force, Twentynine Palms, CA. 1st Battalion, 37th Field Artillery Regiment, Expeditionary Force, Camp Pendleton, CA. SP Curtis R. Spivey, 25, died on April 2, in 2nd Infantry Division, Fort Lewis, WA. He Hospitalman Lucas W.A. Emch, 21, died San Diego, CA, of injuries sustained on Sep- was from Fresno, CA. March 2, when an improvised explosive de- tember 16, 2006, in Baghdad, Iraq, when an I would also like to pay tribute to the two vice detonated in his vicinity while con- improvised explosive device detonated near soldiers from California who have died while ducting combat operations in Al-Anbar Prov- his military vehicle. Specialist Spivey was serving our country in Operation Enduring ince, Iraq. Hospitalman Emch was a hospital assigned to B Troop, 1st Squadron, 10th Cav- Freedom since January 30. corpsman assigned to 1st Marine Logistics alry Regiment, 4th Infantry Division, Fort PFC Kristofer D. S. Thomas, 18, died Feb- Group, 1st Marine Expeditionary Force, Hood, TX. He was from Chula Vista, CA. ruary 18, in southeastern Afghanistan when Camp Pendleton, CA. PFC Gabriel J. Figueroa, 20, died on April the Chinook helicopter he was in crashed. SP Christopher D. Young, 20, died March 2, 3, in Baghdad, Iraq, when he received small Private First Class Thomas was assigned to in Safwan, Iraq, of wounds sustained when an arms fire while on dismounted patrol. Pri- the 3rd Battalion, 75th Ranger Regiment, improvised explosive device detonated near vate First Class Figueroa was assigned to Fort Benning, GA. He was from Roseville, his vehicle. Specialist Young was assigned to Headquarters and Headquarters Company, CA. Company C, 3rd Battalion, 160th Infantry 1st Battalion, 8th Cavalry Regiment, 1st SP Agustin Gutierrez, 19, died on March 29, Regiment, California Army National Guard, Cavalry Division, Fort Hood, TX. He was in Kabul, Afghanistan, when his military ve- San Pedro, CA. He was from Los Angeles, from Baldwin Park, CA. hicle overturned. Specialist Gutierrez was PFC James J. Coon, 22, died April 4, in CA. assigned to the 782nd Brigade Support Bat- Balad, Iraq, of wounds suffered when in im- LCpl Raul S. Bravo, 21, died March 3, while talion, 82nd Airborne Division, Fort Bragg, provised explosive device detonated near his conducting combat operations in Al Anbar NC. He was from San Jacinto, CA. Province, Iraq. Lance Corporal Bravo was as- vehicle. Private First Class Coon was as- signed to 3rd Battalion, 4th Marine Regi- signed to the 1st Battalion, 8th Cavalry Mrs. BOXER. Mr. President, if you ment, 1st Marine Division, I Marine Expedi- Regiment, 2nd Brigade, 1st Cavalry Division, come to my office—I think you have tionary Force, Twentynine Palms, CA. Fort Hood, TX. He was from Walnut Creek, had the opportunity to do so—you will SSG Christopher R. Webb, 28, died March 7, CA. see in front of the entrance at 112 Hart in Baghdad, Iraq, when an improvised explo- PFC Walter Freeman Jr., 20, died April 4, four huge placards with very small sive device detonated near his vehicle during in Baghdad, Iraq, when an improvised explo- print paying tribute to those from Cali- combat operations. Staff Sergeant Webb was sive device detonated near his vehicle during assigned to the 2nd Battalion, 5th Cavalry combat operations. Private First Class Free- fornia who have died in this conflict. Regiment, 1st Brigade, 1st Cavalry Division, man was assigned to the 2nd Battalion, 12th The sadness of all sadness is that we Fort Hood, TX. He was from Winchester, CA. Infantry Regiment, 2nd Brigade Combat keep having to send these posters back SP Adam J. Rosema, 27, died on March 14, Team, 2nd Infantry Division, Fort Carson, to be printed in yet smaller print be- in Balad, Iraq, of injuries sustained when an CO. He was from Lancaster, CA. cause we keep having to add so many improvised explosive device detonated near SSG Jesse L. Williams, 25, died April 8 in to it, and we are actually running out his military vehicle. Specialist Rosema was Balad, Iraq, of wounds suffered from small of space. We will have to get special arms fire while conducting combat oper- assigned to the 215th Brigade Support Bat- permission from the Architect of the talion, 1st Cavalry Division, Fort Hood, TX. ations in Baqubah, Iraq. Staff Sergeant Wil- He was from Pasadena, CA. liams was assigned to the 5th Battalion, 20th Capitol to place yet another placard in SP Stephen M. Kowalczyk, 32, died on Infantry Regiment, 3rd Brigade, 2nd Infantry front of our door. March 14, in Muqdadiyah, Iraq, of injuries Division, Stryker Brigade Combat Team, But we will do it regardless because sustained from small arms fire. Specialist Fort Lewis, WA. He was from Santa Rosa, we must put names on this conflict, Kowalczyk was assigned to C Troop, 6th CA. ages on this conflict, we must pay trib- Squadron, 9th Cavalry Regiment, 1st Cavalry LCpl Daniel J. Santee, 21, died April 14, ute to those who are being sacrificed, Division, Fort Hood, TX. He was from San from a nonhostile vehicle accident in Al in my opinion, by a President who sim- Diego, CA. Anbar Province, Iraq. Lance Corporal Santee PFC Alberto Garcia, Jr., 23, died on March was assigned to Combat Logistics Regiment ply will not change course, for what- 13, in Baghdad, Iraq, when a vehicle-borne 27, 2nd Marine Logistics Group, II Marine ever reason, from a failed course. improvised explosive device detonated near Expeditionary Force, Camp Lejeune, NC. He Anyone who reads the Constitution— his military vehicle was followed by small was from Mission Viejo, CA. I highly recommend it; it is a very

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00007 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.012 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5322 CONGRESSIONAL RECORD — SENATE May 1, 2007 readable document; it is a very concise maybe he has not read it. There is ton, Va. She said it ‘‘kind of bothers’’ document—will see that when it comes time, Mr. President. You have not got- her to know other troops are taking to war, there is a shared responsibility. ten this bill yet. Read it again. Look at hits in the field and she can’t help. As a matter of fact, if you read the it. We are changing course in a respon- SPC Natisha Jetter said: Constitution, you will see Congress sible way, the way the Iraqi Study Our fellow soldiers are out there dying, and mentioned far more times, far many Group that you praised says we should we’re here. . . . more times than the President. The do. That was a bipartisan group. We all Gonzales said the deaths made him realize President cannot act as if he is king. that ‘‘there’s a war going on out there.’’ remember it: Secretary Baker, Lee Fowler sighed. It’s a war between Iraqis, We already had a king, King George. Hamilton, and the others. she said. We have a democracy. This is what the Do you know why we have to change ‘‘We are just interfering, and letting our President says our young people are course? Because the mission you have soldiers die.’’ dying for in Iraq. Yet at home he acts given our military cannot be accom- ‘‘I’d rather be out there helping people sur- as if he is a one-man show when it plished militarily. The mission now vive,’’ Fowler said. . . . comes to Iraq. There was a pause, as the soldiers mulled is—and since the mission has changed that. Mr. President, the American people so many times, we have to go back. ‘‘It’s just terrifying, because you can drive said no to that this past election. Yet The mission now is: Bring stability and the same road for eight months, and then it continues as if there is no Congress, democracy to Iraq, and Iraq at peace one day it’s over,’’ Gonzalez said. there has been no election, there has within its own borders and with its ‘‘Over,’’ Fowler echoed. been no change of heart by the Amer- neighbors, and an ally in the war I ask, rhetorically, in light of what ican people, when, in fact, there has against terror. That is the President’s our troops are feeling, saying—going been an enormous change of heart by goal. That is a political and diplomatic there for a second deployment, third the American people. That change of goal, I say to you, Mr. President. It is deployment and more, and the in- heart is reflected in the election, in the not a military goal. The military can- creased number of deaths of our troops, composition of this Senate, and you, not do that. The military has done ev- and the horrific things that are hap- Mr. President, actually are part of that erything asked of it, and more. pening in Iraq, detailed in the Red change, that message that we wanted a The first mission: Find the weapons Cross report, which I ask unanimous change in the leadership. With all of of mass destruction. They went into consent to be printed in the RECORD, this, it just goes on and on. Mr. President, this International Red Today is the fourth anniversary of every nook and cranny of Iraq. There were none. So that mission: done, ac- Cross report. the President’s speech that major com- There being no objection, the mate- complished. bat operations are over. Four years ago rial was ordered to be printed in the The President said: Go get Saddam. he said that, in a military outfit. Yet, RECORD, as follows: They did it. That mission: accom- still, in today’s paper: April toll is CIVILIANS WITHOUT PROTECTION highest of 2007 for U.S. troops. Over 100 plished. That tyrant is gone forever. He said: Go get his sons because THE EVER-WORSENING HUMANITARIAN CRISIS IN killed this month. The Iraqi deaths are IRAQ maybe they will get the idea we mean far higher. The humanitarian situation is steadily Three years ago the President said: business. The military got his sons, put worsening and it is affecting, directly or in- Major combat operations are over. the pictures on television of their dead directly, all Iraqis. Today we read: The deadliest month in bodies. It did not do the job. Protecting Iraq’s civilian population must 2007. As a matter of fact, in the past 3 What was the next mission? We have be a priority, and the ICRC urgently calls for to hold elections. The military did a better respect for international humani- days—as of yesterday, 3 days prior to tarian law. It appeals to all those with mili- that, we had 14 dead. That is about one magnificent job. Three elections were actually held, and they have a govern- tary or political influence on the ground to for almost every person in the Presi- act now to ensure that the lives of ordinary dent’s Cabinet. ment. Now, that Government will go Iraqis are spared and protected. This is an What would it be like if 14 people sat on vacation, as I understand it, for 2 obligation under international humanitarian around the President’s Cabinet table, months while our troops are dying. law for both States and non-State actors. and every one of them had lost a child? The fact is, the military has done The ICRC aims to ensure that Iraqis re- How long would this war last? How every single thing asked of it. We are ceive the aid they need most. It cooperates closely with the Iraqi Red Crescent. How- long would this war last? But who is now at a point where the only way to win this war is to win it diplomati- ever, humanitarian aid is clearly not enough paying the price? Who is paying the when it comes to addressing the immense price? Our military families. They cally, politically. Yet, this President needs of Iraqis in the present disastrous se- want a change. We want success. will not change course. His solution is, curity situation. How do you get success? It is by more military action, a surge, which A CONFLICT THAT SPARES NO ONE changing course. It is what we sent the was supposed to last a few weeks—now The conflict in Iraq is inflicting immense President. If you read what we sent the we are being told a few months—and suffering on the entire population. Civilians President in this emergency bill—I say our military is paying the price. They bear the brunt of the relentless violence and to the Presiding Officer, I know you are paying the price. the extremely poor security conditions that are so aware of it—it is a change in I want to read from this news article are disrupting the lives and livelihoods of course. We are going to shift, as the today: ‘‘April Toll Is Highest of ’07 for millions. Every day, dozens of people are killed and many more wounded. The plight Iraq Study Group suggested, from a U.S. Troops’’: of Iraqi civilians is a daily reminder of the combat mission to a support mission. On Monday, U.S. troops at Camp Victory, a fact that there has long been a failure to re- We are going to gradually redeploy our sprawling base near Baghdad International spect their lives and dignity. troops out of there—not overnight—but Airport, reflected on April’s deadly toll on Shootings, bombings, abductions, murders, sensibly. We are going to leave forces their comrades. . . . military operations and other forms of vio- in Iraq to target al-Qaida, which never ‘‘It makes me feel depressed to be in Iraq lence are forcing thousands of people to flee was in Iraq before this war, and now right now,’’ said [Private Richard] Gonzalez, their homes and seek safety elsewhere in [22 years old,] who is on his second deploy- they are all over it because they want Iraq or in neighbouring countries. The hun- ment. ‘‘It’s a whole lot different than last dreds of thousands of displaced people scat- to go after our troops. So we are going time.’’ tered across Iraq find it particularly difficult to leave troops there in Iraq. That is Now, he said, soldiers at the base must to cope with the ongoing crisis, as do the what the Feingold-Reid-Boxer bill does carry weapons. Return addresses on letters families who generously agree to host them. as well. It says we have to have a mis- from home must be ripped off and burned, so Health-care facilities are stretched to the sion there to go after al-Qaida when as not to fall into the wrong hands. On his limit as they struggle to cope with mass cas- this war is over. We say training the first deployment, eight months passed before ualties day-in, day-out. Many sick and in- troops is OK. Going after al-Qaida is his Baghdad base was hit by mortar fire. jured people do not go to hospital because what we want to do, and we want to This time, incoming fire every single it’s too dangerous, and the patients and med- day—4 years after ‘‘mission accom- ical staff in those facilities are frequently have enough troops there for force pro- threatened or targeted. tection. plished.’’ Food shortages have been reported in sev- So anyone reading this—when the ‘‘There’s a whole lot more activity,’’ eral areas. According to the Iraqi Red Cres- President says it is irresponsible, said Spec. Krystal Fowler, 21, of Hamp- cent, malnutrition has increased over the

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00008 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.014 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5323 past year. The vastly inadequate water, sew- abduction of colleagues. Hospitals and other graded. They treat an average of over 9,000 age and electricity infrastructure is pre- key services are desperately short of quali- patients per day. senting a risk to public health. fied staff. According to the Iraqi Ministry of More than 32,000 detainees were visited, al- Unemployment and poverty levels are ris- Health, more than half the doctors have left most 9,000 of them individually, during 109 ing and many families continue to rely on the country. visits to 28 places of detention. government food distributions to cover their The mass influx of casualties to hospitals Nearly 6,400 detainees held in Camp Bucca immediate needs. According to government following the daily attacks against civilians and in the Shaiba facility benefited from the sources, an estimated one third of the popu- and other violent incidents is putting the ICRC family-visit programme. lation lives in poverty, while over five per- health-care system under tremendous addi- Nearly 37,000 Red Cross messages were de- cent live in extreme poverty. tional strain. Staff and resources are often livered and over 30,500 collected by the ICRC Much of Iraq’s vital infrastructure is in a stretched to the limit. in conjunction with the Iraqi Red Crescent. poor state of repair owing to lack of mainte- The failure to observe the special status of Mrs. BOXER. This report is called nance and because security constraints have medical staff and facilities is a major con- impeded repair work on electrical power cern. A hospital director in Baghdad told the ‘‘Civilians Without Protection.’’ I will grids, water and sanitation systems, medical ICRC that poor security conditions were pre- go into it in a minute. But in light of facilities and other essential facilities. venting staff from providing medical serv- everything that is happening, how on Power shortages are growing worse ices. And there have been frequent reports of Earth could the President sit in the throughout the country, including northern armed men storming hospitals and forcing Oval Office and say: ‘‘I am vetoing this areas, owing largely to the failure to carry doctors to give their companions priority out maintenance and to increase generation bill that is coming to me, and I want to treatment at the expense of others in more capacity. Fuel shortages affecting power sta- just continue what I am doing’’? A urgent need. tions and acts of sabotage are further aggra- military solution is what he is doing, Road-blocks and check-points sometimes vating the crisis. As a result, water-treat- prevent doctors and patients from reaching and he is going to continue it. ment plants, primary health-care centres health-care centres in time. The lack of se- In light of everything that has gone and hospitals rely mainly on back-up genera- curity also hampers the distribution of med- on, doesn’t this President understand tors, which often break down owing to excess ical supplies in many parts of Iraq. it is time for a change? Doesn’t he lis- usage or fall victim to the chronic fuel short- ages. DIRTY AND SCARCE—THE WATER CRISIS ten to the voters? Doesn’t he read The destructive legacy of previous con- Both the quantity and quality of drinking these articles? ‘‘Send me the bill. I am flicts, from 1980 onwards, and the years of water in Iraq remain insufficient despite going to veto it’’—very macho like. I international sanctions imposed on Iraq limited improvements in some areas, mainly do not think it is macho like. I think after its invasion of Kuwait in 1990 are fur- in the south. Water is often contaminated it is wrong. I do not think it is brave to ther exacerbating the current crisis. owing to the poor repair of sewage and continue a policy that is failing. I do THE ICRC IN IRAQ water-supply networks and the discharge of not think it is courageous not to admit Despite the difficult security situation, the untreated sewage into rivers, which are the it is time for a change. I do not think main source of drinking water. Electricity ICRC spares no effort to help the families it shows strength. I think it is stub- most in need. It works closely with the Iraqi and fuel shortages and the poor maintenance Red Crescent, which regularly distributes re- of infrastructure mean that there is no reg- born. I think it is wrong. And, worst of lief provided by the ICRC and collects and ular and reliable supply of clean water and all, our troops are paying the price for delivers Red Cross messages (brief personal that sewage is often not properly disposed of. this stubbornness. This is not the same messages to relatives made otherwise TORN APART—THE FATE OF SEPARATED as being stubborn in an argument we unreachable by armed conflict). FAMILIES might have about some small matter. The ICRC—a strictly humanitarian organi- Tens of thousands of people are currently Oh, I think this book is better than zation committed to the principles of neu- being detained by the Iraqi authorities and this book, and I think this singer is trality, independence and impartiality— the multinational forces in Iraq. Many fami- strives to monitor and promote respect for better than this one. This is involving lies remain without news of relatives who international humanitarian law and other the lives of our soldiers. legal standards applicable to the current sit- went missing during past conflicts or the Now, this ‘‘Civilians Without Protec- uation in Iraq. current hostilities. tion’’ report is very tough to read, by Visiting people detained in connection SLIDING TO DISASTER with the armed conflict in Iraq remains a hu- the International Red Cross. Let me Since the bombing of the sacred Shiite manitarian priority for the ICRC. Persons share some of it with you: the pictures, shrine of Samarra in February 2006 and the held by the multinational forces or the Kurd- the headlines, the words. subsequent increase in violence, the problem ish regional government are regularly vis- One section is called ‘‘A conflict that of displacement in Iraq has become particu- ited to assess their conditions of detention spares no one.’’ larly acute. Thousands of Iraqis continue to and treatment. be forced out of their homes owing to mili- In some regions, particularly Baghdad and tary operations, general poor security and THE ICRC IN 2006 area, families are often too afraid to leave the destruction of houses. And the outlook is Over 227,000 people, mostly members of dis- their homes to go to work or to shop and too bleak, particularly in Baghdad and other placed families, received food aid in various afraid to send their children to school be- areas with mixed communities, where the parts of Iraq. Over 161,000 people received es- cause of random violence and the threat of situation is likely to worsen. sential household items. kidnapping for ransom. Most displaced people have taken refuge Some 83,000 people, including members of This one is very tough to take—very with host families, who often struggle to displaced families, had their water supply tough to take. It is written by a young cope with the additional burden on their lim- ensured through emergency ICRC water and ited resources. Some have found refuge in sanitation projects. humanitarian worker from Baghdad. It camps, public buildings and abandoned mili- In all, over four million people benefited is in the Red Cross report. tary barracks. Where displaced people decide from water and sanitation projects. Once I was called to an explosion site. to seek refuge often depends on the presence Twenty major hospitals in Hilla, Baghdad, There I saw a four-year-old boy sitting be- of relatives or friends and, because of the Diwaniya, Karbala, Najaf and Tal Afar re- side his mother’s body, which had been de- prevailing sectarian violence, on the reli- ceived medical and surgical supplies for the capitated by the explosion. He was talking to gious or ethnic make-up of the host commu- treatment of wounded patients. her, asking her what had happened. He had nity. Eight limb-fitting centres in Baghdad, been taken out shopping by his mom. Frequently, both the displaced families Hilla, Najaf and Basra were supported by the How do you sit back and say ‘‘status and the communities hosting them are badly ICRC, as was an Iraqi Red Crescent centre in quo’’? How? How? Why not welcome a in need of shelter materials, access to clean Mosul. This was in addition to the Arbil cen- water, adequate sanitation, food and other tre, which is run entirely by the ICRC. In all, change? Why not welcome the Iraq essentials. these centres helped nearly 21,000 patients, Study Group? Why not welcome the The displacement of hundreds of thousands who received 7,300 artificial and some 460 work that has been done here in 50, 60 of people places an additional burden on pairs of crutches. different hearings which we have held? Iraq’s basic infrastructure, which is barely Twelve hospital emergency wards received Another part: ‘‘Sliding to disaster,’’ sufficient to serve the resident population. new equipment. in the International Red Cross report. Humanitarian aid is needed by a wide Ten hospitals, with a combined capacity to range of particularly vulnerable. civilians, Another part: ‘‘Medical care under treat some 5,000 inpatients, had their water threat.’’ Another part: ‘‘Dirty and including elderly and disabled people and fe- and sanitation systems repaired. male-headed households. Sixty-seven primary health-care centres in scarce—the water crisis.’’ Another MEDICAL CARE UNDER THREAT Anbar, Babel, Baghdad, Diwaniya, Karbala, part: ‘‘Torn apart—The fate of sepa- Medical professionals are fleeing the coun- Salah AI Deen and Wasit governorates had rated families.’’ It goes into the agony. try in large numbers following the murder or their sanitation facilities repaired or up- I ask us all to imagine what it would

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00009 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.005 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5324 CONGRESSIONAL RECORD — SENATE May 1, 2007 be like to worry about our kids for clash for power and Britain prepares to draw Fowler sighed. It’s a war between Iraqis, even 15 minutes, let alone days and down its forces. she said. months. The deaths came as the largest bloc of ‘‘We are just interfering, and letting our Sunnis in Iraq’s parliament, the Iraqi Ac- This Red Cross report is printed in soldiers die.’’ cordance Front, threatened to pull out its ‘‘I’d rather be out there helping people sur- the RECORD. ministers from the cabinet, saying that it vive,’’ Fowler said. ‘‘The more of us that are Mr. President, also, I ask unanimous ‘‘had lost hope’’ in having Sunni concerns out there, the more chances they have to consent that the entire article I re- addressed by the Shiite-led government. The survive.’’ ferred to from the newspaper be printed threat prompted President Bush to phone There was a pause, as the soldiers mulled in the RECORD. one of Iraq’s two vice presidents, Tariq al- that. There being no objection, the mate- Hashimi, a Sunni, in an attempt to defuse ‘‘It’s just terrifying, because you can drive rial was ordered to be printed in the the potential political crisis, Hashimi’s of- the same road for eight months, and then fice said in a statement. A Sunni withdrawal one day it’s over,’’ Gonzalez said. RECORD, as follows: could seriously hamper efforts at national ‘‘Over,’’ Fowler echoed. [From the Washington Post Foreign Service, reconciliation and further weaken the gov- Tuesday, May 1, 2007] ernment. Only two weeks ago, six cabinet Mrs. BOXER. This President’s poli- cies left unchecked have been a dis- APRIL TOLL IS HIGHEST OF ’07 FOR U.S. ministers loyal to Shiite cleric Moqtada al- TROOPS Sadr resigned from the cabinet. aster. And what does he want? More of In the province of Diyala, where scores of (By Sudarsan Raghavan and Karin Brulliard) the same. He criticizes us for coming fighters have fled to escape the Baghdad se- up with a new policy, and this new pol- BAGHDAD, April 30.—The deaths of more curity offensive, a car bomb exploded near a than 100 American troops in April made it icy will work because it combines a funeral tent in the town of Khalis, killing 22 gradual redeployment of troops, a focus the deadliest month so far this year for U.S. and wounding 35, said Lt. Mohammed forces in Iraq, underscoring the growing ex- Hakman of the Diyala police Joint Coordina- on getting al-Qaida, a focus on training posure of Americans as thousands of rein- tion Center. Police said they expected the the Iraqis, with a focus on diplomacy forcements arrive for an 11-week-old offen- toll to rise. and a political solution, which is ex- sive to tame sectarian violence. The strike came four days after a suicide actly what everyone says we need. More than 60 Iraqis also were killed or attacker detonated a car packed with bombs General Petraeus says we must have found dead across Iraq on Monday. Casual- at a checkpoint in the town, 50 miles north a political and diplomatic solution. ties among Iraqi civilians and security forces of Baghdad, killing 10 Iraqi soldiers. have outstripped those of Americans Near the Sunni insurgent stronghold of Well, everyone has heard it, but obvi- throughout the war. In March, a total of Ramadi, a car bomb exploded at a police ously not this President. Mr. Presi- 2,762 Iraqi civilians and policemen were checkpoint, killing four policemen and injur- dent, sign this bill. Have a change of killed, down 4 percent from the previous ing six others, police said. In another attack heart. Read the paper today. Read the month, when 2,864 were killed. Iraq’s govern- near Ramadi, a truck exploded near a res- quote from this humanitarian worker. ment has yet to release any monthly totals taurant, killing four civilians, police said. Read what our troops are saying. Read for April. In Baghdad, a car bomb exploded in the al- about it. Reconsider. Attacks killed a total of nine U.S. troops Jihad neighborhood, killing four and wound- Also, Mr. President, take a look at over the weekend, including five whose ing another seven, all civilians, while an- deaths were announced Monday. The week- other car bomb detonated in a local market, what we have done for our people here end’s fatalities brought the toll for the killing five and wounding nine civilians. In at home in this bill. You deride it. You month to 104 Americans killed, in the sixth the Shaab neighborhood, mortar shells make it sound as though we are spend- most-lethal month for American forces since rained down on a house, killing three and in- ing on things we should not. Why the U.S.-led invasion four years ago. juring eight, police said. shouldn’t we fix Walter Reed? Why Under the new counterinsurgency plan, Meanwhile, police found 13 corpses—all shouldn’t we fix the Veterans’ Admin- many U.S. forces have left large, more secure blindfolded, handcuffed and shot in the istration so when our soldiers come head—in different parts of the capital. bases to live in small combat outposts and to home they get mental health care? patrol hostile neighborhoods where the risk On Monday, U.S. troops at Camp Victory, a of insurgents targeting them has multiplied. sprawling base near Baghdad International Why shouldn’t we invest in better tech- Highlighting the vulnerability of American Airport, reflected on April’s deadly toll on nologies to protect our troops from forces, a series of explosions Monday night their comrades. these horrific land mines, car bombs, et rocked Baghdad’s Green Zone, the most Sitting at a picnic table outside a recre- cetera? That is what is in this bill. heavily secured enclave in the capital and ation center, four soldiers smoked Marlboros Why shouldn’t we help our farmers under a starry sky. Part of the Headquarters home to thousands of U.S. troops, Western who lost their money because of hor- diplomats and Iraqi government officials. Headquarters Support Company for the 3rd Infantry Division out of Fort Stewart, Ga., rific droughts, horrific frosts? That is ‘‘There is a duck-and-cover going on right what these bills are for, emergencies. now,’’ said Lt. Col. Christopher C. Garver, a they had arrived last month. They were on U.S. military spokesman, before quickly get- the base, just ‘‘sweeping parking lots and On Sunday, we all learned about the ting off the phone. Later, Garver confirmed waiting for a sandstorm,’’ as Pfc. Richard horror that happened in Oakland, with there had been an assault on the Green Zone, Gonzalez, 22, put it. a gasoline tanker overturning on a but it was unclear what had happened. Local Still, they said, frequent news of troop major interstate connecter. It col- Iraqi television stations reported 10 explo- deaths made even their mission more fright- lapsed onto the freeway below. Miracle sions inside the zone. There were no imme- ening. ‘‘It makes me feel depressed to be in Iraq of miracles: the middle of the night, in diate reports of casualties, Garver said. right now,’’ said Gonzalez, who is on his sec- the early morning, 3:40 or so a.m. No In eastern Baghdad on Sunday, a roadside ond deployment. ‘‘It’s a whole lot different one killed. Thank you, God. And we bomb killed three U.S. soldiers and an Iraqi than last time.’’ pray that the driver survives. interpreter who were on patrol, the military Now, he said, soldiers at the base must said. Attackers shot dead another soldier in But here is the point: There is money carry weapons. Return addresses on letters in this bill for emergencies such as the same section of the capital on Saturday. from home must be ripped off and burned, so Meanwhile, a Marine was killed in the Sunni as not to fall into the wrong hands. On his that. There is a backlog of these emer- insurgent bastion of Anbar province, west of first deployment, eight months passed before gency fixes that have had to be done to Baghdad. On Saturday, the military reported his Baghdad base was hit by mortar fire. our freeways. So, Mr. President, there four U.S. soldiers had been killed on that This time, he said, it seems the Camp Vic- is real beef in this bill for our people, day. tory intercom announces incoming fire every for our veterans, for our fighting men Before the deaths announced Monday, 99 day. U.S. soldiers had been killed during April, and women. And, most important, we ‘‘There’s a whole lot more activity,’’ said change course. We change course. We according to iCasualties.org, an independent Spec. Krystal Fowler, 21, of Hampton, Va. Web site that monitors military deaths. She said it ‘‘kind of bothers’’ her to know don’t have a hard-and-fast date to get Nearly half have died in and around Bagh- other troops are taking hits in the field and out, as others have said. We have a dad, with the next greatest number of deaths she can’t help. goal to get out: in April of 2008. occurring in Anbar and Diyala provinces. In Spec. Natisha Jetter, 23, of Charlotte When I went to Iraq 2 years ago, I December, 112 U.S. soldiers were killed. Amalie, St Thomas, in the Virgin Islands, met with General Petraeus at length. I With 11 combat deaths, April also was the agreed. watched how he was training the Iraqi deadliest month for British troops in Iraq ‘‘Our fellow soldiers are out there dying, soldiers. He was very complimentary. since the beginning of the war, when 27 sol- and we’re here not doing our job,’’ Jetter diers were killed in March 2003. This month’s said. He said they are doing great. I said to British casualties highlighted the growing Gonzalez said the deaths made him realize him: If they are doing so great, why tensions in southern Iraq as Shiite groups that ‘‘there’s a war going on out there.’’ can’t we go home? It is their country.

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00010 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.016 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5325 They have to defend their own country. chased at very high speeds. The family CONCLUSION OF MORNING He said: Well, pretty soon they will be member of this law enforcement offi- BUSINESS able to do it. Clearly, they are not cial was killed as a result. The PRESIDING OFFICER. Morning doing it. Clearly, the Iraqis are turning In the middle of working on this, business is closed. on each other. What is our military to over the years, a county sheriff called f do? me one day. He heard me speak about As Thomas Friedman said, it. He said: You know, just last week PRESCRIPTION DRUG USER FEE Our troops are protecting everyone, and we had a man who was a drunk driver AMENDMENTS OF 2007 yet they are everyone’s target. in our community who had two little The PRESIDING OFFICER. Under They are protecting the Sunnis from children in the backseat. The sheriff’s the previous order, the Senate will re- the Shia. When they are protecting the department attempted to apprehend sume consideration of S. 1082, which Shia, the Sunnis get them. That is an that driver, and he took off at a high the clerk will report. irresponsible policy. So what we need rate of speed. The sheriff’s office de- The legislative clerk read as follows: cided to discontinue the chase imme- to do is get through to this President. A bill (S. 1082) to amend the Federal Food, I ask all the American people to keep diately. They got a license number. Drug, and Cosmetic Act to reauthorize and on speaking out, to ask the President They discontinued the chase. Three amend the prescription drug user fee provi- hours later, they arrested the man. in these next couple of hours to sign sions, and for other purposes. He said: It could have turned out dif- The PRESIDING OFFICER. The time this bill. We can finally change course. ferently. We could have chased that We have been in Iraq longer than World until 12:30 is to be evenly divided be- man at 80 to 100 miles an hour, and the tween the majority leader and Repub- War II. We can’t afford this conflict, end of that chase could have resulted and that doesn’t mean you cut and run. lican leader and to be used for debate in the death of those children in the only. Anyone who says that is what we are backseat of that car. But we didn’t do saying is wrong. Read the bill. We rede- The Senator from North Dakota is that because we had guidelines and we recognized. ploy out of Iraq, we stay in the region had training. to go after al-Qaida and to train the Mr. DORGAN. Mr. President, I ask The Supreme Court yesterday issued unanimous consent that Senator Iraqi forces. a ruling, regrettably, that I believe will BOXER from California be recognized We can’t afford this anymore. Mr. result in more deaths in this country, President: Sign the bill. for 15 minutes, obviously as the next deaths of innocent bystanders, as a re- Democratic speaker following my pres- I yield the floor. sult of high-speed police chases. I think Mr. President, I suggest the absence entation. the ruling is a horrible ruling. The PRESIDING OFFICER. Without of a quorum. Incidentally, the Supreme Court, ap- objection, it is so ordered. The PRESIDING OFFICER. The parently for the first time in history, Mr. DORGAN. Mr. President, I have clerk will call the roll. put a video on their Web site so people come to the floor to talk about the un- The assistant legislative clerk pro- could see the chase which was the sub- derlying bill that is being considered, a ceeded to call the roll. ject of the decision in the case they piece of legislation to amend the Fed- Mr. DORGAN. Mr. President, I ask were considering. Let me suggest to eral Food, Drug, and Cosmetic Act to unanimous consent that the order for the Supreme Court that perhaps they reauthorize and amend the prescription the quorum call be rescinded. could put some other videos on their drug user fee provisions and so on. It The PRESIDING OFFICER. Without Web site. I know high-speed police may be that there will be an agreement objection, it is so ordered. chases have become a form of tele- by which I and some others who will f vision entertainment all too often, but offer legislation or an amendment to POLICE CHASES they all too often end in disaster and end with innocent people losing their deal with the issue of prescription drug Mr. DORGAN. Mr. President, I would lives. There are other videos they could prices will do that at another time and like to talk about a decision by the Su- perhaps put on their Web site, if the not on this bill. If that is the case, I am preme Court yesterday that greatly Supreme Court were interested. Among fine with that. I understand there are troubles me. Some many years ago, I those videos might be the resulting discussions underway now. I would be received a call at 10:31 in the evening crashes of high-speed police chases in perfectly amenable to not offering an that my mother had been killed in a the middle of our cities, at 80 and 100 amendment on this legislation and in- car accident. She was killed in a car miles an hour, where innocent bystand- stead having an opportunity to offer it accident as a result of a high-speed po- ers ended up losing their lives. at a different time. That amendment is lice chase. My mother was driving I understand why the police chase about the reimportation of prescription home from visiting a friend in the hos- when there is a felony, a bank robbery, drugs. pital, going 25 or 30 miles an hour on a a serious crime. I understand that. Let me talk just a little about this street in Bismarck, ND. A drunk, on What I don’t understand is this: why issue. This is an issue which is getting Main Street in Bismarck, ND, was chases ensue in these communities be- a gray beard these days because it has spinning his wheels on his pickup cause of a broken taillight or a person been around so long with so many truck, and the police then decided to going 5 miles an hour over the speed promises to be able to take it up here apprehend him. The drunk driver took limit and a chase ensues. Yes, the re- in the Congress. We have 33 cosponsors flight. Witnesses said he was going 80 sponsibility is in the person fleeing the on a piece of legislation that would try to 100 miles an hour on the city streets. police. Yes, that is the case, I under- to break the back of the pricing mo- Regrettably, that ended in a tragic stand that. But that does not give rise, nopoly that exists with the pharma- crash that took the life of my mother. in my judgment, to reason to endanger ceutical industry for prescription drugs I have spent many years here in Con- people on the city streets with chases in our country. The fact is, the Amer- gress talking about this issue of police at 60, 80, or 100 miles an hour. That is ican consumers are charged the highest chases and training for law enforce- not justified. prices for prescription drugs anywhere ment officials, about guidelines—when Law enforcement needs guidelines. in the world. The highest prices for to chase, when not to chase. I have They need training to understand what prescription drugs are charged to the been joined by a good number of people the consequences are—when to chase, American consumer. It is not right. It around this country who have lost when not to chase. Regrettably, I be- is not fair. It ought to stop. We do have loved ones, innocent loved ones who lieve the Supreme Court ruling yester- price controls on prescription drugs in were killed as a result of high-speed po- day will result in more high-speed po- our country; they are just controlled lice chases. One who came to mind was lice chases and more deaths of innocent by the pharmaceutical industry. That a former member of law enforcement Americans. That is a profound dis- is why we have the highest prices in whose family member was killed when appointment, not just to me but to the world. someone with a taillight that was out many others in this country who have Mr. President, I ask unanimous con- was to be apprehended by the police, seen the results of these high-speed sent to show a couple of bottles of med- and he took flight and the police chases. icine.

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00011 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.018 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5326 CONGRESSIONAL RECORD — SENATE May 1, 2007 The PRESIDING OFFICER. Without that. They also spend a lot of money on are safe and effective. Most notably, it pro- objection, it is so ordered. advertising and promotion. Now, any- vides additional resources to the agency to Mr. DORGAN. Mr. President, these one who was standing in front of a mir- run such a program, oversight by the FDA of two bottles of medicine are Lipitor. ror this morning brushing their teeth, the chain of custody of imported drugs back to the FDA-inspected plants, a mechanism to Lipitor is a very common prescription shaving, perhaps getting ready for review imported drugs to ensure that they drug used by many Americans to re- work and had their television on, one meet FDA’s approval standards, and the reg- duce cholesterol. As you can see, this of those little television sets, if they istration and oversight of importers and ex- drug, Lipitor, is made in Ireland, as a have one, anyone who was engaged in porters to assure that the imported drugs matter of fact, and then imported into doing that probably saw a television meet these standards and are not counter- this country by the pharmaceutical in- commercial. It said this: You should go feit. dustry. From Ireland it is sent many ask your doctor whether the purple pill Let me show you where your pre- places, but in this case the bottle in is right for you. It didn’t necessarily scription drugs come from. The phar- my left hand was sent to Canada, and tell you what the purple pill was for; it maceutical industry is engaged in a the bottle in my right hand was sent to just says you need to talk to your doc- full court press with Members of this the United States. Same bottle, same tor to see if you should have the purple Chamber. They have a fair number of pill, slightly different color on the pill. friends in this Chamber who would front of it. It is an FDA-approved medi- It also makes you want to run out want to help them derail this legisla- cine produced in an FDA-approved and say: Hey, what is this purple pill? tion and continue to be able to charge plant in Ireland and then sent to Can- Maybe I should have some of those pur- the highest prices to the American con- ada and the United States. ple pills, without knowing what they sumer. The difference? No difference—same are for. It goes on all day, every day, Lipitor comes from Dublin, Ireland. plastic in the bottle, same medicine in- advertising directly to consumers for Nexium comes from France. Of course, side—except the price. The Canadian medicines that can only be prescribed these are all imported by the pharma- pays $1.83 per tablet, and the American by a doctor for a prescription saying: ceutical manufacturers themselves. pays $3.57—96 percent more. Let me say Go talk to your doctor. Wouldn’t you Any one of these—Vytorin, Singapore, that again: No difference, same medi- like some of these pills? We have an Italy, the United Kingdom; Actos cine, same bottle, same price, made in unbelievable amount of promotion and comes from Osaka, Japan. All of these the same plant, FDA approved. Dif- advertising with respect to prescrip- are made in other countries, brought ference? The American consumer is tion drugs. That is another issue. I be- back to this country, and, by the way, told: Guess what, we have a special lieve there is only one other industri- sold in every other country in most deal for you, you get to pay 96 percent alized country that allows that; that is cases for a lower price than when they more for the same medicine. New Zealand. But that is another issue are sent back to this country by the Is this unusual? No, it is not. I sat on for another time. manufacturer. a hay bale one day at a farm with an The issue is pricing. I have described The legislation we have introduced is old codger. He was in his eighties. This what is happening with respect to pric- very simple. It gives the American con- is in North Dakota. He said: You know, ing. This is Canada, but I can describe sumer the opportunity to take advan- my wife has been fighting breast can- it for other countries as well. The per- tage of lower prices for an FDA-ap- cer. She has fought this now for 3 cent of adults, ages 19 to 64, not filling proved drug; in many cases, by the years. We have gone to Canada. We had a prescription because of cost, 43 per- way, a drug that was created with the to go to Canada to get the medicine, to cent of the uninsured in this country— very research that the American people buy Tamoxifen, and the reason we had that is 45, 46 million—do not take their paid for through the National Insti- to drive to Canada every 3 months or medicine because they do not have the tutes of Health. so to get the medicine is we save 80 money. They say it costs too much. Some have said, as a result of the percent by buying it in Canada. We The result? Well, often many of them pharmaceutical industry’s entreaties cannot afford the price in the United will end up in the priciest kind of here, well, this can’t be done safely. It States. We can’t afford the price to health care, some kind of an acute care cannot be done safely. Well, appar- have my wife fight this breast cancer. bed through an emergency room in a ently, they do it safely. The chain of The question is, Is it just Canada? hospital. custody, for example, in Canada is vir- No, not at all, but let me at least de- The legislation we have developed in tually identical. I had a quote that I do scribe the situation with the United Congress is bipartisan. It stretches not have here. I had a quote from Dr. States and Canada. I could put up the from—I shouldn’t say stretches because McClelland, the former head of the chart with Italy, Spain, Germany, I am not describing the polls in Con- FDA, virtually identical chain of cus- France, England—I could put up this gress. But we have TED KENNEDY, Dem- tody from Canada as opposed to the chart with virtually every country be- ocrat; CHUCK GRASSLEY, Republican; United States between the pharma- cause the U.S. consumer pays the high- DEBBIE STABENOW, Democrat; JOHN ceutical manufacturer, the wholesaler, est prices in the world. MCCAIN, Republican; back and forth. and the retailer. Lipitor, I just described it; Plavix, we Bipartisan support for a piece of legis- So is the chain of custody in Canada pay 46 percent more; Prevacid we pay lation we have crafted very carefully safe with respect to prescription drugs 97 percent more; Zocor, 31 percent that says: Why shouldn’t the American being sold to Canadian consumers? The more, Nexium, 55 percent; Zoloft, 52 people be able to take advantage of answer is yes. So why would you not be percent more. The list goes on and on, FDA-approved drugs by reimporting able to establish a regime, just as they as you might imagine. them from another country where that have in Europe for many years, called We have a population that receives a same drug is sold for a fraction of the parallel trading? This is not new. If lot of benefit from miracle drugs. price? Why shouldn’t the global econ- you are in Europe and you are living in There are prescription drugs that allow omy work for consumers as well? This Germany and want to buy a prescrip- you to manage your disease without is bipartisan legislation that has sub- tion from Spain, or living in Italy and having to go to an acute care bed in a stantial areas of safety built into it, so find a prescription drug priced lower in hospital. It is a wonderful thing. there is no safety issue. This is from France through a parallel trading sys- A substantial portion of the research Dr. David Kessler, who was head of the tem, you can easily do that. to develop those drugs is done in the FDA for 8 years, 1990 to 1997. ‘‘The Dor- To my knowledge, we have testimony National Institutes of Health, paid for gan-Snowe bill’’—OLYMPIA SNOWE is from one of the people involved. To my by us. We turn that research over to the principal cosponsor, along with me knowledge, there have been no issues of the prescription drug industry, they and many others who have worked on safety at all. They have done it for 20 produce medicine from it, and then this—Senator STABENOW and Senator years. Are those who oppose this say- they sell us the medicine. MCCAIN and others for a long time, ing, well, the Europeans are smarter Another body of research is done by Senator KENNEDY. than we are, they can do it but we the prescription drug industry them- The Dorgan-Snowe bill provides a sound can’t? I don’t understand that. That is selves. They spend a lot of money on framework for assuring that imported drugs not the case. I don’t understand that.

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00012 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.020 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5327 This is a very simple case. We propose You pay the highest prices in the their food. This is a product that is an amendment that would allow drug world, and there is nothing we will let added to food to increase the appear- reimportation and would make it safe. you do that can alter that. That is ance of protein. If you add that to That is the fact. wrong. That is why I and others come grains or other things, you can get a We understand that the pharma- to the floor of the Senate to say let’s higher protein count, and usually the ceutical industry does not like it. That fix this. Not later, let’s fix this now. protein count relates to the price you is a fact, too. I understand why they Mr. President, I yield the floor. get. The more protein, the higher the don’t like it. The PRESIDING OFFICER. The Sen- price. Suppose I were running a pharma- ator from California is recognized. I was talking to the Senator from ceutical company and had the ability Mrs. BOXER. Mr. President, I thank Colorado, Mr. ALLARD, who is a veteri- to price however I wanted to price in- my colleague, Senator DORGAN, for all narian, and he was pointing out this side the United States, one of the most his hard work on this issue of afford- morning that if you take a fingernail, important markets in the world, per- ability of prescription drugs. He has that is 100 percent protein. If you take haps the most important market in the been such a consistent voice. I stand the liver, that is 100 percent protein. world, and I would have no competition with him on that. I thank him. One of the differences is if you grind from lower prices because I was able to (The further remarks of Mrs. BOXER liver up and you put it in food, it is di- keep that out. I understand why they are printed in today’s RECORD under gestible. If you grind a fingernail up would like to keep that deal working Morning Business). and put it in food, it isn’t digestible at for them, but it does not work for the The PRESIDING OFFICER (Ms. all. So you are not getting any protein American people. It is not fair for the KLOBUCHAR). The Senator from Wyo- out of it. So kids have died in China American people; it just isn’t. ming is recognized. who thought they were getting suffi- That is why we have put together a Mr. ENZI. Madam President, this cient food, and they weren’t. The cause bipartisan piece of legislation, the Dor- morning there have been a couple of of death was starvation. One of the gan-Snowe bill, that is supported by topics brought up. The bill before us, of countries that could be getting drugs Republicans and Democrats, which now course, is the reauthorization of the to the United States would be China. If has 33 cosponsors. It is one that should Food and Drug Administration, several they are fooling with our food supply, pass in the Senate. The House has al- important parts of the Food and Drug do you think they would hesitate a ready passed a similar piece of legisla- Administration, and a new section on minute to fool with our prescription tion in the last session. I believe, fi- drug safety to give the Food and Drug drug supply? It worries me a lot. There nally, given a fair opportunity—and I Administration a few more tools for is a lot of risk that is involved in this. believe we will be given that fair op- their tool box. So I will stick to that The Senator from North Dakota held portunity whether it is on this bill or topic instead of addressing the one up two bottles. The bottles were iden- perhaps with some consent to do it on more recently brought up. I have some tical. One was cheaper in Canada than another bill, I believe we will get this very strong feelings on that and some the same bottle in the United States. done. very strong opinions on how America In a minute, I will go into how that This is important. There are some ought to be involved in the war and price difference happens. I could hold things we do that are not very impor- what the consequences are of us pulling up two bottles that would look exactly tant at all. My criticism—it is a great out. However, I want to stick to the the same. One would appear to come privilege to serve here. My criticism of topic of the day, which is our pharma- from Canada, but it might very well this place is from time to time we treat ceutical supply. come through Canada from Saudi Ara- the light way too seriously, and we Most Americans who turn to im- bia, have exactly the same packaging, treat the serious far too lightly. This is ported drugs do so because of the cost. labeling, colors, seals, even the same a serious issue that deserves to be We need to answer a lot of questions look of a pill. But one of the things we treated seriously. before we open our borders to imported found out from some of these drugs It has been around for a long time. drugs to be sure we don’t endanger con- that have come from other countries We have not had a vote on it only be- sumers or jeopardize research or jeop- through Canada is that they don’t cause we have been blocked by, I would ardize the development of new life- work. If you grind them up, they have say, Senator Frist, the majority leader, saving products. Senator DORGAN, of exactly the same chemicals in them, for a long time, despite what I thought course, introduced a bill last year. He but it isn’t just the chemicals that do and my colleagues thought was a rep- made the statement that miracle drugs it, it is the way they are put together resentation by him that he would allow provide no miracles for those who can’t that makes it possible for them to us to have this on the Senate floor. He afford them. I don’t think there is any- solve a medical problem. If they are continued to block it. body in this Chamber who couldn’t put together wrong, they may not even I understand the pharmaceutical in- agree more with that statement, but I digest. If they don’t digest, similar to a dustry is pulling out all of the stops. am sure they would agree that a coun- fingernail, you don’t get the benefit They have a full court press, trying to terfeit or tainted drug is unsafe at any from the drug. If you don’t get the ben- find as many Members of the Senate as price. efit from the drug, you shouldn’t pay they can who will stand up for their As we consider the issue of drug im- anything for it. In fact, there ought to current pricing strategy. And they will portation, the safety of our citizens be some pretty severe action taken find a few, no question about that. I must be our primary concern. As rank- against the person or country or com- think there are some Members of the ing member of the committee charged pany that produced that kind of a drug. Congress who like the pricing strategy with public health, it is certainly mine. We are not able to do that. of saying let’s price drugs so that the You will find the focus of the bill that The Food and Drug Administration is American people pay the highest prices is before us to be on safety. I think ev- charged with watching our borders and in the world. But I am very anxious to erything in the bill leads to safety. I the things that come in to see if the get them here to the floor to debate don’t want to come up with a drugs that come into this country are them on that subject because they are countersituation now that might put legitimate. There are warehouses full wrong. It is just wrong. It is wrong to people at risk. of drugs they have found that are not do this to the American people. I am reminded we are going to have legitimate. So it is a matter of safety, One final point. I don’t disrespect the a little bit of debate on the safety of and we are concentrating on the safety pharmaceutical industry. I say good for our food supply—we talked about that portion of this bill. So I am hoping we you when you produce a miracle drug, a little bit last night—because there is will save the drug importation ques- a lifesaving drug. But miracle drugs a crisis with pet food, in particular, but tion for a separate debate of its own. offer no miracles to people who can’t even some potential for human con- We know each one of us takes a risk afford to buy them. My problem with sumption, partly because of the pet every time we take a drug, but Ameri- the pharmaceutical industry is the food, partly because of some other pos- cans who buy prescription drugs in pricing strategy, the pricing strategy sibilities. There are some kids dying in Canada and other countries or pur- which says to the American people: China because they have melamine in chase drugs from Internet pharmacies

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00013 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.021 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5328 CONGRESSIONAL RECORD — SENATE May 1, 2007 that operate outside the United States which says: If you don’t come in with a safety of pharmaceuticals and medical are taking an even greater risk by ob- low enough price, we are going to give devices and particularly when they taining their prescription medicine your patent away and you would not concern children. We actually forced from pharmacies and Internet sites get anything for it. We have some real the pharmaceutical companies and the that don’t always meet the high stand- patent issues if we are going to have medical device companies to pay to ards we require here at home. Here is people investing in the research to get have their products tested and re- where my concern lies. We already new drugs passed and approved, and we viewed. That is what a big portion of have a problem with counterfeit and should take a little look at the process this bill is about: how they will pay for substandard drugs in the United that you have to go through to get a having the products tested and re- States. Concern about the quickly drug approved. It is about a $1 billion viewed. growing counterfeit market is not lim- project to get a drug approved. They ited to the United States. In Europe, don’t do that because they are wanting That needs to be reauthorized before dangerous counterfeit drugs are al- to donate $1 billion; they are doing it September, or it expires. That would ready a problem, and the problem is because they expect there will be some mean a lot of additional costs on the growing as the European Union ex- profit on the other end of selling the taxpayer if we don’t do those two parts. pands. In addition, we have little drug. Otherwise they wouldn’t go There is also a portion on that which knowledge of the extent of counter- through all that research, all the trou- deals with pharmaceuticals for chil- feiting in Asian markets such as India, ble, all the clinical trials, and then dren. It is important that tests be done Pakistan, and China, other than that it turn it over to people for free. They with the pharmaceuticals to be sure may be the best. give away quite a few drugs, but that is they are safe for children and in what Now, prior to legalizing an untested, to people who can’t afford them. There dosage they are safe for children. There drug importation project on a large is a lot to the fact that we have more is a portion of the bill which gives in- scale across our Nation, we must con- pharmaceutical companies developing centives to companies that will go to sider any new vulnerabilities in our more drugs than anywhere else. I am that extra length to see which of the drug distribution system, especially pleased that through our committee we drugs can be used for children as well. since those vulnerabilities could be found out there are over 650 clinical That is another potential for a fas- massive in size. I know we all share the trials happening right now on various cinating discussion over the next cou- same goals. We want to ensure that cancer drugs. That is just in the area of ple of days. drugs are safe, effective, and will not cancer: 650 drugs in the pipeline. That I compliment the Members who have compromise the integrity of our Na- is a lot of billions of dollars being spent been working on that. Many are on the tion’s prescription drug supply or our for us. world-leading pharmaceutical research, Every once in awhile somebody men- HELP Committee and have been look- and we want it to be at the lowest pos- tions the high cost of insurance. That ing into this with as much depth and sible cost. Similar to many Americans, is something else our committee is detail as I have seen on any bill we I am concerned about the high and ris- working on. I think we have some po- have ever done. I have also seen as ing cost of prescription drugs. How- tential for making some good changes much cooperation between both sides ever, I doubt the importation of drugs there. But one thing I always remind of the aisle as I have seen on any bill from other countries will solve that people of is I could get them 1980 insur- we have done—working together to problem all by itself. We better be cer- ance prices if they would settle for 1980 find a way to take care of the concerns tain about exactly what we are doing treatments. Then they start to realize and make sure we are improving the and how we are going to do it. We have how many things that have been in- safety but also making it possible for had some hearings on that. We have vented since 1980 that make a dif- people to get the pharmaceuticals and also gotten some phone calls from the ference in our life and in our longevity. get them as quickly as possible. It Canadian Minister in charge of the pro- I don’t know of anybody who wants to doesn’t do any good to have a miracle gram who has said: Do you realize that settle for pre-1980 treatments, but they drug and not be able to get it on the if America suddenly started buying its are cheaper. market. It doesn’t help to have a mir- drugs from Canada, we would have to In any importation discussion, it is acle drug with some problems and, be- prohibit Americans from doing it. We critical we limit imported drugs only cause FDA doesn’t have the tools to are a small country. We could not take to those that have been approved by change some of those problems, they the amount of orders we might possibly the FDA. It is important to understand have to pull it off the market and take get because we do have price fixing. how small differences between drugs it away from some people who really We talk about negotiated prices and can mean big differences in patient rely on that drug. That is what this bill we talk about that in the context of health. We are talking about a drug does essentially. Medicare drugs. Congress passed and safety bill on the Senate floor this I think in the substitute, or man- the President implemented Medicare week. We all acknowledge that there agers’ amendment, that will be coming Part D that actually came in consider- are drug safety problems that must be out, many of the difficulties people ably lower in cost for drugs for Amer- addressed. It makes no sense to open have will have been worked out. People ican seniors than what we or the Gov- up our borders when we don’t have are working on them as we speak. That ernment Accountability Office had things quite right here at home. Imag- is why the managers’ amendment has ever anticipated—dramatically lower. ine trying to handle the world’s drug not been laid down. It has been vetted Why? Because of competition. How safety when we are having some prob- with all Members who are interested does a country negotiate drug prices? lems handling drug safety in the and working on this, and there has Well, the way Canada did it was they United States. Furthermore, we should been incredible cooperation. I hope said: If there are five drugs that treat not tell companies with whom we must people will continue to work with us. heart problems, we make a bid for one do business how much they have to sell drug against another drug. If there are and at what price they have to sell it. I do not want anybody to think this five heart drugs, they all don’t do the Those are mandates I strongly believe bill is a complete answer to safety. It same thing. Some doctors would pre- will ultimately limit consumer access doesn’t cover some topics. That is be- scribe one and others would prescribe to drugs. cause we are still working on some top- another. But if you are going to nego- So I look forward to a spirited discus- ics that are not developed to a point tiate prices, you make the five bid sion. I think it will answer some of my yet where they can be done. One is this against each other and you pick one or questions about the legislation and will drug importation. It is being looked at, two, and you tell the rest of them they hopefully inform us all on the best di- hearings are being held, and we are try- can’t sell their drugs there, that the rection we can take from here. There ing to find out some way prices can be Government would not have any part are possibilities for solutions on drug lowered in the United States. of it. This eliminates choices. importation. I hope it will be a sepa- Another problem is biosimilars. Then there is another little caveat rate discussion from how the Food and There is a whole new area of drugs that that some of the countries add to that Drug Administration administers the has come out because the genome has

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00014 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.023 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5329 been unlocked and proteins can be de- the French term. What he was saying ward accomplishing self-help, self-reli- veloped which can be used as medica- was: Help me, help me, help me. ance, and energy independence. In that tion which will solve some of those ge- I do believe that is what the Amer- act, we said conservation would be a netic problems. Those are called bio- ican consumer is saying today—help part of it, as it should be. I, for the logics. There are people who would like me. And to the Congress of the United first time, stepped out and said that I them to become generics right away States and to this Senate, that sound would accept mandatory CAFE stand- because that would bring the cost ought to be echoing through this ards on a growth rate of 4 percent a down. Again, we want to make sure we Chamber and certainly through the year to drive the auto industry into have a bill that takes care of the safety halls and the committee rooms that greater senses of efficiency and lead us of the biosimilars, to be sure they truly deal with national energy policy. toward greater levels of conservation. are similar and will have the same ef- We are where we are today for ab- That was title I of the SAFE Act which fect. The Europeans have been working sence of policy and for some policy we think the Commerce Committee on that for a while. We have looked at that has driven us to less production will mark up in the next week. their model and a number of Sen- and becoming increasingly more reli- We spoke to innovation and innova- ators—again from both sides of the ant upon someone else to produce our tion in the advance of biofuels and the aisle—have been working on that prob- energy for us. It is in that context of a importance of doing that and that we lem. Senator CLINTON and Senator Mayday appeal that I speak for a few really ought to strive toward the 30 bil- HATCH have been very involved in that, moments during this noon hour. lion gallons, which our President spoke providing guidance from both sides of Here is what the chart shows us very to in the State of the Union, by 2020— the aisle. We appreciate their efforts clearly. From 1890 to 2030, these are the 15 of that being picked up by corn but on it. I do not expect that to be a part trend lines. In 1950, we crossed a unique more importantly, now, 15 billion gal- of this bill. point when we began to see our demand lons being picked up by cellulosic en- There are a number of tobacco issues, outstrip our supply, and this now—well ergy—and advancing that as rapidly as and our committee has a lot of concern over 50 percent of our consumption—is we can and getting the loan guarantees on that. There are some bills which being picked up by other countries in out and the grants that will take it out would provide a different way of doing the world that are, in many instances, of the lab and cause it to be a standup that—maybe put the regulation of to- less friendly to us than we would like. commercial refinery using straw, corn bacco under the jurisdiction of the What is happening on May Day—this stover, and all of those types of things FDA. I hope that will not be a part of May Day—to a major supplier to the which are the production that we think this bill. That is not ready yet, either. south of us, a guy by the name of Hugo ought to go on in the cellulosic area. We have a lot of parts that are ready, Chavez in Venezuela is privatizing That is title II of the bill. We think and particularly the user fees need to today all of the oil fields where our that will be marked up tomorrow in be done before a deadline that is com- companies produce. He is bringing the Energy Committee. them into his control, into his form of ing up. But the one that hasn’t yet been petronationalism, and he is saying the I really appreciate the cooperation marked up and the one I wish to spend priority for Venezuelan oil today is not we are having in making sure we can a little time on today is the area of going to be to the United States, it is meet the deadline and have an FDA continued production of hydrocarbons going to be to Cuba, Bolivia, Nica- that is even more responsive and has in the Outer Continental Shelf. I have ragua, and Haiti. He is going to become more tools in their toolbox to make called this in the past the ‘‘no zone’’ their supplier first. He is also going to sure the drugs out there are safe and speech. Let me combine that with May- leave the World Bank and create the that there is a system for making sure day. While we are saying no, our con- Bank of the South. He is one of our safety is maintained and if there is a sumers are saying: Help me, help me, major suppliers, and he is less than problem, that it can be corrected with because I am spending more of my dis- some of the new tools in the toolbox. friendly. Shouldn’t we be speaking out on May cretionary income on consumables and I thank everybody for their coopera- in the form of energy at a rate and tion and patience. Day, as he speaks out toward energy independence, toward a greater sense of level I never had to before. It is causing I yield the floor. the American economy to shift signifi- The PRESIDING OFFICER (Mr. our own responsibility toward our own cantly. CASEY). The Senator from Idaho is rec- consumer? What is Fidel saying today? ognized. He didn’t make the parade, apparently, Here are a variety of things we have Mr. CRAIG. Mr. President, I ask but he sent a letter. He is talking done over the years that have shaped unanimous consent that I may speak about biofuels and saying that America the Outer Continental Shelf capability. for 10 minutes as in morning business. is shifting toward biofuels and they are These areas which are pointed out on The PRESIDING OFFICER. Without going to consume all of the food supply this map are known reserves of oil. objection, it is so ordered. of the hemisphere to produce energy. I Yet, because of attitudes at the State ENERGY find that a bit of a uniqueness. Obvi- level, environmental concerns and frus- Mr. CRAIG. Mr. President, I am on ously, while he produces some oil, he trations, much of that production or the floor, as others have been today, to ships it off to have it refined, and Hugo the ability to explore within those speak to an issue that I think is appro- Chavez and he are deciding that Ven- fields has simply been taken off limits. priate for this day and time. I say so ezuela will be the largest supplier. They became the ‘‘no zone,’’ even after for a variety of reasons but most im- There are a few of us in Congress who technology clearly proved that you can portantly because it is May 1. read those signals, those senses of go into these waters, produce there Let me put it this way, because I emergency, that cry for the ‘‘help me’’ safely, protect the ecosystems in- think it sets the context in which I that I think the American consumer is volved, and reward the American con- would like to speak for a few moments. speaking out to today. Our committees sumer by less dependence upon foreign Mayday, Mayday, Mayday—do you are working their will at this moment oil and reserves. hear me calling? Do you hear the frus- to add to the National Energy Policy This area here, this small area, was a tration of the American consumer Act of 2005, which will continue to push sale and an area we were able to put today who goes to the gas pump and the renaissance of energy production in through just in the beginning of this pays record-high gas prices? I saw this country in all forms, not just for year. This, of course, is the area in the prices in my State of Idaho today hydrocarbons but electricity and other gulf that is being heavily drilled today. verging on an alltime high—$3.32, $3.35, forms, in a way that will increasingly These are the off-limits areas. depending how far you are from the make us independent and self-reliant. I came to the floor some time ago head of the pipeline. Senator BYRON DORGAN and I intro- and spoke of what is going on in Cuba, Mayday, America. Mayday. The year duced the Safe Energy Act of 2007 a and I said that was an unacceptable 1923 is when that term first came into month or so ago, which strikes at the thing and we ought to do something use by Frederick ‘‘Big John’’ Mockford heart of the combination of efforts that about it. So in the legislation we are in an airport in London, speaking in will move us further down the road to- talking about, for greater flexibility

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00015 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.025 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5330 CONGRESSIONAL RECORD — SENATE May 1, 2007 and opportunity in the Outer Conti- Idaho who is talking about an issue to strangle themselves with their own nental Shelf, what we are really talk- that is so important for our country. It rope,’’ said a foreign oil analyst who ing about in the SAFE Act—that last is a wake-up call. Amazingly it is on chose not to be identified for fear of re- title yet to be introduced—that really May Day. I think that is the appro- taliation. balances conservation with new priate moniker for what we are facing President Chavez’s gross mismanage- biofuels and increased production in in this country because of what is hap- ment of the economy should be no sur- this area, better known as the northern pening today. prise to anyone who has followed the Cuban basin. It is an area that is off Mr. President, I wish to talk about career of his Cuban mentor, Fidel Cas- limits to our producers, and Cuba is what I see happening in Venezuela and tro. In less than half a century, Fidel now moving to produce it. They are what I think America should be doing Castro has turned what was once the going to do so by reaching out to other to make sure we maintain the capa- third richest nation in Latin America countries—other than ours because we bility to control our national security into one of the poorest nations in the have a prohibition on our companies and our economic security. world, a real-life prison for 11 million doing business there—and they are Today, President Hugo Chavez is people who rely on remittances from looking at the French, Spaniards, the completing his latest and most omi- abroad to avoid starvation and col- Chinese, and others to come and drill. nous scheme out of the Fidel Castro lapse. Here is my frustration: While we are playbook. He is nationalizing multibil- If President Chavez continues to saying no, all around our coastlines, lion-dollar, heavy oilfields in the Ori- adopt the Castro economic model, the just 45 miles off our coastline, the Cu- noco Belt. This energy-rich region greatest victims will be the Venezuelan bans have let leases for the purpose of southeast of Caracas has so much en- people, but America will also suffer. drilling. ergy potential that some experts claim That is because the deterioration of I was in Cuba a few years ago visiting it could give the country more oil re- Venezuela’s oil industry could spark a with their Interior Minister, and he serves than Saudi Arabia. surge in oil prices for American con- said: We want your companies here. By seizing the Orinoco Belt, Presi- sumers, and we all know that prices Why? Because you have the best tech- dent Chavez is consolidating his polit- have already jumped in the last 30 nology. You are environmentally prov- ical power within Venezuela and in- days. Anyone who has filled a gasoline en. You place this valuable ecosystem creasing his ability to manipulate tank knows this would be a huge hit on at less risk. That we know. But our global oil markets. the American economy. In fact, some policy today denies us that. This nation now accounts for 14 per- economists say every time oil prices There is an interesting little anom- cent of America’s oil imports, and Mr. rise by 10 percent, an average of 150,000 aly that happened—and I praise the Chavez has promised to use his ‘‘strong Americans lose their jobs because it new Secretary of the Interior for doing oil card’’ to, in his words, ‘‘finish off presses the economy. Margins are nar- what he did—and that was opening, the U.S. empire,’’ even if that means rowed, and that means people are laid right off the coast of Virginia, an op- colluding with some of the most nefar- off. portunity to seek natural gas and to ious regimes on Earth. So what should our response be? see if those reserves are out there, Similar to Fidel Castro, who America must recharge its efforts to which I think will drive increased pro- partnered with the Soviet Union during adopt a comprehensive plan for Amer- duction. the Cold War, President Chavez is mak- ican energy independence, including So today I come to the floor on May ing common cause with America’s en- more exploration for oil and gas at Day saying: Mayday, America, May- emies, including the world’s largest home. It should be a comprehensive day, because Americans as they go to state sponsor of terrorism, the Govern- plan that includes conservation, renew- the gas pump are saying: Help us, help ment of Iran. able energy, new research for new me; change the way this is happening. Earlier this year, he met with Ira- forms of energy that we have not yet America, we have a great opportunity nian President Mahmoud Ahmadinejad explored, and it should include more to move ourselves toward energy inde- and made plans for a $2 billion joint pendence, less dependence on those un- exploration and drilling for our own re- fund, part of which will be used as a stable areas of the world where we now sources which we can be assured of con- ‘‘mechanism for liberation’’ against seek well over 50 percent of our hydro- trolling. American allies. I wrote an editorial in one of the De- carbon oil base. Shame on us. That is President Chavez hopes that the prof- cember issues of the Houston Chronicle bad policy, and we have the power to its from the Orinoco Belt will flood his that said we should be looking to the change it if we have the will to change coffers for other foreign adventures. it. The will comes from the ability to Outer Continental Shelf of the United But by asserting government control build a complete portfolio of conserva- States, the Gulf of Mexico, Alaska and over this coveted region, he is actually tion, new technologies, and current even the Virginia shores and other killing the golden goose that feeds his production in areas where we know our shores on the Pacific and Atlantic reserves are, by building them up dur- socialist-inspired revolution. sides. President Chavez’s national oil com- Using the comprehensive energy leg- ing this period of transition as our pany has already shown signs of stress. country moves to new technologies. islation we passed last year, I was very This is a great opportunity. The only Despite record oil prices that should be pleased to see the announcement yes- reason we are not doing it is because of a boon for the industry, the state-run terday by the Department of the Inte- resistance right here in the Congress of company has been forced to accumu- rior that we would, in fact, increase the United States, in part, put on by late a rapid increase in debt to pay for production of the natural resources in pressure from some special interests. a doubling of ‘‘social development this country. The Secretary, Dirk But my guess is that if we listen close- spending.’’ Meanwhile, its spending on Kempthorne, who was once a Member ly to the American consumer today, energy exploration and production of this body, announced that there they would agree that the SAFE Act badly trails its global peers. would be 21 lease sales in eight plan- and all titles of the SAFE Act ought to In addition, the Orinoco Belt pro- ning areas which could produce 10 bil- become public policy and that America nouncement has made ExxonMobil, lion barrels of oil and 45 trillion cubic clearly ought to be articulating a pol- Conoco Phillips, and other energy com- feet of natural gas over 40 years. That icy of greater energy independence so panies extremely cautious about put- would generate about $170 billion in to- that next May Day, we can say: We ting their employees and billions of day’s dollars. heard you call out for help, and we are dollars in assets under Venezuelan The potential for this amount of oil answering that call. Mayday, America, management, and for good reason. exploration alone is equivalent to 20 Mayday. If those American corporations de- years’ worth of what we import from I yield the floor. cide to withhold their expertise and in- Saudi Arabia or Venezuela. The PRESIDING OFFICER. The Sen- vestment, it could further weaken the They are doing exactly what Con- ator from Texas. Chavez Government’s pursuit of social- gress has authorized them to do—look- Mrs. HUTCHISON. Mr. President, I ist dreams and redistribution of ing in the Outer Continental Shelf. am pleased to follow the Senator from wealth. ‘‘It seems as if they are going Even the Commonwealth of Virginia is

VerDate Aug 31 2005 03:06 May 02, 2007 Jkt 059060 PO 00000 Frm 00016 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.026 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5331 positive about this move because there Lincoln and prematurely announced ites have hated each other for cen- are now incentives for States to allow ‘‘mission accomplished’’ in Iraq. turies. Their enmity goes way back. production in the waters they control. Today, 4 years later, there is one thing They will continue to hate each other, This is one part of what we must do as on which the American people, bipar- to not work with each other, to fight part of a comprehensive approach to tisan majorities in both Houses of Con- with each other long after we have energy independence. gress, military experts, and the Iraq gone, whether we stay 3 months or 3 We also need to increase research Study Group all agree: We clearly have years. Yet most of the time our troops, into alternative fuels, such as solar and not accomplished our mission in Iraq, our brave men and women, are simply wind power. In March, I introduced leg- and the only way to succeed is to caught in the middle of a civil war, and islation called the CREST Act, which change our current course of action. we have not even chosen a side. We are provides a comprehensive, coordinated It seems only the President and his just in the middle, and they are just in national research effort that would small band of advisers think we have the middle—trying to defend them- spur the development of renewable en- accomplished our mission in Iraq. Only selves in the middle of a civil war when ergy for the marketplace. The oceans he thinks we should stay the course. we don’t know which side we are on, and the Gulf of Mexico have potential Only President Bush seems to think and we are unable to bring the two for energy production and electricity the only way to support our troops is sides together. It is a debacle. production. Just as we have seen wind for the Congress to be a rubberstamp to That is why the Congress is demand- energy become a factor on land, it can his policies. That is not what the ing that the President change the cur- also be a factor in our bodies of water. American people want, and that is not rent mission in Iraq. As we all know, We have the resources to achieve en- what America is about. The American including General Petraeus, the solu- ergy independence—the resources un- people want a change in mission. They tion to violence in Iraq is ultimately derneath our land and water—and the want a new direction, not more of the political and not military, and that is best resource of all, the ingenuity of same failed policies. That is why, if the why Congress has imposed tough our free, creative minds. Now we need President really supports our brave benchmarks on the Government of the willpower to use it. men and women fighting in Afghani- Iraq. We cannot afford to send more President Chavez’s announcement stan and Iraq, he will sign the legisla- military troops without doing some- today is a tremendous challenge to tion that we will send to him very thing to change this weak, almost America’s energy future, but if we soon. feckless Government. Our original pur- choose to be proactive, as we’ve always The bill provides reasonable and pose in Iraq was to fight terrorism. I been throughout our history, we can meaningful guidelines to protect our believe we must continue to fight ter- regain control of our energy resources, troops by ensuring that all units that rorism; I know that from what hap- and be the strongest Nation on Earth. are sent overseas to fight are ready, We can write our own history, and pened to my city, my beloved city, and trained, and equipped to fight. It will today is the wake-up call that assures the friends I lost and think of every we must do it. require the Department of Defense to day. I yield the floor, and I suggest the ab- adhere to its own guidelines to ensure This legislation says let’s go back to sence of a quorum. that every unit that is deployed is that original purpose, counterterror- The PRESIDING OFFICER. The ‘‘fully mission capable’’ for the task at ism, as well as force protection and clerk will call the roll. hand. training the Iraqis. Instead of policing The assistant legislative clerk pro- Why would the President want to a civil war, U.S. forces will protect ceeded to call the roll. send our troops into Afghanistan and U.S. facilities and citizens, including Mr. SCHUMER. Mr. President, I ask Iraq, into fierce battles against the members of the U.S. Armed Forces en- unanimous consent the order for the Taliban and the Sunni insurgency gaged in targeted counterterrorism quorum call be rescinded. without the training and equipment missions to prevent anything that hap- The PRESIDING OFFICER. Without needed to get the job done and to come pens in Iraq from hurting us at home objection, it is so ordered. home safely? But if the President ve- and continue to train and equip Iraqi Mr. SCHUMER. Mr. President, I un- toes this bill, he will not be so re- security forces, although I must say derstand the Senate has been scheduled quired. that has not worked out very well thus to recess at 12:30. First, I thank the More important, this legislation far. Presiding Officer for waiting for me shows both the United States and the I believe these benchmarks are rea- here. As always he is gracious and Government of Iraq how to change the sonable and achievable with renewed kind. failing strategy in Iraq. It has been political will from this administration I now ask unanimous consent that I clear all along that this administration and from the Government in Iraq. The be permitted to speak for 5 minutes has failed to plan for the war. They benchmarks were not just pulled out of and that following my statement, the gave no thought what it would take to the air. They were suggested by the bi- Senate stand in recess under the pre- accomplish this mission. There was no partisan, highly qualified, highly vious order. planning for the day after. knowledgeable, highly experienced The PRESIDING OFFICER. Without When you think about this, it is infu- Baker-Hamilton commission. But more objection, it is so ordered. riating; to think that just showing important, they signify the changes in EMERGENCY SUPPLEMENTAL APPROPRIATIONS strength alone would solve the whole strategy that must be implemented to Mr. SCHUMER. Mr. President, I rise problem. That kind of careless, narrow correct the administration’s failing today to join so many of my col- thinking has led us to where we are strategy in Iraq. leagues, so many of those in the mili- now. This is President Bush’s war, but he tary and so many of the American peo- This administration and its Presi- has failed time and time again to make ple in urging the President to sign the dent seem to be lost in Iraq. They can the difficult leadership decisions that emergency spending bill that relates to only do more of the same. We put in are needed to protect our troops in Iraq when it reaches his desk. Despite more troops to support a government Iraq. If he vetoes this bill, as he has what the President keeps repeating, we that every day gets weaker and weak- threatened to do on many occasions, can do both—we can fund the troops er, that seems to be crumbling from our brave men and women will con- and change our mission in Iraq. The both the Shiite and Sunni side. Why tinue to fight a brutal war with no for- emergency spending bill we will send are we putting more troops in Iraq to ward-look strategy, no long-term plan, to the President shortly gives our defend a government that nobody little regional support, and little troops all the money they need and seems to like and in whom nobody chance of establishing a stable, rep- even more than the President re- seems to have much faith? The esca- resentative government in Iraq. Every quested, and it changes our mission in lation is not working. day it becomes more clear the Presi- Iraq from policing a civil war to focus- As a result, our mission in Iraq has dent never had a working plan for Iraq. ing on counterterrorism. devolved so that most of what we do is So we have a mission. It is a sacred It has been 4 long years since Presi- patrol, police, and stand in the middle and important mission. We must dent Bush landed on the USS Abraham of a civil war. The Sunnis and the Shi- change the mission in Iraq away from

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00017 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.028 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5332 CONGRESSIONAL RECORD — SENATE May 1, 2007 policing a civil war and toward coun- The bill clerk proceeded to call the drug, potentially a drug upon which terterrorism, which requires fewer roll. millions of Americans depend to man- troops and gets many more of them out The PRESIDING OFFICER. The Sen- age an illness, unless it is overwhelm- of harm’s way. That is what our bill ator from Oklahoma is recognized. ingly certain that the action is nec- does. It is what the American people Mr. INHOFE. Mr. President, I ask essary, is understandable. However, want. It is what the facts on the unanimous consent that the order for prescription drug users suffer as a re- ground demand. the quorum call be rescinded. sult since the ‘‘nuclear option’’ offers a I urge the President to strongly re- The PRESIDING OFFICER. Without forceful, but ultimately limited re- consider this threat to veto this legis- objection, it is so ordered. sponse. Pulling a drug from the market lation. If he does, he will be making a Mr. INHOFE. Mr. President, I ask potentially delays action and places in- terrible mistake, one that all of us and unanimous consent to withdraw my dividuals at major health risks in the maybe even he will come to regret. I amendments, No. 988 and No. 987, with interim. On the flip side, pulling a drug urge the President to sign the supple- the intention to resubmit them when a prematurely may needlessly deny pa- mental because it gives our troops and substitute is made in a few minutes. tients important, and in some cases, veterans the resources they need. It The PRESIDING OFFICER. Without singular, treatments for their health honors the sacrifices of those serving objection, it is so ordered. needs. This bill offers what I believe is in Iraq with a change in mission that is Mr. INHOFE. Mr. President, I yield a good solution to this paradox; one long overdue, and it is my hope that the floor. that considers input from patients one day we will all be able to say that The PRESIDING OFFICER. The Sen- rights organizations, industry rep- we have accomplished our mission in ator from Rhode Island. resentatives, and the FDA, but ulti- Iraq. But until we change our mission Mr. REED. Mr. President, I believe mately places patients at the top of the and put in place a winning strategy, the Food and Drug Administration Re- list. vitalization Act before us today raises that day will continue to elude us. The risk evaluation and mitigation, and addresses issues that are critically I yield the floor. REMS, system, the primary tool in the The PRESIDING OFFICER. Under important to the public’s health and drug safety title of this bill, bolsters the previous order, the Senate will well-being. Congress has a historic op- the FDA’s intermediary authority to stand in recess. portunity to strengthen and increase require drug manufacturers to monitor knowledge about drug safety and effec- f and provide important information re- tiveness, bring more transparency to garding their products. By so doing, RECESS the process of drug approval and sur- the FDA can actively require drug The PRESIDING OFFICER. Under veillance, as well as reassess the goals companies to provide information the previous order, the Senate will of the prescription drug and medical about the medications millions of stand in recess until the hour of 2:15 device user fee programs, and fortify Americans are taking and not just pas- p.m. and expand essential safety programs sively request drug companies to com- Thereupon, the Senate, at 12:46 p.m., for children. The FDA Revitalization ply. recessed until 2:15 p.m. and reassem- Act strikes a careful balance between bled when called to order by the Pre- these many important priorities and Most importantly, the REMS system siding Officer (Mr. CARPER). objectives. focuses the FDA’s efforts and resources f Recent serious adverse drug events on postmarket surveillance. Increased related to several widely used drugs on drug user fees would be used to review PRESCRIPTION DRUG USER FEE REMS as well as for general drug safe- AMENDMENTS OF 2007—Continued the market underscore the urgency with which we should address and im- ty surveillance. User fee revenue will The PRESIDING OFFICER. The Sen- prove drug safety in this country. increase by $50 million to fund drug ator from Oklahoma is recognized. Moreover, as the population ages and safety activities, of which $30 million is Mr. INHOFE. Mr. President, on the science inevitably advances, more and authorized for the routine drug surveil- bill under consideration at the present more drugs will come to market, pre- lance once they are marketed. Many of time, it is my intention to—and I have senting potentially groundbreaking us would like to eliminate the need for already placed at the desk two amend- health benefits to the public, but si- industry paid user fees, but this ar- ments, 987 and 988. multaneously increasing the need for rangement, agreed on by industry and Briefly, what is the order right now? the FDA, offers the best workable solu- The PRESIDING OFFICER. The Sen- sophisticated mechanisms for moni- tion in this strained budget environ- ator is recognized. The Senator has as toring and assuring drug safety. ment. much time as he may consume. The FDA Revitalization Act is an op- Mr. INHOFE. Today I have submitted portunity to improve our current sys- Another important objective of the amendments to S. 1082 requiring paren- tem of drug approval and drug moni- FDA Revitalization Act is to improve tal consent for intrusive physical toring, but it also adeptly anticipates the integrity of the agency and to en- exams administered under the Head changes in the future of prescription hance transparency on its actions. I am Start Program. Young children attend- drugs and consumer safety brought pleased that this bill improves the ing Head Start Programs should not be about by advances in science and an public’s access to information about subjected to these intrusive types of ever expanding market for prescription clinical trials and, more importantly, physical exams. We had an incident in drugs. the results of those trials. The bill en- my town of Tulsa, OK, where we felt The primary mechanism this bill hances patient enrollment in trials by that their rights, children’s rights, uses to strengthen drug safety is to requiring late phase II, as well as phase were violated. They were subjected to strengthen and rearticulate the FDA’s III and phase IV clinical trials on drugs different types of intrusive examina- authority. The bill clarifies, and in are registered in a publicly available tions. I will be bringing this up at an some cases fortifies, the FDA’s author- database. This will improve the appropriate time. ity with regard to drug safety. Cur- public’s knowledge of important and Secondly, briefly, as I see the man- rently, if the FDA detects a problem, potentially life saving clinical studies. ager of the bill is here, we will be intro- or a potential problem with a drug post The bill also creates a publicly avail- ducing an amendment No. 988, having approval, they have few options beyond able database of the results of those to do with protecting children from what is often referred to as the ‘‘nu- trials. This means, for instance, that a parents being coerced into admin- clear option.’’ That is, pulling a drug parent who wishes to understand why a istering a controlled substance or psy- from the market. While the FDA’s au- much-talked about treatment for juve- chotropic drug in order to attend thority to pull a drug from the market- nile diabetes failed to advance past a school. place is a powerful tool, it is a blunt in- clinical trial stage can track the Mr. President, I yield the floor, and I strument. In order to prevent problems progress of a treatment using this suggest the absence of a quorum. from spiraling into major public health database. It is important that we em- The PRESIDING OFFICER. The crises, the FDA needs intermediary au- power patients and consumers to gath- clerk will call the roll. thority. The FDA’s reluctance to pull a er information from primary sources so

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00018 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.029 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5333 that they can engage in treatment de- (Purpose: To provide a complete substitute) ‘‘(A) the Committee on Energy and Com- cisions and make informed choices re- Strike all after the enacting clause and in- merce of the House of Representatives; garding their family’s health care sert the following: ‘‘(B) the Committee on Health, Education, needs. SECTION 1. SHORT TITLE. Labor, and Pensions of the Senate; ‘‘(C) scientific and academic experts; I am also pleased to see efforts to in- This Act may be cited as the ‘‘Food and Drug Administration Revitalization Act’’. ‘‘(D) health care professionals; crease research on pediatric drug safe- TITLE I—PRESCRIPTION DRUG USER ‘‘(E) representatives of patient and con- ty, pediatric clinical trials, and pedi- FEES sumer advocacy groups; and atric medical devices in title IV of the SEC. 101. SHORT TITLE; REFERENCES IN TITLE. ‘‘(F) the regulated industry. FDA Revitalization Act. The bill in- (a) SHORT TITLE.—This title may be cited ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— cludes reauthorizations of the Best as the ‘‘Prescription Drug User Fee Amend- After negotiations with the regulated indus- Pharmaceuticals for Children Act, ments of 2007’’. try, the Secretary shall— BPCA, championed by my colleague, (b) REFERENCES IN TITLE.—Except as other- ‘‘(A) present the recommendations devel- Senator DODD, which I have cospon- wise specified, whenever in this title an oped under paragraph (1) to the Congres- sored, and the Pediatric Research Im- amendment is expressed in terms of an sional committees specified in such para- amendment to a section or other provision, graph; provement Act, PRIA, championed by the reference shall be considered to be made ‘‘(B) publish such recommendations in the my colleague, Senator CLINTON, which to a section or other provision of the Federal Federal Register; have been particularly successful at in- Food, Drug, and Cosmetic Act (21 U.S.C. 301 ‘‘(C) provide for a period of 30 days for the creasing the availability of pediatric et seq.). public to provide written comments on such specific data on drug products, as well SEC. 102. DRUG FEES. recommendations; as greatly expanding the number of Section 735 (21 U.S.C. 379g) is amended— ‘‘(D) hold a meeting at which the public treatments that have been tested and (1) by striking the section designation and may present its views on such recommenda- labeled for use in pediatric popu- all that follows through ‘‘For purposes of tions; and lations. The bill also includes a new this subchapter:’’ and inserting the fol- ‘‘(E) after consideration of such public lowing: proposal to expand the collection and views and comments, revise such rec- ‘‘SEC. 735. DRUG FEES. availability of pediatric data on med- ommendations as necessary. ‘‘(a) PURPOSE.—It is the purpose of this ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— ical devices, an area of the medical de- part that the fees authorized under this part Not later than January 15, 2012, the Sec- vice market that remains seriously un- be dedicated toward expediting the drug de- retary shall transmit to Congress the revised derdeveloped, and as a result places in- velopment process, the process for the review recommendations under paragraph (2), a fants and children at risk for inferior of human drug applications, and postmarket summary of the views and comments re- or inadequate care at best, and tragic drug safety, as set forth in the goals identi- ceived under such paragraph, and any and needless loss of life at worst. More- fied for purposes of this part in the letters changes made to the recommendations in re- from the Secretary to the Chairman of the sponse to such views and comments. over, BPCA also includes a new provi- Committee on Health, Education, Labor, and sion on patent exclusivity for block- Pensions of the Senate and the Chairman of ‘‘(d) DEFINITIONS.—For purposes of this buster drugs that strikes a sound com- the Committee on Energy and Commerce of part:’’; promise between creating an appro- the House of Representatives, as set forth in (2) in subsection (d)— priate financial incentive for drug com- the Congressional Record. (A) in paragraph (1)— panies to conduct much needed re- ‘‘(b) REPORTS.— (i) in subparagraph (A), by striking search, while also providing the FDA ‘‘(1) PERFORMANCE REPORT.—For fiscal ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; years 2008 through 2012, not later than 120 with important information about pe- (ii) by striking subparagraph (B); days after the end of each fiscal year during (iii) by redesignating subparagraph (C) as diatric drugs. which fees are collected under this part, the subparagraph (B); and Mr. President, the FDA is responsible Secretary shall prepare and submit to the (iv) in the matter following subparagraph for overseeing the safety of a wide Committee on Health, Education, Labor, and (B), as so redesignated, by striking ‘‘subpara- range of products consumed by mil- Pensions of the Senate and the Committee graph (C)’’ and inserting ‘‘subparagraph (B)’’; lions of Americans each and every day. on Energy and Commerce of the House of (B) in paragraph (3)(C), by— We can and must ensure that this crit- Representatives, a report concerning the (i) striking ‘‘the list’’ and inserting ‘‘the ical agency has the tools and resources progress of the Food and Drug Administra- list (not including the discontinued section tion in achieving the goals identified in the it needs to perform the myriad of tasks of such list)’’; and letters described in subsection (a) during (ii) striking ‘‘a list’’ and inserting ‘‘a list under its purview. We need to get this such fiscal year and the future plans of the right for the millions of Americans (not including the discontinued section of Food and Drug Administration for meeting such a list)’’; the goals. The report for a fiscal year shall who rely on the FDA to approve the (C) in paragraph (4), by inserting before the include information on all previous cohorts drugs that they take to treat serious period at the end the following: ‘‘(such as for which the Secretary has not given a com- illnesses. The FDA Revitalization Act capsules, tablets, and lyophilized products plete response on all human drug applica- creates an opportunity to improve before reconstitution)’’; tions and supplements in the cohort. science at the FDA, strengthen drug (D) by amending paragraph (6)(F) to read ‘‘(2) FISCAL REPORT.—For fiscal years 2008 safety by devoting resources to through 2012, not later than 120 days after as follows: postmarket surveillance, and ‘‘revi- the end of each fiscal year during which fees ‘‘(F) In the case of drugs approved under talize’’ the FDA’s authority. are collected under this part, the Secretary human drug applications or supplements, Mr. President, I yield the floor and shall prepare and submit to the Committee postmarket safety activities, including— suggest the absence of a quorum. on Health, Education, Labor, and Pensions of ‘‘(i) collecting, developing, and reviewing the Senate and the Committee on Energy safety information on approved drugs (in- The PRESIDING OFFICER. The cluding adverse event reports); clerk will call the roll. and Commerce of the House of Representa- tives, a report on the implementation of the ‘‘(ii) developing and using improved ad- The bill clerk proceeded to call the authority for such fees during such fiscal verse event data collection systems (includ- roll. year and the use, by the Food and Drug Ad- ing information technology systems); and Mr. KENNEDY. Mr. President, I ask ministration, of the fees collected during ‘‘(iii) developing and using improved ana- unanimous consent that the order for such fiscal year for which the report is made. lytical tools to assess potential safety prob- the quorum call be rescinded. ‘‘(3) PUBLIC AVAILABILITY.—The Secretary lems (including by accessing external data shall make the reports required under para- bases).’’; The PRESIDING OFFICER. Without (E) in paragraph (8)— objection, it is so ordered. graphs (1) and (2) available to the public on the Internet website of the Food and Drug (i) by striking ‘‘April of the preceding fis- MODIFICATION TO REPORTED COMMITTEE Administration. cal year’’ and inserting ‘‘October of the pre- SUBSTITUTE ‘‘(c) REAUTHORIZATION.— ceding fiscal year’’; and Mr. KENNEDY. Mr. President, on be- ‘‘(1) CONSULTATION.—In developing rec- (ii) by striking ‘‘April 1997’’ and inserting half of the HELP Committee, I send to ommendations to present to Congress with ‘‘October 1996’’; the desk a modification to the com- respect to the goals, and plans for meeting (F) by redesignating paragraph (9) as para- the goals, for the process for the review of graph (10); and mittee substitute. human drug applications for the first 5 fiscal (G) by inserting after paragraph (8) the fol- The PRESIDING OFFICER. The com- years after fiscal year 2012, and for the reau- lowing: mittee substitute is so modified. thorization of this part for such fiscal years, ‘‘(9) The term ‘person’ includes an affiliate The modification is as follows: the Secretary shall consult with— of such person.’’.

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SEC. 103. AUTHORITY TO ASSESS AND USE DRUG (c) ADJUSTMENTS TO FEES.— (i) by striking ‘‘2007’’ each place it appears FEES. (1) INFLATION ADJUSTMENT.—Section and inserting ‘‘2012’’; and (a) TYPES OF FEES.—Section 736(a) (21 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended— (ii) by striking ‘‘2008’’ and inserting ‘‘2013’’; U.S.C. 379h(a)) is amended— (A) in the matter preceding subparagraph and (1) in the matter preceding paragraph (1), (A) by striking ‘‘The revenues established in (B) in paragraph (5), as redesignated by by striking ‘‘2003’’ and inserting ‘‘2008’’; subsection (b)’’ and inserting ‘‘Beginning this subsection, by striking ‘‘2002’’ and in- (2) in paragraph (1)— with fiscal year 2009, the revenues estab- serting ‘‘2007’’. (A) in subparagraph (D)— lished in subsection (b)’’; (d) FEE WAIVER OR REDUCTION.—Section (i) in the heading, by inserting ‘‘OR WITH- (B) in subparagraph (A) by striking ‘‘or’’ at 736(d) (21 U.S.C. 379h(d)) is amended— DRAWN BEFORE FILING’’ after ‘‘REFUND OF FEE the end; (1) in paragraph (1), in the matter pre- IF APPLICATION REFUSED FOR FILING’’; and (C) in subparagraph (B) by striking the pe- ceding subparagraph (A), by— (ii) by inserting before the period at the riod at the end and inserting ‘‘, or,’’; (A) inserting ‘‘to a person who is named as end the following: ‘‘or withdrawn without a (D) by inserting after subparagraph (B) the the applicant’’ after ‘‘The Secretary shall waiver before filing’’; following: grant’’; (B) by redesignating subparagraphs (E) and ‘‘(C) the average annual change in the cost, (B) inserting ‘‘to that person’’ after ‘‘a (F) as subparagraphs (F) and (G), respec- per full-time equivalent position of the Food waiver from or a reduction of one or more tively; and and Drug Administration, of all personnel fees assessed’’; and (C) by inserting after subparagraph (D) the compensation and benefits paid with respect (C) striking ‘‘finds’’ and inserting ‘‘deter- following: to such positions, for the first 5 fiscal years mines’’; ‘‘(E) FEE FOR APPLICATION PREVIOUSLY RE- of the previous 6 fiscal years.’’; and (2) by redesignating paragraphs (2) and (3) FUSED FOR FILING OR WITHDRAWN BEFORE FIL- (E) in the matter following subparagraph as paragraphs (3) and (4), respectively; ING.—An application or supplement that has (C) (as added by this paragraph), by striking (3) by inserting after paragraph (1) the fol- been refused for filing or that was withdrawn ‘‘fiscal year 2003’’ and inserting ‘‘fiscal year lowing: before filing, if filed under protest or resub- 2008’’. ‘‘(2) EVALUATION.—For the purpose of de- mitted, shall be subject to the fee under sub- (2) WORKLOAD ADJUSTMENT.—Section termining whether to grant a waiver or re- paragraph (A) (unless an exception under 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended— duction of a fee under paragraph (1), the Sec- subparagraph (C) or (F) applies or the fee is (A) in the matter preceding subparagraph retary shall consider only the circumstances waived or reduced under subsection (d)), (A,) by striking ‘‘2004’’ and inserting ‘‘2009’’; and assets of the applicant and any affiliate without regard to previous payment of such (B) in the first sentence of subparagraph of the applicant.’’; and a fee and the refund of 75 percent of that fee (A)— (4) in paragraph (4), as redesignated by this under subparagraph (D).’’; and (i) by striking ‘‘, commercial investiga- subsection, in subparagraph (A), by inserting (3) in paragraph (2)— tional new drug applications’’ and inserting before the period at the end ‘‘, and that does (A) in subparagraph (A), by striking ‘‘sub- ‘‘(adjusted for changes in review activities)’’; not have a drug product that has been ap- paragraph (B)’’ and inserting ‘‘subparagraphs and proved under a human drug application and (B) and (C)’’; and (ii) by inserting before the period at the introduced or delivered for introduction into (B) by adding at the end the following: end ‘‘, and the change in the number of com- interstate commerce’’. ‘‘(C) SPECIAL RULES FOR COMPOUNDED mercial investigational new drug applica- (e) CREDITING AND AVAILABILITY OF FEES.— POSITRON EMISSION TOMOGRAPHY DRUGS.— tions with a submission during the previous (1) AUTHORIZATION OF APPROPRIATIONS.— ‘‘(i) IN GENERAL.—Except as provided in 12-month period (adjusted for changes in re- Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is clause (ii), each person who is named as the view activities)’’; amended to read as follows: applicant in an approved human drug appli- (C) in subparagraph (B), by adding at the ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— cation for a compounded positron emission end the following new sentence: ‘‘Further, There are authorized to be appropriated for tomography drug shall be subject under sub- any adjustment for changes in review activi- fees under this section such sums as are au- paragraph (A) to one-fifth of an annual es- ties made in setting fees and fee revenue thorized to be assessed and collected under tablishment fee with respect to each such es- amounts for fiscal year 2009 may not result this section in each of fiscal years 2008 tablishment identified in the application as in the total workload adjustment being more through 2012.’’. producing compounded positron emission to- than 2 percentage points higher than it (2) OFFSET.—Section 736(g)(4) (21 U.S.C. mography drugs under the approved applica- would be absent the adjustment for changes 379h(g)(4)) is amended to read as follows: tion. in review activities.’’; and ‘‘(4) OFFSET.—If the cumulative amount of ‘‘(ii) EXCEPTION FROM ANNUAL ESTABLISH- (D) by adding at the end the following: fees collected during fiscal years 2008, 2009, MENT FEE.—Each person who is named as the ‘‘(C) The Secretary shall contract with an and 2010, plus the amount estimated to be applicant in an application described in independent accounting firm to study the ad- collected for fiscal year 2011, exceeds the clause (i) shall not be assessed an annual es- justment for changes in review activities ap- amount of fees specified in aggregate in ap- tablishment fee for a fiscal year if the person plied in setting fees for fiscal year 2009 and propriation Acts for such fiscal years, the certifies to the Secretary, at a time specified to make recommendations, if warranted, on aggregate amount in excess shall be credited by the Secretary and using procedures speci- future changes in the methodology for calcu- to the appropriation account of the Food and fied by the Secretary, that— lating the adjustment for changes in review Drug Administration as provided in para- ‘‘(I) the person is a not-for-profit medical activity. After review of the recommenda- graph (1), and shall be subtracted from the center that has only 1 establishment for the tions by the independent accounting firm, amount of fees that would otherwise be au- production of compounded positron emission the Secretary shall make appropriate thorized to be collected under this section tomography drugs; and changes to the workload adjustment method- pursuant to appropriation Acts for fiscal ‘‘(II) at least 95 percent of the total num- ology in setting fees for fiscal years 2010 year 2012.’’. ber of doses of each compounded positron through 2012. If the study is not conducted, (f) CONFORMING AMENDMENTS.— emission tomography drug produced by such no adjustment for changes in review activi- (1) Section 736(a) (21 U.S.C. 379h(a)), as establishment during such fiscal year will be ties shall be made after fiscal year 2009.’’. amended by this section, is amended— used within the medical center.’’. (3) RENT AND RENT-RELATED COST ADJUST- (A) in paragraph (1)(A), by striking ‘‘sub- (b) FEE REVENUE AMOUNTS.—Section 736(b) MENT.—Section 736(c) (21 U.S.C. 379h(c)) is section (c)(4)’’ each place it appears and in- (21 U.S.C. 379h(b)) is amended to read as fol- amended— serting ‘‘subsection (c)(5)’’; lows: (A) by redesignating paragraphs (3), (4), (B) in paragraph (2), by striking ‘‘sub- ‘‘(b) FEE REVENUE AMOUNTS.—Except as and (5) as paragraphs (4), (5), and (6), respec- section (c)(4)’’ and inserting ‘‘subsection provided in subsections (c), (d), (f), and (g), tively; and (c)(5)’’; and fees under subsection (a) shall be established (C) in paragraph (3), by striking ‘‘sub- to generate the following revenue amounts, (B) by inserting after paragraph (2) the fol- lowing: section (c)(4)’’ and inserting ‘‘subsection in each fiscal year beginning with fiscal year (c)(5)’’. ‘‘(3) RENT AND RENT-RELATED COST ADJUST- 2008 and continuing through fiscal year 2012: (2) Section 736A(h)(3), as added by section MENT.—Beginning with fiscal year 2010, the $392,783,000, plus an adjustment for workload 104 of this title, is amended by striking Secretary shall, before making the adjust- on $354,893,000 of this amount. Such adjust- ‘‘735(3)’’ and inserting ‘‘735(d)(3)’’. ment shall be made in accordance with the ments under paragraphs (1) and (2), reduce the fee amounts established in subsection SEC. 104. AUTHORITY TO ASSESS AND USE PRE- workload adjustment provisions in effect for SCRIPTION DRUG ADVERTISING fiscal year 2007, except that instead of com- (b), if actual costs paid for rent and rent-re- FEES. mercial investigational new drug applica- lated expenses are less than $11,721,000. The Chapter VII, subchapter C, part 2 (21 U.S.C. tions submitted to the Secretary, all com- reductions made under this paragraph, if 379g et seq.) is amended by adding after sec- mercial investigational new drug applica- any, shall not exceed the amounts by which tion 736 the following new section: tions with a submission during the previous costs fell below $11,721,000, and shall not ex- ‘‘SEC. 736A. PROGRAM TO ASSESS AND USE FEES 12-month period shall be used in the deter- ceed $11,721,000 in any fiscal year.’’. FOR THE ADVISORY REVIEW OF PRE- mination. One-third of the revenue amount (4) FINAL YEAR ADJUSTMENT.—Section 736(c) SCRIPTION DRUG ADVERTISING. shall be derived from application fees, one- (21 U.S.C. 379h(c)) is amended— ‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELE- third from establishment fees, and one-third (A) in paragraph (4), as redesignated by VISION ADVERTISEMENT REVIEW FEES.—Begin- from product fees.’’. this subsection— ning with fiscal year 2008, the Secretary

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00020 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.008 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5335 shall assess and collect fees in accordance under subsection (d)(2) only in the first fiscal that exceeds 150 by $27,600 (adjusted each with this section as follows: year in which an advisory review fee is as- year beginning with fiscal year 2009 for infla- ‘‘(1) ADVISORY REVIEW FEE.— sessed. tion in accordance with paragraph (1)). ‘‘(A) IN GENERAL.—Except as provided in ‘‘(B) PAYMENT.—Except as provided in sub- ‘‘(ii) PUBLICATION IN FEDERAL REGISTER.— subparagraph (B), each person that on or paragraph (C), the fee required by subpara- The Secretary shall publish in the Federal after October 1, 2007, submits a proposed di- graph (A) shall be due not later than October Register, as part of the notice described in rect-to-consumer television advertisement 1 of the first fiscal year in which the person paragraph (1), the fee revenues and fees re- for advisory review by the Secretary prior to is required to pay an advisory review fee sulting from the adjustment made under this its initial public dissemination shall be sub- under paragraph (1). paragraph and the supporting methodologies. ject to a fee established under subsection ‘‘(C) LATE NOTICE OF SUBMISSION.—If, in the ‘‘(C) LIMITATION.—Under no circumstances (c)(3). first fiscal year of a person’s participation in shall the adjustment made under this para- ‘‘(B) EXCEPTION FOR REQUIRED SUBMIS- the Program, that person submits any di- graph result in fee revenues for a fiscal year SIONS.—A direct-to-consumer television ad- rect-to-consumer television advertisements that are less than the fee revenues estab- vertisement that is required to be submitted for advisory review that are in excess of the lished for the prior fiscal year. to the Secretary prior to initial public dis- number identified by that person in response ‘‘(3) ANNUAL FEE SETTING.— semination shall not be assessed a fee unless to the Federal Register notice described in ‘‘(A) NUMBER OF ADVERTISEMENTS.—The the sponsor designates it as a submission for subsection (c)(3)(A), that person must pay an Secretary shall, 120 days before the start of advisory review. operating reserve fee for each of those advi- each fiscal year, publish a notice in the Fed- ‘‘(C) PAYMENT.—The fee required by sub- sory reviews equal to the advisory review fee eral Register requesting any person to notify paragraph (A) shall be due not later than Oc- for each submission established under para- the Secretary within 30 days of the number tober 1 of the fiscal year in which the direct- graph (1)(D)(ii). Fees required by this sub- of direct-to-consumer television advertise- to-consumer television advertisement shall paragraph shall be in addition to the fees re- ments the person intends to submit for advi- be submitted to the Secretary for advisory quired under subparagraph (B), if any. Fees sory review by the Secretary in the next fis- review. under this subparagraph shall be due 20 days cal year. Notification to the Secretary of the ‘‘(D) MODIFICATION OF ADVISORY REVIEW before any direct-to-consumer television ad- number of advertisements a person intends FEE.— vertisement is submitted by such person to to submit for advisory review prior to initial ‘‘(i) LATE PAYMENT.—If, on or before No- the Secretary for advisory review. broadcast shall be a legally binding commit- vember 1 of the fiscal year in which the fees ‘‘(b) ADVISORY REVIEW FEE REVENUE ment by that person to pay the annual advi- AMOUNTS.—Fees under subsection (a)(1) shall are due, a person has not paid all fees that sory review fee for that number of submis- be established to generate revenue amounts were due and payable for advisory reviews sions on or before October 1 of the fiscal year of $6,250,000 for each of fiscal years 2008 identified in response to the Federal Reg- in which the advertisement is intended to be through 2012, as adjusted pursuant to sub- ister notice described in subsection (c)(3)(A), submitted. A person shall at the same time the fees shall be regarded as late. Such fees section (c). ‘‘(c) ADJUSTMENTS.— also notify the Secretary if such person in- shall be due and payable 20 days before any tends to use a paid submission from the pre- direct-to-consumer television advertisement ‘‘(1) INFLATION ADJUSTMENT.—Beginning vious fiscal year under subsection is submitted by such person to the Secretary with fiscal year 2009, the revenues estab- (a)(1)(E)(i). If such person does not so notify for advisory review. Notwithstanding any lished in subsection (b) shall be adjusted by the Secretary, all submissions for advisory other provision of this section, such fees the Secretary by notice, published in the review shall be subject to advisory review shall be due and payable for each of those ad- Federal Register, for a fiscal year to reflect fees. visory reviews in the amount of 150 percent the greater of— ‘‘(B) ANNUAL FEE.—The Secretary shall, 60 of the advisory review fee established for ‘‘(A) the total percentage change that oc- days before the start of each fiscal year, es- that fiscal year pursuant to subsection (c)(3). curred in the Consumer Price Index for all tablish, for the next fiscal year, the direct- ‘‘(ii) LATE NOTICE OF SUBMISSION.—If any urban consumers (all items; United States to-consumer television advertisement advi- person submits any direct-to-consumer tele- city average), for the 12-month period ending vision advertisements for advisory review June 30 preceding the fiscal year for which sory review fee under subsection (a)(1), based that are in excess of the number identified fees are being established; on the revenue amounts established under by that person in response to the Federal ‘‘(B) the total percentage change for the subsection (b), the adjustments provided Register notice described in subsection previous fiscal year in basic pay under the under this subsection and the number of di- (c)(3)(A), that person must pay a fee for each General Schedule in accordance with section rect-to-consumer television advertisements of those advisory reviews in the amount of 5332 of title 5, as adjusted by any locality- identified pursuant to subparagraph (A), ex- 150 percent of the advisory review fee estab- based comparability payment pursuant to cluding allowable previously paid carry over lished for that fiscal year pursuant to sub- section 5304 of such title for Federal employ- submissions. The annual advisory review fee section (c)(3). Fees under this subparagraph ees stationed in the District of Columbia; or shall be established by dividing the fee rev- shall be due 20 days before the direct-to-con- ‘‘(C) the average annual change in the cost, enue for a fiscal year (as adjusted pursuant sumer television advertisement is submitted per full-time equivalent position of the Food to this subsection) by the number of direct- by such person to the Secretary for advisory and Drug Administration, of all personnel to-consumer television advertisements iden- review. compensation and benefits paid with respect tified pursuant to subparagraph (A), exclud- ‘‘(E) LIMITS.— to such positions, for the first 5 fiscal years ing allowable previously paid carry over sub- ‘‘(i) IN GENERAL.—The payment of a fee of the previous 6 fiscal years. missions. under this paragraph for a fiscal year enti- The adjustment made each fiscal year by ‘‘(C) FISCAL YEAR 2008 FEE LIMIT.—Notwith- tles the person that pays the fee to accept- this paragraph shall be added on a com- standing subsection (b), the fee established ance for advisory review by the Secretary of pounded basis to the sum of all adjustments under subparagraph (B) for fiscal year 2008 1 direct-to-consumer television advertise- made each fiscal year after fiscal year 2008 may not be more than $83,000 per submission ment and acceptance of 1 resubmission for under this subsection. for advisory review. advisory review of the same advertisement. ‘‘(2) WORKLOAD ADJUSTMENT.— ‘‘(D) ANNUAL FEE LIMIT.—Notwithstanding The advertisement shall be submitted for re- ‘‘(A) IN GENERAL.—Beginning with fiscal subsection (b), the fee established under sub- view in the fiscal year for which the fee was year 2009, after the fee revenues established paragraph (B) for a fiscal year after fiscal assessed, except that a person may carry in subsection (b) of this section are adjusted year 2008 may not be more than 50 percent over no more than 1 paid advisory review for a fiscal year for inflation in accordance more than the fee established for the prior submission to the next fiscal year. Re- with paragraph (1), the fee revenues shall be fiscal year. submissions may be submitted without re- adjusted further for such fiscal year to re- ‘‘(E) LIMIT.—The total amount of fees obli- gard to the fiscal year of the initial advisory flect changes in the workload of the Sec- gated for a fiscal year may not exceed the review submission. retary with respect to the submission of pro- total costs for such fiscal year for the re- ‘‘(ii) NO REFUND.—Except as provided by posed direct-to-consumer television adver- sources allocated for the process for the ad- subsection (f), fees paid under this paragraph tisements for advisory review prior to initial visory review of prescription drug adver- shall not be refunded. broadcast. tising. ‘‘(iii) NO WAIVER, EXEMPTION, OR REDUC- ‘‘(B) DETERMINATION OF WORKLOAD ADJUST- ‘‘(d) OPERATING RESERVES.— TION.—The Secretary shall not grant a waiv- MENT.— ‘‘(1) IN GENERAL.—The Secretary shall es- er, exemption, or reduction of any fees due ‘‘(i) IN GENERAL.—The workload adjust- tablish in the Food and Drug Administration or payable under this section. ment under this paragraph for a fiscal year salaries and expenses appropriation account ‘‘(iv) NON-TRANSFERABILITY.—The right to shall be determined by the Secretary— without fiscal year limitation a Direct-to- an advisory review is not transferable, ex- ‘‘(I) based upon the number of direct-to- Consumer Advisory Review Operating Re- cept to a successor in interest. consumer television advertisements identi- serve, of at least $6,250,000 in fiscal year 2008, ‘‘(2) OPERATING RESERVE FEE.— fied pursuant to paragraph (3)(A) for that fis- to continue the Program in the event the ‘‘(A) IN GENERAL.—Each person that, on or cal year, excluding allowable previously paid fees collected in any subsequent fiscal year after October 1, 2007, is assessed an advisory carry over submissions; and pursuant to subsection (c)(3) do not generate review fee under paragraph (1) shall be sub- ‘‘(II) by multiplying the number of such the fee revenue amount established for that ject to an operating reserve fee established advertisements projected for that fiscal year fiscal year.

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‘‘(2) FEE SETTING.—The Secretary shall es- account for salaries and expenses with such ‘‘(A) officers and employees of the Food tablish the operating reserve fee under sub- fiscal year limitation. The sums transferred and Drug Administration, contractors of the section (a)(2)(A) for each person required to shall be available solely for the process for Food and Drug Administration, advisory pay the fee by multiplying the number of di- the advisory review of prescription drug ad- committees, and costs related to such offi- rect-to-consumer television advertisements vertising. cers, employees, and committees, and to con- identified by that person pursuant to sub- ‘‘(2) COLLECTIONS AND APPROPRIATION tracts with such contractors; section (c)(3)(A) by the advisory review fee ACTS.—The fees authorized by this section— ‘‘(B) management of information, and the established pursuant to subsection (c)(3) for ‘‘(A) shall be retained in each fiscal year in acquisition, maintenance, and repair of com- that fiscal year. In no case shall the oper- an amount not to exceed the amount speci- puter resources; ating reserve fee assessed be less than the fied in appropriation Acts, or otherwise ‘‘(C) leasing, maintenance, renovation, and operating reserve fee assessed if the person made available for obligation for such fiscal repair of facilities and acquisition, mainte- had first participated in the Program in fis- year; and nance, and repair of fixtures, furniture, sci- cal year 2008. ‘‘(B) shall be available for obligation only entific equipment, and other necessary ma- ‘‘(3) USE OF OPERATING RESERVE.—The Sec- if appropriated budget authority continues terials and supplies; retary may use funds from the reserves to support at least the total combined num- ‘‘(D) collection of fees under this section under this subsection only to the extent nec- ber of full-time equivalent employees in the and accounting for resources allocated for essary in any fiscal year to make up the dif- Food and Drug Administration, Center for the advisory review of prescription drug ad- ference between the fee revenue amount es- Drug Evaluation and Research, Division of vertising; and tablished for that fiscal year under sub- Drug Marketing, Advertising, and Commu- ‘‘(E) terminating the Program under sub- section (b) and the amount of fees collected nications, and the Center for Biologics Eval- section (f)(2), if necessary. for that fiscal year pursuant to subsection uation and Research, Advertising and Pro- ‘‘(8) The term ‘resubmission’ means a sub- (a), or to pay costs of ending the Program if motional Labeling Branch supported in fis- sequent submission for advisory review of a it is terminated pursuant to subsection (f) or cal year 2007. direct-to-consumer television advertisement if it is not reauthorized after fiscal year 2012. ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— that has been revised in response to the Sec- ‘‘(4) REFUND OF OPERATING RESERVES.— There are authorized to be appropriated for retary’s comments on an original submis- Within 120 days of the end of fiscal year 2012, fees under this section not less than sion. A resubmission may not introduce sig- or if the Program is terminated pursuant to $6,250,000 for each of fiscal years 2008, 2009, nificant new concepts or creative themes subsection (f), the Secretary, after setting 2010, 2011, and 2012, as adjusted to reflect ad- into the television advertisement. aside sufficient operating reserve amounts to justments in the total fee revenues made ‘‘(9) The term ‘submission for advisory re- terminate the Program, shall refund all under this section, plus amounts collected view’ means an original submission of a di- amounts remaining in the operating reserve for the reserve fund under subsection (d). rect-to-consumer television advertisement on a pro rata basis to each person that paid ‘‘(4) OFFSET.—Any amount of fees collected for which the sponsor voluntarily requests an operating reserve fee assessment. In no for a fiscal year under this section that ex- advisory comments before the advertisement event shall the refund to any person exceed ceeds the amount of fees specified in appro- is publicly disseminated. priation Acts for such fiscal year shall be the total amount of operating reserve fees ‘‘SEC. 736B. SUNSET. paid by such person pursuant to subsection credited to the appropriation account of the Food and Drug Administration as provided ‘‘This part shall cease to be effective on (a)(2). October 1, 2012, except that subsection (b) of ‘‘(e) EFFECT OF FAILURE TO PAY FEES.— in paragraph (1), and shall be subtracted from the amount of fees that would other- section 736 with respect to reports shall Notwithstanding any other law or regulation cease to be effective on January 31, 2013.’’. of the Secretary, a submission for advisory wise be collected under this section pursuant review of a direct-to-consumer television ad- to appropriation Acts for a subsequent fiscal SEC. 105. SAVINGS CLAUSE. vertisement submitted by a person subject to year. Notwithstanding section 509 of the Pre- fees under subsection (a) shall be considered ‘‘(h) DEFINITIONS.—For purposes of this sec- scription Drug User Fee Amendments of 2002 incomplete and shall not be accepted for re- tion: (21 U.S.C. 379g note), and notwithstanding view by the Secretary until all fees owed by ‘‘(1) The term ‘advisory review’ means re- the amendments made by this title, part 2 of such person under this section have been viewing and providing advisory comments subchapter C of chapter VII of the Federal paid. regarding compliance of a proposed adver- Food, Drug, and Cosmetic Act, as in effect on ‘‘(f) EFFECT OF INADEQUATE FUNDING OF tisement with the requirements of this Act the day before the date of enactment of this PROGRAM.— prior to its initial public dissemination. title, shall continue to be in effect with re- ‘‘(1) FIRST FISCAL YEAR.—If on November 1, ‘‘(2) The term ‘carry over submission’ spect to human drug applications and supple- 2007, or 120 days after enactment of the Pre- means a submission for an advisory review ments (as defined in such part as of such scription Drug User Fee Amendments of 2007, for which a fee was paid in a fiscal year that day) that on or after October 1, 2002, but be- whichever is later, the Secretary has re- is submitted for review in the following fis- fore October 1, 2007, were accepted by the ceived less than $11,250,000 in advisory review cal year. Food and Drug Administration for filing fees and operating reserve fees combined, the ‘‘(3) The term ‘direct-to-consumer tele- with respect to assessing and collecting any Program shall be terminated and all col- vision advertisement’ means an advertise- fee required by such part for a fiscal year lected fees shall be refunded. ment for a prescription drug product as de- prior to fiscal year 2008. ‘‘(2) SUBSEQUENT FISCAL YEARS.—Beginning fined in section 735(3) intended to be dis- SEC. 106. TECHNICAL AMENDMENT. in fiscal year 2009, if, on November 1 of a fis- played on any television channel for less Section 739 (21 U.S.C. 379j–11) is amended in cal year, the combination of the operating than 2 minutes. the matter preceding paragraph (1), by strik- reserves, annual fee revenues from that fis- ‘‘(4) The term ‘person’ includes an indi- ing ‘‘subchapter’’ and inserting ‘‘part’’. cal year, and unobligated fee revenues from vidual, a partnership, a corporation, and an SEC. 107. EFFECTIVE DATES. prior fiscal years is less than $9,000,000, ad- association, and any affiliate thereof or suc- (a) IN GENERAL.—Except as provided in justed for inflation (in accordance with sub- cessor in interest. subsection (b), the amendments made by this section (c)(1)), the Program shall be termi- ‘‘(5) The term ‘process for the advisory re- title shall take effect October 1, 2007. nated, and the Secretary shall notify all par- view of prescription drug advertising’ means (b) EXCEPTION.—The amendment made by ticipants, retain any money from the unused the activities necessary to review and pro- section 104 of this title shall take effect on advisory review fees and the operating re- vide advisory comments on proposed direct- the date of enactment of this title. serves needed to terminate the Program, and to-consumer television advertisements prior TITLE II—DRUG SAFETY refund the remainder of the unused fees and to public dissemination and, to the extent SEC. 200. SHORT TITLE. operating reserves. To the extent required to the Secretary has additional staff resources This title may be cited as the ‘‘Enhancing terminate the Program, the Secretary shall available under the Program that are not Drug Safety and Innovation Act of 2007’’. first use unobligated advisory review fee rev- necessary for the advisory review of direct- enues from prior fiscal years, then the oper- to-consumer television advertisements, the Subtitle A—Risk Evaluation and Mitigation ating reserves, and then unused advisory re- activities necessary to review and provide Strategies view fees from the relevant fiscal year. advisory comments on other proposed adver- SEC. 201. ROUTINE ACTIVE SURVEILLANCE AND ‘‘(g) CREDITING AND AVAILABILITY OF tisements and promotional material prior to ASSESSMENT. FEES.— public dissemination. (a) IN GENERAL.—Subsection (k) of section ‘‘(1) IN GENERAL.—Fees authorized under ‘‘(6) The term ‘Program’ means the Pro- 505 of the Federal Food, Drug, and Cosmetic subsection (a) shall be collected and avail- gram to assess, collect, and use fees for the Act (21 U.S.C. 355) is amended by adding at able for obligation only to the extent and in advisory review of prescription drug adver- the end the following: the amount provided in advance in appro- tising established by this section. ‘‘(3) ROUTINE ACTIVE SURVEILLANCE AND AS- priations Acts. Such fees are authorized to ‘‘(7) The term ‘resources allocated for the SESSMENT.— remain available until expended. Such sums process for the advisory review of prescrip- ‘‘(A) DEVELOPMENT OF THE POSTMARKET as may be necessary may be transferred from tion drug advertising’ means the expenses in- RISK IDENTIFICATION AND ANALYSIS SYSTEM.— the Food and Drug Administration salaries curred in connection with the process for the The Secretary shall, not later than 2 years and expenses appropriation account without advisory review of prescription drug adver- after the date of enactment of the Enhancing fiscal year limitation to such appropriation tising for— Drug Safety and Innovation Act of 2007, act

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00022 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.008 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5337 in collaboration with academic institutions priority drug safety questions, the Secretary cluding advising on the development of effec- and private entities to— shall develop, support, and participate in tive research methods for the study of drug ‘‘(i) establish minimum standards for col- complementary approaches to gather and safety questions; lection and transmission of postmarketing analyze such data and information, includ- ‘‘(ee) focus postmarket studies under sub- data elements from electronic health data ing— section (o)(4)(B) and postapproval clinical systems; and ‘‘(I) approaches that are complementary trials under subsection (o)(4)(C) more effec- ‘‘(ii) establish, through partnerships, a with respect to assessing the safety of use of tively on cases for which reports under para- validated and integrated postmarket risk a drug in domestic populations not included graph (1) and other safety signal detection is identification and analysis system to inte- in the trials used to approve the drug (such not sufficient to resolve whether there is an grate and analyze safety data from multiple as older people, people with comorbidities, elevated risk of a serious adverse event asso- sources, with the goals of including, in ag- pregnant women, or children); and ciated with the use of a drug; and gregate— ‘‘(II) existing approaches such as the Vac- ‘‘(I) at least 25,000,000 patients by July 1, cine Adverse Event Reporting System and ‘‘(ff) carry out other activities as the Sec- 2010; and the Vaccine Safety Datalink or successor retary deems necessary to carry out the pur- ‘‘(II) at least 100,000,000 patients by July 1, databases. poses of this paragraph. 2012. ‘‘(v) AUTHORITY FOR CONTRACTS.—The Sec- ‘‘(II) REQUEST FOR SPECIFIC METHOD- ‘‘(B) DATA COLLECTION ACTIVITIES.— retary may enter into contracts with public OLOGY.—The procedures described in sub- ‘‘(i) IN GENERAL.—The Secretary shall, not and private entities to fulfill the require- clause (I) shall permit the Secretary to re- later than 1 year after the establishment of ments of this subparagraph. quest that a specific methodology be used by the minimum standards and the identifica- ‘‘(C) RISK IDENTIFICATION AND ANALYSIS.— the qualified entity. The qualified entity tion and analysis system under subparagraph ‘‘(i) PURPOSE.—To carry out this para- shall work with the Secretary to finalize the (A), establish and maintain an active sur- graph, the Secretary shall establish collabo- methodology to be used. veillance infrastructure— rations with other Government, academic, ‘‘(iv) USE OF ANALYSES.—The Secretary ‘‘(I) to collect and report data for pharma- and private entities, including the Centers shall provide the analyses described under ceutical postmarket risk identification and for Education and Research on Therapeutics this subparagraph, including the methods analysis, in compliance with the regulations under section 912 of the Public Health Serv- and results of such analyses, about a drug to promulgated under section 264(c) of the ice Act, to provide for the risk identification the sponsor or sponsors of such drug. Health Insurance Portability and Account- and analysis of the data collected under sub- ‘‘(v) QUALIFIED ENTITIES.— ability Act of 1996; and paragraph (B) and data that is publicly avail- ‘‘(I) IN GENERAL.—The Secretary shall ‘‘(II) that includes, in addition to the col- able or is provided by the Secretary, in order enter into contracts with a sufficient num- lection and monitoring (in a standardized to— ber of qualified entities to develop and pro- form) of data on all serious adverse drug ex- ‘‘(I) improve the quality and efficiency of vide information to the Secretary in a time- periences (as defined in subsection (o)(2)(C)) postmarket drug safety risk-benefit anal- ly manner. required to be submitted to the Secretary ysis; ‘‘(II) QUALIFICATION.—The Secretary shall under paragraph (1), and those events volun- ‘‘(II) provide the Secretary with routine enter into a contract with an entity under tarily submitted from patients, providers, access to expertise to study advanced drug subclause (I) only if the Secretary deter- and drug, when appropriate, procedures to— safety data; and mines that the entity— ‘‘(aa) provide for adverse event surveil- ‘‘(III) enhance the ability of the Secretary ‘‘(aa) has the research capability and ex- lance by collecting and monitoring Federal to make timely assessments based on drug pertise to conduct and complete the activi- health-related electronic data (such as data safety data. ties under this paragraph; from the Medicare program and the health ‘‘(ii) PUBLIC PROCESS FOR PRIORITY QUES- systems of the Department of Veterans Af- TIONS.—At least biannually, the Secretary ‘‘(bb) has in place an information tech- fairs); shall seek recommendations from the Drug nology infrastructure to support adverse ‘‘(bb) provide for adverse event surveil- Safety and Risk Management Advisory Com- event surveillance data and operational lance by collecting and monitoring private mittee (or successor committee) and from standards to provide security for such data; sector health-related electronic data (such other advisory committees, as appropriate, ‘‘(cc) has experience with, and expertise on, as pharmaceutical purchase data and health to the Food and Drug Administration on— the development of drug safety and effective- insurance claims data); ‘‘(I) priority drug safety questions; and ness research using electronic population ‘‘(cc) provide for adverse event surveillance ‘‘(II) mechanisms for answering such ques- data; by monitoring standardized electronic tions, including through— ‘‘(dd) has an understanding of drug devel- health records, as available; ‘‘(aa) routine active surveillance under opment and risk/benefit balancing in a clin- ‘‘(dd) provide for adverse event surveil- subparagraph (B); and ical setting; and lance by collecting and monitoring other in- ‘‘(bb) when such surveillance is not suffi- ‘‘(ee) has a significant business presence in formation as the Secretary deems necessary cient, postmarket studies under subsection the United States. to create a robust system to identify adverse (o)(4)(B) and postapproval clinical trials ‘‘(vi) CONTRACT REQUIREMENTS.—Each con- events and potential drug safety signals; under subsection (o)(4)(C). tract with a qualified entity shall contain ‘‘(ee) enable the program to identify cer- ‘‘(iii) PROCEDURES FOR THE DEVELOPMENT the following requirements: tain trends and patterns with respect to data OF DRUG SAFETY COLLABORATIONS.— ‘‘(I) ENSURING PRIVACY.—The qualified en- reported to the program; ‘‘(I) IN GENERAL.—Not later than 180 days tity shall provide assurances that the entity ‘‘(ff) enable the program to provide regular after the date of the establishment of the ac- will not use the data provided by the Sec- reports to the Secretary concerning adverse tive surveillance infrastructure under sub- retary in a manner that violates— event trends, adverse event patterns, inci- paragraph (B), the Secretary shall establish ‘‘(aa) the regulations promulgated under dence and prevalence of adverse events, lab- and implement procedures under which the section 264(c) of the Health Insurance Port- oratory data, and other information deter- Secretary may routinely collaborate with a ability and Accountability Act of 1996; or mined appropriate, which may include data qualified entity to— ‘‘(bb) sections 552 or 552a of title 5, United on comparative national adverse event ‘‘(aa) clean, classify, or aggregate data col- States Code, with regard to the privacy of in- trends; and lected under subparagraph (B) and data that dividually-identifiable beneficiary health in- ‘‘(gg) enable the program to export data in is publicly available or is provided by the formation. a form appropriate for further aggregation, Secretary; ‘‘(II) COMPONENT OF ANOTHER ORGANIZA- statistical analysis, and reporting. ‘‘(bb) allow for prompt investigation of pri- TION.—If a qualified entity is a component of ‘‘(ii) TIMELINESS OF REPORTING.—The proce- ority drug safety questions, including— dures developed under clause (i) shall ensure ‘‘(AA) unresolved safety questions for another organization— that such data are collected, monitored, and drugs or classes of drugs; and ‘‘(aa) the qualified entity shall maintain reported in a timely, routine, and automatic ‘‘(BB) for a newly-approved drug: safety the data related to the activities carried out manner, taking into consideration the need signals from clinical trials used to approve under this paragraph separate from the other for data completeness, coding, cleansing, and the drug and other preapproval trials; rare, components of the organization and estab- transmission. serious drug side effects; and the safety of lish appropriate security measures to main- ‘‘(iii) PRIVATE SECTOR RESOURCES.—To en- use in domestic populations not included in tain the confidentiality and privacy of such sure the establishment of the active surveil- the trials used to approve the drug (such as data; and lance infrastructure by the date described older people, people with comorbidities, ‘‘(bb) the entity shall not make an unau- under clause (i), the Secretary may, on a pregnant women, or children); thorized disclosure of such data to the other temporary or permanent basis, implement ‘‘(cc) perform advanced research and anal- components of the organization in breach of systems or products developed by private en- ysis on identified drug safety risks; such confidentiality and privacy require- tities. ‘‘(dd) convene an expert advisory com- ment. ‘‘(iv) COMPLEMENTARY APPROACHES.—To the mittee to oversee the establishment of ‘‘(III) TERMINATION OR NONRENEWAL.—If a extent the active surveillance infrastructure standards for the ethical and scientific uses contract with a qualified entity under this established under clause (i) is not sufficient for, and communication of, postmarketing subparagraph is terminated or not renewed, to gather data and information relevant to data collected under subparagraph (B), in- the following requirements shall apply:

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‘‘(aa) CONFIDENTIALITY AND PRIVACY PRO- ‘‘(I) the approval of such strategy; or scribed in this paragraph, so long as the Sec- TECTIONS.—The entity shall continue to com- ‘‘(II) the last assessment of such strategy. retary makes the determination required ply with the confidentiality and privacy re- ‘‘(C) SERIOUS ADVERSE DRUG EXPERIENCE.— with respect to each additional included ele- quirements under this paragraph with re- The term ‘serious adverse drug experience’ is ment. spect to all data disclosed to the entity. an adverse drug experience that— ‘‘(B) POSTAPPROVAL STUDIES.—If the Sec- ‘‘(bb) DISPOSITION OF DATA.—The entity ‘‘(i) results in— retary determines that the reports under shall return to the Secretary all data dis- ‘‘(I) death; subsection (k)(1) and routine active surveil- closed to the entity or, if returning the data ‘‘(II) the placement of the patient at imme- lance as available under subsection (k)(3) (in- is not practicable, destroy the data. diate risk of death from the adverse drug ex- cluding available complementary approaches ‘‘(vii) COMPETITIVE PROCEDURES.—The Sec- perience as it occurred (not including an ad- under subsection (k)(3)(B)(iv)) will not be retary shall use competitive procedures (as verse drug experience that might have sufficient to— defined in section 4(5) of the Federal Pro- caused death had it occurred in a more se- ‘‘(i) assess a signal of a serious risk with curement Policy Act) to enter into contracts vere form); use of a drug; or under clause (v). ‘‘(III) inpatient hospitalization or prolon- ‘‘(ii) identify, based on a review of a dem- ‘‘(viii) REVIEW OF CONTRACT IN THE EVEN OF gation of existing hospitalization; onstrated pattern of use of the drug, unex- A MERGER OR ACQUISITION.—The Secretary ‘‘(IV) a persistent or significant incapacity pected serious risks in a domestic popu- shall review the contract with a qualified en- or substantial disruption of the ability to lation, including older people, people with tity under this paragraph in the event of a conduct normal life functions; or comorbidities, pregnant women, or children, ‘‘(V) a congenital anomaly or birth defect; merger or acquisition of the entity in order the risk evaluation and mitigation strategy or to ensure that the requirements under this for the drug may require that the applicant ‘‘(ii) based on appropriate medical judg- subparagraph will continue to be met. conduct an appropriate postapproval study, ment, may jeopardize the patient and may ‘‘(D) COORDINATION.—In carrying out this such as a prospective or retrospective obser- require a medical or surgical intervention to paragraph, the Secretary shall provide for vational study, of the drug (which shall in- prevent an outcome described under clause appropriate communications to the public, clude a timeframe specified by the Secretary (i). scientific, public health, and medical com- for completing the study and reporting the ‘‘(D) SERIOUS RISK.—The term ‘serious risk’ munities, and other key stakeholders, and results to the Secretary). provide for the coordination of the activities means a risk of a serious adverse drug expe- rience. ‘‘(C) POSTAPPROVAL CLINICAL TRIALS.—If of private entities, professional associations, the Secretary determines that the reports or other entities that may have sources of ‘‘(E) SIGNAL OF A SERIOUS RISK.—The term ‘signal of a serious risk’ means information under subsection (k)(1), routine active sur- surveillance data.’’. veillance as available under subsection (k)(3) (b) AUTHORIZATION OF APPROPRIATIONS.—To related to a serious adverse drug experience (including available complementary ap- carry out activities under the amendment derived from— made by this section for which funds are ‘‘(i) a clinical trial; proaches under subsection (k)(3)(B)(iv)), and made available under section 736 of the Fed- ‘‘(ii) adverse event reports under sub- a study or studies under subparagraph (B) eral Food, Drug, and Cosmetic Act (21 U.S.C. section (k)(1); will likely be inadequate to assess a signal of 379h), there are authorized to be appro- ‘‘(iii) routine active surveillance under a serious risk with use of a drug, and there priated to carry out the amendment made by subsection (k)(3); is no effective approved application for the this section, in addition to such funds, ‘‘(iv) a postapproval study, including a drug under subsection (j) as of the date that $25,000,000 for each of fiscal years 2008 study under paragraph (4)(B); or the requirement is first imposed, the risk through 2012. ‘‘(v) peer-reviewed biomedical literature. evaluation and mitigation strategy for the SEC. 202. RISK EVALUATION AND MITIGATION ‘‘(F) UNEXPECTED SERIOUS RISK.—The term drug may require that the applicant conduct STRATEGIES. ‘unexpected serious risk’ means a serious ad- an appropriate postapproval clinical trial of Section 505 of the Federal Food, Drug, and verse drug experience that— the drug (which shall include a timeframe Cosmetic Act (21 U.S.C. 355) is amended by ‘‘(i) is not listed in the labeling of a drug; specified by the Secretary for completing the adding at the end the following: or clinical trial and reporting the results to the ‘‘(o) RISK EVALUATION AND MITIGATION ‘‘(ii) is symptomatically and Secretary) to be included in the clinical trial STRATEGY.— pathophysiologically related to an adverse registry data bank provided for under sub- ‘‘(1) IN GENERAL.—In the case of any drug drug experience listed in the labeling of the sections (i) and (j) of section 402 of the Public subject to subsection (b) or to section 351 of drug, but differs from such adverse drug ex- Health Service Act. the Public Health Service Act for which a perience because of greater severity, speci- ‘‘(5) ADDITIONAL POTENTIAL COMMUNICATION risk evaluation and mitigation strategy is ficity, or prevalence. ELEMENTS OF A RISK EVALUATION AND MITIGA- approved as provided for in this subsection, ‘‘(3) REQUIRED ELEMENTS OF A RISK EVALUA- TION STRATEGY.— the applicant shall comply with the require- TION AND MITIGATION STRATEGY.—If a risk ‘‘(A) RISK COMMUNICATION.—If a risk eval- ments of such strategy. evaluation and mitigation strategy for a uation and mitigation strategy for a drug is ‘‘(2) DEFINITIONS.—In this subsection: drug is required, such strategy shall in- required, such strategy may include 1 or ‘‘(A) ADVERSE DRUG EXPERIENCE.—The term clude— more of the additional communication ele- ‘adverse drug experience’ means any adverse ‘‘(A) the labeling for the drug for use by ments described in this paragraph, so long as event associated with the use of a drug in health care providers as approved under sub- the Secretary makes the determination re- humans, whether or not considered drug re- section (c); quired with respect to each additional in- lated, including— ‘‘(B) a timetable for submission of assess- cluded element. ‘‘(i) an adverse event occurring in the ments of the strategy, that— ‘‘(B) MEDGUIDE; PATIENT PACKAGE INSERT.— course of the use of the drug in professional ‘‘(i) for a drug no active ingredient (includ- The risk evaluation and mitigation strategy practice; ing any ester or salt of the active ingredient) for a drug may require that the applicant de- ‘‘(ii) an adverse event occurring from an of which has been approved in any other ap- velop for distribution to each patient when overdose of the drug, whether accidental or plication under this section or section 351 of the drug is dispensed either or both of the intentional; the Public Health Service Act— following: ‘‘(iii) an adverse event occurring from ‘‘(I) shall be no less frequently than 18 ‘‘(i) A Medication Guide, as provided for abuse of the drug; months and 3 years after the drug is initially under part 208 of title 21, Code of Federal ‘‘(iv) an adverse event occurring from with- approved and at a frequency specified in the Regulations (or any successor regulations). drawal of the drug; and strategy for subsequent years; and ‘‘(ii) A patient package insert, if the Sec- ‘‘(v) any failure of expected pharma- ‘‘(II) may be eliminated after the first 3 retary determines that such insert may help cological action of the drug. years if the Secretary determines that seri- mitigate a serious risk listed in the labeling ‘‘(B) NEW SAFETY INFORMATION.—The term ous risks of the drug have been adequately of the drug. ‘new safety information’ with respect to a identified and assessed and are being ade- ‘‘(C) COMMUNICATION PLAN.—If the Sec- drug means information about— quately managed; retary determines that a communication ‘‘(i) a serious risk or an unexpected serious ‘‘(ii) for a drug other than a drug described plan to health care providers may support risk with use of the drug that the Secretary under clause (i), shall occur at a frequency implementation of an element of the risk has become aware of since the later of— determined by the Secretary; and evaluation and mitigation strategy for a ‘‘(I) the date of initial approval of the drug ‘‘(iii) may be increased or reduced in fre- drug, such as a labeling change, the strategy under this section or initial licensure of the quency as necessary as provided for in para- may require that the applicant conduct such drug under section 351 of the Public Health graph (7)(B)(v)(VI). a plan, which may include— Service Act; or ‘‘(4) ADDITIONAL POTENTIAL EVALUATION ‘‘(i) sending letters to health care pro- ‘‘(II) if applicable, the last assessment of ELEMENTS OF A RISK EVALUATION AND MITIGA- viders; the approved risk evaluation and mitigation TION STRATEGY.— ‘‘(ii) disseminating information about the strategy for the drug; or ‘‘(A) RISK EVALUATION.—If a risk evalua- elements of the strategy to encourage imple- ‘‘(ii) the effectiveness of the approved risk tion and mitigation strategy for a drug is re- mentation by health care providers of com- evaluation and mitigation strategy for the quired, such strategy may include 1 or more ponents that apply to such health care pro- drug obtained since the later of— of the additional evaluation elements de- viders, or to explain certain safety protocols

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00024 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.008 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5339 (such as medical monitoring by periodic lab- ‘‘(I) consider the concern identified under ‘‘(v) each patient using the drug be subject oratory tests); or clause (ii)(II) with respect to such drug to be to certain monitoring; or ‘‘(iii) disseminating information to health a priority drug safety question under sub- ‘‘(vi) each patient using the drug be en- care providers through professional societies section (k)(3)(B); rolled in a registry. about any serious risks of the drug and any ‘‘(II) no less frequently than every 3 ‘‘(D) IMPLEMENTATION SYSTEM.—The ele- protocol to assure safe use. months, evaluate the reports under sub- ments to assure safe use under subparagraph ‘‘(D) PREREVIEW.— section (k)(1) and the routine active surveil- (A) that are described in clauses (ii), (iii), or ‘‘(i) IN GENERAL.—If the Secretary deter- lance as available under subsection (k)(3) (iv) of subparagraph (C) may include a sys- mines that prereview of advertisements is with respect to such concern to determine tem through which the applicant is able to necessary to ensure the inclusion of a true whether serious risks that might occur take reasonable steps to— statement in such advertisements of infor- among patients expected to be treated with ‘‘(i) monitor and evaluate implementation mation in brief summary relating to a seri- the drug have been adequately identified; of such elements by health care providers, ous risk listed in the labeling of a drug, or and pharmacists, and other parties in the health relating to a protocol to ensure the safe use ‘‘(III) if such serious risks have been ade- care system who are responsible for imple- described in the labeling of the drug, the risk quately identified, remove such temporary menting such elements; and evaluation and mitigation strategy for the moratorium as an element of such strategy. ‘‘(ii) work to improve implementation of drug may require that the applicant submit ‘‘(6) PROVIDING SAFE ACCESS FOR PATIENTS such elements by such persons. to the Secretary advertisements of the drug TO DRUGS WITH KNOWN SERIOUS RISKS THAT ‘‘(E) EVALUATION OF ELEMENTS TO ASSURE for prereview not later than 45 days before WOULD OTHERWISE BE UNAVAILABLE.— SAFE USE.—The Secretary, through the Drug dissemination of the advertisement ‘‘(A) ALLOWING SAFE ACCESS TO DRUGS WITH Safety and Risk Management Advisory Com- ‘‘(ii) SPECIFICATION OF ADVERTISEMENTS.— KNOWN SERIOUS RISKS.—The Secretary may mittee (or successor committee) of the Food The Secretary may specify the advertise- require that the risk evaluation and mitiga- and Drug Administration, shall— ments required to be submitted under clause tion strategy for a drug include such ele- ‘‘(i) seek input from patients, physicians, (i). ments as are necessary to assure safe use of pharmacists, and other health care providers ‘‘(E) SPECIFIC DISCLOSURES.— the drug, because of its inherent toxicity or about how elements to assure safe use under ‘‘(i) SERIOUS RISK; SAFETY PROTOCOL.—If the Secretary determines that advertise- potential harmfulness, if the Secretary de- this paragraph for 1 or more drugs may be ments lacking a specific disclosure about a termines that— standardized so as not to be— serious risk listed in the labeling of a drug or ‘‘(i) the drug, which has been shown to be ‘‘(I) unduly burdensome on patient access about a protocol to ensure safe use described effective, but is associated with a serious ad- to the drug; and in the labeling of the drug would be false or verse drug experience, can be approved only ‘‘(II) to the extent practicable, minimize misleading, the risk evaluation and mitiga- if, or would be withdrawn unless, such ele- the burden on the health care delivery sys- tion strategy for the drug may require that ments are required as part of such strategy tem; the applicant include in advertisements of to mitigate a specific serious risk listed in ‘‘(ii) at least annually, evaluate, for 1 or the drug such disclosure. the labeling of the drug; and more drugs, the elements to assure safe use ‘‘(ii) DATE OF APPROVAL.—If the Secretary ‘‘(ii) for a drug initially approved without of such drug to assess whether the ele- determines that advertisements lacking a elements to assure safe use, other elements ments— specific disclosure of the date a drug was ap- under paragraphs (3), (4), and (5) are not suf- ‘‘(I) assure safe use of the drug; proved and notification that the existing in- ficient to mitigate such serious risk. ‘‘(II) are not unduly burdensome on patient formation may not have identified or al- ‘‘(B) ASSURING ACCESS AND MINIMIZING BUR- access to the drug; and lowed for full assessment of all serious risks DEN.—Such elements to assure safe use under ‘‘(III) to the extent practicable, minimize of using the drug would be false or mis- subparagraph (A) shall— the burden on the health care delivery sys- leading, the risk evaluation and mitigation ‘‘(i) be commensurate with the specific se- tem; and strategy for the drug may require that the rious risk listed in the labeling of the drug; ‘‘(iii) considering such input and evalua- applicant include in advertisements of the ‘‘(ii) within 30 days of the date on which tions— drug such disclosure any element under subparagraph (A) is im- ‘‘(I) issue or modify agency guidance about ‘‘(iii) SPECIFICATION OF ADVERTISEMENTS.— posed, be posted publicly by the Secretary how to implement the requirements of this The Secretary may specify the advertise- with an explanation of how such elements paragraph; and ments required to include a specific disclo- will mitigate the observed safety risk; ‘‘(II) modify elements under this paragraph sure under clause (i) or (ii). ‘‘(iii) considering such risk, not be unduly for 1 or more drugs as appropriate. ‘‘(F) TEMPORARY MORATORIUM.— burdensome on patient access to the drug, ‘‘(F) ADDITIONAL MECHANISMS TO ASSURE AC- ‘‘(i) IN GENERAL.—To the extent consistent considering in particular— CESS.—The mechanisms under section 561 to with the Constitution, the risk evaluation ‘‘(I) patients with serious or life-threat- provide for expanded access for patients with and mitigation strategy for a drug may re- ening diseases or conditions; and serious or life-threatening diseases or condi- quire that the applicant not issue or cause to ‘‘(II) patients who have difficulty accessing tions may be used to provide access for pa- be issued direct-to-consumer advertisements health care (such as patients in rural or tients with a serious or life-threatening dis- of the drug for a fixed period after initial ap- medically underserved areas); and ease or condition, the treatment of which is proval of the drug, not to exceed 2 years. ‘‘(iv) to the extent practicable, so as to not an approved use for the drug, to a drug ‘‘(ii) CONDITIONS.—The Secretary may re- minimize the burden on the health care de- that is subject to elements to assure safe use quire the strategy for a drug to include such livery system— under this paragraph. a temporary moratorium on direct-to-con- ‘‘(I) conform with elements to assure safe ‘‘(G) WAIVER IN PUBLIC HEALTH EMER- sumer advertising only if the Secretary de- use for other drugs with similar, serious GENCIES.—The Secretary may waive any re- termines that— risks; and quirement of this paragraph during the pe- ‘‘(I) direct-to-consumer advertisements of ‘‘(II) be designed to be compatible with es- riod described in section 319(a) of the Public the drug would be inherently misleading tablished distribution, procurement, and dis- Health Service Act with respect to a quali- even if the disclosure under subparagraph pensing systems for drugs. fied countermeasure described under section (E)(ii) were required; and ‘‘(C) ELEMENTS TO ASSURE SAFE USE.—The 319F-1(a)(2) of such Act, to which a require- ‘‘(II) other elements under this subsection elements to assure safe use under subpara- ment under this paragraph has been applied, would not be sufficient to mitigate the con- graph (A) shall include 1 or more goals to if the Secretary has— cern that clinical trials used to approve the mitigate a specific serious risk listed in the ‘‘(i) declared a public health emergency drug may not have identified serious risks labeling of the drug and, to mitigate such under such section 319; and that might occur among patients expected to risk, may require that— ‘‘(ii) determined that such waiver is re- be treated with the drug. ‘‘(i) health care providers that prescribe quired to mitigate the effects of, or reduce ‘‘(iii) CONSIDERATIONS.—Before making the drug have particular training or experi- the severity of, such public health emer- such determinations, the Secretary shall ence, or are specially certified (which train- gency. consider— ing or certification shall be available to any ‘‘(7) SUBMISSION AND REVIEW OF RISK EVAL- ‘‘(I) the number of patients who may be willing provider from a frontier area); UATION AND MITIGATION STRATEGY.— treated with the drug; ‘‘(ii) pharmacies, practitioners, or health ‘‘(A) PROPOSED RISK EVALUATION AND MITI- ‘‘(II) the seriousness of the condition for care settings that dispense the drug are spe- GATION STRATEGY.— which the drug will be used; and cially certified (which certification shall be ‘‘(i) VOLUNTARY PROPOSAL.—If there is a ‘‘(III) the serious risks listed in the label- available to any willing provider from a signal of a serious risk with a drug, an appli- ing of the drug. frontier area); cant may include a proposed risk evaluation ‘‘(iv) REQUIRED SAFETY MONITORING.—If the ‘‘(iii) the drug be dispensed to patients and mitigation strategy for the drug in an approved risk evaluation and mitigation only in certain health care settings, such as application, including in a supplemental ap- strategy for a drug includes a temporary hospitals; plication, for the drug under subsection (b) moratorium on direct-to-consumer adver- ‘‘(iv) the drug be dispensed to patients with or section 351 of the Public Health Service tisements of the drug under this subpara- evidence or other documentation of safe-use Act. graph, the Secretary shall— conditions, such as laboratory test results; ‘‘(ii) REQUIRED PROPOSAL.—

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00025 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.009 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5340 CONGRESSIONAL RECORD — SENATE May 1, 2007

‘‘(I) DETERMINATION NECESSARY TO REQUIRE an assessment of, and may propose a modi- ‘‘(IV) adding, modifying, or removing an A PROPOSAL.— fication to, such approved strategy for the element on advertising under subparagraph ‘‘(aa) IN GENERAL.—The Secretary may re- drug— (D), (E), or (F) of paragraph (5); quire that the applicant for a drug submit a ‘‘(I) when submitting an application, in- ‘‘(V) adding, modifying, or removing an proposed risk evaluation and mitigation cluding a supplemental application, for a element to assure safe use under paragraph strategy for a drug if the Secretary (acting new indication under subsection (b) or sec- (6); or through the office responsible for reviewing tion 351 of the Public Health Service Act; ‘‘(VI) modifying the timetable for assess- the drug and the office responsible for post- ‘‘(II) when required by the strategy, as pro- ments of the strategy under paragraph (3)(B), approval safety with respect to the drug) de- vided for in the timetable under paragraph including to eliminate assessments. termines that, based on a signal of a serious (3)(B); ‘‘(C) REVIEW.—The Secretary (acting risk with the drug, a risk evaluation and ‘‘(III) within a timeframe specified by the through the offices described in subpara- mitigation strategy is necessary to assess Secretary, not to be less than 45 days, when graph (A)(ii)(I)) shall promptly review the such signal or mitigate such serious risk. ordered by the Secretary (acting through the proposed risk evaluation and mitigation ‘‘(bb) NON-DELEGATION.—A determination offices described in subparagraph (A)(ii)(I)), under item (aa) for a drug shall be made by if the Secretary determines that new safety strategy for a drug submitted under subpara- individuals at or above the level of individ- information indicates that an element under graph (A), or an assessment of the approved uals empowered to approve a drug (such as paragraph (3) or (4) should be modified or risk evaluation and mitigation strategy for a division directors within the Center for Drug added to the strategy; drug submitted under subparagraph (B). Evaluation and Research). ‘‘(IV) within 90 days when ordered by the ‘‘(D) DISCUSSION.—The Secretary (acting ‘‘(II) CIRCUMSTANCES IN WHICH A PROPOSAL Secretary (acting through such offices), if through the offices described in subpara- MAY BE REQUIRED.—The applicant shall sub- the Secretary determines that new safety in- graph (A)(ii)(I)) shall initiate discussions of mit a proposed risk evaluation and mitiga- formation indicates that an element under the proposed risk evaluation and mitigation tion strategy for a drug— paragraph (6) should be modified or added to strategy for a drug submitted under subpara- ‘‘(aa) in response to a letter from the Sec- the strategy; or graph (A), or of an assessment of the ap- retary (acting through the office responsible ‘‘(V) within 15 days when ordered by the proved risk evaluation and mitigation strat- for reviewing the drug and the office respon- Secretary (acting through such offices), if egy for a drug submitted under subparagraph sible for postapproval safety with respect to the Secretary determines that there may be (B), with the applicant to determine a strat- the drug) sent regarding an application, in- a cause for action by the Secretary under egy— cluding a supplemental application, for the subsection (e). ‘‘(i) if the proposed strategy or assessment drug, if the Secretary determines that data ‘‘(iii) CONTENT OF ORDER.—An order under is submitted as part of an application (in- or information in the application indicates subclauses (III), (IV), or (V) of clause (ii) cluding a supplemental application) under that an element under paragraph (4), (5), or shall describe— subparagraph (A)(i), (A)(ii)(II)(aa), or (6) should be included in a strategy for the ‘‘(I) the new safety information with re- (B)(ii)(I), by the target date for communica- drug; spect to the drug that warrants an assess- tion of feedback from the review team to the ‘‘(bb) within a timeframe specified by the ment of the approved risk evaluation and applicant regarding proposed labeling and Secretary, not to be less than 45 days, when mitigation strategy for the drug; and postmarketing study commitments, as set ordered by the Secretary (acting through ‘‘(II) whether and how such strategy should forth in the letters described in section such offices), if the Secretary determines be modified because of such information. 735(a); that new safety information indicates that— ‘‘(iv) ASSESSMENT.—An assessment of the ‘‘(ii) if the proposed strategy is submitted ‘‘(AA) the labeling of the drug should be approved risk evaluation and mitigation changed; or strategy for a drug shall include— under subparagraph (A)(ii)(II)(bb) or the as- ‘‘(BB) an element under paragraph (4) or (5) ‘‘(I) a description of new safety informa- sessment is submitted under subclause (II) or should be included in a strategy for the drug; tion, if any, with respect to the drug; (III) of subparagraph (B)(ii), not later than 20 or ‘‘(II) whether and how to modify such days after such submission; ‘‘(cc) within 90 days when ordered by the strategy because of such information; ‘‘(iii) if the proposed strategy is submitted Secretary (acting through such offices), if ‘‘(III) with respect to any postapproval under subparagraph (A)(ii)(II)(cc) or the as- the Secretary determines that new safety in- study required under paragraph (4)(B) or oth- sessment is submitted under subparagraph formation indicates that an element under erwise undertaken by the applicant to inves- (B)(i) or under subparagraph (B)(ii)(IV), not paragraph (6) should be included in a strat- tigate a safety issue, the status of such later than 30 days after such submission; or egy for the drug. study, including whether any difficulties ‘‘(iv) if the assessment is submitted under ‘‘(iii) CONTENT OF LETTER.—A letter under completing the study have been encountered; subparagraph (B)(ii)(V), not later than 10 clause (ii)(II)(aa) shall describe— ‘‘(IV) with respect to any postapproval days after such submission. ‘‘(I) the data or information in the applica- clinical trial required under paragraph (4)(C) ‘‘(E) ACTION.— tion that warrants the proposal of a risk or otherwise undertaken by the applicant to ‘‘(i) IN GENERAL.—Unless the applicant re- evaluation and mitigation strategy for the investigate a safety issue, the status of such quests the dispute resolution process as de- drug; and clinical trial, including whether enrollment scribed under subparagraph (F) or (G), the ‘‘(II) what elements under paragraphs (4), has begun, the number of participants en- Secretary (acting through the offices de- (5), or (6) should be included in a strategy for rolled, the expected completion date, wheth- scribed in subparagraph (A)(ii)(I)) shall ap- the drug. er any difficulties completing the clinical prove and include the risk evaluation and ‘‘(iv) CONTENT OF ORDER.—An order under trial have been encountered, and registration mitigation strategy for a drug, or any modi- item (aa) or (bb) of clause (ii)(II) shall de- information with respect to requirements fication to the strategy (including a time- scribe— under subsections (i) and (j) of section 402 of frame for implementing such modification), ‘‘(I) the new safety information with re- the Public Health Service Act; and with— spect to the drug that warrants the proposal ‘‘(V) with respect to any goal under para- ‘‘(I) the action letter on the application, if of a risk evaluation and mitigation strategy graph (6) and considering input and evalua- a proposed strategy is submitted under sub- for the drug; and tions, if applicable, under paragraph (6)(E), paragraph (A)(i) or (A)(ii)(II)(aa) or an as- ‘‘(II) whether and how the labeling of the an assessment of how well the elements to sessment of the strategy is submitted under drug should be changed and what elements assure safe use are meeting the goal of in- subparagraph (B)(ii)(I); or under paragraphs (4), (5), or (6) should be in- creasing safe access to drugs with known se- ‘‘(II) an order, which shall be made public, cluded in a strategy for the drug. rious risks or whether the goal or such ele- issued not later than 50 days after the date ‘‘(v) CONTENT OF PROPOSAL.—A proposed ments should be modified. discussions of such proposed strategy or risk evaluation and mitigation strategy— ‘‘(v) MODIFICATION.—A modification ‘‘(I) shall include a timetable as described (whether an enhancement or a reduction) to modification begin under subparagraph (D), under paragraph (3)(B); and the approved risk evaluation and mitigation if a proposed strategy is submitted under ‘‘(II) may also include additional elements strategy for a drug may include the addition item (bb) or (cc) of subparagraph (A)(ii)(II) or as provided for under paragraphs (4), (5), and or modification of any element under sub- an assessment of the strategy is submitted (6). paragraph (A) or (B) of paragraph (3) or the under subparagraph (B)(i) or under subclause ‘‘(B) ASSESSMENT AND MODIFICATION OF A addition, modification, or removal of any (II), (III), (IV), or (V) of subparagraph (B)(ii). RISK EVALUATION AND MITIGATION STRATEGY.— element under paragraph (4), (5), or (6), such ‘‘(ii) INACTION.—An approved risk evalua- ‘‘(i) VOLUNTARY ASSESSMENTS.—If a risk as— tion and mitigation strategy shall remain in evaluation and mitigation strategy for a ‘‘(I) a labeling change, including the addi- effect until the Secretary acts, if the Sec- drug is required, the applicant may submit tion of a boxed warning; retary fails to act as provided under clause to the Secretary an assessment of, and pro- ‘‘(II) adding a postapproval study or clin- (i). pose a modification to, such approved strat- ical trial requirement; ‘‘(F) DISPUTE RESOLUTION AT INITIAL AP- egy for the drug at any time. ‘‘(III) modifying a postapproval study or PROVAL.—If a proposed risk evaluation and ‘‘(ii) REQUIRED ASSESSMENTS.—If a risk clinical trial requirement (such as a change mitigation strategy is submitted under sub- evaluation and mitigation strategy for a in trial design due to legitimate difficulties paragraph (A)(i) or (A)(ii)(II)(aa) in an appli- drug is required, the applicant shall submit recruiting participants); cation for initial approval of a drug and

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00026 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.009 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5341 there is a dispute about the strategy, the ap- ‘‘(bb) 7 days after receiving the rec- ‘‘(I) convened, after appropriate public no- plicant shall use the major dispute resolu- ommendation of the Drug Safety Oversight tice, 1 or more public meetings to consider tion procedures as set forth in the letters de- Board. possible responses to such concern; or scribed in section 735(a). ‘‘(II) ORDER.—With respect to a proposed ‘‘(II) gathered additional information or ‘‘(G) DISPUTE RESOLUTION IN ALL OTHER risk evaluation and mitigation strategy sub- data about such concern. CASES.— mitted under item (bb) or (cc) of subpara- ‘‘(ii) PUBLIC MEETINGS.—Such public meet- ‘‘(i) REQUEST FOR REVIEW.—In any case graph (A)(ii)(II) or an assessment of the risk ings may include— other than a submission under subparagraph evaluation and mitigation strategy under ‘‘(I) 1 or more meetings of the applicants (A)(i) or (A)(ii)(II)(aa) in an application for subparagraph (B)(i) or under subclause (II), for such drugs; initial approval of a drug if there is a dispute (III), (IV), or (V) of subparagraph (B)(ii), the ‘‘(II) 1 or more meetings of 1 or more advi- about the strategy, not earlier than 15 days, Secretary shall issue an order, which (with sory committees of the Food and Drug Ad- and not later than 35 days, after discussions the recommendation of the Drug Safety ministration, as provided for under subpara- under subparagraph (D) have begun, the ap- Oversight Board) shall be made public, that graph (H); or plicant shall request in writing that the dis- resolves the dispute not later than 7 days ‘‘(III) 1 or more workshops of scientific ex- pute be reviewed by the Drug Safety Over- after receiving the recommendation of the perts and other stakeholders. sight Board. Drug Safety Oversight Board. ‘‘(iii) ACTION.—After considering the dis- ‘‘(ii) SCHEDULING REVIEW.—If the applicant ‘‘(vii) INACTION.—An approved risk evalua- cussions from any meetings under clause (ii), requests review under clause (i), the Sec- tion and mitigation strategy shall remain in the Secretary may— retary— effect until the Secretary acts, if the Sec- ‘‘(I) announce in the Federal Register a ‘‘(I)(aa) shall schedule the dispute for re- retary fails to act as provided for under planned regulatory action, including a modi- view at 1 of the next 2 regular meetings of clause (vi). fication to each risk evaluation and mitiga- the Drug Safety Oversight Board, whichever ‘‘(viii) EFFECT ON ACTION DEADLINE.—With tion strategy, for drugs in the pharma- meeting date is more practicable; or respect to the application or supplemental cological class; ‘‘(bb) may convene a special meeting of the application in which a proposed risk evalua- ‘‘(II) seek public comment about such ac- Drug Safety Oversight Board to review the tion and mitigation strategy is submitted tion; and matter more promptly, including to meet an under subparagraph (A)(i) or (A)(ii)(II)(aa) or ‘‘(III) after seeking such comment, issue an action deadline on an application (including in which an assessment of the strategy is order addressing such regulatory action. a supplemental application); submitted under subparagraph (B)(ii)(I), the ‘‘(J) INTERNATIONAL COORDINATION.—The ‘‘(II) shall give advance notice to the pub- Secretary shall be considered to have met Secretary (acting through the offices de- lic through the Federal Register and on the the action deadline for the action letter on scribed in subparagraph (A)(ii)(I)) may co- Internet website of the Food and Drug Ad- such application if the applicant requests the ordinate the timetable for submission of as- ministration— dispute resolution process described in this sessments under paragraph (3)(B), a study ‘‘(aa) that the drug is to be discussed by subparagraph and if the Secretary— under paragraph (4)(B), or a clinical trial the Drug Safety Oversight Board; and ‘‘(I) has initiated the discussions described under paragraph (4)(C), with efforts to iden- ‘‘(bb) of the date on which the Drug Safety under subparagraph (D) by the target date tify and assess the serious risks of such drug Oversight Board shall discuss such drug; and referred to in subparagraph (D)(i); and by the marketing authorities of other coun- ‘‘(III) shall apply section 301(j), section 552 ‘‘(II) has complied with the timing require- tries whose drug approval and risk manage- of title 5, and section 1905 of title 18, United ments of scheduling review by the Drug Safe- ment processes the Secretary deems com- States Code, to any request for information ty Oversight Board, providing a written rec- parable to the drug approval and risk man- about such review. ommendation, and issuing an action letter agement processes of the United States. ‘‘(iii) AGREEMENT AFTER DISCUSSION OR AD- under clauses (ii), (v), and (vi), respectively. ‘‘(K) EFFECT.—Use of the processes de- MINISTRATIVE APPEALS.— ‘‘(ix) DISQUALIFICATION.—No individual who scribed in subparagraphs (I) and (J) shall not ‘‘(I) FURTHER DISCUSSION OR ADMINISTRA- is an employee of the Food and Drug Admin- delay action on an application or a supple- TIVE APPEALS.—A request for review under istration and who reviews a drug or who par- ment to an application for a drug. clause (i) shall not preclude— ticipated in an administrative appeal under ‘‘(L) NO EFFECT ON LABELING CHANGES THAT ‘‘(aa) further discussions to reach agree- clause (iii)(I) with respect to such drug may DO NOT REQUIRE PREAPPROVAL.—In the case of ment on the risk evaluation and mitigation serve on the Drug Safety Oversight Board at a labeling change to which section 314.70 of strategy; or a meeting under clause (iv) to review a dis- title 21, Code of Federal Regulations (or any ‘‘(bb) the use of administrative appeals pute about the risk evaluation and mitiga- successor regulation), applies for which the within the Food and Drug Administration to tion strategy for such drug. submission of a supplemental application is reach agreement on the strategy, including ‘‘(x) ADDITIONAL EXPERTISE.—The Drug not required or for which distribution of the the major dispute resolution procedures as Safety Oversight Board may add members drug involved may commence upon the re- set forth in the letters described in section with relevant expertise from the Food and ceipt by the Secretary of a supplemental ap- 735(a). Drug Administration, including the Office of plication for the change, the submission of ‘‘(II) AGREEMENT TERMINATES DISPUTE RES- Pediatrics, the Office of Women’s Health, or an assessment of the approved risk evalua- OLUTION.—At any time before a decision and the Office of Rare Diseases, or from other tion and mitigation strategy for the drug order is issued under clause (vi), the Sec- Federal public health or health care agen- under this subsection is not required. retary (acting through the offices described cies, for a meeting under clause (iv) of the ‘‘(8) DRUG SAFETY OVERSIGHT BOARD.— in subparagraph (A)(ii)(I)) and the applicant Drug Safety Oversight Board. ‘‘(A) IN GENERAL.—There is established a may reach an agreement on the risk evalua- ‘‘(H) USE OF ADVISORY COMMITTEES.—The Drug Safety Oversight Board. tion and mitigation strategy through further Secretary (acting through the offices de- ‘‘(B) COMPOSITION; MEETINGS.—The Drug discussion or administrative appeals, termi- scribed in subparagraph (A)(ii)(I)) may con- Safety Oversight Board shall— nating the dispute resolution process, and vene a meeting of 1 or more advisory com- ‘‘(i) be composed of scientists and health the Secretary shall issue an action letter or mittees of the Food and Drug Administra- care practitioners appointed by the Sec- order, as appropriate, that describes the tion to— retary, each of whom is an employee of the strategy. ‘‘(i) review a concern about the safety of a Federal Government; ‘‘(iv) MEETING OF THE BOARD.—At the meet- drug or class of drugs, including before an as- ‘‘(ii) include representatives from offices ing of the Drug Safety Oversight Board de- sessment of the risk evaluation and mitiga- throughout the Food and Drug Administra- scribed in clause (ii), the Board shall— tion strategy or strategies of such drug or tion (including the offices responsible for ‘‘(I) hear from both parties; and drugs is required to be submitted under sub- postapproval safety of drugs); ‘‘(II) review the dispute. clause (II), (III), (IV), or (V) of subparagraph ‘‘(iii) include at least 1 representative each ‘‘(v) RECOMMENDATION OF THE BOARD.—Not (B)(ii); from the National Institutes of Health, the later than 5 days after such meeting of the ‘‘(ii) review the risk evaluation and miti- Department of Health and Human Services Drug Safety Oversight Board, the Board gation strategy or strategies of a drug or (other than the Food and Drug Administra- shall provide a written recommendation on group of drugs; or tion), and the Veterans Health Administra- resolving the dispute to the Secretary. ‘‘(iii) with the consent of the applicant, re- tion; and ‘‘(vi) ACTION BY THE SECRETARY.— view a dispute under subparagraph (G). ‘‘(iv) meet at least monthly to provide ‘‘(I) ACTION LETTER.—With respect to a pro- ‘‘(I) PROCESS FOR ADDRESSING DRUG CLASS oversight and advice to the Secretary on the posed risk evaluation and mitigation strat- EFFECTS.— management of important drug safety egy submitted under subparagraph (A)(i) or ‘‘(i) IN GENERAL.—When a concern about a issues.’’. (A)(ii)(II)(aa) or to an assessment of the serious risk of a drug may be related to the SEC. 203. ENFORCEMENT. strategy submitted under subparagraph pharmacological class of the drug, the Sec- (a) MISBRANDING.—Section 502 of the Fed- (B)(ii)(I), the Secretary shall issue an action retary (acting through the offices described eral Food, Drug, and Cosmetic Act (21 U.S.C. letter that resolves the dispute not later in subparagraph (A)(ii)(I)) may defer assess- 352) is amended by adding at the end the fol- than the later of— ments of the approved risk evaluation and lowing: ‘‘(aa) the action deadline for the action let- mitigation strategies for such drugs until ‘‘(x) If it is a drug subject to an approved ter on the application; or the Secretary has— risk evaluation and mitigation strategy

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00027 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.009 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5342 CONGRESSIONAL RECORD — SENATE May 1, 2007 under section 505(o) and the applicant for ‘‘(III) Prereview of advertising, if required mined under this subparagraph is the sum such drug fails to— under subsection (o)(5)(D) for the applicable of— ‘‘(1) make a labeling change required by listed drug. ‘‘(i) $392,783,000; plus such strategy after the Secretary has ap- ‘‘(IV) Specific disclosures in advertising, if ‘‘(ii) the amount equal to— proved such strategy or completed review of, required under subsection (o)(5)(E) for the ‘‘(I)(aa) for fiscal year 2008, $25,000,000; and acted on, an assessment of such strategy applicable listed drug. ‘‘(bb) for fiscal year 2009, $35,000,000; under paragraph (7) of such section; or ‘‘(V) A temporary moratorium on direct- ‘‘(cc) for fiscal year 2010, $45,000,000; ‘‘(2) comply with a requirement of such to-consumer advertising, if required under ‘‘(dd) for fiscal year 2011, $55,000,000; and strategy with respect to advertising as pro- subsection (o)(5)(F) for the applicable listed ‘‘(ee) for fiscal year 2012, $65,000,000; minus vided for under subparagraph (D), (E), or (F) drug. ‘‘(II) the amount equal to one-fifth of the of paragraph (5) of such section.’’. ‘‘(VI) Elements to assure safe use, if re- amount by which the appropriations for sala- (b) CIVIL PENALTIES.—Section 303(f) of the quired under subsection (o)(6) for the appli- ries and expenses of the Food and Drug Ad- Federal Food, Drug, and Cosmetic Act (21 cable listed drug, except that such drug may ministration for such fiscal year (excluding U.S.C. 333(f)) is amended— use a different, comparable aspect of such the amount of fees appropriated for such fis- (1) by redesignating paragraphs (3), (4), and elements as are necessary to assure safe use cal year) exceed the amount of appropria- (5) as paragraphs (4), (5), and (6), respec- of such drug if — tions for the salaries and expenses of the tively; ‘‘(aa) the corresponding aspect of the ele- Food and Drug Administration for the fiscal (2) by inserting after paragraph (2) the fol- ments to assure safe use for the applicable year 2007 (excluding the amount of fees ap- lowing: listed drug is claimed by a patent that has propriated for such fiscal year), adjusted as ‘‘(3) An applicant (as such term is used in not expired or is a method or process that as provided under subsection (c)(1). section 505(o)) who knowingly fails to com- a trade secret is entitled to protection; and In making the adjustment under subclause ply with a requirement of an approved risk ‘‘(bb) the applicant certifies that it has (II) for any fiscal year 2008 through 2012, sub- evaluation and mitigation strategy under sought a license for use of such aspect of the section (c)(1) shall be applied by substituting such section 505(o) shall be subject to a civil elements to assure safe use for the applicable ‘2007’ for ‘2008’. money penalty of not less than $15,000 and listed drug. ‘‘(C) LIMITATION.—This paragraph shall not not more than $250,000 per violation, and not ‘‘(ii) ACTION BY SECRETARY.—For an appli- apply for any fiscal year if the amount de- to exceed $1,000,000 for all such violations ad- cable listed drug for which a drug is ap- scribed under subparagraph (B)(ii) is less judicated in a single proceeding.’’; proved under this subsection, the Sec- than 0.’’. (3) in paragraph (2)(C), by striking ‘‘para- retary— (c) STRATEGIC PLAN FOR INFORMATION graph (3)(A)’’ and inserting ‘‘paragraph ‘‘(I) shall undertake any communication TECHNOLOGY.—Not later than 1 year after the (4)(A)’’; plan to health care providers required under date of enactment of this title, the Secretary (4) in paragraph (4), as so redesignated, by section (o)(5)(C) for the applicable listed of Health and Human Services (referred to in striking ‘‘paragraph (1) or (2)’’ each place it drug; this title as the ‘‘Secretary’’) shall submit to appears and inserting ‘‘paragraph (1), (2), or ‘‘(II) shall conduct, or contract for, any the Committee on Health, Education, Labor, (3)’’; and postapproval study required under sub- and Pensions and the Committee on Appro- (5) in paragraph (6), as so redesignated, by section (o)(4)(B) for the applicable listed priations of the Senate and the Committee striking ‘‘paragraph (4)’’ each place it ap- drug; on Energy and Commerce and the Committee pears and inserting ‘‘paragraph (5)’’. ‘‘(III) shall inform the applicant for a drug on Appropriations of the House of Represent- approved under this subsection if the ap- atives, a strategic plan on information tech- SEC. 204. REGULATION OF DRUGS THAT ARE BIO- proved risk evaluation and mitigation strat- LOGICAL PRODUCTS. nology that includes— egy for the applicable listed drug is modified; Section 351 of the Public Health Service (1) an assessment of the information tech- and Act (42 U.S.C. 262) is amended— nology infrastructure, including systems for ‘‘(IV) in order to minimize the burden on (1) in subsection (a)(2), by adding at the data collection, access to data in external the health care delivery system of different end the following: health care databases, data mining capabili- elements to assure safe use for the drug ap- ‘‘(D) RISK EVALUATION AND MITIGATION ties, personnel, and personnel training pro- proved under this subsection and the applica- STRATEGY.—A person that submits an appli- grams, needed by the Food and Drug Admin- ble listed drug, may seek to negotiate a vol- cation for a license for a drug under this istration to— untary agreement with the owner of the pat- paragraph may submit to the Secretary as (A) comply with the requirements of this ent, method, or process for a license under part of the application a proposed risk eval- subtitle (and the amendments made by this which the applicant for such drug may use uation and mitigation strategy as described subtitle); an aspect of the elements to assure safe use, under section 505(o) of the Federal Food, (B) achieve interoperability within and if required under subsection (o)(6) for the ap- Drug, and Cosmetic Act.’’; and among the centers of the Food and Drug Ad- plicable listed drug, that is claimed by a pat- (2) in subsection (j), by inserting ‘‘, includ- ministration and between the Food and Drug ent that has not expired or is a method or ing the requirements under section 505(o) of Administration and product application process that as a trade secret is entitled to such Act,’’ after ‘‘, and Cosmetic Act’’. sponsors; protection.’’. SEC. 205. NO EFFECT ON WITHDRAWAL OR SUS- (C) utilize electronic health records; SEC. 207. RESOURCES. PENSION OF APPROVAL. (D) implement routine active surveillance (a) USER FEES.—Subparagraph (F) of sec- Section 505(e) of the Federal Food, Drug, under section 505(k)(3) (including com- tion 735(d)(6) of the Federal Food, Drug, and plementary approaches under subsection (c) and Cosmetic Act (21 U.S.C. 355(e)) is amend- Cosmetic Act (21 U.S.C. 379g(d)(6)), as amend- ed by adding at the end the following: ‘‘The of such section) of the Federal Food, Drug, ed by section 103, as amended— and Cosmetic Act, as added by section 201 of Secretary may withdraw the approval of an (1) in clause (ii), by striking ‘‘systems); application submitted under this section, or this Act; and and’’ and inserting ‘‘systems);’’ (E) communicate drug safety information suspend the approval of such an application, (2) in clause (iii), by striking ‘‘bases).’’ and as provided under this subsection, without to physicians and other health care pro- inserting ‘‘bases); and’’; and viders; first ordering the applicant to submit an as- (3) by adding at the end the following: sessment of the approved risk evaluation and (2) an assessment of the extent to which ‘‘(iv) reviewing, implementing, and ensur- the current information technology assets of mitigation strategy for the drug under sub- ing compliance with risk evaluation and section (o)(7)(B)(ii)(V).’’. the Food and Drug Administration are suffi- mitigation strategies.’’. cient to meet the needs assessments under SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED (b) ADDITIONAL FEE REVENUES FOR DRUG paragraph (1); NEW DRUG APPLICATION. SAFETY.—Section 736 of the Federal Food, Section 505(j)(2) of the Federal Food, Drug, Drug, and Cosmetic Act (21 U.S.C. 379h), as (3) a plan for enhancing the information and Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by section 103, is amended by— technology assets of the Food and Drug Ad- amended by adding at the end the following: (1) striking the subsection designation and ministration toward meeting the needs as- ‘‘(E) RISK EVALUATION AND MITIGATION all that follows through ‘‘.—Except’’ and in- sessments under paragraph (1); and STRATEGY REQUIREMENT.— serting the following: (4) an assessment of additional resources ‘‘(i) IN GENERAL.—A drug that is the sub- ‘‘(b) FEE REVENUE AMOUNTS.— needed to so enhance the information tech- ject of an abbreviated new drug application ‘‘(1) IN GENERAL.—Except’’; and nology assets of the Food and Drug Adminis- under this subsection shall be subject to only (2) adding at the end the following: tration. the following elements of the approved risk ‘‘(2) ADDITIONAL FEE REVENUES FOR DRUG SEC. 208. SAFETY LABELING CHANGES. evaluation and mitigation strategy if re- SAFETY.— (a) IN GENERAL.—Subchapter A of chapter quired under subsection (o) for the applicable ‘‘(A) IN GENERAL.—Subject to subparagraph V of the Federal Food, Drug, and Cosmetic listed drug: (C), in each of fiscal years 2008 through 2012, Act (21 U.S.C. 351 et seq.) is amended by in- ‘‘(I) Labeling, as required under subsection paragraph (1) shall be applied by substituting serting after section 506C the following: (o)(3)(A) for the applicable listed drug. the amount determined under subparagraph ‘‘SEC. 506D. SAFETY LABELING CHANGES. ‘‘(II) A Medication Guide or patient pack- (B) for ‘$392,783,000’. ‘‘(a) NEW SAFETY INFORMATION.— age insert, if required under subsection ‘‘(B) AMOUNT DETERMINED.—For any fiscal ‘‘(1) NOTIFICATION.—The holder of an ap- (o)(5)(B) for the applicable listed drug. year 2008 through 2012, the amount deter- proved application under section 505 of this

VerDate Aug 31 2005 03:06 May 02, 2007 Jkt 059060 PO 00000 Frm 00028 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.009 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5343 Act or a license under section 351 of the Pub- than 45 calendar days after the initiation of subparagraph (A) or (B) of paragraph (5), lic Health Service Act (referred to in this the accelerated labeling review process. does not agree to make a safety labeling section as a ‘holder’) shall promptly notify ‘‘(C) DISPUTE PROCEEDINGS.—If the Sec- change ordered by the Secretary, the Sec- the Secretary if the holder becomes aware of retary and holder do not reach an agreement retary may deem the drug that is the subject new safety information that the holder be- regarding the safety labeling changes by not of the request to be misbranded. lieves should be included in the labeling of later than 25 calendar days after the initi- ‘‘(d) RULE OF CONSTRUCTION.—Nothing in the drug. The Secretary shall promptly no- ation of the accelerated labeling review proc- this section shall be construed to change the tify the holder if the Secretary becomes ess, the dispute automatically shall be re- standards in existence on the date of enact- aware of new safety information that the ferred to the director of the drug evaluation ment of this section for determining whether Secretary believes should be included in the office responsible for the drug under consid- safety labeling changes are necessary or ap- labeling of the drug. eration, who shall be required to take an ac- propriate.’’. ‘‘(2) DISCUSSION REGARDING LABELING tive role in such discussions. (b) CONFORMING AMENDMENT.—Section 502 CHANGES.—Following notification pursuant ‘‘(3) REQUEST FOR SAFETY LABELING CHANGE of the Federal Food, Drug, and Cosmetic Act to paragraph (1), the Secretary and holder AND FAILURE TO AGREE.—If the Secretary and (21 U.S.C. 352 et seq.), as amended by section shall initiate discussions of the new safety holder fail to reach an agreement on appro- 203, is further amended by adding at the end information in order to reach agreement on priate safety labeling changes by not later the following: whether the labeling for the drug should be than 45 calendar days after the initiation of ‘‘(y) If it is a drug and the holder does not modified to reflect the new safety informa- the accelerated labeling review process— agree to make a safety labeling change or- tion and, if so, on the contents of such label- ‘‘(A) on the next calendar day (other than dered by the Secretary under section 506D(c) ing changes. a weekend or Federal holiday) after such pe- within 10 days after issuance of such an order.’’. ‘‘(3) SUPPLEMENT.—If the Secretary deter- riod, the Secretary shall— mines that there is reasonable scientific evi- ‘‘(i) request in writing that the holder SEC. 209. POSTMARKET DRUG SAFETY INFORMA- TION FOR PATIENTS AND PRO- dence that an adverse event is associated make any safety labeling change that the VIDERS. with use of the drug, the Secretary may re- Secretary determines to be necessary and ap- Section 505 of the Federal Food, Drug, and quest the holder to submit a supplement to propriate based upon the new safety informa- Cosmetic Act (21 U.S.C. 355), as amended by an application under section 505 of this Act tion; or section 251, is amended by adding at the end or to a license under section 351 of the Public ‘‘(ii) notify the holder in writing that the the following: Health Service Act (referred to in this sec- Secretary has determined that no safety la- ‘‘(r) POSTMARKET DRUG SAFETY INFORMA- tion as a ‘supplement’) proposing changes to beling change is necessary or appropriate; TION FOR PATIENTS AND PROVIDERS.— the approved labeling to reflect the new safe- and ‘‘(1) ESTABLISHMENT.—Not later than 1 year ty information, including changes to boxed ‘‘(B) if the Secretary fails to act within the after the date of enactment of the Enhancing warnings, contraindications, warnings, pre- specified time, or if the holder does not agree Drug Safety and Innovation Act of 2007, the cautions, or adverse reactions (referred to in to make a safety labeling change requested Secretary shall improve the transparency of this section as a ‘safety labeling change’). If by the Secretary or does not agree with the pharmaceutical data and allow patients and the Secretary determines that no safety la- Secretary’s determination that no labeling health care providers better access to phar- beling change is necessary or appropriate change is necessary or appropriate, the Sec- maceutical data by developing and maintain- based upon the new safety information, the retary (on his own initiative or upon request ing an Internet website that— Secretary shall notify the holder of this de- by the holder) shall refer the matter for ex- ‘‘(A) provides comprehensive drug safety termination in writing. pedited review to the Drug Safety Oversight information for prescription drugs that are ‘‘(b) LABELING SUPPLEMENTS.— Board. approved by the Secretary under this section ‘‘(1) IN GENERAL.—The holder shall submit ‘‘(4) ACTION BY THE DRUG SAFETY OVERSIGHT or licensed under section 351 of the Public a supplement whenever the holder seeks, ei- BOARD.—Not later than 45 days after receiv- Health Service Act; and ther at the holder’s own initiative or at the ing a referral under paragraph (3)(B), the ‘‘(B) improves communication of drug safe- request of the Secretary, to make a safety Drug Safety Oversight Board shall— ty information to patients and providers. labeling change. ‘‘(A) review the new safety information; ‘‘(2) INTERNET WEBSITE.—The Secretary ‘‘(2) NONACCELERATED PROCESS.—Unless the ‘‘(B) review all written material submitted shall carry out paragraph (1) by— accelerated labeling review process described by the Secretary and the holder; ‘‘(A) developing and maintaining an acces- in subsection (c) is initiated, any supplement ‘‘(C) convene a meeting to hear oral pres- sible, consolidated Internet website with eas- proposing a safety labeling change shall be entations and arguments from the Secretary ily searchable drug safety information, in- reviewed and acted upon by the Secretary and holder; and cluding the information found on United not later than 30 days after the date the Sec- ‘‘(D) make a written recommendation to States Government Internet websites, such retary receives the supplement. Until the the Secretary— as the United States National Library of Secretary acts on such a supplement pro- ‘‘(i) concerning appropriate safety labeling Medicine’s Daily Med and Medline Plus posing a safety labeling change, the existing changes, if any; or websites, in addition to other such websites approved labeling shall remain in effect and ‘‘(ii) stating that no safety labeling maintained by the Secretary; be distributed by the holder without change. changes are necessary or appropriate based ‘‘(B) ensuring that the information pro- ‘‘(3) NEW SAFETY INFORMATION.—Nothing in upon the new safety information. vided on the Internet website is comprehen- this section shall prohibit the Secretary ‘‘(5) CONSIDERATION OF RECOMMENDATIONS.— sive and includes, when available and appro- from informing health care professionals or ‘‘(A) ACTION BY THE SECRETARY.—The Sec- priate— the public about new safety information retary shall consider the recommendation of ‘‘(i) patient labeling and patient packaging prior to approval of a supplement proposing the Drug Safety Oversight Board made under inserts; a safety labeling change. paragraph (4)(D) and, not later than 20 days ‘‘(ii) a link to a list of each drug, whether ‘‘(c) ACCELERATED LABELING REVIEW PROC- after receiving the recommendation— approved under this section or licensed under ESS.—An accelerated labeling review process ‘‘(i) issue an order requiring the holder to such section 351, for which a Medication shall be available to resolve disagreements make any safety labeling change that the Guide, as provided for under part 208 of title in a timely manner between the Secretary Secretary determines to be necessary and ap- 21, Code of Federal Regulations (or any suc- and a holder about the need for, or content propriate; or cessor regulations), is required; of, a safety labeling change, as follows: ‘‘(ii) if the Secretary determines that no ‘‘(iii) a link to the clinical trial registry ‘‘(1) REQUEST TO INITIATE ACCELERATED safety labeling change is necessary or appro- data bank provided for under subsections (i) PROCESS.—The accelerated labeling review priate, the Secretary shall notify the holder and (j) of section 402 of the Public Health process shall be initiated upon the written of this determination in writing. Service Act; request of either the Secretary or the holder. ‘‘(B) FAILURE TO ACT.—If the Secretary ‘‘(iv) the most recent safety information Such request may be made at any time after fails to act by not later than 20 days after re- and alerts issued by the Food and Drug Ad- the notification described in subsection ceiving the recommendation of the Drug ministration for drugs approved by the Sec- (a)(1), including during the Secretary’s re- Safety Oversight Board, the written rec- retary under this section, such as product re- view of a supplement proposing a safety la- ommendation of the Drug Safety Oversight calls, warning letters, and import alerts; beling change. Board shall be considered the order of the ‘‘(v) publicly available information about ‘‘(2) SCIENTIFIC DISCUSSION AND MEETINGS.— Secretary under this paragraph. implemented RiskMAPs and risk evaluation ‘‘(A) IN GENERAL.—Following initiation of ‘‘(C) NONDELEGATION.—The Secretary’s au- and mitigation strategies under subsection the accelerated labeling review process, the thority under this paragraph shall not be re- (o); Secretary and holder shall immediately ini- delegated to an individual below the level of ‘‘(vi) guidance documents and regulations tiate discussions to review and assess the the Director of the Center for Drug Evalua- related to drug safety; and new safety information and to reach agree- tion and Research, or the Director of the ‘‘(vii) other material determined appro- ment on whether safety labeling changes are Center for Biologics Evaluation and Re- priate by the Secretary; necessary and appropriate and, if so, the con- search, of the Food and Drug Administra- ‘‘(C) including links to non-Food and Drug tent of such safety labeling changes. tion. Administration Internet resources that pro- ‘‘(B) TIME PERIOD.—The discussions under ‘‘(6) MISBRANDING.—If the holder, not later vide access to relevant drug safety informa- this paragraph shall not extend for more than 10 days after receiving an order under tion, such as medical journals and studies;

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REFERRAL TO ADVISORY COMMITTEE. sponsors to submit adverse event reports application. Section 505 of the Federal Food, Drug, and through the Internet website; ‘‘(ii) Documents pertaining to the format Cosmetic Act, as amended by section 202, is ‘‘(F) providing educational materials for and content of the application generated further amended by adding at the end the patients and providers about the appropriate during drug development. following: means of disposing of expired, damaged, or ‘‘(iii) Labeling submitted by the applicant. ‘‘(p) REFERRAL TO ADVISORY COMMITTEE.— unusable medications; and ‘‘(iv) A summary review that documents ‘‘(1) IN GENERAL.—Prior to the approval of ‘‘(G) supporting initiatives that the Sec- conclusions from all reviewing disciplines a drug no active ingredient (including any retary determines to be useful to fulfill the about the drug, noting any critical issues ester or salt of the active ingredient) of purposes of the Internet website. and disagreements with the applicant and which has been approved in any other appli- ‘‘(3) POSTING OF DRUG LABELING.—The Sec- how they were resolved, recommendation for cation under this section or section 351 of retary shall post on the Internet website es- action, and an explanation of any nonconcur- the Public Health Service Act, the Secretary tablished under paragraph (1) the approved rence with review conclusions. shall refer such drug to a Food and Drug Ad- professional labeling and any required pa- ‘‘(v) If applicable, a separate review from a ministration advisory committee for review tient labeling of a drug approved under this supervisor who does not concur with the at a meeting of such advisory committee. section or licensed under such section 351 not summary review. ‘‘(2) EXCEPTION.—Notwithstanding para- later than 21 days after the date the drug is ‘‘(vi) Identification by name of each officer graph (1), an advisory committee review of a approved or licensed, including in a supple- or employee of the Food and Drug Adminis- drug described under such paragraph may mental application with respect to a labeling tration who— occur within 1 year after approval of such a change. ‘‘(I) participated in the decision to approve drug if— ‘‘(4) PRIVATE SECTOR RESOURCES.—To en- the application; and ‘‘(A) the clinical trial that formed the pri- sure development of the Internet website by ‘‘(II) consents to have his or her name in- mary basis of the safety and efficacy deter- the date described in paragraph (1), the Sec- cluded in the package. mination was halted by a drug safety moni- retary may, on a temporary or permanent ‘‘(D) DISAGREEMENTS.—A scientific review toring board or an Institutional Review basis, implement systems or products devel- of an application is considered the work of Board before its scheduled completion due to oped by private entities. the reviewer and shall not be altered by early unanticipated therapeutic results; or ‘‘(5) AUTHORITY FOR CONTRACTS.—The Sec- management or the reviewer once final. Dis- ‘‘(B) the Secretary determines that it retary may enter into contracts with public agreements by team leaders, division direc- would be beneficial to the public health.’’. and private entities to fulfill the require- tors, or office directors with any or all of the SEC. 213. RESPONSE TO THE INSTITUTE OF MEDI- ments of this subsection. major conclusions of a reviewer shall be doc- CINE. (a) IN GENERAL.—Not later than 1 year ‘‘(6) REVIEW.—The Advisory Committee on ument in a separate review or in an adden- Risk Communication under section 566 shall, dum to the review. after the date of enactment of this title, the Secretary shall issue a report responding to on a regular basis, perform a comprehensive ‘‘(E) CONFIDENTIAL INFORMATION.—This the 2006 report of the Institute of Medicine review and evaluation of the types of risk paragraph does not authorize the disclosure entitled ‘‘The Future of Drug Safety—Pro- communication information provided on the of any trade secret or confidential commer- moting and Protecting the Health of the Internet website established under paragraph cial or financial information described in Public’’. (1) and, through other means, shall identify, section 552(b)(4) of title 5, United States (b) CONTENT OF REPORT.—The report issued clarify, and define the purposes and types of Code, unless the Secretary declares an emer- by the Secretary under subsection (a) shall information available to facilitate the effi- gency under section 319 of the Public Health include— cient flow of information to patients and Service Act and such disclosure is necessary (1) an update on the implementation by the providers, and shall recommend ways for the to mitigate the effects of such emergency.’’. Food and Drug Administration of its plan to Food and Drug Administration to work with SEC. 211. RISK COMMUNICATION. respond to the Institute of Medicine report outside entities to help facilitate the dis- Subchapter E of chapter V of the Federal described under such subsection; and pensing of risk communication information Food, Drug, and Cosmetic Act (21 U.S.C. (2) an assessment of how the Food and to patients and providers.’’. 360bbb et seq.) is amended by adding at the Drug Administration has implemented— SEC. 210. ACTION PACKAGE FOR APPROVAL. end the following: (A) the recommendations described in such Section 505(l) of the Federal Food, Drug, ‘‘SEC. 566. RISK COMMUNICATION. Institute of Medicine report; and and Cosmetic Act (21 U.S.C. 355(l)) is amend- ‘‘(a) ADVISORY COMMITTEE ON RISK COMMU- (B) the requirement under paragraph (7) of ed by— NICATION.— section 505(o) of the Federal Food, Drug, and (1) redesignating paragraphs (1), (2), (3), (4), ‘‘(1) IN GENERAL.—The Secretary shall es- Cosmetic Act (as added by this title), that and (5) as subparagraphs (A), (B), (C), (D), tablish an advisory committee to be known the appropriate office responsible for review- and (E), respectively; as the ‘Advisory Committee on Risk Commu- ing a drug and the office responsible for post- (2) striking ‘‘(l) Safety and’’ and inserting nication’ (referred to in this section as the approval safety with respect to the drug act ‘‘(l)(1) Safety and’’; and ‘Committee’). together to assess, implement, and ensure (3) adding at the end the following: ‘‘(2) DUTIES OF COMMITTEE.—The Com- compliance with the requirements of such ‘‘(2) ACTION PACKAGE FOR APPROVAL.— mittee shall advise the Commissioner on section 505(o). ‘‘(A) ACTION PACKAGE.—The Secretary shall methods to effectively communicate risks SEC. 214. EFFECTIVE DATE AND APPLICABILITY. publish the action package for approval of an associated with the products regulated by (a) EFFECTIVE DATES.— application under subsection (b) or section the Food and Drug Administration. (1) IN GENERAL.—Except as provided in 351 of the Public Health Service Act on the ‘‘(3) MEMBERS.—The Secretary shall ensure paragraph (2), this subtitle shall take effect Internet website of the Food and Drug that the Committee is composed of experts 180 days after the date of enactment of this Administration– on risk communication, experts on the risks title. ‘‘(i) not later than 30 days after the date of described in subsection (b), and representa- (2) USER FEES.—The amendments made by approval of such application for a drug no ac- tives of patient, consumer, and health pro- subsections (a) through (c) of section 207 tive ingredient (including any ester or salt of fessional organizations. shall take effect on October 1, 2007. the active ingredient) of which has been ap- ‘‘(4) PERMANENCE OF COMMITTEE.—Section (b) DRUGS DEEMED TO HAVE RISK EVALUA- proved in any other application under this 14 of the Federal Advisory Committee Act TION AND MITIGATION STRATEGIES.— section or section 351 of the Public Health shall not apply to the Committee established (1) IN GENERAL.—A drug that was approved Service Act; and under this subsection. before the effective date of this subtitle shall ‘‘(ii) not later than 30 days after the third ‘‘(b) PARTNERSHIPS FOR RISK COMMUNICA- be deemed to have an approved risk evalua- request for such action package for approval TION.— tion and mitigation strategy under section received under section 552 of title 5, United ‘‘(1) IN GENERAL.—The Secretary shall part- 505(o) of the Federal Food, Drug, and Cos- States Code, for any other drug. ner with professional medical societies, med- metic Act (as added by this subtitle) if there ‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY ical schools, academic medical centers, and are in effect on the effective date of this sub- REVIEW.—Notwithstanding subparagraph (A), other stakeholders to develop robust and title restrictions on distribution or use— the Secretary shall publish, on the Internet multi-faceted systems for communication to (A) required under section 314.520 or sec- website of the Food and Drug Administra- health care providers about emerging tion 601.42 of title 21, Code of Federal Regula- tion, the materials described in subpara- postmarket drug risks. tions; or graph (C)(iv) not later than 48 hours after ‘‘(2) PARTNERSHIPS.—The systems devel- (B) otherwise agreed to by the applicant the date of approval of the drug, except oped under paragraph (1) shall— and the Secretary for such drug.

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(2) RISK EVALUATION AND MITIGATION STRAT- mural and extramural research and develop- ‘‘(I) 4 shall be representatives of the gen- EGY.—The approved risk evaluation and ment programs relating to the goals and pri- eral pharmaceutical, device, food, cosmetic, mitigation strategy deemed in effect for a orities established under paragraph (2), co- and biotechnology industries; drug under paragraph (1) shall consist of the ordinate Foundation activities with such ‘‘(II) 3 shall be representatives of academic elements described in subparagraphs (A) and programs, and minimize Foundation duplica- research organizations; (B) of paragraph (3) of such section 505(o) and tion of existing efforts; ‘‘(III) 2 shall be representatives of Govern- any other additional elements under para- ‘‘(4) award grants to, or enter into con- ment agencies, including the Food and Drug graphs (4), (5), and (6) in effect for such drug tracts, memoranda of understanding, or co- Administration and the National Institutes on the effective date of this subtitle. operative agreements with, scientists and of Health; (3) NOTIFICATION.—Not later than 30 days entities, which may include the Food and ‘‘(IV) 2 shall be representatives of patient after the effective date of this subtitle, the Drug Administration, university consortia, or consumer advocacy organizations; and Secretary shall notify the applicant for each public-private partnerships, institutions of ‘‘(V) 1 shall be a representative of health drug described in paragraph (1)— higher education, entities described in sec- care providers. (A) that such drug is deemed to have an ap- tion 501(c)(3) of the Internal Revenue Code ‘‘(ii) REQUIREMENT.—The ex officio mem- proved risk evaluation and mitigation strat- (and exempt from tax under section 501(a) of bers shall ensure the Board membership in- egy pursuant to such paragraph; and such Code), and industry, to efficiently and cludes individuals with expertise in areas in- (B) of the date, which, unless a safety issue effectively advance the goals and priorities cluding the sciences of developing, manufac- with the drug arises, shall be no earlier than established under paragraph (2); turing, and evaluating the safety and effec- ‘‘(5) recruit meeting participants and hold 6 months after the applicant is so notified, tiveness of devices, including diagnostics, or sponsor (in whole or in part) meetings as by which the applicant shall submit to the biologics, and drugs, and the safety of food, appropriate to further the goals and prior- Secretary an assessment of such approved food ingredients, and cosmetics. ities established under paragraph (2); strategy under paragraph (7)(B) of such sec- ‘‘(D) INITIAL MEETING.— ‘‘(6) release and publish information and tion 505(o). ‘‘(i) IN GENERAL.—Not later than 30 days data and, to the extent practicable, license, (4) ENFORCEMENT ONLY AFTER ASSESSMENT after the date of the enactment of the En- distribute, and release material, reagents, AND REVIEW.—Neither the Secretary nor the hancing Drug Safety and Innovation Act of Attorney General may seek to enforce a re- and techniques to maximize, promote, and coordinate the availability of such material, 2007, the Secretary shall convene a meeting quirement of a risk evaluation and mitiga- of the ex officio members of the Board to— tion strategy deemed in effect under para- reagents, and techniques for use by the Food and Drug Administration, nonprofit organi- ‘‘(I) incorporate the Foundation; and graph (1) before the Secretary has completed ‘‘(II) appoint the members of the Board in review of, and acted on, the first assessment zations, and academic and industrial re- searchers to further the goals and priorities accordance with subparagraph (C). of such strategy under such section 505(o). ‘‘(ii) SERVICE OF EX OFFICIO MEMBERS.— (c) NO EFFECT ON VETERINARY MEDICINE.— established under paragraph (2); ‘‘(7) ensure that— Upon the appointment of the members of the This subtitle, and the amendments made by Board under clause (i)(II), the terms of serv- this subtitle, shall have no effect on the use ‘‘(A) action is taken as necessary to obtain patents for inventions developed by the ice of the ex officio members of the Board as of drugs approved under section 505 of the members of the Board shall terminate. Federal Food, Drug, and Cosmetic Act by, or Foundation or with funds from the Founda- ‘‘(iii) CHAIR.—The ex officio members of on the lawful written or oral order of, a li- tion; the Board under subparagraph (B) shall des- censed veterinarian within the context of a ‘‘(B) action is taken as necessary to enable ignate an appointed member of the Board to veterinarian-client-patient relationship, as the licensing of inventions developed by the serve as the Chair of the Board. provided for under section 512(a)(5) of such Foundation or with funds from the Founda- Act. tion; and ‘‘(2) DUTIES OF BOARD.—The Board shall— ‘‘(C) executed licenses, memoranda of un- ‘‘(A) establish bylaws for the Foundation Subtitle B—Reagan-Udall Foundation for the that— Food and Drug Administration derstanding, material transfer agreements, contracts, and other such instruments, pro- ‘‘(i) are published in the Federal Register SEC. 221. THE REAGAN-UDALL FOUNDATION FOR mote, to the maximum extent practicable, and available for public comment; THE FOOD AND DRUG ADMINISTRA- ‘‘(ii) establish policies for the selection of TION. the broadest conversion to commercial and the officers, employees, agents, and contrac- (a) IN GENERAL.—Chapter VII of the Fed- noncommercial applications of licensed and tors of the Foundation; eral Food, Drug, and Cosmetic Act (21 U.S.C. patented inventions of the Foundation to ‘‘(iii) establish policies, including ethical 371 et seq.) is amended by adding at the end further the goals and priorities established the following: under paragraph (2); standards, for the acceptance, solicitation, ‘‘(8) provide objective clinical and sci- and disposition of donations and grants to ‘‘Subchapter I—Reagan-Udall Foundation for entific information to the Food and Drug Ad- the Foundation and for the disposition of the the Food and Drug Administration ministration and, upon request, to other assets of the Foundation, including appro- ‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF Federal agencies to assist in agency deter- priate limits on the ability of donors to des- THE FOUNDATION. minations of how to ensure that regulatory ignate, by stipulation or restriction, the use ‘‘(a) IN GENERAL.—A nonprofit corporation policy accommodates scientific advances and or recipient of donated funds; to be known as the Reagan-Udall Foundation meets the agency’s public health mission; ‘‘(iv) establish policies that would subject for the Food and Drug Administration (re- ‘‘(9) conduct annual assessments of the all employees, fellows, and trainees of the ferred to in this subchapter as the ‘Founda- Foundation to the conflict of interest stand- tion’) shall be established in accordance with unmet needs identified in paragraph (1); and ards under section 208 of title 18, United this section. The Foundation shall be headed ‘‘(10) carry out such other activities con- States Code; by an Executive Director, appointed by the sistent with the purposes of the Foundation ‘‘(v) establish licensing, distribution, and members of the Board of Directors under as the Board determines appropriate. subsection (e). The Foundation shall not be ‘‘(d) BOARD OF DIRECTORS.— publication policies that support the widest an agency or instrumentality of the United ‘‘(1) ESTABLISHMENT.— and least restrictive use by the public of in- States Government. ‘‘(A) IN GENERAL.—The Foundation shall formation and inventions developed by the ‘‘(b) PURPOSE OF FOUNDATION.—The purpose have a Board of Directors (referred to in this Foundation or with Foundation funds to of the Foundation is to advance the mission subchapter as the ‘Board’), which shall be carry out the duties described in paragraphs of the Food and Drug Administration to composed of ex officio and appointed mem- (6) and (7) of subsection (c), and may include modernize medical, veterinary, food, food in- bers in accordance with this subsection. All charging cost-based fees for published mate- gredient, and cosmetic product development, appointed members of the Board shall be vot- rial produced by the Foundation; accelerate innovation, and enhance product ing members. ‘‘(vi) specify principles for the review of safety. ‘‘(B) EX OFFICIO MEMBERS.—The ex officio proposals and awarding of grants and con- ‘‘(c) DUTIES OF THE FOUNDATION.—The members of the Board shall be the following tracts that include peer review and that are Foundation shall— individuals or their designees: consistent with those of the Foundation for ‘‘(1) taking into consideration the Critical ‘‘(i) The Commissioner. the National Institutes of Health, to the ex- Path reports and priorities published by the ‘‘(ii) The Director of the National Insti- tent determined practicable and appropriate Food and Drug Administration, identify tutes of Health. by the Board; unmet needs in the development, manufac- ‘‘(iii) The Director of the Centers for Dis- ‘‘(vii) specify a cap on administrative ex- ture, and evaluation of the safety and effec- ease Control and Prevention. penses for recipients of a grant, contract, or tiveness, including postapproval, of devices, ‘‘(iv) The Director of the Agency for cooperative agreement from the Foundation; including diagnostics, biologics, and drugs, Healthcare Research and Quality. ‘‘(viii) establish policies for the execution and the safety of food, food ingredients, and ‘‘(C) APPOINTED MEMBERS.— of memoranda of understanding and coopera- cosmetics; ‘‘(i) IN GENERAL.—The ex officio members tive agreements between the Foundation and ‘‘(2) establish goals and priorities in order of the Board under subparagraph (B) shall, other entities, including the Food and Drug to meet the unmet needs identified in para- by majority vote, appoint to the Board 12 in- Administration; graph (1); dividuals, from a list of candidates to be pro- ‘‘(ix) establish policies for funding training ‘‘(3) in consultation with the Secretary, vided by the National Academy of Sciences. fellowships, whether at the Foundation, aca- identify existing and proposed Federal intra- Of such appointed members— demic or scientific institutions, or the Food

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00031 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.010 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5346 CONGRESSIONAL RECORD — SENATE May 1, 2007 and Drug Administration, for scientists, doc- ‘‘(B) general operations of the Foundation port on an annual basis for the duration of tors, and other professionals who are not em- are to be conducted; and such grant, contract, fellowship, memo- ployees of regulated industry, to foster ‘‘(C) the privileges granted to the Board by randum of understanding, or cooperative greater understanding of and expertise in law are exercised and enjoyed; agreement, that describes the activities car- new scientific tools, diagnostics, manufac- ‘‘(4) with the consent of the applicable ex- ried out under such grant, contract, fellow- turing techniques, and potential barriers to ecutive department or independent agency, ship, memorandum of understanding, or co- translating basic research into clinical and use the information, services, and facilities operative agreement. regulatory practice; of such department or agencies in carrying ‘‘(2) REPORT TO CONGRESS AND THE FDA.— ‘‘(x) specify a process for annual Board re- out this section; Beginning with fiscal year 2009, the Execu- view of the operations of the Foundation; ‘‘(5) enter into contracts with public and tive Director shall submit to Congress and and private organizations for the writing, edit- the Commissioner an annual report that— ‘‘(xi) establish specific duties of the Execu- ing, printing, and publishing of books and ‘‘(A) describes the activities of the Founda- tive Director; other material; tion and the progress of the Foundation in ‘‘(B) prioritize and provide overall direc- ‘‘(6) hold, administer, invest, and spend furthering the goals and priorities estab- tion to the activities of the Foundation; any gift, devise, or bequest of real or per- lished under subsection (c)(2), including the ‘‘(C) evaluate the performance of the Exec- sonal property made to the Foundation practical impact of the Foundation on regu- utive Director; and under subsection (i); lated product development; ‘‘(D) carry out any other necessary activi- ‘‘(7) enter into such other contracts, leases, ‘‘(B) provides a specific accounting of the ties regarding the functioning of the Founda- cooperative agreements, and other trans- source and use of all funds used by the Foun- tion. actions as the Board considers appropriate to dation to carry out such activities; and ‘‘(3) TERMS AND VACANCIES.— conduct the activities of the Foundation; ‘‘(C) provides information on how the re- ‘‘(A) TERM.—The term of office of each ‘‘(8) modify or consent to the modification sults of Foundation activities could be incor- member of the Board appointed under para- of any contract or agreement to which it is porated into the regulatory and product re- graph (1)(C) shall be 4 years, except that the a party or in which it has an interest under view activities of the Food and Drug Admin- terms of offices for the initial appointed this subchapter; istration. members of the Board shall expire on a stag- ‘‘(9) take such action as may be necessary ‘‘(m) SEPARATION OF FUNDS.—The Execu- gered basis as determined by the ex officio to obtain patents and licenses for devices tive Director shall ensure that the funds re- members. and procedures developed by the Foundation ceived from the Treasury are held in sepa- ‘‘(B) VACANCY.—Any vacancy in the mem- and its employees; rate accounts from funds received from enti- bership of the Board— ‘‘(10) sue and be sued in its corporate name, ties under subsection (i). ‘‘(i) shall not affect the power of the re- and complain and defend in courts of com- ‘‘(n) FUNDING.—From amounts appro- maining members to execute the duties of petent jurisdiction; priated to the Food and Drug Administration the Board; and ‘‘(11) appoint other groups of advisors as for each fiscal year, the Commissioner shall ‘‘(ii) shall be filled by appointment by the may be determined necessary to carry out transfer not less than $500,000 and not more appointed members described in paragraph the functions of the Foundation; and than $1,250,000, to the Foundation to carry (1)(C) by majority vote. ‘‘(12) exercise other powers as set forth in out subsections (a), (b), and (d) through ‘‘(C) PARTIAL TERM.—If a member of the this section, and such other incidental pow- (m).’’. Board does not serve the full term applicable ers as are necessary to carry out its powers, (b) OTHER FOUNDATION PROVISIONS.—Chap- under subparagraph (A), the individual ap- duties, and functions in accordance with this ter VII (21 U.S.C. 371 et seq.) (as amended by pointed under subparagraph (B) to fill the re- subchapter. subsection (a)) is amended by adding at the sulting vacancy shall be appointed for the re- ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER end the following: mainder of the term of the predecessor of the SOURCES.—The Executive Director may so- ‘‘SEC. 771. LOCATION OF FOUNDATION. individual. licit and accept on behalf of the Foundation, ‘‘The Foundation shall, if practicable, be ‘‘(D) SERVING PAST TERM.—A member of any funds, gifts, grants, devises, or bequests located not more than 20 miles from the Dis- the Board may continue to serve after the of real or personal property made to the trict of Columbia. Foundation, including from private entities, expiration of the term of the member until a ‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG successor is appointed. for the purposes of carrying out the duties of ADMINISTRATION. the Foundation. ‘‘(4) COMPENSATION.—Members of the Board ‘‘(a) IN GENERAL.—The Commissioner shall ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Fed- may not receive compensation for service on receive and assess the report submitted to eral Government employees may serve on the Board. Such members may be reimbursed the Commissioner by the Executive Director for travel, subsistence, and other necessary committees advisory to the Foundation and otherwise cooperate with and assist the of the Foundation under section 770(l)(2). expenses incurred in carrying out the duties Foundation in carrying out its functions, so ‘‘(b) REPORT TO CONGRESS.—Beginning with of the Board, as set forth in the bylaws long as such employees do not direct or con- fiscal year 2009, the Commissioner shall sub- issued by the Board. trol Foundation activities. mit to Congress an annual report summa- ‘‘(e) INCORPORATION.—The ex officio mem- ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; rizing the incorporation of the information bers of the Board shall serve as incorporators FELLOWSHIPS.— provided by the Foundation in the report de- and shall take whatever actions necessary to ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Fed- scribed under section 770(l)(2) and by other incorporate the Foundation. eral Government employees may be detailed recipients of grants, contracts, memoranda ‘‘(f) NONPROFIT STATUS.—The Foundation from Federal agencies with or without reim- of understanding, or cooperative agreements shall be considered to be a corporation under bursement to those agencies to the Founda- into regulatory and product review activities section 501(c) of the Internal Revenue Code tion at any time, and such detail shall be of the Food and Drug Administration. of 1986, and shall be subject to the provisions without interruption or loss of civil service ‘‘(c) EXTRAMURAL GRANTS.—The provisions of such section. status or privilege. Each such employee shall of this subchapter shall have no effect on ‘‘(g) EXECUTIVE DIRECTOR.— abide by the statutory, regulatory, ethical, any grant, contract, memorandum of under- ‘‘(1) IN GENERAL.—The Board shall appoint and procedural standards applicable to the standing, or cooperative agreement between an Executive Director who shall serve at the employees of the agency from which such the Food and Drug Administration and any pleasure of the Board. The Executive Direc- employee is detailed and those of the Foun- other entity entered into before, on, or after tor shall be responsible for the day-to-day dation. the date of enactment of the Enhancing Drug operations of the Foundation and shall have ‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF Safety and Innovation Act of 2007.’’. such specific duties and responsibilities as FEDERAL EMPLOYEES.— (c) CONFORMING AMENDMENT.—Section the Board shall prescribe. ‘‘(A) FOUNDATION.—The Executive Director 742(b) of the Federal Food, Drug, and Cos- ‘‘(2) COMPENSATION.—The compensation of of the Foundation may accept the services of metic Act (21 U.S.C. 379l(b)) is amended by the Executive Director shall be fixed by the employees detailed from Federal agencies adding at the end the following: ‘‘Any such Board but shall not be greater than the com- with or without reimbursement to those fellowships and training programs under this pensation of the Commissioner. agencies. section or under section 770(d)(2)(A)(ix) may ‘‘(h) ADMINISTRATIVE POWERS.—In carrying ‘‘(B) FOOD AND DRUG ADMINISTRATION.—The include provision by such scientists and phy- out this subchapter, the Board, acting Commissioner may accept the uncompen- sicians of services on a voluntary and un- through the Executive Director, may— sated services of Foundation fellows or train- compensated basis, as the Secretary deter- ‘‘(1) adopt, alter, and use a corporate seal, ees. Such services shall be considered to be mines appropriate. Such scientists and phy- which shall be judicially noticed; undertaking an activity under contract with sicians shall be subject to all legal and eth- ‘‘(2) hire, promote, compensate, and dis- the Secretary as described in section 708. ical requirements otherwise applicable to of- charge 1 or more officers, employees, and ‘‘(l) ANNUAL REPORTS.— ficers or employees of the Department of agents, as may be necessary, and define their ‘‘(1) REPORTS TO FOUNDATION.—Any recipi- Health and Human Services.’’. duties; ent of a grant, contract, fellowship, memo- SEC. 222. OFFICE OF THE CHIEF SCIENTIST. ‘‘(3) prescribe the manner in which— randum of understanding, or cooperative Chapter IX of the Federal Food, Drug, and ‘‘(A) real or personal property of the Foun- agreement from the Foundation under this Cosmetic Act (21 U.S.C. 391 et seq.) is amend- dation is acquired, held, and transferred; section shall submit to the Foundation a re- ed by adding at the end the following:

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00032 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.010 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5347 ‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. plete an entry in the clinical trial registry ‘‘(IV) requires the inclusion of such other ‘‘(a) ESTABLISHMENT; APPOINTMENT.—The data bank under paragraph (2). data elements to the registry data bank as Secretary shall establish within the Office of ‘‘(iv) COMPLETION DATE.—The term ‘com- appropriate; and the Commissioner an office to be known as pletion date’ means, with respect to an appli- ‘‘(V) becomes effective 90 days after the Office of the Chief Scientist. The Sec- cable drug clinical trial or an applicable de- issuance of the final rule. retary shall appoint a Chief Scientist to lead vice clinical trial, the date on which the last ‘‘(B) FORMAT AND STRUCTURE.— such Office. patient enrolled in the clinical trial has ‘‘(i) SEARCHABLE CATEGORIES.—The Direc- ‘‘(b) DUTIES OF THE OFFICE.—The Office of completed his or her last medical visit of the tor of NIH shall ensure that the public may the Chief Scientist shall— clinical trial, whether the clinical trial con- search the entries in the registry data bank ‘‘(1) oversee, coordinate, and ensure qual- cluded according to the prespecified protocol by 1 or more of the following criteria: ity and regulatory focus of the intramural plan or was terminated. ‘‘(I) The disease or condition being studied research programs of the Food and Drug Ad- ‘‘(v) DEVICE.—The term ‘device’ means a in the clinical trial, using Medical Subject ministration; device as defined in section 201(h) of the Fed- Headers (MeSH) descriptors. ‘‘(2) track and, to the extent necessary, co- eral Food, Drug, and Cosmetic Act. ‘‘(II) The treatment being studied in the ordinate intramural research awards made ‘‘(vi) DRUG.—The term ‘drug’ means a drug clinical trial. by each center of the Administration or as defined in section 201(g) of the Federal ‘‘(III) The location of the clinical trial. science-based office within the Office of the Food, Drug, and Cosmetic Act or a biological ‘‘(IV) The age group studied in the clinical Commissioner, and ensure that there is no product as defined in section 351 of this Act. trial, including pediatric subpopulations. duplication of research efforts sup- ‘‘(vii) RESPONSIBLE PARTY.—The term ‘re- ‘‘(V) The study phase of the clinical trial. ported by the Reagan-Udall Founda- sponsible party’, with respect to a clinical ‘‘(VI) The source of support for the clinical tion for the Food and Drug Administra- trial of a drug or device, means— trial, which may be the National Institutes tion; ‘‘(I) the sponsor of the clinical trial (as de- of Health or other Federal agency, a private ‘‘(3) develop and advocate for a budget to fined in section 50.3 of title 21, Code of Fed- industry source, or a university or other or- support intramural research; eral Regulations (or any successor regula- ganization. ‘‘(4) develop a peer review process by which tions)) or the principal investigator of such ‘‘(VII) The recruitment status of the clin- intramural research can be evaluated; and clinical trial if so designated by such spon- ical trial. ‘‘(5) identify and solicit intramural re- sor; or ‘‘(VIII) The National Clinical Trial number search proposals from across the Food and ‘‘(II) if no sponsor exists, the grantee, con- or other study identification for the clinical Drug Administration through an advisory tractor, or awardee for a trial funded by a trial. board composed of employees of the Admin- Federal agency or the principal investigator ‘‘(ii) FORMAT.—The Director of the NIH istration that shall include— of such clinical trial if so designated by such shall ensure that the registry data bank is ‘‘(A) representatives of each of the centers grantee, contractor, or awardee. easily used by the public, and that entries and the science-based offices within the Of- ‘‘(B) REQUIREMENT.—The Secretary shall are easily compared. fice of the Commissioner; and develop a mechanism by which— ‘‘(C) DATA SUBMISSION.—The responsible ‘‘(B) experts on trial design, epidemiology, ‘‘(i) the responsible party for each applica- party for an applicable drug clinical trial demographics, pharmacovigilance, basic ble drug clinical trial and applicable device shall submit to the Director of NIH for inclu- science, and public health.’’. clinical trial shall submit the identity and sion in the registry data bank the clinical trial information described in subparagraph Subtitle C—Clinical Trials contact information of such responsible party to the Secretary at the time of submis- (A)(ii). SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY sion of clinical trial information under para- ‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMA- DATA BANK. graph (2); and TION.— (a) IN GENERAL.—Section 402 of the Public ‘‘(i) IN GENERAL.—The clinical trial infor- ‘‘(ii) other Federal agencies may identify Health Service Act (42 U.S.C. 282) is amended mation submitted by a responsible party the responsible party for an applicable drug by— under this paragraph shall not be false or clinical trial or applicable device clinical (1) redesignating subsections (j) and (k) as misleading in any particular. trial. subsections (k) and (l), respectively; and ‘‘(ii) EFFECT.—Clause (i) shall not have the ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY (2) inserting after subsection (i) the fol- effect of requiring clinical trial information DATA BANK WITH RESPECT TO CLINICAL TRIAL lowing: with respect to an applicable drug clinical INFORMATION.— ‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY trial or an applicable device clinical trial to ‘‘(A) IN GENERAL.— DATA BANK.— include information from any source other ‘‘(i) EXPANSION OF DATA BANK.—To enhance ‘‘(1) DEFINITIONS; REQUIREMENT.— than such clinical trial involved. patient enrollment and provide a mechanism ‘‘(A) DEFINITIONS.—In this subsection: ‘‘(E) CHANGES IN CLINICAL TRIAL STATUS.— to track subsequent progress of clinical ‘‘(i) APPLICABLE DEVICE CLINICAL TRIAL.— ‘‘(i) ENROLLMENT.—The responsible party The term ‘applicable device clinical trial’ trials, the Secretary, acting through the Di- for an applicable drug clinical trial or an ap- means— rector of NIH, shall expand, in accordance plicable device clinical trial shall update the ‘‘(I) a prospective study of health outcomes with this subsection, the clinical trials reg- enrollment status not later than 30 days comparing an intervention against a control istry of the data bank described under sub- after the enrollment status of such clinical in human subjects intended to support an ap- section (i)(3)(A) (referred to in this sub- trial changes. plication under section 515 or 520(m), or a re- section as the ‘registry data bank’). The Di- ‘‘(ii) COMPLETION.—The responsible party port under section 510(k), of the Federal rector of NIH shall ensure that the registry for an applicable drug clinical trial or appli- Food, Drug, and Cosmetic Act (other than a data bank is made publicly available cable device clinical trial shall report to the limited study to gather essential informa- through the Internet. Director of NIH that such clinical trial is tion used to refine the device or design a piv- ‘‘(ii) CONTENT.—Not later than 18 months complete not later than 30 days after the otal trial and that is not intended to deter- after the date of enactment of the Enhancing completion date of the clinical trial. mine safety and effectiveness of a device); Drug Safety and Innovation Act of 2007, and ‘‘(F) TIMING OF SUBMISSION.—The clinical and after notice and comment, the Secretary trial information for an applicable drug clin- ‘‘(II) a pediatric postmarket surveillance shall promulgate regulations to expand the ical trial or an applicable device clinical as required under section 522 of the Federal registry data bank to require the submission trial required to be submitted under this Food, Drug, and Cosmetic Act. to the registry data bank of clinical trial in- paragraph shall be submitted not later than ‘‘(ii) APPLICABLE DRUG CLINICAL TRIAL.— formation for applicable drug clinical trials 21 days after the first patient is enrolled in ‘‘(I) IN GENERAL.—The term ‘applicable and applicable device clinical trials that— such clinical trial. drug clinical trial’ means a controlled clin- ‘‘(I) conforms to the International Clinical ‘‘(G) POSTING OF DATA.— ical investigation, other than a phase I clin- Trials Registry Platform trial registration ‘‘(i) APPLICABLE DRUG CLINICAL TRIAL.—The ical investigation, of a product subject to data set of the World Health Organization; Director of NIH shall ensure that clinical section 505 of the Federal Food, Drug, and ‘‘(II) includes the city, State, and zip code trial information for an applicable drug clin- Cosmetic Act or to section 351 of this Act. for each clinical trial location, or a toll-free ical trial submitted in accordance with this ‘‘(II) CLINICAL INVESTIGATION.—For pur- number through which such location infor- paragraph is posted publicly within 30 days poses of subclause (I), the term ‘clinical in- mation may be accessed; of such submission. vestigation’ has the meaning given that ‘‘(III) if the drug is not approved under sec- ‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.— term in section 312.3 of title 21, Code of Fed- tion 505 of the Federal Food, Drug, and Cos- The Director of NIH shall ensure that clin- eral Regulations. metic Act or licensed under section 351 of ical trial information for an applicable de- ‘‘(III) PHASE I.—The term ‘phase I’ has the this Act, specifies whether or not there is ex- vice clinical trial submitted in accordance meaning given that term in section 312.21 of panded access to the drug under section 561 with this paragraph is posted publicly within title 21, Code of Federal Regulations. of the Federal Food, Drug, and Cosmetic Act 30 days of clearance under section 510(k) of ‘‘(iii) CLINICAL TRIAL INFORMATION.—The for those who do not qualify for enrollment the Federal Food, Drug, and Cosmetic Act, term ‘clinical trial information’ means those in the clinical trial and how to obtain infor- or approval under section 515 or section data elements that are necessary to com- mation about such access; 520(m) of such Act, as applicable.

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‘‘(H) VOLUNTARY SUBMISSIONS.—A respon- ‘‘(ii) not later than 18 months after initi- of the World Health Organization when pro- sible party for a clinical trial that is not an ating such study, submit to the Secretary mulgating the regulations under subpara- applicable drug clinical trial or an applicable any findings and recommendations of such graph (C). device clinical trial may submit clinical study. ‘‘(E) TRUTHFUL CLINICAL TRIAL INFORMA- trial information to the registry data bank ‘‘(C) NEGOTIATED RULEMAKING.— TION.— in accordance with this subsection. ‘‘(i) IN GENERAL.—The Secretary shall es- ‘‘(i) IN GENERAL.—The clinical trial infor- ‘‘(3) EXPANSION OF REGISTRY DATA BANK TO tablish a negotiated rulemaking process pur- mation submitted by a responsible party INCLUDE RESULTS OF CLINICAL TRIALS.— suant to subchapter IV of chapter 5 of title 5, under this paragraph shall not be false or ‘‘(A) LINKING REGISTRY DATA BANK TO EX- United States Code, to determine, for appli- misleading in any particular. ISTING RESULTS.— cable drug clinical trials— ‘‘(ii) EFFECT.—Clause (i) shall not have the ‘‘(i) IN GENERAL.—Beginning not later than ‘‘(I) how to ensure quality and validate effect of requiring clinical trial information 90 days after the date of enactment of the methods of expanding the registry data bank with respect to an applicable drug clinical Enhancing Drug Safety and Innovation Act to include clinical trial results information trial or an applicable device clinical trial to of 2007, for those clinical trials that form the for trials not within the scope of this Act; include information from any source other primary basis of an efficacy claim or are ‘‘(II) the clinical trials of which the results than such clinical trial involved. conducted after the drug involved is ap- information is appropriate for adding to the ‘‘(F) WAIVERS REGARDING CERTAIN CLINICAL proved or after the device involved is cleared expanded registry data bank; and TRIAL RESULTS.—The Secretary may waive or approved, the Secretary shall ensure that ‘‘(III) the appropriate timing of the posting any applicable requirements of this para- the registry data bank includes links to re- of such results information. graph for an applicable drug clinical trial or sults information for such clinical trial— ‘‘(ii) TIME REQUIREMENT.—The process de- an applicable device clinical trial, upon a ‘‘(I) not earlier than 30 days after the date scribed in paragraph (1) shall be conducted in written request from the responsible person, of the approval of the drug involved or clear- a timely manner to ensure that— if the Secretary determines that extraor- ance or approval of the device involved; or ‘‘(I) any recommendation for a proposed dinary circumstances justify the waiver and ‘‘(II) not later than 30 days after such in- rule— that providing the waiver is in the public in- formation becomes publicly available, as ap- ‘‘(aa) is provided to the Secretary not later terest, consistent with the protection of pub- plicable. than 21 months after the date of the enact- lic health, or in the interest of national secu- ‘‘(ii) REQUIRED INFORMATION.— ment of the Enhancing Drug Safety and In- rity. Not later than 30 days after any part of ‘‘(I) FDA INFORMATION.—The Secretary novation Act of 2007; and a waiver is granted, the Secretary shall no- shall ensure that the registry data bank in- ‘‘(bb) includes an assessment of the bene- tify, in writing, the appropriate committees cludes links to the following information: fits and costs of the recommendation; and of Congress of the waiver and provide an ex- ‘‘(aa) If an advisory committee considered ‘‘(II) a final rule is promulgated not later planation for why the waiver was granted. at a meeting an applicable drug clinical trial than 30 months after the date of the enact- ‘‘(4) COORDINATION AND COMPLIANCE.— or an applicable device clinical trial, any ment of the Enhancing Drug Safety and In- ‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS posted Food and Drug Administration sum- novation Act of 2007, taking into account the FROM FEDERAL AGENCIES.— mary document regarding such applicable recommendations under subclause (I) and the ‘‘(i) IN GENERAL.—No Federal agency may drug clinical trial or applicable clinical de- results of the feasibility study conducted release funds under a research grant to an vice trial. under subparagraph (B). awardee who has not complied with para- ‘‘(bb) If an applicable drug clinical trial ‘‘(iii) REPRESENTATION ON NEGOTIATED graph (2) for any applicable drug clinical was conducted under section 505A or 505B of RULEMAKING COMMITTEE.—The negotiated trial or applicable device clinical trial for the Federal Food, Drug, and Cosmetic Act, a rulemaking committee established by the which such person is the responsible party. link to the posted Food and Drug Adminis- Secretary pursuant to clause (i) shall include ‘‘(ii) GRANTS FROM CERTAIN FEDERAL AGEN- tration assessment of the results of such members representing— CIES.—If an applicable drug clinical trial or trial. ‘‘(I) the Food and Drug Administration; applicable device clinical trial is funded in ‘‘(cc) Food and Drug Administration public ‘‘(II) the National Institutes of Health; whole or in part by a grant from the Food health advisories regarding the drug or de- ‘‘(III) other Federal agencies as the Sec- and Drug Administration, National Insti- vice that is the subject of the applicable drug retary determines appropriate; tutes of Health, the Agency for Healthcare clinical trial or applicable device clinical ‘‘(IV) patient advocacy and health care Research and Quality, or the Department of trial, respectively, if any. provider groups; Veterans Affairs, any grant or progress re- ‘‘(dd) For an applicable drug clinical trial, ‘‘(V) the pharmaceutical industry; port forms required under such grant shall the Food and Drug Administration action ‘‘(VI) contract clinical research organiza- include a certification that the responsible package for approval document required tions; party has made all required submissions to under section 505(l)(2) of the Food Drug and ‘‘(VII) the International Committee of the Director of NIH under paragraph (2). Cosmetic Act. Medical Journal Editors; and ‘‘(iii) VERIFICATION BY FEDERAL AGENCIES.— ‘‘(ee) For an applicable device clinical ‘‘(VIII) other interested parties, including The heads of the agencies referred to in trial, in the case of a premarket application, experts in privacy protection, pediatrics, clause (ii), as applicable, shall verify that the detailed summary of information re- health information technology, health lit- the clinical trial information for each appli- specting the safety and effectiveness of the eracy, communication, clinical trial design cable drug clinical trial or applicable device device required under section 520(h)(1) of the and implementation, and health care ethics. clinical trial for which a grantee is the re- Federal Food, Drug, and Cosmetic Act, or, in ‘‘(iv) CONTENT OF REGULATIONS.—The regu- sponsible party has been submitted under the case of a report under section 510(k) of lations promulgated pursuant to clause (i) paragraph (2) before releasing any remaining such Act, the section 510(k) summary of the shall establish— funding for a grant or funding for a future safety and effectiveness data required under ‘‘(I) procedures to determine which clinical grant to such grantee. section 807.95(d) of title 21, Code of Federal trials results information data elements ‘‘(iv) NOTICE AND OPPORTUNITY TO REM- Regulations (or any successor regulations). shall be included in the registry data bank, EDY.—If the head of an agency referred to in ‘‘(II) NIH INFORMATION.—The Secretary taking into account the needs of different clause (ii), as applicable, verifies that a shall ensure that the registry data bank in- populations of users of the registry data grantee has not submitted clinical trial in- cludes links to the following information: bank; formation as described in clause (iii), such ‘‘(aa) Medline citations to any publications ‘‘(II) a standard format for the submission agency head shall provide notice to such regarding each applicable drug clinical trial of clinical trials results to the registry data grantee of such non-compliance and allow and applicable device clinical trial. bank; such grantee 30 days to correct such non- ‘‘(bb) The entry for the drug that is the ‘‘(III) a standard procedure for the submis- compliance and submit the required clinical subject of an applicable drug clinical trial in sion of clinical trial results information, in- trial information. the National Library of Medicine database of cluding the timing of submission and the ‘‘(v) CONSULTATION WITH OTHER FEDERAL structured product labels, if available. timing of posting of results information, to AGENCIES.—The Secretary shall— ‘‘(iii) RESULTS FOR EXISTING DATA BANK EN- the registry data bank, taking into account ‘‘(I) consult with other agencies that con- TRIES.—The Secretary may include the links the possible impacts on publication of manu- duct research involving human subjects in described in clause (ii) for data bank entries scripts based on the clinical trial; accordance with any section of part 46 of for clinical trials submitted to the data bank ‘‘(IV) a standard procedure for the title 45, Code of Federal Regulations (or any prior to enactment of the Enhancing Drug verification of clinical trial results informa- successor regulations), to determine if any Safety and Innovation Act of 2007, as avail- tion, including ensuring that free text data such research is an applicable drug clinical able. elements are non-promotional; and trial or an applicable device clinical trial ‘‘(B) FEASIBILITY STUDY.—The Director of ‘‘(V) an implementation plan for the under paragraph (1); and NIH shall— prompt inclusion of clinical trials results in- ‘‘(II) develop with such agencies procedures ‘‘(i) conduct a study to determine the best, formation in the registry data bank. comparable to those described in clauses (ii), validated methods of making the results of ‘‘(D) CONSIDERATION OF WORLD HEALTH OR- (iii), and (iv) to ensure that clinical trial in- clinical trials publicly available after the ap- GANIZATION DATA SET.—The Secretary shall formation for such applicable drug clinical proval of the drug that is the subject of an consider the status of the consensus data ele- trials and applicable device clinical trial is applicable drug clinical trial; and ments set for reporting clinical trial results submitted under paragraph (2).

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‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, BI- (3) NEW DRUGS AND DEVICES.— (d) TRANSITION RULE; EFFECTIVE DATE OF OLOGICAL PRODUCT, AND DEVICE SUBMIS- (A) INVESTIGATIONAL NEW DRUGS.—Section FUNDING RESTRICTIONS.— SIONS.—At the time of submission of an ap- 505(i) of the Federal Food, Drug, and Cos- (1) TRANSITION RULE FOR CLINICAL TRIALS plication under section 505 of the Federal metic Act (21 U.S.C. 355(i)) is amended in INITIATED PRIOR TO EXPANSION OF REGISTRY Food, Drug, and Cosmetic Act, section 515 of paragraph (4), by adding at the end the fol- DATA BANK.—The responsible party (as de- such Act, section 520(m) of such Act, or sec- lowing: ‘‘The Secretary shall update such fined in paragraph (1) of section 402(j) of the tion 351 of this Act, or submission of a report regulations to require inclusion in the in- Public Health Service Act (as added by this under section 510(k) of such Act, such appli- formed consent form a statement that clin- section)) for an applicable drug clinical trial cation or submission shall be accompanied ical trial information for such clinical inves- or applicable device clinical trial (as defined by a certification that all applicable require- tigation has been or will be submitted for in- under such paragraph (1)) that is initiated ments of this subsection have been met. clusion in the registry data bank pursuant to after the date of enactment of this subtitle Where available, such certification shall in- subsections (i) and (j) of section 402 of the and before the effective date of the regula- clude the appropriate National Clinical Trial Public Health Service Act.’’. tions promulgated under paragraph (2) of control numbers. (B) NEW DRUG APPLICATIONS.—Section such section 402(j), shall submit required ‘‘(C) VERIFICATION OF SUBMISSION PRIOR TO 505(b) of the Federal, Food, Drug, and Cos- clinical trial information under such section POSTING.—In the case of clinical trial infor- metic Act (21 U.S.C. 355(b)) is amended by not later than 120 days after such effective mation that is submitted under paragraph adding at the end the following: date. (2), but is not made publicly available pend- ‘‘(6) An application submitted under this (2) FUNDING RESTRICTIONS.—Subparagraph ing regulatory approval or clearance, as ap- subsection shall be accompanied by the cer- (A) of paragraph (4) of such section 402(j) plicable, the Director of NIH shall respond to tification required under section 402(j)(4)(B) shall take effect 210 days after the effective inquiries from other Federal agencies and of the Public Health Service Act. Such cer- date of the regulations promulgated under peer-reviewed scientific journals to confirm tification shall not be considered an element paragraph (2) of such section 402(j). that such clinical trial information has been of such application.’’. (e) EFFECTIVE DATE.— submitted but has not yet been posted. (C) DEVICE REPORTS UNDER SECTION 510(k).— (1) IN GENERAL.—Beginning 90 days after ‘‘(5) LIMITATION ON DISCLOSURE OF CLINICAL Section 510(k) of the Federal Food, Drug, and the date of enactment of this title, the re- TRIAL INFORMATION.— Cosmetic Act (21 U.S.C. 360(k)) is amended by sponsible party for an applicable drug clin- ‘‘(A) IN GENERAL.—Nothing in this sub- adding at the end the following: ical trial or an applicable device clinical section (or under section 552 of title 5, ‘‘A notification submitted under this sub- trial (as that term is defined in such section United States Code) shall require the Sec- section that contains clinical trial data for 402(j)) that is initiated after the date of en- retary to publicly disclose, from any record an applicable device clinical trial (as defined actment of this title and before the effective or source other than the registry data bank in section 402(j)(1) of the Public Health Serv- date of the regulations issued under subpara- expanded under this subsection, information ice Act) shall be accompanied by the certifi- graph (A) of paragraph (2) of such subsection, described in subparagraph (B). cation required under section 402(j)(4)(B) of shall submit clinical trial information under ‘‘(B) INFORMATION DESCRIBED.—Information such Act. Such certification shall not be con- such paragraph (2). described in this subparagraph is— sidered an element of such notification.’’. (2) RULEMAKING.— ‘‘(i) information submitted to the Director (D) DEVICE PREMARKET APPROVAL APPLICA- (A) IN GENERAL.—Except as provided in of NIH under this subsection, or information TION.—Section 515(c) of the Federal Food, subparagraph (B), subsection (c)(1) shall be- of the same general nature as (or integrally Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is come effective on the date on which the reg- associated with) the information so sub- amended— ulation promulgated pursuant to section mitted; and (i) in subparagraph (F), by striking ‘‘; and’’ 402(j)(3)(C)(i) of the Public Health Service ‘‘(ii) not otherwise publicly available, in- and inserting a semicolon; Act, as added by this section, becomes effec- cluding because it is protected from disclo- (ii) by redesignating subparagraph (G) as tive. sure under section 552 of title 5, United subparagraph (H); and (B) EXCEPTION.—Subsection (c)(1) shall States Code. (iii) by inserting after subparagraph (F) apply with respect to any clinical trial for ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.— the following: which the registry data bank includes links There are authorized to be appropriated to ‘‘(G) the certification required under sec- to results information, as provided for under carry out this subsection $10,000,000 for each tion 402(j)(4)(B) of the Public Health Service section 402(j)(3)(A) of such Act, as added by fiscal year.’’. Act (which shall not be considered an ele- this section. (b) CONFORMING AMENDMENTS.— ment of such application); and’’. Subtitle D—Conflicts of Interest ROHIBITED ACTS (1) P .—Section 301 of the (E) HUMANITARIAN DEVICE EXEMPTION.—Sec- SEC. 241. CONFLICTS OF INTEREST. Federal Food, Drug, and Cosmetic Act (21 tion 520(m)(2) of the Federal Food, Drug, and (a) IN GENERAL.—Subchapter A of chapter U.S.C. 331) is amended by adding at the end Cosmetic Act (21 U.S.C. 360e(c)) is amended VII of the Federal Food, Drug, and Cosmetic the following: in the first sentence in the matter following Act (21 U.S.C. 371 et seq.) is amended by in- ‘‘(jj)(1) The failure to submit the certifi- subparagraph (C), by inserting at the end be- serting at the end the following: cation required by section 402(j)(4)(B) of the fore the period ‘‘and such application shall Public Health Service Act, or knowingly sub- ‘‘SEC. 712. CONFLICTS OF INTEREST. include the certification required under sec- ‘‘(a) DEFINITIONS.—For purposes of this sec- mitting a false certification under such sec- tion 402(j)(4)(B) of the Public Health Service tion. tion: Act (which shall not be considered an ele- ‘‘(2) The submission of clinical trial infor- ‘‘(1) ADVISORY COMMITTEE.—The term ‘advi- mation under subsection (i) or (j) of section ment of such application)’’. sory committee’ means an advisory com- 402 of the Public Health Service Act that is (c) PREEMPTION.— mittee under the Federal Advisory Com- promotional or false or misleading in any (1) IN GENERAL.—No State or political sub- mittee Act that provides advice or rec- particular under paragraph (2) or (3) of such division of a State may establish or continue ommendations to the Secretary regarding subsection (j).’’. in effect any requirement for the registra- activities of the Food and Drug Administra- (2) CIVIL MONEY PENALTIES.—Section 303(f) tion of clinical trials or for the inclusion of tion. of the Federal Food, Drug, and Cosmetic Act information relating to the results of clin- ‘‘(2) FINANCIAL INTEREST.—The term ‘finan- (21 U.S.C. 333(f)), as amended by section 203, ical trials in a database. cial interest’ means a financial interest is further amended by— (2) RULE OF CONSTRUCTION.—The fact of under section 208(a) of title 18, United States (A) redesignating paragraphs (4), (5), and submission of clinical trial information, if Code. (6) as paragraphs (5), (6), and (7), respec- submitted in compliance with subsection (i) ‘‘(b) APPOINTMENTS TO ADVISORY COMMIT- tively; and (j) of section 402 of the Public Health TEES.— (B) inserting after paragraph (3) the fol- Service Act (as amended by this section), ‘‘(1) RECRUITMENT.— lowing: that relates to a use of a drug or device not ‘‘(A) IN GENERAL.—Given the importance of ‘‘(4) Any person who violates section 301(jj) included in the official labeling of the ap- advisory committees to the review process at shall be subject to a civil monetary penalty proved drug or device shall not be construed the Food and Drug Administration, the Sec- of not more than $10,000 for the first viola- by the Secretary or in any administrative or retary shall carry out informational and re- tion, and not more than $20,000 for each sub- judicial proceeding, as evidence of a new in- cruitment activities for purposes of recruit- sequent violation.’’; tended use of the drug or device that is dif- ing individuals to serve as advisory com- (C) in paragraph (2)(C), by striking ‘‘para- ferent from the intended use of the drug or mittee members. The Secretary shall seek graph (4)(A)’’ and inserting ‘‘paragraph device set forth in the official labeling of the input from professional medical and sci- (5)(A)’’; drug or device. The availability of clinical entific societies to determine the most effec- (D) in paragraph (5), as so redesignated, by trial information through the data bank tive informational and recruitment activi- striking ‘‘paragraph (1), (2), or (3)’’ each under such subsections (i) and (j), if sub- ties. The Secretary shall also take into ac- place it appears and inserting ‘‘paragraph (1), mitted in compliance with such subsections, count the advisory committees with the (2), (3), or (4)’’; and shall not be considered as labeling, adultera- greatest number of vacancies. (E) in paragraph (7), as so redesignated, by tion, or misbranding of the drug or device ‘‘(B) RECRUITMENT ACTIVITIES.—The re- striking ‘‘paragraph (5)’’ each place it ap- under the Federal Food, Drug, and Cosmetic cruitment activities under subparagraph (A) pears and inserting ‘‘paragraph (6)’’. Act (21 U.S.C. 301 et seq.). may include—

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00035 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.011 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5350 CONGRESSIONAL RECORD — SENATE May 1, 2007 ‘‘(i) advertising the process for becoming ‘‘(i) the type, nature, and magnitude of the Subtitle E—Other Drug Safety Provisions an advisory committee member at medical financial interests of the advisory com- SEC. 251. DATABASE FOR AUTHORIZED GENERIC and scientific society conferences; mittee member to which such determina- DRUGS. ‘‘(ii) making widely available, including by tion, certification, or waiver applies; and Section 505 of the Federal Food, Drug, and using existing electronic communications ‘‘(ii) the reasons of the Secretary for such Cosmetic Act (21 U.S.C. 355), as amended by channels, the contact information for the determination, certification, or waiver. this title, is further amended by adding at Food and Drug Administration point of con- ‘‘(B) LESS THAN 30 DAYS IN ADVANCE.—In the the end the following: tact regarding advisory committee nomina- case of a financial interest that becomes ‘‘(q) DATABASE FOR AUTHORIZED GENERIC tions; and known to the Secretary less than 30 days DRUGS.— ‘‘(iii) developing a method through which prior to a meeting of an advisory committee ‘‘(1) IN GENERAL.— an entity receiving National Institutes of to which a written determination as referred ‘‘(A) PUBLICATION.—The Commissioner Health funding can identify a person who the to in section 208(b)(1) of title 18, United shall— Food and Drug Administration can contact States Code, a written certification as re- ‘‘(i) not later than 9 months after the date regarding the nomination of individuals to ferred to in section 208(b)(3) of title 18, of enactment of the Enhancing Drug Safety serve on advisory committees. United States Code, or a waiver as referred and Innovation Act of 2007, publish a com- ‘‘(2) EVALUATION AND CRITERIA.—When con- to in paragraph (3) applies, the Secretary plete list on the Internet website of the Food sidering a term appointment to an advisory shall disclose (other than information ex- and Drug Administration of all authorized committee, the Secretary shall review the empted from disclosure under section 552 of generic drugs (including drug trade name, expertise of the individual and the financial title 5, United States Code, and section 552a brand company manufacturer, and the date disclosure report filed by the individual pur- of title 5, United States Code) on the Inter- the authorized generic drug entered the mar- suant to the Ethics in Government Act of net website of the Food and Drug Adminis- ket); and 1978 for each individual under consideration tration, the information described in clauses ‘‘(ii) update the list quarterly to include for the appointment, so as to reduce the like- (i) and (ii) of subparagraph (A) as soon as each authorized generic drug included in an lihood that an appointed individual will practicable after the Secretary makes such annual report submitted to the Secretary by later require a written determination as re- determination, certification, or waiver, but the sponsor of a listed drug during the pre- ferred to in section 208(b)(1) of title 18, in no case later than the date of such meet- ceding 3-month period. United States Code, a written certification ing. ‘‘(B) NOTIFICATION.—The Commissioner as referred to in section 208(b)(3) of title 18, ‘‘(d) PUBLIC RECORD.—The Secretary shall shall notify relevant Federal agencies, in- United States Code, or a waiver as referred ensure that the public record and transcript cluding the Centers for Medicare & Medicaid to in subsection (c)(3) of this section for serv- of each meeting of an advisory committee Services and the Federal Trade Commission, ice on the committee at a meeting of the includes the disclosure required under sub- any time the Commissioner updates the in- committee. section (c)(5) (other than information ex- formation described in subparagraph (A). ‘‘(c) GRANTING AND DISCLOSURE OF WAIV- empted from disclosure under section 552 of ‘‘(2) INCLUSION.—The Commissioner shall ERS.— title 5, United States Code, and section 552a include in the list described in paragraph (1) ‘‘(1) IN GENERAL.—Prior to a meeting of an of title 5, United States Code). each authorized generic drug included in an advisory committee regarding a ‘particular ‘‘(e) ANNUAL REPORT.—Not later than Feb- annual report submitted to the Secretary by matter’ (as that term is used in section 208 of ruary 1 of each year, the Secretary shall sub- the sponsor of a listed drug after January 1, title 18, United States Code), each member of mit to the Inspector General of the Depart- 1999. the committee who is a full-time Govern- ment of Health and Human Services, the ‘‘(3) AUTHORIZED GENERIC DRUG.—In this ment employee or special Government em- Committee on Appropriations and the Com- section, the term ‘authorized generic drug’ ployee shall disclose to the Secretary finan- mittee on Health, Education, Labor, and means a listed drug (as that term is used in cial interests in accordance with subsection Pensions of the Senate, and the Committee subsection (j)) that— (b) of such section 208. on Appropriations and the Committee on En- ‘‘(A) has been approved under subsection ‘‘(2) FINANCIAL INTEREST OF ADVISORY COM- ergy and Commerce of the House of Rep- (c); and MITTEE MEMBER OR FAMILY MEMBER.—No resentatives, a report that describes— ‘‘(B) is marketed, sold, or distributed di- member of an advisory committee may vote ‘‘(1) with respect to the fiscal year that rectly or indirectly to retail class of trade with respect to any matter considered by the ended on September 30 of the previous year, under a different labeling, packaging (other advisory committee if such member (or an the number of vacancies on each advisory than repackaging as the listed drug in blister immediate family member of such member) committee, the number of nominees received packs, unit doses, or similar packaging for has a financial interest that could be af- for each committee, and the number of such use in institutions), product code, labeler fected by the advice given to the Secretary nominees willing to serve; code, trade name, or trade mark than the with respect to such matter, excluding inter- ‘‘(2) with respect to such year, the aggre- listed drug.’’. ests exempted in regulations issued by the gate number of disclosures required under SEC. 252. MEDICAL MARIJUANA. Director of the Office of Government Ethics subsection (c)(5) for each meeting of each ad- The Secretary shall require that State-le- as too remote or inconsequential to affect visory committee and the percentage of indi- galized medical marijuana be subject to the the integrity of the services of the Govern- viduals to whom such disclosures did not full regulatory requirements of the Food and ment officers or employees to which such apply who served on such committee for each Drug Administration, including a risk eval- regulations apply. such meeting; uation and mitigation strategy and all other ‘‘(3) WAIVER.—The Secretary may grant a ‘‘(3) with respect to such year, the number requirements and penalties of the Federal waiver of the prohibition in paragraph (2) if of times the disclosures required under sub- Food, Drug, and Cosmetic Act (21 U.S.C. 301 such waiver is necessary to afford the advi- section (c)(5) occurred under subparagraph et seq.) regarding safe and effective reviews, sory committee essential expertise. (B) of such subsection; and approval, sale, marketing, and use of phar- ‘‘(4) LIMITATION.—The Secretary may not ‘‘(4) how the Secretary plans to reduce the maceuticals. grant a waiver under paragraph (3) for a number of vacancies reported under para- TITLE III—MEDICAL DEVICES member of an advisory committee when the graph (1) during the fiscal year following member’s own scientific work is involved. such year, and mechanisms to encourage the SEC. 300. REFERENCES. ‘‘(5) DISCLOSURE OF WAIVER.—Notwith- nomination of individuals for service on an Except as otherwise specified, whenever in standing section 107(a)(2) of the Ethics in advisory committee, including those who are this title an amendment is expressed in Government Act (5 U.S.C. App.), the fol- classified by the Food and Drug Administra- terms of an amendment to a section or other lowing shall apply: tion as academicians or practitioners. provision, the reference shall be considered ‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As soon ‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not to be made to a section or other provision of as practicable, but in no case later than 15 less than once every 5 years, the Secretary the Federal Food, Drug, and Cosmetic Act days prior to a meeting of an advisory com- shall review guidance of the Food and Drug (21 U.S.C. 301 et seq.). mittee to which a written determination as Administration regarding conflict of interest Subtitle A—Device User Fees referred to in section 208(b)(1) of title 18, waiver determinations with respect to advi- SEC. 301. SHORT TITLE. United States Code, a written certification sory committees and update such guidance This subtitle may be cited as the ‘‘Medical as referred to in section 208(b)(3) of title 18, as necessary.’’. Device User Fee Amendments of 2007’’. United States Code, or a waiver as referred (b) CONFORMING AMENDMENT.—Section to in paragraph (3) applies, the Secretary 505(n) of the Federal Food, Drug, and Cos- SEC. 302. DEVICE FEES. shall disclose (other than information ex- metic Act (21 U.S.C. 355(n)) is amended by— Section 737 (21 U.S.C. 379i) is amended— empted from disclosure under section 552 of (1) striking paragraph (4); and (1) by striking the section designation and title 5, United States Code, and section 552a (2) redesignating paragraphs (5), (6), (7), all that follows through ‘‘For purposes of of title 5, United States Code (popularly and (8) as paragraphs (4), (5), (6), and (7), re- this subchapter’’ and inserting the following: known as the Freedom of Information Act spectively. ‘‘SEC. 737. DEVICE FEES. and the Privacy Act of 1974, respectively)) on (c) EFFECTIVE DATE.—The amendments ‘‘(a) PURPOSE.—It is the purpose of this the Internet website of the Food and Drug made by this section shall take effect on Oc- part that the fees authorized under this part Administration— tober 1, 2007. be dedicated toward expediting the process

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00036 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.011 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5351 for the review of device applications and for recommendations under paragraph (2), a (I) in clause (iii), by inserting ‘‘75 percent assuring the safety and effectiveness of de- summary of the views and comments re- of’’ after ‘‘a fee equal to’’; vices, as set forth in the goals identified for ceived under such paragraph, and any (II) in clause (iv), by striking ‘‘21.5’’ and in- purposes of this part in the letters from the changes made to the recommendations in re- serting ‘‘15’’; Secretary to the Chairman of the Committee sponse to such views and comments. (III) in clause (v), by striking ‘‘7.2’’ and in- on Health, Education, Labor, and Pensions of ‘‘(d) DEFINITIONS.—For purposes of this serting ‘‘7’’; the Senate and the Chairman of the Com- part:’’; (IV) by redesignating clauses (vi) and (vii) mittee on Energy and Commerce of the (2) by redesignating paragraphs (5), (6), (7), as clauses (vii) and (viii), respectively; House of Representatives, as set forth in the and (8), as paragraphs (7), (8), (9), and (11), re- (V) by inserting after clause (v) the fol- Congressional Record. spectively; lowing: ‘‘(b) REPORTS.— (3) in paragraph (4)— ‘‘(vi) For a 30-day notice, a fee equal to 1.6 ‘‘(1) PERFORMANCE REPORT.—For fiscal (A) in subparagraph (A), by striking ‘‘or an percent of the fee that applies under clause years 2008 through 2012, not later than 120 efficacy supplement,’’ and inserting ‘‘an effi- (i).’’; days after the end of each fiscal year during cacy supplement, or a 30-day notice,’’; and (VI) in clause (viii), as redesignated by sub- which fees are collected under this part, the (B) by adding at the end the following: clause (IV)— Secretary shall prepare and submit to the ‘‘(F) The term ‘30-day notice’ means a sup- (aa) by striking ‘‘1.42’’ and inserting ‘‘1.84’’; Committee on Health, Education, Labor, and plement to an approved premarket applica- and Pensions of the Senate and the Committee tion or premarket report under section 515 (bb) by striking ‘‘, subject to any adjust- on Energy and Commerce of the House of that is limited to a request to make modi- ment under subsection (e)(2)(C)(ii)’’; and Representatives, a report concerning the fications to manufacturing procedures or (VII) by adding at the end the following: progress of the Food and Drug Administra- methods of manufacture affecting the safety ‘‘(ix) For a request for classification infor- tion in achieving the goals identified in the and effectiveness of the device.’’; mation, a fee equal to 1.35 percent of the fee letters described in subsection (a) during (4) by inserting after paragraph (4) the fol- that applies under clause (i). such fiscal year and the future plans of the lowing: ‘‘(x) For periodic reporting concerning a Food and Drug Administration for meeting ‘‘(5) The term ‘request for classification in- class III device, the annual fee shall be equal the goals. The report for a fiscal year shall formation’ means a request made under sec- to 3.5 percent of the fee that applies under include information on all previous cohorts tion 513(g) for information respecting the clause (i).’’; for which the Secretary has not given a com- class in which a device has been classified or (iii) in subparagraph (C)— plete response on all device premarket appli- the requirements applicable to a device. (I) in the first sentence— cations, supplements, and premarket notifi- ‘‘(6) The term ‘annual fee for periodic re- (aa) by striking ‘‘or’’; and cations in the cohort. porting concerning a class III device’ means (bb) by striking ‘‘except that’’ and all that ‘‘(2) FISCAL REPORT.—For fiscal years 2008 the fee associated with reports imposed by a follows through the period and inserting ‘‘, through 2012, not later than 120 days after premarket application approval order (as de- 30-day notice, request for classification in- the end of each fiscal year during which fees scribed in section 814.82(a)(7) of title 21, Code formation, or periodic report concerning a are collected under this part, the Secretary of Federal Regulations), usually referred to class III device.’’; and shall prepare and submit to the Committee as ‘annual reports.’’’; (II) by striking the third sentence; and on Health, Education, Labor, and Pensions of (5) in paragraph (9), as redesignated by (iv) in subparagraph (D)— the Senate and the Committee on Energy paragraph (2)— (I) in clause (iii), by striking the last two and Commerce of the House of Representa- (A) by striking ‘‘April of’’ and inserting sentences; and tives, a report on the implementation of the ‘‘October of’’; and (II) by adding at the end the following: authority for such fees during such fiscal (B) by striking ‘‘April 2002’’ and inserting ‘‘(iv) MODULAR APPLICATION WITHDRAWN BE- year and the use, by the Food and Drug Ad- ‘‘October 2001’’; FORE FIRST ACTION.—The Secretary shall re- ministration, of the fees collected during (6) by inserting after paragraph (9), as re- fund 75 percent of the application fee paid for such fiscal year for which the report is made. designated by paragraph (2), the following: a modular application submitted under sec- ‘‘(3) PUBLIC AVAILABILITY.—The Secretary ‘‘(10) The term ‘person’ includes an affil- tion 515(c)(4) that is withdrawn before a sec- shall make the reports required under para- iate of such person.’’; and ond module is submitted and before a first graphs (1) and (2) available to the public on (7) by adding at the end the following: action on the first module. If the modular the Internet website of the Food and Drug ‘‘(12) The term ‘establishment subject to a application is withdrawn after a second or Administration. registration fee’ means an establishment re- subsequent module is submitted but before ‘‘(c) REAUTHORIZATION.— quired to register with the Secretary under any first action, the Secretary may return a ‘‘(1) CONSULTATION.—In developing rec- section 510 at which any of the following portion of the fee. The amount of refund, if ommendations to present to Congress with types of activities are conducted: any, shall be based on the level of effort al- respect to the goals, and plans for meeting ‘‘(A) MANUFACTURER.—An establishment ready expended on the review of the modules the goals, for the process for the review of that makes by any means any article that is submitted. device applications for the first 5 fiscal years a device including an establishment that ‘‘(v) SOLE DISCRETION TO REFUND.—The Sec- after fiscal year 2012, and for the reauthor- sterilizes or otherwise makes such article for retary shall have sole discretion to refund a ization of this part for such fiscal years, the or on behalf of a specification developer or fee or portion of the fee under this subpara- Secretary shall consult with— any other person. graph. A determination by the Secretary ‘‘(A) the Committee on Energy and Com- ‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An concerning a refund under this paragraph merce of the House of Representatives; establishment that performs manufacturing shall not be reviewable.’’; and ‘‘(B) the Committee on Health, Education, operations on a single-use device that has (B) by adding at the end the following: Labor, and Pensions of the Senate; previously been used on a patient. ‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION ‘‘(C) scientific and academic experts; ‘‘(C) SPECIFICATION DEVELOPER.—An estab- FEE.— ‘‘(D) health care professionals; lishment that develops specifications for a ‘‘(A) IN GENERAL.—Except as provided in ‘‘(E) representatives of patient and con- device that is distributed under the estab- subparagraph (B), each establishment sub- sumer advocacy groups; and lishment’s name but that performs no manu- ject to a registration fee shall be subject to ‘‘(F) the regulated industry. facturing, including establishments that, in a fee for each initial or annual registration ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— addition to developing specifications, ar- beginning with its registration for fiscal After negotiations with the regulated indus- range for the manufacturing of devices la- year 2008. try, the Secretary shall— beled with another establishment’s name by ‘‘(B) EXCEPTION FOR FEDERAL OR STATE GOV- ‘‘(A) present the recommendations devel- a contract manufacturer. ERNMENT ESTABLISHMENT.—No fee shall be re- oped under paragraph (1) to the Congres- ‘‘(13) The term ‘establishment registration quired under subparagraph (A) for an estab- sional committees specified in such para- fee’ means a fee assessed under section lishment operated by a Federal or State gov- graph; 738(a)(3) for the registration of an establish- ernment entity unless a device manufactured ‘‘(B) publish such recommendations in the ment subject to a registration fee. by the establishment is to be distributed Federal Register; ‘‘(e) SUNSET.—This part shall cease to be commercially. ‘‘(C) provide for a period of 30 days for the effective on October 1, 2012, except that sub- ‘‘(C) PAYMENT.—The annual establishment public to provide written comments on such section (b) with respect to reports shall cease registration fee shall be due once each fiscal recommendations; to be effective January 31, 2013.’’. year, upon the initial registration of the es- ‘‘(D) hold a meeting at which the public SEC. 303. AUTHORITY TO ASSESS AND USE DE- tablishment or upon the annual registration may present its views on such recommenda- VICE FEES. under section 510.’’; tions; and Section 738 (21 U.S.C. 379j) is amended— (2) by striking subsection (b) and inserting ‘‘(E) after consideration of such public (1) in subsection (a)— the following: views and comments, revise such rec- (A) in paragraph (2)— ommendations as necessary. (i) in the header, by inserting ‘‘, AND AN- ‘‘(b) FEE AMOUNTS.—Except as provided in ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— NUAL FEE FOR PERIODIC REPORTING CON- subsections (c), (d), and (e), the fees under Not later than January 15, 2012, the Sec- CERNING A CLASS III DEVICE’’ after ‘‘FEE’’; subsection (a) shall be based on the following retary shall transmit to Congress the revised (ii) in subparagraph (A)— fee amounts:

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00037 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.011 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5352 CONGRESSIONAL RECORD — SENATE May 1, 2007

Fiscal Fiscal Fiscal Fiscal Fiscal Fee Type Year Year Year Year Year 2008 2009 2010 2011 2012

Premarket Application ...... $185,000 $200,725 $217,787 $236,298 $256,384 ...... Establishment Registration Fee ...... $1,706 $1,851 $2,008 $2,179 $2,364’’;

(3) in subsection (c)— applicant meets the criteria for a small busi- the local currency and in United States dol- (A) in the heading, by striking ‘‘Annual ness. lars, and the exchange rate used in making Fee Setting.—’’ and inserting ‘‘ANNUAL FEE ‘‘(II) A certification, in English, from the such conversion to dollars, and the dates SETTING.—’’; national taxing authority of the country in during which such receipts and sales were (B) in paragraph (1), by striking the second which it is headquartered. Such certification collected, and it shall bear the official seal of sentence; shall provide the applicant’s gross receipts the national taxing authority. (C) by redesignating paragraphs (2) and (3) and sales for the most recent year, in both ‘‘(III) Identical certifications shall be pro- as paragraphs (3) and (4), respectively; the local currency and in United States dol- vided for each of the applicant’s affiliates. (D) by inserting after paragraph (1) the fol- lars, the exchange rate used in making this ‘‘(IV) A statement signed by the head of lowing: conversion to dollars, and the dates during the applicant or its chief financial officer ‘‘(2) ADJUSTMENT OF ANNUAL ESTABLISH- which these receipts and sales were col- that it has submitted certifications for all of MENT REGISTRATION FEE.— lected, and it shall bear the official seal of its affiliates, or that it had no affiliates, ‘‘(A) IN GENERAL.—When setting the fees the national taxing authority. whichever is applicable.’’; and for fiscal year 2010, the Secretary may in- ‘‘(III) Identical certifications shall be pro- (iii) by striking subparagraph (C) and in- crease the establishment registration fee vided for each of the applicant’s affiliates. serting the following: specified in subsection (b) only if the Sec- ‘‘(IV) A statement signed by the head of ‘‘(C) REDUCED FEES.—For fiscal year 2008 retary estimates that the number of estab- the applicant or its chief financial officer and each subsequent fiscal year, where the lishments submitting fees for fiscal year 2009 that it has submitted certifications for all of Secretary finds that the applicant involved is less than 12,250. The percent increase shall its affiliates, or that it had no affiliates, meets the definition under subparagraph (A), be the percent by which the estimate of es- whichever is applicable.’’; and the fee for a premarket notification submis- tablishments submitting fees in fiscal year (iii) in subparagraph (C)— sion may be paid at 50 percent of the fee that 2009 is less than 12,750, but in no case shall (I) by striking ‘‘reduced rate of’’ and in- applies under subsection (a)(2)(A)(viii) and as the percent increase be more than 8.5 percent serting ‘‘reduced rate of—’’; and established under subsection (c)(1).’’; over the amount for such fee specified in sub- (II) by striking ‘‘38 percent’’ and all that (6) by striking subsection (f) and inserting section (b) for fiscal year 2010. If the Sec- follows through the period and inserting the the following: retary makes any adjustment to the estab- following: ‘‘(f) EFFECT OF FAILURE TO PAY FEES.— lishment registration fee for fiscal year 2010, ‘‘(i) 25 percent of the fee established under ‘‘(1) IN GENERAL.—A premarket applica- then the establishment registration fee for such subsection for a premarket application, tion, premarket report, supplement, or pre- fiscal years 2011 and 2012 under subsection (b) a premarket report, a supplement, or a peri- market notification submission, 30-day no- shall be adjusted as follows: the fee for fiscal odic report concerning a class III device; and tice, request for classification information, year 2011 shall be equal to the adjusted fee ‘‘(ii) 50 percent of the fee established under or periodic report concerning a class III de- for fiscal year 2010, increased by 8.5 percent, such subsection for a 30-day notice or a re- vice submitted by a person subject to fees and the fee for fiscal year 2012 shall be equal quest for classification information.’’; under paragraphs (2) and (3) of subsection (a) to the adjusted fee for fiscal year 2011, in- (5) in subsection (e)— shall be considered incomplete and shall not creased by 8.5 percent. (A) in paragraph (1), by striking ‘‘2004’’ and be accepted by the Secretary until all fees ‘‘(B) PUBLICATION IN THE FEDERAL REG- inserting ‘‘2008’’; and owed by such person have been paid. ISTER.—The Secretary shall publish any de- (B) in paragraph (2)— ‘‘(2) REGISTRATION INFORMATION.—Registra- termination with respect to any establish- (i) in subparagraph (A), by striking ‘‘, part- tion information submitted by an establish- ment registration fee adjustment made ners, and parent firms’’; ment subject to a registration fee under sub- under subparagraph (A), and the rationale (ii) by striking subparagraph (B) and in- section (a)(3) shall be considered incomplete for such determination, in the Federal Reg- serting the following: and shall not be accepted by the Secretary ister.’’; and ‘‘(B) EVIDENCE OF QUALIFICATION.— until the registration fee owed for the estab- (E) in paragraph (4)(A), as so redesig- ‘‘(i) IN GENERAL.—An applicant shall pay lishment has been paid. Until the fee is paid nated— the higher fees established by the Secretary and the registration is complete, the estab- (i) by striking ‘‘For fiscal years 2006 and each year unless the applicant submits evi- lishment shall be deemed to have failed to 2007, the’’ and inserting ‘‘The’’; and dence that it qualifies for the lower fee rate. register in accordance with section 510.’’; (ii) by striking ‘‘of fiscal year 2008’’ and in- ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO (7) in subsection (g)— serting ‘‘of the next fiscal year’’; THE UNITED STATES INTERNAL REVENUE SERV- (A) by striking paragraph (1) and inserting (4) in subsection (d)— ICE.—The applicant shall support its claim the following: (A) in paragraph (1), by striking ‘‘, part- that it meets the definition under subpara- ‘‘(1) PERFORMANCE GOALS; TERMINATION OF ners, and parent firms’’; graph (A) by submission of a copy of its most PROGRAM.—With respect to the amount that, (B) in paragraph (2)— recent Federal income tax return for a tax- under the salaries and expenses account of (i) in subparagraph (A), by striking ‘‘, part- able year, and a copy of such returns of its the Food and Drug Administration, is appro- ners, and parent firms’’; affiliates, which show an amount of gross priated for a fiscal year for devices and radi- (ii) in subparagraph (B)— sales or receipts that is less than the max- ological products, fees may not be assessed (I) by striking ‘‘An applicant shall’’ and in- imum established in subparagraph (A). The under subsection (a) for the fiscal year, and serting the following: applicant, and each of such affiliates, shall the Secretary is not expected to meet any ‘‘(i) IN GENERAL.—An applicant shall’’; certify that the information provided is a performance goals identified for the fiscal (II) by striking ‘‘The applicant shall sup- true and accurate copy of the actual tax year, if— port’’ and inserting the following: forms they submitted to the Internal Rev- ‘‘(A) the amount so appropriated for the ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO enue Service. If no tax forms are submitted fiscal year, excluding the amount of fees ap- THE UNITED STATES INTERNAL REVENUE SERV- for affiliates, the applicant shall certify that propriated for the fiscal year, is more than 1 ICE.—The applicant shall support’’; the applicant has no affiliates. percent less than $205,720,000 multiplied by (III) by striking ‘‘, partners, and parent ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS the adjustment factor applicable to such fis- firms’’ both places the term appears; TO THE UNITED STATES INTERNAL REVENUE cal year; or (IV) by striking ‘‘partners, or parent firms, SERVICE.—The applicant shall support its ‘‘(B) fees were not assessed under sub- the’’ and inserting ‘‘the’’; claim that it meets the definition under sub- section (a) for the previous fiscal year.’’; and (V) by striking ‘‘, partners, or parent paragraph (A) by submission of the fol- (B) in paragraph (2), by striking ‘‘and pre- firms, respectively’’; and lowing: market notification submissions, and’’ and (VI) by adding at the end the following: ‘‘(I) A signed certification, in such form as inserting ‘‘premarket notification submis- ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS the Secretary may direct through a notice sions, 30-day notices, requests for classifica- TO THE UNITED STATES INTERNAL REVENUE published in the Federal Register, that the tion information, periodic reports con- SERVICE.—The applicant shall support its applicant meets the criteria for a small busi- cerning a class III device, and establishment claim that it meets the definition under sub- ness. registrations’’; and paragraph (A) by submission of the fol- ‘‘(II) A certification, in English, from the (8) in subsection (h), by striking para- lowing: national taxing authority of the country in graphs (3) and (4) and inserting the following: ‘‘(I) A signed certification, in such form as which it is headquartered. Such certification ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— the Secretary may direct through a notice shall provide the applicant’s gross receipts There are authorized to be appropriated for published in the Federal Register, that the and sales for the most recent year, in both fees under this section—

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00038 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.011 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5353 ‘‘(A) $48,431,000 for fiscal year 2008; ‘‘(I) provides the date of the last inspection clearance to participate as provided under ‘‘(B) $52,547,000 for fiscal year 2009; of the establishment by the Secretary and subparagraph (C). ‘‘(C) $57,014,000 for fiscal year 2010; the classification of that inspection; ‘‘(C)(i) The Secretary may deny clearance ‘‘(D) $61,860,000 for fiscal year 2011; and ‘‘(II) states the intention of the owner or to a device establishment if the Secretary ‘‘(E) $67,118,000 for fiscal year 2012. operator to use an accredited person to con- has evidence that the certification under ‘‘(4) OFFSET.—If the cumulative amount of duct inspections of the establishment; subparagraph (A)(ii)(IV) is untrue and the fees collected during fiscal years 2008, 2009, ‘‘(III) identifies the particular accredited Secretary provides to the owner or operator and 2010, added to the amount estimated to person the owner or operator intends to se- of the establishment a statement summa- be collected for fiscal year 2011 (which esti- lect to conduct such inspections; and rizing such evidence. mate shall be based upon the amount of fees ‘‘(IV) includes a certification that, with re- ‘‘(ii) The Secretary may deny clearance to received by the Secretary through June 30, spect to the devices that are manufactured, a device establishment if the Secretary de- 2011), exceeds the amount of fees specified in prepared, propagated, compounded, or proc- termines that the establishment has failed aggregate in paragraph (3) for such 4 fiscal essed in the establishment— to demonstrate consistent compliance for years, the aggregate amount in excess shall ‘‘(aa) at least 1 of such devices is marketed purposes of subparagraph (B)(iii)(I) and the be credited to the appropriation account of in the United States; and Secretary provides to the owner or operator the Food and Drug Administration as pro- ‘‘(bb) at least 1 of such devices is mar- of the establishment a statement of the rea- vided in paragraph (1), and shall be sub- keted, or is intended to be marketed, in 1 or sons for such determination. ‘‘(iii)(I) The Secretary may reject the se- tracted from the amount of fees that would more foreign countries, 1 of which countries lection of the accredited person identified in otherwise be authorized to be collected under certifies, accredits, or otherwise recognizes the notice under subparagraph (A)(ii) if the this section pursuant to appropriation Acts the person accredited under paragraph (2) Secretary provides to the owner or operator for fiscal year 2012.’’. and identified under subclause (III) as a per- of the establishment a statement of the rea- son authorized to conduct inspections of de- SEC. 304. SAVINGS CLAUSE. sons for such rejection. Reasons for the re- vice establishments. Notwithstanding section 107 of the Medical jection may include that the establishment ‘‘(B)(i) Except with respect to the require- Device User Fee and Modernization Act of or the accredited person, as the case may be, 2002 (Public Law 107–250), and notwith- ment of subparagraph (A)(i), a device estab- lishment is deemed to have clearance to par- has failed to fully respond to the request, or standing the amendments made by this sub- ticipate in the program and to use the ac- that the Secretary has concerns regarding title, part 3 of subchapter C of chapter VII of credited person identified in the notice under the relationship between the establishment the Federal Food, Drug, and Cosmetic Act, subparagraph (A)(ii) for inspections of the es- and such accredited person. as in effect on the day before the date of en- ‘‘(II) If the Secretary rejects the selection tablishment unless the Secretary, not later actment of this subtitle, shall continue to be of an accredited person by the owner or oper- than 30 days after receiving such notice, in effect with respect to premarket applica- ator of a device establishment, the owner or issues a response that— tions, premarket reports, premarket notifi- operator may make an additional selection ‘‘(I) denies clearance to participate as pro- cation submissions, and supplements (as de- of an accredited person by submitting to the vided under subparagraph (C); or fined in such part as of such day) that on or Secretary a notice that identifies the addi- ‘‘(II) makes a request under clause (ii). after October 1, 2002, but before October 1, ‘‘(ii) The Secretary may request from the tional selection. Clauses (i) and (ii) of sub- 2007, were accepted by the Food and Drug Ad- owner or operator of a device establishment paragraph (B), and subclause (I) of this ministration for filing with respect to assess- in response to the notice under subparagraph clause, apply to the selection of an accred- ing and collecting any fee required by such (A)(ii) with respect to the establishment, or ited person through a notice under the pre- part for a fiscal year prior to fiscal year 2008. from the particular accredited person identi- ceding sentence in the same manner and to SEC. 305. EFFECTIVE DATE. fied in such notice— the same extent as such provisions apply to The amendments made by this subtitle ‘‘(I) compliance data for the establishment a selection of an accredited person through a shall take effect on October 1, 2007. in accordance with clause (iii)(I); or notice under subparagraph (A)(ii). ‘‘(II) information concerning the relation- ‘‘(iv) In the case of a device establishment Subtitle B—Amendments Regarding that is denied clearance under clause (i) or Regulation of Medical Devices ship between the owner or operator of the es- tablishment and the accredited person iden- (ii) or with respect to which the selection of SEC. 311. INSPECTIONS BY ACCREDITED PER- tified in such notice in accordance with the accredited person is rejected under SONS. clause (iii)(II). clause (iii), the Secretary shall designate a Section 704(g) (21 U.S.C. 374(g)) is amend- The owner or operator of the establishment, person to review the statement of reasons, or ed— or such accredited person, as the case may statement summarizing such evidence, as (1) in paragraph (1), by striking ‘‘Not later be, shall respond to such a request not later the case may be, of the Secretary under such than one year after the date of enactment of than 60 days after receiving such request. clause if, during the 30-day period beginning this subsection, the Secretary’’ and inserting ‘‘(iii)(I) The compliance data to be sub- on the date on which the owner or operator ‘‘The Secretary’’; mitted by the owner or operation of a device of the establishment receives such state- (2) in paragraph (2), by— establishment in response to a request under ment, the owner or operator requests the re- (A) striking ‘‘Not later than 180 days after clause (ii)(I) are data describing whether the view. The review shall commence not later the date of enactment of this subsection, quality controls of the establishment have than 30 days after the owner or operator re- the’’ and inserting ‘‘The Secretary’’; and been sufficient for ensuring consistent com- quests the review, unless the Secretary and (B) striking the fifth sentence; pliance with current good manufacturing the owner or operator otherwise agree.’’; (3) in paragraph (3), by adding at the end practice within the meaning of section 501(h) (5) in paragraph (7)— the following: and with other applicable provisions of this (A) by amending subparagraph (A) to read ‘‘(F) Such person shall notify the Sec- Act. Such data shall include complete re- as follows: retary of any withdrawal, suspension, re- ports of inspectional findings regarding good ‘‘(A) Persons accredited under paragraph striction, or expiration of certificate of con- manufacturing practice or other quality con- (2) to conduct inspections shall record in formance with the quality systems standard trol audits that, during the preceding 2-year writing their inspection observations and referred to in paragraph (7) for any device es- period, were conducted at the establishment shall present the observations to the device tablishment that such person inspects under by persons other than the owner or operator establishment’s designated representative this subsection not later than 30 days after of the establishment, together with all other and describe each observation. Additionally, such withdrawal, suspension, restriction, or compliance data the Secretary deems nec- such accredited person shall prepare an in- expiration. essary. Data under the preceding sentence spection report in a form and manner des- ‘‘(G) Such person may conduct audits to shall demonstrate to the Secretary whether ignated by the Secretary to conduct inspec- establish conformance with the quality sys- the establishment has facilitated consistent tions, taking into consideration the goals of tems standard referred to in paragraph (7).’’; compliance by promptly correcting any com- international harmonization of quality sys- (4) by amending paragraph (6) to read as pliance problems identified in such inspec- tems standards. Any official classification of follows: tions. the inspection shall be determined by the ‘‘(6)(A) Subject to subparagraphs (B) and ‘‘(II) A request to an accredited person Secretary.’’; and (C), a device establishment is eligible for in- under clause (ii)(II) may not seek any infor- (B) by adding at the end the following: spection by persons accredited under para- mation that is not required to be maintained ‘‘(F) For the purpose of setting risk-based graph (2) if the following conditions are met: by such person in records under subsection inspectional priorities, the Secretary shall ‘‘(i) The Secretary classified the results of (f)(1). accept voluntary submissions of reports of the most recent inspection of the establish- ‘‘(iv) A device establishment is deemed to audits assessing conformance with appro- ment as ‘no action indicated’ or ‘voluntary have clearance to participate in the program priate quality systems standards set by the action indicated’. and to use the accredited person identified in International Organization for Standardiza- ‘‘(ii) With respect to inspections of the es- the notice under subparagraph (A)(ii) for in- tion (ISO) and identified by the Secretary in tablishment to be conducted by an accred- spections of the establishment unless the public notice. If the owner or operator of an ited person, the owner or operator of the es- Secretary, not later than 60 days after re- establishment elects to submit audit reports tablishment submits to the Secretary a no- ceiving the information requested under under this subparagraph, the owner or oper- tice that— clause (ii), issues a response that denies ator shall submit all such audit reports with

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00039 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.011 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5354 CONGRESSIONAL RECORD — SENATE May 1, 2007 respect to the establishment during the pre- feasible, unless the Secretary grants a re- (E) by striking ‘‘(B) if the drug is des- ceding 2-year periods.’’; and quest for waiver of such requirement because ignated’’ and inserting ‘‘(ii) if the drug is (6) in paragraphs (10)(C)(iii), by striking use of electronic means is not reasonable for designated’’; ‘‘based’’ and inserting ‘‘base’’. the person requesting such waiver. (F) by striking ‘‘(2)(A)’’ and inserting SEC. 312. EXTENSION OF AUTHORITY FOR THIRD ‘‘(2) With regard to any establishment en- ‘‘(B)(i)’’; PARTY REVIEW OF PREMARKET NO- gaged in the manufacture, preparation, prop- (G) by striking ‘‘(i) a listed patent’’ and in- TIFICATION. agation, compounding, or processing of a de- serting ‘‘(I) a listed patent’’; Section 523(c) (21 U.S.C. 360m(c)) is amend- vice, the registration and listing information (H) by striking ‘‘(ii) a listed patent’’ and ed by striking ‘‘2007’’ and inserting ‘‘2012’’. required by this section shall be submitted inserting ‘‘(II) a listed patent’’; SEC. 313. REGISTRATION. to the Secretary by electronic means, unless (I) by striking ‘‘(B) if the drug is the sub- (a) ANNUAL REGISTRATION OF PRODUCERS OF the Secretary grants a waiver because elec- ject’’ and inserting ‘‘(ii) if the drug is the DRUGS AND DEVICES.—Section 510(b) (21 tronic registration and listing is not reason- subject’’; U.S.C. 359(b)) is amended— able for the person requesting such waiver.’’. (J) by striking ‘‘If’’ and all that follows (1) by redesignating the existing text as TITLE IV—PEDIATRIC MEDICAL through ‘‘subsection (d)(3)’’ and inserting the paragraph (1), and indenting and relocating PRODUCTS following: it appropriately; Subtitle A—Best Pharmaceuticals for ‘‘(1) IN GENERAL.—Except as provided in (2) in paragraph (1), as so redesignated, by Children paragraph (2), if the Secretary determines striking ‘‘or a device or devices’’; and SEC. 401. SHORT TITLE. that information relating to the use of an (3) by adding at the end the following new This subtitle may be cited as the ‘‘Best approved drug in the pediatric population paragraph: Pharmaceuticals for Children Amendments may produce health benefits in that popu- ‘‘(2) Between October 1 and December 31 of of 2007’’. lation and makes a written request to the each year every person who owns or operates SEC. 402. PEDIATRIC STUDIES OF DRUGS. holder of an approved application under sec- any establishment in any State engaged in (a) IN GENERAL.—Section 505A of the Fed- tion 505(b)(1) for pediatric studies (which the manufacture, preparation, propagation, eral Food, Drug, and Cosmetic Act (21 U.S.C. shall include a timeframe for completing compounding, or processing of a device or de- 355a) is amended— such studies), the holder agrees to the re- vices shall register with the Secretary his (1) in subsection (a), by inserting before quest, such studies are completed using ap- name, places of business, and all such estab- the period at the end the following: ‘‘, and, propriate formulations for each age group for lishments.’’. at the discretion of the Secretary, may in- which the study is requested within any such (b) REGISTRATION OF FOREIGN ESTABLISH- clude preclinical studies’’; timeframe, and the reports thereof are sub- MENTS.—Section 510(i)(1) (21 U.S.C. 359(i)(1)) (2) in subsection (b)— mitted and accepted in accordance with sub- is amended— (A) in paragraph (1)(A)(i), by striking ‘‘(D)’’ section (d)(3), and if the Secretary deter- (1) by redesignating the existing text as both places it appears and inserting ‘‘(E)’’; mines that labeling changes are appropriate, subparagraph (A), and indenting and relo- (B) in paragraph (1)(A)(ii), by striking such changes are made within the timeframe cating it appropriately; ‘‘(D)’’ and inserting ‘‘(E)’’; requested by the Secretary—’’; and (2) in subparagraph (A), as so redesig- (C) by striking ‘‘(1)(A)(i)’’ and inserting (K) by adding at the end the following: nated— ‘‘(A)(i)(I)’’; ‘‘(2) EXCEPTION.—The Secretary shall not (A) by striking ‘‘processing of a drug or a (D) by striking ‘‘(ii) the’’ and inserting extend a period referred to in paragraph device that is imported’’ and inserting ‘‘proc- ‘‘(II) the’’; (1)(A) or in paragraph (1)(B) later than 9 essing of a drug that is imported’’; and (E) by striking ‘‘(B) if the drug is des- months prior to the expiration of such pe- (B) by striking ‘‘or device’’ each place it ignated’’ and inserting ‘‘(ii) if the drug is riod.’’; appears; and designated’’; (4) by striking subsection (d) and inserting (3) by adding after such subparagraph (A) (F) by striking ‘‘(2)(A)’’ and inserting the following: the following new subparagraph: ‘‘(B)(i)’’; ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— ‘‘(1) REQUEST FOR STUDIES.— ‘‘(B) Between October 1 and December 31 of (G) by striking ‘‘(i) a listed patent’’ and in- ‘‘(A) IN GENERAL.—The Secretary may, each year, any establishment within any for- serting ‘‘(I) a listed patent’’; after consultation with the sponsor of an ap- eign country engaged in the manufacture, (H) by striking ‘‘(ii) a listed patent’’ and plication for an investigational new drug preparation, propagation, compounding, or inserting ‘‘(II) a listed patent’’; under section 505(i), the sponsor of an appli- processing of a device that is imported or of- (I) by striking ‘‘(B) if the drug is the sub- cation for a new drug under section 505(b)(1), fered for import into the United States shall, ject’’ and inserting ‘‘(ii) if the drug is the or the holder of an approved application for through electronic means in accordance with subject’’; a drug under section 505(b)(1), issue to the the criteria of the Secretary, register with (J) by striking ‘‘If’’ and all that follows sponsor or holder a written request for the the Secretary the name and place of business through ‘‘subsection (d)(3)’’ and inserting the following: conduct of pediatric studies for such drug. In of the establishment, the name of the United issuing such request, the Secretary shall ‘‘(1) IN GENERAL.—Except as provided in States agent for the establishment, the name take into account adequate representation of of each importer of such device in the United paragraph (2), if, prior to approval of an ap- plication that is submitted under section children of ethnic and racial minorities. States that is known to the establishment, Such request to conduct pediatric studies and the name of each person who imports or 505(b)(1), the Secretary determines that in- formation relating to the use of a new drug shall be in writing and shall include a time- offers for import such device to the United frame for such studies and a request to the States for purposes of importation.’’. in the pediatric population may produce health benefits in that population, the Sec- sponsor or holder to propose pediatric label- SEC. 314. FILING OF LISTS OF DRUGS AND DE- ing resulting from such studies. VICES MANUFACTURED PREPARED, retary makes a written request for pediatric INGLE WRITTEN REQUEST PROPAGATED AND COMPOUNDED studies (which shall include a timeframe for ‘‘(B) S .—A single BY REGISTRANTS; STATEMENTS; AC- completing such studies), the applicant written request— COMPANYING DISCLOSURES. agrees to the request, such studies are com- ‘‘(i) may relate to more than 1 use of a Section 510(j)(2) (21 U.S.C. 360(j)(2) is pleted using appropriate formulations for drug; and amended, in the matter preceding subpara- each age group for which the study is re- ‘‘(ii) may include uses that are both ap- graph (A), to read as follows: quested within any such timeframe, and the proved and unapproved. ‘‘(2) Each person who registers with the reports thereof are submitted and accepted ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUD- Secretary under this section shall report to in accordance with subsection (d)(3), and if IES.— the Secretary (i) with regard to drugs, once the Secretary determines that labeling ‘‘(A) REQUEST AND RESPONSE.— during the month of June of each year and changes are appropriate, such changes are ‘‘(i) IN GENERAL.—If the Secretary makes a once during the month of December of each made within the timeframe requested by the written request for pediatric studies (includ- year, and (ii) with regard to devices, once Secretary—’’; and ing neonates, as appropriate) under sub- each year between October 1 and December (K) by adding at the end the following: section (b) or (c), the applicant or holder, not 31, the following information:’’. ‘‘(2) EXCEPTION.—The Secretary shall not later than 180 days after receiving the writ- SEC. 315. ELECTRONIC REGISTRATION AND LIST- extend a period referred to in paragraph ten request, shall respond to the Secretary ING. (1)(A) or in paragraph (1)(B) later than 9 as to the intention of the applicant or holder Section 510(p) (21 U.S.C. 360(p)) is amended months prior to the expiration of such pe- to act on the request by— to read as follows: riod.’’; ‘‘(I) indicating when the pediatric studies ‘‘(p)(1) With regard to any establishment (3) in subsection (c)— will be initiated, if the applicant or holder engaged in the manufacture, preparation, (A) in paragraph (1)(A)(i), by striking ‘‘(D)’’ agrees to the request; or propagation, compounding, or processing of a both places it appears and inserting ‘‘(E)’’; ‘‘(II) indicating that the applicant or hold- drug, registrations under subsections (b), (c), (B) in paragraph (1)(A)(ii), by striking er does not agree to the request and the rea- (d), and (i) of this section (including the sub- ‘‘(D)’’ and inserting ‘‘(E)’’; sons for declining the request. mission of updated information) shall be sub- (C) by striking ‘‘(1)(A)(i)’’ and inserting ‘‘(ii) DISAGREE WITH REQUEST.—If, on or mitted to the Secretary by electronic means, ‘‘(A)(i)(I)’’; after the date of enactment of the Best Phar- upon a finding by the Secretary that the (D) by striking ‘‘(ii) the’’ and inserting maceuticals for Children Amendments of electronic receipt of such registrations is ‘‘(II) the’’; 2007, the applicant or holder does not agree

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00040 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.012 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5355 to the request on the grounds that it is not ‘‘(vii) One or more experts from the Office ceeded $1,000,000,000 in a calendar year as de- possible to develop the appropriate pediatric of Pediatric Therapeutics, including an ex- scribed in subparagraph (A). Prior to desig- formulation, the applicant or holder shall pert in pediatric ethics. nating such organization, the Secretary submit to the Secretary the reasons such pe- ‘‘(viii) Other individuals as designated by shall determine that such organization is diatric formulation cannot be developed. the Secretary. independent and is qualified to evaluate the ‘‘(B) ADVERSE EVENT REPORTS.—An appli- ‘‘(2) REVIEW OF WRITTEN REQUESTS.—All sales of pharmaceutical products. The Sec- cant or holder that, on or after the date of written requests under this section shall be retary shall re-evaluate the designation of enactment of the Best Pharmaceuticals for reviewed and approved by the committee es- such organization once every 3 years. Children Amendments of 2007, agrees to the tablished under paragraph (1) prior to being ‘‘(C) NOTIFICATION.—Once a year at a time request for such studies shall provide the issued. designated by the Secretary, the organiza- Secretary, at the same time as submission of ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The tion designated under subparagraph (B) shall the reports of such studies, with all committee established under paragraph (1) notify the Food and Drug Administration of postmarket adverse event reports regarding shall review all studies conducted pursuant all drugs with the same active moiety with the drug that is the subject of such studies to this section to determine whether to ac- combined annual gross sales that exceed and are available prior to submission of such cept or reject such reports under subsection $1,000,000,000 during the previous calendar reports. (d)(3). year.’’; ‘‘(3) MEETING THE STUDIES REQUIREMENT.— ‘‘(4) TRACKING PEDIATRIC STUDIES AND LA- (7) in subsection (i)— Not later than 180 days after the submission BELING CHANGES.—The committee established (A) in the heading, by striking ‘‘SUPPLE- of the reports of the studies, the Secretary under paragraph (1) shall be responsible for MENTS’’ and inserting ‘‘CHANGES’’; shall accept or reject such reports and so no- tracking and making available to the public, (B) in paragraph (1)— tify the sponsor or holder. The Secretary’s in an easily accessible manner, including (i) in the heading, by inserting ‘‘APPLICA- only responsibility in accepting or rejecting through posting on the website of the Food TIONS AND’’ after ‘‘PEDIATRIC’’; the reports shall be to determine, within the and Drug Administration— (ii) by inserting ‘‘application or’’ after 180 days, whether the studies fairly respond ‘‘(A) the number of studies conducted ‘‘Any’’; to the written request, have been conducted under this section; (iii) by striking ‘‘change pursuant to a re- in accordance with commonly accepted sci- ‘‘(B) the specific drugs and drug uses, in- port on a pediatric study under’’ and insert- entific principles and protocols, and have cluding labeled and off-labeled indications, ing ‘‘change as a result of any pediatric been reported in accordance with the re- studied under this section; study conducted pursuant to’’; and quirements of the Secretary for filing. ‘‘(C) the types of studies conducted under (iv) by inserting ‘‘application or’’ after ‘‘to ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this section, including trial design, the num- be a priority’’; and this subsection alters or amends section ber of pediatric patients studied, and the (C) in paragraph (2)(A), by— 301(j) of this Act or section 552 of title 5 or number of centers and countries involved; (i) striking ‘‘If the Commissioner’’ and in- section 1905 of title 18, United States Code.’’; ‘‘(D) the number of pediatric formulations serting ‘‘If, on or after the date of enactment (5) by striking subsections (e) and (f) and developed and the number of pediatric for- of the Best Pharmaceuticals for Children inserting the following: mulations not developed and the reasons Amendments of 2007, the Commissioner’’; ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES such formulations were not developed; and REQUIREMENT.— ‘‘(E) the labeling changes made as a result (ii) striking ‘‘an application with’’ and all ‘‘(1) IN GENERAL.—The Secretary shall pub- of studies conducted under this section; that follows through ‘‘on appropriate’’ and lish a notice of any determination, made on ‘‘(F) an annual summary of labeling inserting ‘‘the sponsor and the Commissioner or after the date of enactment of the Best changes made as a result of studies con- have been unable to reach agreement on ap- Pharmaceuticals for Children Amendments ducted under this section for distribution propriate’’; of 2007, that the requirements of subsection pursuant to subsection (k)(2); and (8) by striking subsection (m); (d) have been met and that submissions and ‘‘(G) information regarding reports sub- (9) by redesignating subsections (j), (k), (l), approvals under subsection (b)(2) or (j) of mitted on or after the date of enactment of and (n), as subsections (k), (m), (o), and (p), section 505 for a drug will be subject to the the Best Pharmaceuticals for Children provisions of this section. Such notice shall Amendments of 2007.’’; respectively; be published not later than 30 days after the (6) in subsection (g)— (10) by inserting after subsection (i) the date of the Secretary’s determination re- (A) in paragraph (1)— following: garding market exclusivity and shall include (i) by striking ‘‘(c)(1)(A)(ii)’’ and inserting ‘‘(j) OTHER LABELING CHANGES.—If, on or a copy of the written request made under ‘‘(c)(1)(A)(i)(II)’’; and after the date of enactment of the Best Phar- subsection (b) or (c). (ii) by striking ‘‘(c)(2)’’ and inserting maceuticals for Children Amendments of ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.— ‘‘(c)(1)(B)’’; 2007, the Secretary determines that a pedi- The Secretary shall publish a notice identi- (B) in paragraph (2), by striking ‘‘(c)(1)(B)’’ atric study conducted under this section fying any drug for which, on or after the date and inserting ‘‘(c)(1)(A)(ii)’’; does or does not demonstrate that the drug of enactment of the Best Pharmaceuticals (C) by redesignating paragraphs (1) and (2) that is the subject of the study is safe and ef- for Children Amendments of 2007, a pediatric as subparagraphs (A) and (B), respectively; fective, including whether such study results formulation was developed, studied, and (D) by striking ‘‘LIMITATIONS.—A drug’’ are inconclusive, in pediatric populations or found to be safe and effective in the pediatric and inserting ‘‘LIMITATIONS.— subpopulations, the Secretary shall order the population (or specified subpopulation) if the ‘‘(1) IN GENERAL.—Notwithstanding sub- labeling of such product to include informa- pediatric formulation for such drug is not in- section (c)(2), a drug’’; and tion about the results of the study and a troduced onto the market within 1 year of (E) by adding at the end the following: statement of the Secretary’s determina- the date that the Secretary publishes the no- ‘‘(2) EXCLUSIVITY ADJUSTMENT.— tion.’’; tice described in paragraph (1). Such notice ‘‘(A) ADJUSTMENT.— (11) in subsection (k), as redesignated by identifying such drug shall be published not ‘‘(i) IN GENERAL.—With respect to any drug, paragraph (9)— later than 30 days after the date of the expi- if the organization designated under sub- (A) in paragraph (1)— ration of such 1 year period. paragraph (B) notifies the Secretary that the (i) by striking ‘‘a summary of the medical ‘‘(f) INTERNAL REVIEW OF WRITTEN RE- combined annual gross sales for all drugs and’’ and inserting ‘‘the medical, statistical, QUESTS AND PEDIATRIC STUDIES.— with the same active moiety exceeded and’’; and ‘‘(1) INTERNAL REVIEW.— $1,000,000,000 in any calendar year prior to (ii) by striking ‘‘for the supplement’’ and ‘‘(A) IN GENERAL.—The Secretary shall cre- the time the sponsor or holder agrees to the all that follows through the period and in- ate an internal review committee to review initial written request pursuant to sub- serting ‘‘under subsection (b) or (c).’’; all written requests issued and all reports section (d)(2), then each period of market ex- (B) by redesignating paragraph (2) as para- submitted on or after the date of enactment clusivity deemed or extended under sub- graph (3); and of the Best Pharmaceuticals for Children section (b) or (c) shall be reduced by 3 (C) by inserting after paragraph (1) the fol- Amendments of 2007, in accordance with months for such drug. lowing: paragraphs (2) and (3). ‘‘(ii) DETERMINATION.—The determination ‘‘(2) DISSEMINATION OF INFORMATION RE- ‘‘(B) MEMBERS.—The committee under sub- under clause (i) of the combined annual gross GARDING LABELING CHANGES.—Beginning on paragraph (A) shall include individuals, each sales shall be determined— the date of enactment of the Best Pharma- of whom is an employee of the Food and ‘‘(I) taking into account only those sales ceuticals for Children Amendments of 2007, Drug Administration, with the following ex- within the United States; and the Secretary shall require that the sponsors pertise: ‘‘(II) taking into account only the sales of of the studies that result in labeling changes ‘‘(i) Pediatrics. all drugs with the same active moiety of the that are reflected in the annual summary de- ‘‘(ii) Biopharmacology. sponsor or holder and its affiliates. veloped pursuant to subsection (f)(4)(F) dis- ‘‘(iii) Statistics. ‘‘(B) DESIGNATION.—The Secretary shall tribute, at least annually (or more fre- ‘‘(iv) Drugs and drug formulations. designate an organization other than the quently if the Secretary determines that it ‘‘(v) Legal issues. Food and Drug Administration to evaluate would be beneficial to the public health), ‘‘(vi) Appropriate expertise pertaining to whether the combined annual gross sales for such information to physicians and other the pediatric product under review. all drugs with the same active moiety ex- health care providers.’’;

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(12) by inserting after subsection (k), as re- ‘‘(3) EFFECT OF SUBSECTION.—Nothing in sioner of Food and Drugs for pediatric stud- designated by paragraph (9), the following: this subsection alters or amends section ies of a specific pediatric indication identi- ‘‘(l) ADVERSE EVENT REPORTING.— 301(j) of this Act or section 552 of title 5 or fied under subsection (a). Such a proposed ‘‘(1) REPORTING IN YEAR ONE.—Beginning on section 1905 of title 18, United States Code.’’; pediatric study request shall be made in a the date of enactment of the Best Pharma- and manner equivalent to a written request made ceuticals for Children Amendments of 2007, (14) in subsection (p), as redesignated by under subsection (b) or (c) of section 505A of during the 1-year period beginning on the paragraph (9)— the Federal Food, Drug, and Cosmetic Act, date a labeling change is made pursuant to (A) striking ‘‘6-month period’’ and insert- including with respect to the information subsection (i), the Secretary shall ensure ing ‘‘3-month or 6-month period’’; provided on the pediatric studies to be con- that all adverse event reports that have been (B) by striking ‘‘subsection (a)’’ and insert- ducted pursuant to the request. The Director received for such drug (regardless of when ing ‘‘subsection (b)’’; and of the National Institutes of Health may sub- such report was received) are referred to the (C) by striking ‘‘2007’’ both places it ap- mit a proposed pediatric study request for a Office of Pediatric Therapeutics established pears and inserting ‘‘2012’’. drug for which— under section 6 of the Best Pharmaceuticals (b) EFFECTIVE DATE.—Except as otherwise ‘‘(A)(i) there is an approved application for Children Act (Public Law 107–109). In con- provided in the amendments made by sub- under section 505(j) of the Federal Food, sidering such reports, the Director of such section (a), such amendments shall apply to Drug, and Cosmetic Act; or Office shall provide for the review of the re- written requests under section 505A of the ‘‘(ii) there is a submitted application that port by the Pediatric Advisory Committee, Federal Food, Drug, and Cosmetic Act (21 could be approved under the criteria of sec- including obtaining any recommendations of U.S.C. 355a) made after the date of enact- tion 505(j) of the Federal Food, Drug, and such Committee regarding whether the Sec- ment of this subtitle. Cosmetic Act; retary should take action under this section SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF ‘‘(B) there is no patent protection or mar- in response to such reports. DRUGS. ket exclusivity protection for at least 1 form ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol- Section 409I of the Public Health Service of the drug under the Federal Food, Drug, lowing the 1-year period described in para- Act (42 U.S.C. 284m) is amended— and Cosmetic Act; and graph (1), the Secretary shall, as appro- (1) by striking subsections (a) and (b) and ‘‘(C) additional studies are needed to assess priate, refer to the Office of Pediatric Thera- inserting the following: the safety and effectiveness of the use of the ‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC peutics all pediatric adverse event reports drug in the pediatric population.’’; THERAPEUTICS.— for a drug for which a pediatric study was (E) in paragraph (2), as redesignated by conducted under this section. In considering ‘‘(1) IN GENERAL.—Not later than 1 year subparagraph (C)— such reports, the Director of such Office may after the date of enactment of the Best Phar- (i) by inserting ‘‘based on the proposed pe- provide for the review of such reports by the maceuticals for Children Amendments of diatric study request for the indication or in- Pediatric Advisory Committee, including ob- 2007, the Secretary, acting through the Di- dications submitted pursuant to paragraph taining any recommendation of such Com- rector of the National Institutes of Health (1)’’ after ‘‘issue a written request’’; mittee regarding whether the Secretary and in consultation with the Commissioner (ii) by striking ‘‘in the list described in should take action in response to such re- of Food and Drugs and experts in pediatric subsection (a)(1)(A) (except clause (iv))’’ and ports. research, shall develop and publish a priority inserting ‘‘under subsection (a)’’; and ‘‘(3) EFFECT.—The requirements of this list of needs in pediatric therapeutics, in- (iii) by inserting ‘‘and using appropriate subsection shall supplement, not supplant, cluding drugs or indications that require formulations for each age group for which other review of such adverse event reports by study. The list shall be revised every 3 years. the study is requested’’ before the period at the Secretary.’’; ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA- the end; (13) by inserting after subsection (m), as TION.—In developing and prioritizing the list (F) in paragraph (3), as redesignated by redesignated by paragraph (9), the following: under paragraph (1), the Secretary shall con- subparagraph (C)— ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT sider— (i) in the heading, by striking ‘‘CONTRACT’’; COMPLETED.— ‘‘(A) therapeutic gaps in pediatrics that (ii) by striking ‘‘paragraph (1)’’ and insert- ‘‘(1) IN GENERAL.—Beginning on the date of may include developmental pharmacology, ing ‘‘paragraph (2)’’; enactment of the Best Pharmaceuticals for pharmacogenetic determinants of drug re- (iii) by striking ‘‘or if a referral described Children Amendments of 2007, if pediatric sponse, metabolism of drugs and biologics in in subsection (a)(1)(A)(iv) is made,’’; studies of a drug have not been completed children, and pediatric clinical trials; (iv) by striking ‘‘for contract proposals’’ under subsection (d) and if the Secretary, ‘‘(B) particular pediatric diseases, dis- and inserting ‘‘for proposals’’; and through the committee established under orders or conditions where more complete (v) by inserting ‘‘in accordance with sub- subsection (f), determines that there is a knowledge and testing of therapeutics, in- section (b)’’ before the period at the end; continuing need for information relating to cluding drugs and biologics, may be bene- (G) in paragraph (4), as redesignated by the use of the drug in the pediatric popu- ficial in pediatric populations; and subparagraph (C)— lation (including neonates, as appropriate), ‘‘(C) the adequacy of necessary infrastruc- (i) by striking ‘‘contract’’; and the Secretary shall carry out the following: ture to conduct pediatric pharmacological (ii) by striking ‘‘paragraph (2)’’ and insert- ‘‘(A) For a drug for which a listed patent research, including research networks and ing ‘‘paragraph (3)’’; has not expired, make a determination re- trained pediatric investigators. (H) in paragraph (5)— garding whether an assessment shall be re- ‘‘(b) PEDIATRIC STUDIES AND RESEARCH.— quired to be submitted under section 505B. The Secretary, acting through the National (i) by striking the heading and inserting Prior to making such determination, the Institutes of Health, shall award funds to en- ‘‘CONTRACTS, GRANTS, OR OTHER FUNDING Secretary may take not more than 60 days to tities that have the expertise to conduct pe- MECHANISMS’’; and certify whether the Foundation for the Na- diatric clinical trials or other research (in- (ii) by striking ‘‘A contract’’ and all that tional Institutes of Health has sufficient cluding qualified universities, hospitals, lab- follows through ‘‘is submitted’’ and inserting funding at the time of such certification to oratories, contract research organizations, ‘‘A contract, grant, or other funding may be initiate 1 or more of the pediatric studies of practice groups, federally funded programs awarded under this section only if a proposal such drug referred to in the sentence pre- such as pediatric pharmacology research is submitted’’; ceding this paragraph and fund 1 or more of units, other public or private institutions, or (I) in paragraph (6)(A)— such studies in their entirety. Only if the individuals) to enable the entities to conduct (i) by striking ‘‘a contract awarded’’ and Secretary makes such certification in the af- the drug studies or other research on the inserting ‘‘an award’’; and firmative, the Secretary shall refer such pe- issues described in subsection (a). The Sec- (ii) by inserting ‘‘, including a written re- diatric study or studies to the Foundation retary may use contracts, grants, or other quest if issued’’ after ‘‘with the study’’; and for the National Institutes of Health for the appropriate funding mechanisms to award (3) by inserting after subsection (c) the fol- conduct of such study or studies. funds under this subsection.’’; lowing: ‘‘(B) For a drug that has no listed patents (2) in subsection (c)— ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMA- or has 1 or more listed patents that have ex- (A) in the heading, by striking ‘‘CON- TION.—Not later than 1 year after the date of pired, the Secretary shall refer the drug for TRACTS’’ and inserting ‘‘PROPOSED PEDIATRIC enactment of the Best Pharmaceuticals for inclusion on the list established under sec- STUDY REQUESTS’’; Children Amendments of 2007, the Secretary, tion 409I of the Public Health Service Act for (B) by striking paragraphs (4) and (12); acting through the Director of the National the conduct of studies. (C) by redesignating paragraphs (1), (2), and Institutes of Health, shall study the feasi- ‘‘(2) PUBLIC NOTICE.—The Secretary shall (3), as paragraphs (2), (3), and (4); bility of establishing a compilation of infor- give the public notice of— (D) by inserting before paragraph (2), as re- mation on pediatric drug use and report the ‘‘(A) a decision under paragraph (1)(A) not designated by subparagraph (C), the fol- findings to Congress.’’ to require an assessment under section 505B lowing: ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— and the basis for such decision; and ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC ‘‘(1) IN GENERAL.—There are authorized to ‘‘(B) any referral under paragraph (1)(B) of STUDY REQUEST.—The Director of the Na- be appropriated to carry out this section— a drug for inclusion on the list established tional Institutes of Health shall, as appro- ‘‘(A) $200,000,000 for fiscal year 2008; and under section 409I of the Public Health Serv- priate, submit proposed pediatric study re- ‘‘(B) such sums as are necessary for each of ice Act. quests for consideration by the Commis- the 4 succeeding fiscal years.

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‘‘(2) AVAILABILITY.—Any amount appro- SEC. 405. TRAINING OF PEDIATRIC PHARMA- 2008, unless such Commissioner issues the priated under paragraph (1) shall remain COLOGISTS. final rule before such date. available to carry out this section until ex- (a) INVESTMENT IN TOMORROW’S PEDIATRIC (b) LIMITATION.—The proposed rule that pended.’’. RESEARCHERS.—Section 452G(2) of the Public takes effect under subsection (a), or the final SEC. 404. REPORTS AND STUDIES. Health Service Act (42 U.S.C. 285g–10(2)) is rule described under subsection (a), shall, (a) GAO REPORT.—Not later than January amended by adding before the period at the notwithstanding section 17(a) of the Best 31, 2011, the Comptroller General of the end the following: ‘‘, including pediatric Pharmaceuticals for Children Act (21 U.S.C. United States, in consultation with the Sec- pharmacological research’’. 355b(a)), not apply to a drug— retary of Health and Human Services, shall (b) PEDIATRIC RESEARCH LOAN REPAYMENT (1) for which an application is approved submit to Congress a report that addresses PROGRAM.—Section 487F(a)(1) of the Public under section 505 of the Federal Food, Drug, the effectiveness of section 505A of the Fed- Health Service Act (42 U.S.C. 288–6(a)(1)) is and Cosmetic Act (21 U.S.C. 355); eral Food, Drug, and Cosmetic Act (21 U.S.C. amended by inserting ‘‘including pediatric (2) that is not described under section 355a) in ensuring that medicines used by pharmacological research,’’ after ‘‘pediatric 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and children are tested and properly labeled, in- research,’’. (3) the packaging of which includes a toll- cluding— SEC. 406. FOUNDATION FOR THE NATIONAL IN- free number through which consumers can (1) the number and importance of drugs for STITUTES OF HEALTH. report complaints to the manufacturer or children that are being tested as a result of Section 499(c)(1)(C) of the Public Health distributor of the drug. the amendments made by this subtitle and Service Act (42 U.S.C. 290b(c)(1)(C)) is amend- Subtitle B—Pediatric Research Improvement the importance for children, health care pro- ed by striking ‘‘and studies listed by the Sec- SEC. 411. SHORT TITLE. viders, parents, and others of labeling retary pursuant to section 409I(a)(1)(A) of the This subtitle may be cited as the ‘‘Pedi- changes made as a result of such testing; is Act and referred under section atric Research Improvement Act’’. (2) the number and importance of drugs for 505A(d)(4)(C) of the Federal Food, Drug and SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPO- children that are not being tested for their Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)’’ and LATIONS, AND DEFERRALS. use notwithstanding the provisions of this inserting ‘‘and studies for which the Sec- Section 505B(a) of the Federal Food, Drug, subtitle and the amendments made by this retary issues a certification under section and Cosmetic Act (21 U.S.C. 355c(a)) is subtitle, and possible reasons for the lack of 505A(n)(1)(A) of the Federal Food, Drug, and amended— testing, including whether the number of Cosmetic Act (21 U.S.C. 355a(n)(1)(A))’’. (1) in paragraph (4)(C), by adding at the end written requests declined by sponsors or SEC. 407. CONTINUATION OF OPERATION OF the following: ‘‘An applicant seeking either a holders of drugs subject to section 505A(g)(2) COMMITTEE. partial or full waiver on this ground shall of the Federal Food, Drug, and Cosmetic Act Section 14 of the Best Pharmaceuticals for submit to the Secretary documentation de- (21 U.S.C. 355a(g)(2)), has increased or de- Children Act (42 U.S.C. 284m note) is amend- tailing why a pediatric formulation cannot creased as a result of the amendments made ed by adding at the end the following: be developed, and, if the waiver is granted, by this subtitle; ‘‘(d) CONTINUATION OF OPERATION OF COM- the applicant’s submission shall promptly be (3) the number of drugs for which testing is MITTEE.—Notwithstanding section 14 of the made available to the public in an easily ac- being done and labeling changes required, in- Federal Advisory Committee Act (5 U.S.C. cessible manner, including through posting cluding the date labeling changes are made App.), the advisory committee shall continue on the website of the Food and Drug Admin- and which labeling changes required the use to operate during the 5-year period beginning istration’’; of the dispute resolution process established on the date of enactment of the Best Phar- (2) in paragraph (2)(B), by adding at the pursuant to the amendments made by this maceuticals for Children Amendments of end the following: subtitle, together with a description of the 2007.’’. ‘‘(iii) INFORMATION ON EXTRAPOLATION.—A outcomes of such process, including a de- SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ON- brief documentation of the scientific data scription of the disputes and the rec- COLOGIC DRUGS ADVISORY COM- supporting the conclusion under clauses (i) ommendations of the Pediatric Advisory MITTEE. and (ii) shall be included in any pertinent re- Committee; Section 15 of the Best Pharmaceuticals for views for the application under section 505 or (4) any recommendations for modifications Children Act (42 U.S.C. 284m note) is amend- section 351 of the Public Health Service to the programs established under section ed— Act.’’; and 505A of the Federal Food, Drug and Cosmetic (1) in subsection (a)— (3) by striking paragraph (3) and inserting Act (21 U.S.C. 355a) and section 409I of the (A) in paragraph (1)— the following: Public Health Service Act (42 U.S.C. 284m) (i) in subparagraph (B), by striking ‘‘and’’ ‘‘(3) DEFERRAL.— that the Secretary determines to be appro- after the semicolon; ‘‘(A) IN GENERAL.—On the initiative of the priate, including a detailed rationale for (ii) in subparagraph (C), by striking the pe- Secretary or at the request of the applicant, each recommendation; and riod at the end and inserting ‘‘; and’’; and the Secretary may defer submission of some (5)(A) the efforts made by the Secretary to (iii) by adding at the end the following: or all assessments required under paragraph increase the number of studies conducted in ‘‘(D) provide recommendations to the in- (1) until a specified date after approval of the the neonate population; and ternal review committee created under sec- drug or issuance of the license for a biologi- (B) the results of those efforts, including tion 505A(f) of the Federal Food, Drug, and cal product if— efforts made to encourage the conduct of ap- Cosmetic Act (21 U.S.C. 355a(f)) regarding the ‘‘(i) the Secretary finds that— propriate studies in neonates by companies implementation of amendments to sections ‘‘(I) the drug or biological product is ready with products that have sufficient safety and 505A and 505B of the Federal Food, Drug, and for approval for use in adults before pediatric other information to make the conduct of Cosmetic Act (21 U.S.C. 355a and 355c) with studies are complete; the studies ethical and safe. respect to the treatment of pediatric can- ‘‘(II) pediatric studies should be delayed (b) IOM STUDY.—Not later than 3 years cers.’’; and until additional safety or effectiveness data after the date of enactment of this subtitle, (B) by adding at the end the following: have been collected; or the Secretary of Health and Human Services ‘‘(3) CONTINUATION OF OPERATION OF SUB- ‘‘(III) there is another appropriate reason shall enter into a contract with the Institute COMMITTEE.—Notwithstanding section 14 of for deferral; and of Medicine to conduct a study and report to the Federal Advisory Committee Act (5 ‘‘(ii) the applicant submits to the Sec- Congress regarding the written requests U.S.C. App.), the Subcommittee shall con- retary— made and the studies conducted pursuant to tinue to operate during the 5-year period be- ‘‘(I) certification of the grounds for defer- section 505A of the Federal Food, Drug, and ginning on the date of enactment of the Best ring the assessments; Cosmetic Act. The Institute of Medicine may Pharmaceuticals for Children Amendments ‘‘(II) a description of the planned or ongo- devise an appropriate mechanism to review a of 2007.’’; and ing studies; representative sample of requests made and (2) in subsection (d), by striking ‘‘2003’’ and ‘‘(III) evidence that the studies are being studies conducted pursuant to such section inserting ‘‘2009’’. conducted or will be conducted with due dili- in order to conduct such study. Such study gence and at the earliest possible time; and SEC. 409. EFFECTIVE DATE AND LIMITATION FOR shall— RULE RELATING TO TOLL-FREE ‘‘(IV) a timeline for the completion of such (1) review such representative written re- NUMBER FOR ADVERSE EVENTS ON studies. quests issued by the Secretary since 1997 LABELING FOR HUMAN DRUG PROD- ‘‘(B) ANNUAL REVIEW.— under subsections (b) and (c) of such section UCTS. ‘‘(i) IN GENERAL.—On an annual basis fol- 505A; (a) IN GENERAL.—Notwithstanding sub- lowing the approval of a deferral under sub- (2) review and assess such representative chapter II of chapter 5, and chapter 7, of title paragraph (A), the applicant shall submit to pediatric studies conducted under such sub- 5, United States Code (commonly known as the Secretary the following information: sections (b) and (c) since 1997 and labeling the ‘‘Administrative Procedure Act’’) and ‘‘(I) Information detailing the progress changes made as a result of such studies; and any other provision of law, the proposed rule made in conducting pediatric studies. (3) review the use of extrapolation for pedi- issued by the Commissioner of Food and ‘‘(II) If no progress has been made in con- atric subpopulations, the use of alternative Drugs entitled ‘‘Toll-Free Number for Re- ducting such studies, evidence and docu- endpoints for pediatric populations, neonatal porting Adverse Events on Labeling for mentation that such studies will be con- assessment tools, and ethical issues in pedi- Human Drug Products’’, 69 Fed. Reg. 21778, ducted with due diligence and at the earliest atric clinical trials. (April 22, 2004) shall take effect on January 1, possible time.

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‘‘(ii) PUBLIC AVAILABILITY.—The informa- ‘‘(A) Pediatrics. ‘‘(ii) if the sponsor does not agree to make tion submitted through the annual review ‘‘(B) Biopharmacology. a labeling change requested by the Commis- under clause (i) shall promptly be made ‘‘(C) Statistics. sioner, the Commissioner shall refer the available to the public in an easily accessible ‘‘(D) Drugs and drug formulations. matter to the Pediatric Advisory Com- manner, including through the website of the ‘‘(E) Pediatric ethics. mittee. Food and Drug Administration.’’. ‘‘(F) Legal issues. ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY SEC. 413. IMPROVING AVAILABILITY OF PEDI- ‘‘(G) Appropriate expertise pertaining to COMMITTEE.—Not later than 90 days after re- ATRIC DATA FOR ALREADY MAR- the pediatric product under review. ceiving a referral under subparagraph (A)(ii), KETED PRODUCTS. ‘‘(H) 1 or more experts from the Office of the Pediatric Advisory Committee shall— Section 505B(b) of the Federal Food, Drug, Pediatric Therapeutics. ‘‘(i) review the pediatric study reports; and and Cosmetic Act (21 U.S.C. 355c(b)) is ‘‘(I) Other individuals as designated by the ‘‘(ii) make a recommendation to the Com- amended— Secretary. missioner concerning appropriate labeling (1) by striking paragraph (1) and inserting ‘‘(2) REVIEW OF REQUESTS FOR PEDIATRIC AS- changes, if any. the following: SESSMENTS, DEFERRALS, AND WAIVERS.—All ‘‘(C) CONSIDERATION OF RECOMMENDA- ‘‘(1) IN GENERAL.—After providing notice in written requests for a pediatric assessment TIONS.—The Commissioner shall consider the the form of a letter, or a written request issued pursuant to this section and all re- recommendations of the Pediatric Advisory under section 505A that was declined by the quests for deferrals and waivers from the re- Committee and, if appropriate, not later sponsor or holder, and an opportunity for quirement to conduct a pediatric assessment than 30 days after receiving the rec- written response and a meeting, which may under this section shall be reviewed and ap- ommendation, make a request to the sponsor include an advisory committee meeting, the proved by the committee established under of the application or supplement to make Secretary may (by order in the form of a let- paragraph (1). any labeling changes that the Commissioner ter) require the sponsor or holder of an ap- ‘‘(3) REVIEW OF ASSESSMENTS.—The com- determines to be appropriate. proved application for a drug under section mittee established under paragraph (1) shall ‘‘(D) MISBRANDING.—If the sponsor, within 505 or the holder of a license for a biological review all assessments conducted under this 30 days after receiving a request under sub- product under section 351 of the Public section to determine whether such assess- paragraph (C), does not agree to make a la- Health Service Act (42 U.S.C. 262) to submit ments meet the requirements of this section. beling change requested by the Commis- by a specified date the assessments described ‘‘(4) TRACKING OF ASSESSMENTS AND LABEL- sioner, the Commissioner may deem the drug in subsection (a)(2) and the written request, ING CHANGES.—The committee established that is the subject of the application or sup- as appropriate, if the Secretary finds that— under paragraph (1) is responsible for track- plement to be misbranded. ‘‘(A)(i) the drug or biological product is ing and making public in an easily accessible ‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in used for a substantial number of pediatric manner, including through posting on the this subsection limits the authority of the patients for the labeled indications; and website of the Food and Drug Administra- United States to bring an enforcement ac- ‘‘(ii) adequate pediatric labeling could con- tion— tion under this Act when a drug lacks appro- fer a benefit on pediatric patients; ‘‘(A) the number of assessments conducted priate pediatric labeling. Neither course of ‘‘(B) there is reason to believe that the under this section; action (the Pediatric Advisory Committee drug or biological product would represent a ‘‘(B) the specific drugs and drug uses as- process or an enforcement action referred to meaningful therapeutic benefit over existing sessed under this section; in the preceding sentence) shall preclude, therapies for pediatric patients for 1 or more ‘‘(C) the types of assessments conducted delay, or serve as the basis to stay the other of the claimed indications; or under this section, including trial design, the course of action. ‘‘(C) the absence of adequate pediatric la- number of pediatric patients studied, and the ‘‘(3) OTHER LABELING CHANGES.—If the Sec- beling could pose a risk to pediatric pa- number of centers and countries involved; retary makes a determination that a pedi- tients.’’; ‘‘(D) the total number of deferrals re- atric assessment conducted under this sec- (2) in paragraph (2)(C), by adding at the end quested and granted under this section, and, tion does or does not demonstrate that the the following: ‘‘An applicant seeking either a if granted, the reasons for such deferrals, the drug that is the subject of such assessment is partial or full waiver shall submit to the timeline for completion, and the number safe and effective, including whether such as- Secretary documentation detailing why a pe- completed and pending by the specified date, sessment results are inconclusive, in pedi- diatric formulation cannot be developed, as outlined in subsection (a)(3); atric populations or subpopulations, the Sec- and, if the waiver is granted, the applicant’s ‘‘(E) the number of waivers requested and retary shall order the labeling of such prod- submission shall promptly be made available granted under this section, and, if granted, uct to include information about the results to the public in an easily accessible manner, the reasons for the waivers; of the assessment and a statement of the including through posting on the website of ‘‘(F) the number of pediatric formulations Secretary’s determination. the Food and Drug Administration.’’; and developed and the number of pediatric for- ‘‘(h) DISSEMINATION OF PEDIATRIC INFORMA- (3) by striking paragraph (3) and inserting mulations not developed and the reasons any TION.— the following: such formulations were not developed; ‘‘(1) IN GENERAL.—Not later than 180 days ‘‘(G) the labeling changes made as a result after the date of submission of a pediatric as- ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section of assessments conducted under this section; sessment under this section, the Secretary 301(j) of this Act or section 552 of title 5 or ‘‘(H) an annual summary of labeling shall make available to the public in an eas- section 1905 of title 18, United States Code.’’. changes made as a result of assessments con- ily accessible manner the medical, statis- ducted under this section for distribution tical, and clinical pharmacology reviews of SEC. 414. SUNSET; REVIEW OF PEDIATRIC AS- SESSMENTS; ADVERSE EVENT RE- pursuant to subsection (i)(2); and such pediatric assessments and shall post PORTING; LABELING CHANGES; AND ‘‘(I) an annual summary of the information such assessments on the website of the Food PEDIATRIC ASSESSMENTS. submitted pursuant to subsection (a)(3)(B). and Drug Administration. Section 505B of the Federal Food, Drug, ‘‘(g) LABELING CHANGES.— ‘‘(2) DISSEMINATION OF INFORMATION RE- and Cosmetic Act (21 U.S.C. 355c) is amend- ‘‘(1) PRIORITY STATUS FOR PEDIATRIC SUP- GARDING LABELING CHANGES.—The Secretary ed— PLEMENT.—Any supplement to an application shall require that the sponsors of the assess- (1) redesignating subsection (h) as sub- under section 505 and section 351 of the Pub- ments that result in labeling changes that section (j); lic Health Service Act proposing a labeling are reflected in the annual summary devel- (2) in subsection (j), as so redesignated, by change as a result of any pediatric assess- oped pursuant to subsection (f)(4)(H) dis- striking ‘‘505A(n)’’ and inserting ‘‘505A(p)’’; ments conducted pursuant to this section— tribute such information to physicians and (3) by redesignating subsection (f) as sub- ‘‘(A) shall be considered a priority supple- other health care providers. section (k); ment; and ‘‘(3) EFFECT OF SUBSECTION.—Nothing in (4) by redesignating subsection (g) as sub- ‘‘(B) shall be subject to the performance this subsection shall alter or amend section section (l); and goals established by the Commissioner for 301(j) of this Act or section 552 of title 5, (5) by inserting after subsection (e) the fol- priority drugs. United States Code, or section 1905 of title lowing: ‘‘(2) DISPUTE RESOLUTION.— 18, United States Code. ‘‘(f) REVIEW OF PEDIATRIC ASSESSMENT RE- ‘‘(A) REQUEST FOR LABELING CHANGE AND ‘‘(i) ADVERSE EVENT REPORTING.— QUESTS, PEDIATRIC ASSESSMENTS, DEFER- FAILURE TO AGREE.—If the Commissioner de- ‘‘(1) REPORTING IN YEAR 1.—During the 1- RALS, AND WAIVERS.— termines that a sponsor and the Commis- year period beginning on the date a labeling ‘‘(1) REVIEW.—The Secretary shall create sioner have been unable to reach agreement change is made pursuant to subsection (g), an internal committee to review all pedi- on appropriate changes to the labeling for the Secretary shall ensure that all adverse atric assessment requests issued under this the drug that is the subject of the applica- event reports that have been received for section, all pediatric assessments conducted tion or supplement, not later than 180 days such drug (regardless of when such report under this section, and all deferral and waiv- after the date of the submission of the appli- was received) are referred to the Office of Pe- er requests made pursuant to this section. cation or supplement— diatric Therapeutics. In considering such re- Such internal committee shall include indi- ‘‘(i) the Commissioner shall request that ports, the Director of such Office shall pro- viduals, each of whom is an employee of the the sponsor make any labeling change that vide for the review of the report by the Pedi- Food and Drug Administration, with the fol- the Commissioner determines to be appro- atric Advisory Committee, including obtain- lowing expertise: priate; and ing any recommendations of such committee

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00044 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.013 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5359 regarding whether the Secretary should take of the dispute resolution process established has the meaning given the term in section action under this Act in response to such re- under such section 505B, together with a de- 520(m)(6)(E)(ii).’’. port. scription of the outcomes of such process, in- SEC. 423. MODIFICATION TO HUMANITARIAN DE- ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol- cluding a description of the disputes and the VICE EXEMPTION. lowing the 1-year period described in para- recommendations of the Pediatric Advisory (a) IN GENERAL.—Section 520(m) of the Fed- graph (1), the Secretary shall, as appro- Committee. eral Food, Drug, and Cosmetic Act (21 U.S.C. priate, refer to the Office of Pediatric Thera- SEC. 417. TECHNICAL CORRECTIONS. 360j(m)) is amended— peutics with all pediatric adverse event re- Section 505B(a)(2)(B)(ii) of the Federal (1) in paragraph (3), by striking ‘‘No’’ and ports for a drug for which a pediatric study Food, Drug, and Cosmetic Act (21 U.S.C. inserting ‘‘Except as provided in paragraph (6), no’’; was conducted under this section. In consid- 355c(a)(2)(B)(ii)) is amended by striking (2) in paragraph (5)— ering such reports, the Director of such Of- ‘‘one’’ and inserting ‘‘1’’. fice may provide for the review of such re- (A) by inserting ‘‘, if the Secretary has rea- Subtitle C—Pediatric Medical Devices ports by the Pediatric Advisory Committee, son to believe that the requirements of para- including obtaining any recommendation of SEC. 421. SHORT TITLE. graph (6) are no longer met,’’ after ‘‘public such Committee regarding whether the Sec- This subtitle may be cited as the ‘‘Pedi- health’’; and retary should take action in response to such atric Medical Device Safety and Improve- (B) by adding at the end the following: ‘‘If report. ment Act of 2007’’. the person granted an exemption under para- ‘‘(3) EFFECT.—The requirements of this SEC. 422. TRACKING PEDIATRIC DEVICE APPROV- graph (2) fails to demonstrate continued subsection shall supplement, not supplant, ALS. compliance with the requirements of this other review of such adverse event reports by Chapter V of the Federal Food, Drug, and subsection, the Secretary may suspend or the Secretary.’’. Cosmetic Act (21 U.S.C. 351 et seq.) is amend- withdraw the exemption from the effective- ness requirements of sections 514 and 515 for SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT. ed by inserting after section 515 the fol- a humanitarian device only after providing Section 505B(c) of the Federal Food, Drug, lowing: notice and an opportunity for an informal and Cosmetic Act (21 U.S.C. 355c) is amend- ‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. hearing.’’; ed— ‘‘(a) NEW DEVICES.— (3) by striking paragraph (6) and inserting (1) by striking ‘‘estimates’’ and inserting ‘‘(1) IN GENERAL.—A person that submits to the following: ‘‘determines’’; and the Secretary an application under section ‘‘(6)(A) Except as provided in subparagraph (2) by striking ‘‘would’’ and inserting 520(m), or an application (or supplement to (D), the prohibition in paragraph (3) shall ‘‘could’’. an application) or a product development not apply with respect to a person granted SEC. 416. REPORTS. protocol under section 515, shall include in an exemption under paragraph (2) if each of (a) INSTITUTE OF MEDICINE STUDY.— the application or protocol the information the following conditions apply: (1) IN GENERAL.—Not later than 3 years described in paragraph (2). ‘‘(i)(I) The device with respect to which the after the date of enactment of this subtitle, ‘‘(2) REQUIRED INFORMATION.—The applica- exemption is granted is intended for the the Secretary shall contract with the Insti- tion or protocol described in paragraph (1) treatment or diagnosis of a disease or condi- tute of Medicine to conduct a study and re- shall include, with respect to the device for tion that occurs in pediatric patients or in a port to Congress regarding the pediatric which approval is sought and if readily avail- pediatric subpopulation, and such device is studies conducted pursuant to section 505B able— labeled for use in pediatric patients or in a of the Federal Food, Drug, and Cosmetic Act ‘‘(A) a description of any pediatric sub- pediatric subpopulation in which the disease (21 U.S.C. 355c) since 1997. populations that suffer from the disease or or condition occurs. (2) CONTENT OF STUDY.—The study under condition that the device is intended to ‘‘(II) The device was not previously ap- paragraph (1) shall review and assess— treat, diagnose, or cure; and proved under this subsection for the pedi- (A) pediatric studies conducted pursuant to ‘‘(B) the number of affected pediatric pa- atric patients or the pediatric subpopulation section 505B of the Federal Food, Drug, and tients. described in subclause (I) prior to the date of Cosmetic Act (21 U.S.C. 355c) since 1997 and ‘‘(3) ANNUAL REPORT.—Not later than 18 enactment of the Pediatric Medical Device labeling changes made as a result of such months after the date of enactment of this Safety and Improvement Act of 2007. studies; and section, and annually thereafter, the Sec- ‘‘(ii) During any calendar year, the number (B) the use of extrapolation for pediatric retary shall submit to the Committee on of such devices distributed during that year subpopulations, the use of alternative Health, Education, Labor, and Pensions of does not exceed the annual distribution num- endpoints for pediatric populations, neonatal the Senate and the Committee on Energy ber specified by the Secretary when the Sec- assessment tools, number and type of pedi- and Commerce of the House of Representa- retary grants such exemption. The annual atric adverse events, and ethical issues in pe- tives a report that includes— distribution number shall be based on the diatric clinical trials. ‘‘(A) the number of devices approved in the number of individuals affected by the disease (3) REPRESENTATIVE SAMPLE.—The Insti- year preceding the year in which the report or condition that such device is intended to tute of Medicine may devise an appropriate is submitted, for which there is a pediatric treat, diagnose, or cure, and of that number, mechanism to review a representative sam- subpopulation that suffers from the disease the number of individuals likely to use the ple of studies conducted pursuant to section or condition that the device is intended to device, and the number of devices reasonably 505B of the Federal Food, Drug, and Cos- treat, diagnose, or cure; necessary to treat such individuals. In no metic Act (21 U.S.C. 355c) from each review ‘‘(B) the number of devices approved in the case shall the annual distribution number division within the Center for Drug Evalua- year preceding the year in which the report exceed the number identified in paragraph tion and Research and the Center for Bio- is submitted, labeled for use in pediatric pa- (2)(A). logics Evaluation and Research in order to tients; ‘‘(iii) Such person immediately notifies the make the required assessment. ‘‘(C) the number of pediatric devices ap- Secretary if the number of such devices dis- (b) GAO REPORT.—Not later than Sep- proved in the year preceding the year in tributed during any calendar year exceeds tember 1, 2010, the Comptroller General of which the report is submitted, exempted the annual distribution number referred to the United States, in consultation with the from a fee pursuant to section 738(a)(2)(B)(v); in clause (ii). Secretary of Health and Human Services, and ‘‘(iv) The request for such exemption is shall submit to Congress a report that ad- ‘‘(D) the review time for each device de- submitted on or before October 1, 2012. dresses the effectiveness of section 505B of scribed in subparagraphs (A), (B), and (C). ‘‘(B) The Secretary may inspect the records relating to the number of devices dis- the Federal Food, Drug, and Cosmetic Act ‘‘(b) DETERMINATION OF PEDIATRIC EFFEC- tributed during any calendar year of a per- (21 U.S.C. 355a) in ensuring that medicines TIVENESS BASED ON SIMILAR COURSE OF DIS- son granted an exemption under paragraph used by children are tested and properly la- EASE OR CONDITION OR SIMILAR EFFECT OF DE- (2) for which the prohibition in paragraph (3) beled, including— VICE ON ADULTS.— does not apply. (1) the number and importance of drugs for ‘‘(1) IN GENERAL.—If the course of the dis- ‘‘(C) A person may petition the Secretary children that are being tested as a result of ease or condition and the effects of the de- to modify the annual distribution number this provision and the importance for chil- vice are sufficiently similar in adults and pe- specified by the Secretary under subpara- dren, health care providers, parents, and oth- diatric patients, the Secretary may conclude graph (A)(ii) with respect to a device if addi- ers of labeling changes made as a result of that adult data may be used to support a de- tional information on the number of individ- such testing; termination of a reasonable assurance of ef- uals affected by the disease or condition (2) the number and importance of drugs for fectiveness in pediatric populations, as ap- arises, and the Secretary may modify such children that are not being tested for their propriate. number but in no case shall the annual dis- use notwithstanding the provisions of such ‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULA- tribution number exceed the number identi- section 505B, and possible reasons for the TIONS.—A study may not be needed in each fied in paragraph (2)(A). lack of testing; and pediatric subpopulation if data from one sub- ‘‘(D) If a person notifies the Secretary, or (3) the number of drugs for which testing is population can be extrapolated to another the Secretary determines through an inspec- being done and labeling changes required, in- subpopulation. tion under subparagraph (B), that the num- cluding the date labeling changes are made ‘‘(c) PEDIATRIC SUBPOPULATION.—In this ber of devices distributed during any cal- and which labeling changes required the use section, the term ‘pediatric subpopulation’ endar year exceeds the annual distribution

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00045 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.013 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5360 CONGRESSIONAL RECORD — SENATE May 1, 2007 number, as required under subparagraph (10) an evaluation of the demonstration ing, prototype development, postmarket (A)(iii), and modified under subparagraph grants described in section 425, which shall needs, and other activities consistent with (C), if applicable, then the prohibition in include an evaluation of the number of pedi- the purposes of this section. paragraph (3) shall apply with respect to atric medical devices— (d) COORDINATION.— such person for such device for any sales of (A) that have been or are being studied in (1) NATIONAL INSTITUTES OF HEALTH.—Each such device after such notification. children; and consortium that receives a grant or contract ‘‘(E)(i) In this subsection, the term ‘pedi- (B) that have been submitted to the Food under this section shall— atric patients’ means patients who are 21 and Drug Administration for approval, clear- (A) coordinate with the National Institutes years of age or younger at the time of the di- ance, or review under such section 520(m) (as of Health’s pediatric device contact point or agnosis or treatment. amended by this Act) and any regulatory ac- ‘‘(ii) In this subsection, the term ‘pediatric office, designated under section 424; and tions taken. (B) provide to the National Institutes of subpopulation’ means 1 of the following pop- (c) GUIDANCE.—Not later than 180 days Health any identified pediatric device needs ulations: after the date of enactment of this subtitle, that the consortium lacks sufficient capac- ‘‘(I) Neonates. the Commissioner of Food and Drugs shall ity to address or those needs in which the ‘‘(II) Infants. issue guidance for institutional review com- ‘‘(III) Children. mittees on how to evaluate requests for ap- consortium has been unable to stimulate ‘‘(IV) Adolescents.’’; and proval for devices for which a humanitarian manufacturer interest. (4) by adding at the end the following: device exemption under section 520(m)(2) of (2) FOOD AND DRUG ADMINISTRATION.—Each ‘‘(7) The Secretary shall refer any report of the Federal Food, Drug, and Cosmetic Act consortium that receives a grant or contract an adverse event regarding a device for (21 U.S.C. 360j(m)(2)) has been granted. under this section shall coordinate with the which the prohibition under paragraph (3) SEC. 424. CONTACT POINT FOR AVAILABLE FUND- Commissioner of Food and Drugs and device does not apply pursuant to paragraph (6)(A) ING. companies to facilitate the application for that the Secretary receives to the Office of Section 402(b) of the Public Health Service approval or clearance of devices labeled for Pediatric Therapeutics, established under Act (42 U.S.C. 282(b)) is amended— pediatric use. section 6 of the Best Pharmaceuticals for (1) in paragraph (21), by striking ‘‘and’’ (3) EFFECTIVENESS AND OUTCOMES.—Each Children Act (Public Law 107–109)). In consid- after the semicolon at the end; consortium that receives a grant or contract ering the report, the Director of the Office of (2) in paragraph (22), by striking the period under this section shall annually report to Pediatric Therapeutics, in consultation with at the end and inserting ‘‘; and’’; and the Secretary of Health and Human Services experts in the Center for Devices and Radio- (3) by inserting after paragraph (22) the fol- on— logical Health, shall provide for periodic re- lowing: (A) the effectiveness of activities con- view of the report by the Pediatric Advisory ‘‘(23) shall designate a contact point or of- ducted under subsection (c); Committee, including obtaining any rec- fice to help innovators and physicians iden- (B) the impact of activities conducted ommendations of such committee regarding tify sources of funding available for pediatric under subsection (c) on pediatric device de- whether the Secretary should take action medical device development.’’. velopment; and under this Act in response to the report.’’. SEC. 425. DEMONSTRATION GRANTS FOR IM- (C) the status of pediatric device develop- (b) REPORT.—Not later than January 1, PROVING PEDIATRIC DEVICE AVAIL- ment that has been facilitated by the consor- 2012, the Comptroller General of the United ABILITY. tium. States shall submit to the Committee on (a) IN GENERAL.— Health, Education, Labor, and Pensions of (e) AUTHORIZATION OF APPROPRIATIONS.— (1) REQUEST FOR PROPOSALS.—Not later There are authorized to be appropriated to the Senate and the Committee on Energy than 90 days after the date of enactment of and Commerce of the House of Representa- carry out this section $6,000,000 for each of this subtitle, the Secretary of Health and fiscal years 2008 through 2012. tives a report on the impact of allowing per- Human Services shall issue a request for pro- sons granted an exemption under section posals for 1 or more grants or contracts to SEC. 426. AMENDMENTS TO OFFICE OF PEDI- 520(m)(2) of the Federal Food, Drug, and Cos- nonprofit consortia for demonstration ATRIC THERAPEUTICS AND PEDI- metic Act (21 U.S.C. 360j(m)(2)) with respect projects to promote pediatric device develop- ATRIC ADVISORY COMMITTEE. to a device to profit from such device pursu- ment. (a) IN GENERAL.— ant to section 520(m)(6) of such Act (21 U.S.C. (2) DETERMINATION ON GRANTS OR CON- (1) OFFICE OF PEDIATRIC THERAPEUTICS.— 360j(m)(6)) (as amended by subsection (a)), in- TRACTS.—Not later than 180 days after the Section 6(b) of the Best Pharmaceuticals for cluding— date the Secretary of Health and Human Children Act (21 U.S.C. 393a(b)) is amended (1) an assessment of whether such section Services issues a request for proposals under by inserting ‘‘, including increasing pediatric 520(m)(6) (as amended by subsection (a)) has paragraph (1), the Secretary shall make a de- access to medical devices’’ after ‘‘pediatric increased the availability of pediatric de- termination on the grants or contracts under issues’’. vices for conditions that occur in small num- this section. (2) PLAN FOR PEDIATRIC MEDICAL DEVICE RE- bers of children, including any increase or (b) APPLICATION.—A nonprofit consortium SEARCH.— decrease in the number of— that desires to receive a grant or contract (A) IN GENERAL.—Not later than 270 days (A) exemptions granted under such section under this section shall submit an applica- after the date of enactment of this subtitle, 520(m)(2) for pediatric devices; and tion to the Secretary of Health and Human the Office of Pediatric Therapeutics, in col- (B) applications approved under section 515 Services at such time, in such manner, and laboration with the Director of the National of such Act (21 U.S.C. 360e) for devices in- containing such information as the Sec- Institutes of Health and the Director of the tended to treat, diagnose, or cure conditions retary may require. that occur in pediatric patients or for de- Agency for Healthcare Research and Quality, (c) USE OF FUNDS.—A nonprofit consortium shall submit to the Committee on Health, vices labeled for use in a pediatric popu- that receives a grant or contract under this Education, Labor, and Pensions of the Sen- lation; section shall facilitate the development, pro- ate and the Committee on Energy and Com- (2) the conditions or diseases the pediatric duction, and distribution of pediatric med- merce of the House of Representatives a plan devices were intended to treat or diagnose ical devices by— for expanding pediatric medical device re- and the estimated size of the pediatric pa- (1) encouraging innovation and connecting search and development. In developing such tient population for each condition or dis- qualified individuals with pediatric device ease; ideas with potential manufacturers; plan, the Commissioner of Food and Drugs (3) the costs of the pediatric devices, based (2) mentoring and managing pediatric de- shall consult with individuals and organiza- on a survey of children’s hospitals; vice projects through the development proc- tions with appropriate expertise in pediatric (4) the extent to which the costs of such ess, including product identification, proto- medical devices. devices are covered by health insurance; type design, device development, and mar- (B) CONTENTS.—The plan under subpara- (5) the impact, if any, of allowing profit on keting; graph (A) shall include— access to such devices for patients; (3) connecting innovators and physicians (i) the current status of federally funded (6) the profits made by manufacturers for to existing Federal and non-Federal re- pediatric medical device research; each device that receives an exemption; sources, including resources from the Food (ii) any gaps in such research, which may (7) an estimate of the extent of the use of and Drug Administration, the National Insti- include a survey of pediatric medical pro- the pediatric devices by both adults and pe- tutes of Health, the Small Business Adminis- viders regarding unmet pediatric medical de- diatric populations for a condition or disease tration, the Department of Energy, the De- vice needs, as needed; and other than the condition or disease on the partment of Education, the National Science (iii) a research agenda for improving pedi- label of such devices; Foundation, the Department of Veterans Af- atric medical device development and Food (8) recommendations of the Comptroller fairs, the Agency for Healthcare Research and Drug Administration clearance or ap- General of the United States regarding the and Quality, and the National Institute of proval of pediatric medical devices, and for effectiveness of such section 520(m)(6) (as Standards and Technology; evaluating the short- and long-term safety amended by subsection (a)) and whether any (4) assessing the scientific and medical and effectiveness of pediatric medical de- modifications to such section 520(m)(6) (as merit of proposed pediatric device projects; vices. amended by subsection (a)) should be made; and (b) PEDIATRIC ADVISORY COMMITTEE.—Sec- (9) existing obstacles to pediatric device (5) providing assistance and advice as need- tion 14 of the Best Pharmaceuticals for Chil- development; and ed on business development, personnel train- dren Act (42 U.S.C. 284m note) is amended—

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00046 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.013 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5361 (1) in subsection (a), by inserting ‘‘(includ- et seq.), as amended by section 241, is further adjustments and changes that we had ing drugs and biological products) and med- amended by adding at the end the following: indicated during the course of our ical devices’’ after ‘‘therapeutics’’; and ‘‘SEC. 713. POLICY ON THE REVIEW AND CLEAR- markup. We had a number of amend- (2) in subsection (b)— ANCE OF SCIENTIFIC ARTICLES PUB- ments that were offered. We indicated (A) in paragraph (1), by inserting ‘‘(includ- LISHED BY FDA EMPLOYEES. ing drugs and biological products) and med- ‘‘(a) DEFINITION.—In this section, the term to the members we would try to work ical devices’’ after ‘‘therapeutics’’; and ‘article’ means a paper, poster, abstract, through some of the points that were (B) in paragraph (2)— book, book chapter, or other published writ- raised. I commend our staffs on both (i) in subparagraph (A), by striking ‘‘and ing. sides who have been diligent in doing 505B’’ and inserting ‘‘505B, 510(k), 515, and ‘‘(b) POLICIES.—The Secretary, through the so. 520(m)’’; Commissioner of Food and Drugs, shall es- These are alterations, changes that (ii) by striking subparagraph (B) and in- tablish and make publicly available clear are known to the majority and the mi- serting the following: written policies to implement this section ‘‘(B) identification of research priorities and govern the timely submission, review, nority and all the staff members. Later related to therapeutics (including drugs and clearance, and disclaimer requirements for on in the discussion and debate we can biological products) and medical devices for articles. go into some in greater detail. Most of pediatric populations and the need for addi- ‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If them are clarifications. Some of them tional diagnostics and treatments for spe- an officer or employee, including a Staff Fel- are simplifications. I think all of them cific pediatric diseases or conditions; and’’; low and a contractor who performs staff are worthy and justified, and I think and work, of the Food and Drug Administration they help to strengthen the legislation. (iii) in subparagraph (C), by inserting ‘‘(in- is required by the policies established under So we are very grateful to all of our cluding drugs and biological products) and subsection (b) to submit an article to the su- medical devices’’ after ‘‘therapeutics’’. pervisor of such officer or employee, or to colleagues on our committee who of- SEC. 427. SURVEILLANCES. some other official of the Food and Drug Ad- fered the amendments, and, most par- (a) POSTMARKET SURVEILLANCES.—Section ministration, for review and clearance before ticularly, we are very grateful for their 522 of the Federal Food, Drug, and Cosmetic such officer or employee may seek to publish willingness to work with us to try to Act (21 U.S.C. 360l) is amended— or present such an article at a conference, work through these alterations and (1) by striking subsection (a) and inserting such officer or employee shall submit such changes. the following: article for such review and clearance not less Mr. President, this legislation, as ‘‘(a) POSTMARKET SURVEILLANCE.— than 30 days before submitting the article ‘‘(1) IN GENERAL.— was pointed out in the excellent state- for publication or presentation. ment made by our friend and colleague ‘‘(A) CONDUCT.—The Secretary may by ‘‘(d) TIMING FOR REVIEW AND CLEARANCE.— order require a manufacturer to conduct The supervisor or other reviewing official from Rhode Island, Mr. REED, and oth- postmarket surveillance for any device of shall review such article and provide written ers, is complex, but it is incredibly im- the manufacturer that is a class II or class clearance, or written clearance on the condi- portant in terms of American families, III device— tion of specified changes being made, to such most precisely with regard to drug ‘‘(i) the failure of which would be reason- officer or employee not later than 30 days safety. We have reviewed those provi- ably likely to have serious adverse health after such officer or employee submitted consequences; sions. Senator ENZI made an excellent such article for review. presentation yesterday. We tried to go ‘‘(ii) that is expected to have significant ‘‘(e) NON-TIMELY REVIEW.—If, 31 days after use in pediatric populations; or such submission under subsection (c), the su- through those in some detail yesterday ‘‘(iii) that is intended to be implanted in pervisor or other reviewing official has not afternoon. I might go through some of the human body for more than 1 year, or a cleared or has not reviewed such article and those again this afternoon. life sustaining or life supporting device used provided written clearance, such officer or But we want our Members to know outside a device user facility. employee may consider such article not to we are ready to consider amendments. ‘‘(B) CONDITION.—The Secretary may order have been cleared and may submit the arti- We know there are several that are just a postmarket surveillance under subpara- cle for publication or presentation with an graph (A) as a condition to approval of an ap- about ready to be offered. We urge appropriate disclaimer as specified in the those who are considering bringing plication (or a supplement to an application) policies established under subsection (b).’’. or a product development protocol under sec- them to the floor, let’s begin the de- SEC. 502. TECHNICAL AMENDMENTS. tion 515 or as a condition to clearance of a bate and discussion. We have one or premarket notification under section 510(k) The Public Health Service Act (42 U.S.C. 201 et seq.) is amended— two that are still being worked on. So only for a device described in subparagraph even though it does not appear like we (A)(ii). (1) in section 319C–2(j)(3)(B), by striking ‘‘section 319C–1(h)’’ and inserting ‘‘section are making progress on this legislation ‘‘(2) RULE OF CONSTRUCTION.—The provi- sions of paragraph (1) shall have no effect on 319C–1(i)’’; at the moment, progress is being made authorities otherwise provided under the Act (2) in section 402(b)(4), by inserting ‘‘minor- in making sure we are going to have or regulations issued under this Act.’’; and ity and other’’ after ‘‘reducing’’; strong FDA reauthorization legisla- (2) in subsection (b)— (3) in section 403(a)(4)(C)(iv)(III), by insert- tion. But we do hope we can get to the ing ‘‘and post doctoral training funded (A) by striking ‘‘(b) SURVEILLANCE AP- amendments very soon, and we expect through investigator-initiated research PROVAL.—Each’’ and inserting the following: grant awards’’ before the semicolon; and to be able to do so. ‘‘(b) SURVEILLANCE APPROVAL.— The PRESIDING OFFICER. The Sen- ‘‘(1) IN GENERAL.—Each’’; (4) in section 403C(a)— (A) in the matter preceding paragraph (1), ator from Wyoming. (B) by striking ‘‘The Secretary, in con- Mr. ENZI. Mr. President, I rise at sultation’’ and inserting ‘‘Except as provided by inserting ‘‘graduate students supported in paragraph (2), the Secretary, in consulta- by NIH for’’ after ‘‘with respect to’’; this moment to support the substitute tion’’; (B) in paragraph (1), by inserting ‘‘such’’ that has been put into S. 1082, the Food (C) by striking ‘‘Any determination’’ and after ‘‘percentage of’’; and and Drug Administration Revitaliza- inserting ‘‘Except as provided in paragraph (C) in paragraph (2), by inserting ‘‘(not in- tion Act. I have said a lot about this (2), any determination’’; and cluding any leaves of absence)’’ after ‘‘aver- important bill, and I do intend to say age time’’. (D) by adding at the end the following: more. The most important thing I can ‘‘(2) LONGER SURVEILLANCES FOR PEDIATRIC SEC. 503. SEVERABILITY CLAUSE. say right now is this is the product of If any provision of this Act, an amendment DEVICES.—The Secretary may by order re- a lot of bipartisan work by members of quire a prospective surveillance period of made this Act, or the application of such more than 36 months with respect to a device provision or amendment to any person or the Senate Committee on Health, Edu- that is expected to have significant use in circumstance is held to be unconstitutional, cation, Labor, and Pensions. We have a pediatric populations if such period of more the remainder of this Act, the amendments great process that wound up with a than 36 months is necessary in order to as- made by this Act, and the application of the work in progress, which wound up with sess the impact of the device on growth and provisions of such to any person or cir- this substitute bill. development, or the effects of growth, devel- cumstances shall not be affected thereby. Now we do have one major out- opment, activity level, or other factors on Amend the title so as to read: ‘‘To amend standing issue to figure out; that is, the Federal Food, Drug, and Cosmetic Act the safety of the device.’’. the direct consumer advertising for TITLE V—OTHER PROVISIONS and the Public Health Service Act to reau- thorize drug and device user fees and ensure prescription drugs. I do believe we will SEC. 501. POLICY ON THE REVIEW AND CLEAR- work something out, but we are not ANCE OF SCIENTIFIC ARTICLES PUB- the safety of medical products, and for other LISHED BY FDA EMPLOYEES. purposes.’’. quite there yet. So I would ask my col- Subchapter A of chapter VII of the Federal Mr. KENNEDY. Mr. President, this leagues’ indulgence to work that out, Food, Drug, and Cosmetic Act (21 U.S.C. 371 basically incorporates a number of the and I hope I have the assurance of the

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00047 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.013 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5362 CONGRESSIONAL RECORD — SENATE May 1, 2007 chairman that we will engage in a seri- be printed at the appropriate place in necessary changes in our strategy in ous dialog about the various provisions the RECORD. Iraq. It is with this spirit that we in that are included in that direct con- The PRESIDING OFFICER. Without Congress continue to reach out to the sumer issue. That will be a real key to objection, it is so ordered. President for a responsible change of finishing up. f course in Iraq. I congratulate the Senator from Mas- Last month, I visited Baghdad and IRAQ SUPPLEMENTAL FUNDING sachusetts, Mr. KENNEDY, for the out- Fallujah. I saw firsthand the bravery standing way he and his staff have Ms. KLOBUCHAR. Madam President, and commitment of our troops. The worked with all the Members on our I come to the floor today to express my very best thing we can do for these side of the aisle to clear up. As he said, deep disappointment and the dis- young men and women is not only give in some cases, clarifications were need- appointment of so many people in my them the equipment they deserve but ed, and in some cases it was the expan- State with the President’s expected de- to get this policy right. This means sion of wording; in some cases, a reduc- cision to veto the supplemental fund- sending a clear message to the Iraqi tion in wording. But, at any rate, we ing bill delivered to him by the bipar- Government that we are not staying got it to where I think both sides un- tisan majority in Congress. This bill there indefinitely. This means, as rec- derstand and agree on many of the provided our troops in Iraq and Afghan- ommended by the bipartisan Iraq issues that are included. I hope we can istan with all the equipment and the Study Group, that we begin the process have other amendments brought to the resources they need to continue the du- of redeploying our troops, with the floor so we can debate them and get ties they have been so bravely per- goal of withdrawing combat forces by them worked out. forming for more than 4 years. The next year, while acknowledging that Of course, it would be nice if any amount appropriated by Congress rose some troops may remain to train the Senator thinking about offering an well above the amount the President Iraqi police and special forces to pro- amendment would share their idea requested to give our soldiers on the vide security for those who remain and with us prior to filing it. We might be battlefield. Let it be clear: Congress to conduct special operations. This able to save some time that way and has given our soldiers on the battle- means not a surge in troops but a surge make sure debate flows in an orderly field all the funding they need. It is the in diplomacy and economy and Iraqi process. We are trying to keep the bill President who will now be blocking it. responsibility. to relevant amendments. A few weeks ago, I was driving in When I was over in Baghdad and The PRESIDING OFFICER. The Sen- Minnesota. It was a beautiful spring Fallujah, I saw many things, including ator from Massachusetts. day outside of Ortonville, MN, and as the bravery of our troops. I was struck Mr. KENNEDY. Mr. President, I am has happened too many times in my a few weeks later when another delega- pleased to continue working with my short time as a Senator, I called one of tion of people from Congress went colleague from Kansas, Senator ROB- the mothers of the Minnesota soldiers there, and one of the Congressmen re- ERTS, and my colleague from Iowa, who died in this war. Of the 22,000 turned and said he had been visiting a Senator HARKIN, on the important troops the President has included in market there. He said it reminded him issue of direct-to-consumer adver- this surge, 3,000 of them are Minnesota of a farmers market in Indiana. tising. Guard and Reserves who were expected Those are not the enduring memories We have to strike an important bal- to come home in January and February of my trip to Iraq. My most enduring ance between seeing that consumers and now have been extended. Now the memory is standing on the tarmac in get accurate information on drug safe- moms I am calling are the moms of the Baghdad Airport with nine fire- ty and seeing that we do not improp- these soldiers who would have been fighters from the Duluth National erly restrain free speech. home in January or February. Guard, who called me over to stand Senator HARKIN has a proposal to add I asked this mother: How are you with them while they saluted as six safety information to drug ads. Sen- doing? caskets draped in the American flag ator ROBERTS has an idea to allow FDA She said: You know, people keep ask- were loaded onto a plane. As every cas- to impose fines for inaccurate ads. Our ing me that, and I don’t really know ket was loaded on, they saluted. They bill includes a moratorium—only to be what to say. Do you have any ideas were standing tall for their fallen sol- used in rare cases—on DTC ads. The about what I should say? diers that day. Now is our time for IOM went further and recommended a I thought, and I told her: Well, I can Congress to stand tall. Our troops have moratorium on DTC for all new drugs. tell you what all the other mothers done everything they have been asked We rejected that recommendation due have been saying. They have been say- to do. They have deposed an evil dic- to the first amendment concerns but ing that they wake up every morning tator, and they gave the Iraqi people included more limited authority that and they try hard to hang together for the opportunity to vote and establish a we believe meets the constitutional their family, and then something hap- new government. It is now the Iraqi test. pens. They see a picture or they re- Government’s responsibility to govern. Still, some have raised concerns member something, and they are never But stability and progress in Iraq de- about our current proposal, and we the same for the rest of the day. They pend on the political reforms Iraqi take those concerns seriously. We will have their good moments, but their leaders have promised many times yet continue to work on this important lives will never be the same. failed to deliver. After 4 years, despite issue with our colleagues and constitu- I told her that her son stood tall, and many promises, Iraq has yet to approve tional experts. I think we are making that now is the time for people in a provincial election law. After 4 years, progress through the afternoon and, Washington to stand tall. despite many promises, Iraq has yet to hopefully, by tomorrow we will have After 4 years of extensive American approve a law to share oil revenues. some recommendation. military involvement in Iraq, the After 4 years, despite many promises, I suggest the absence of a quorum. President refuses to accept the prudent Iraq has yet to approve a The PRESIDING OFFICER. The change of course recommended by the debaathification law to promote rec- clerk will call the roll. bipartisan Iraq Study Group and sup- onciliation. After 4 years, despite many The bill clerk proceeded to call the ported by a clear majority of the Amer- promises, Iraq has yet to approve a law roll. ican people. By passing this bill, we in reining in the militia. Our men and Ms. KLOBUCHAR. Madam President, Congress fulfilled our constitutional women in uniform cannot deliver these I ask unanimous consent that the order duties to, first, continue funding for kinds of reforms to Iraq. This is up to for the quorum call be rescinded. America’s Armed Forces in harm’s way the Iraqis themselves. The PRESIDING OFFICER (Mrs. and, second, to ensure that our Govern- As the bipartisan Iraq Study Group MCCASKILL). Without objection, it is so ment pursues policies in the best inter- recommended, Iraqi leaders must pay a ordered. ests of our soldiers and of our Nation. price if they continue to fail to make Ms. KLOBUCHAR. Madam President, As we work with the President in the good on key reforms they have prom- I ask unanimous consent to speak as in days and weeks and months to come, ised the Iraqi people. After 4 years, morning business and that my remarks we must continue to advocate for the what have we gotten? Benchmarks

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00048 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.035 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5363 without progress, promises without re- nance, possible looting, and the fact coming back from Iraq and Afghani- sults, claims of accountability without that expensive equipment was avail- stan would need health care. The ac- any consequences. Why should we ex- able but never used. tual number is four times that amount. pect the Iraqi leaders to do any better Prior to the 2003 invasion, Iraq’s Last year, they were 87,000 soldiers when they know the President con- power system produced 4,500 short in their estimate of how many tinues to accept their excuses for inac- megawatts a day. Today, the same sys- soldiers would need help coming back tion and fails to impose any penalties tem produces 3,832 megawatts a day. In from this war. Now I know why those for their lack of progress. Baghdad, the city enjoys an average of people were wandering around asking That is why the bipartisan Iraq 6.5 hours of electricity a day. A year for help. It is because they weren’t get- Study Group made clear that ‘‘if the ago, Baghdad received 8 hours of elec- ting the help they deserve. Iraqi government does not make sub- tricity a day. Before the war, the city Another critical problem that has stantial progress toward the achieve- received an average of 16 to 24 hours a been ignored by this administration— ment of milestones on national rec- day. and one that is particularly important onciliation, security, and governance, Congress has provided $4.2 billion for to the people of my State—has been the United States should reduce its po- reconstruction of Iraq’s power system, the tremendous damage recent na- litical, military, or economic support and the result has been a more than 50 tional disasters have been inflicting on for the Iraqi government.’’ That report percent decrease in the length of time our farmers and ranchers. The supple- was issued 5 months ago. Meanwhile, the citizens of Baghdad have access to mental spending bill was a combina- the President has simply stayed the electricity on any given day. tion of a 2-year effort to secure disaster course he has continued to pursue for Congress has provided nearly $2 bil- assistance for America’s farmers. Min- the past 4 years and, not surprisingly, lion to provide clean drinking water nesota farmers have been hit with little progress has been achieved in and repair sewer systems. But accord- heavy losses for 2 consecutive years— Iraq. The Iraqi Government will under- ing to the World Health Organization, storms and flooding in 2005 and, again, stand and finally take responsibility 70 percent of Iraqis lack access to clean drought in 2006. All told, they lost only when it is crystal clear to them drinking water. more than $700 million in crop and live- that our combat presence is not indefi- The Defense Department has esti- stock losses. nite and that American combat troops mated that the unemployment rate in The supplemental funding would are going to leave. That is the respon- Iraq is anywhere between 13.6 percent have provided $3.5 billion to com- sible change of course we in Congress to 60 percent. In a recent survey, only pensate farmers for a portion of their are seeking. The American people are 16 percent of Iraqis said their current crop and livestock losses over the past looking to their leaders in Washington incomes met their basic needs. 2 years. Our farmers have waited too at both ends of Pennsylvania Avenue So after 4 years, we are facing a secu- long for this disaster relief. I am deeply to work together to get this policy rity situation that continues to dete- disappointed that the President has right. riorate, an economic situation that turned his back on the urgent need for Two weeks ago, I went to the White continues to stagnate, and a recon- their assistance. House and met with the President, struction effort that cannot provide The bill we sent to the President of along with three other Senators, in- even the most basic services. the United States provided the re- cluding two Republicans. I appreciated My colleagues and I have been asking sources and support our soldiers need the time he took to honestly discuss the difficult questions and demanding on the battlefield and after they return our points of agreement and disagree- answers from this administration. The home. A few months ago, I attended a ment on the war. I told him that now supplemental bill demonstrates that funeral of one of the brave men who is the time to forge cooperation with Congress is reclaiming its rightful role was killed in the line of duty. The our Democrats in Congress. But the in setting Iraq policy and, more broad- priest stood up, and he said to the President has chosen instead to veto ly, in our system of government. The thousand people in the cathedral: You this bill. President’s veto only strengthens our know, this was a good kid. He was 6 As we move forward on the funding of resolve. feet 2 inches tall, but he was still our this war, we in Congress will do noth- Madam President, I also wish to child. ing that threatens the safety of Amer- speak briefly in support of a few other When we send our kids to war and ican soldiers in the field. But we must provisions in this bill that I believe re- they are 6 feet tall, they are still our continue to fulfill our constitutional spond to critical challenges our Nation kids and they are standing tall. We duty to exercise oversight of American faces and that the administration has need to stand tall. policies in Iraq. A critical part of this deemed unnecessary. The traumatic brain injury victims I oversight must be demanding account- The White House and many of my have seen at the veterans hospital in ability for the way in which funds are friends on the other side of the aisle Minnesota, even in their wheelchairs, spent on the reconstruction projects in have argued that this bill should not are standing tall. Iraq. contain funding for anything other Those moms whom I talked to on the For the past 4 years, the administra- than the current war. If we were sacri- phone, as they struggle every day just tion has demanded—and received—a ficing funding for our troops in order to to get out of bed to deal with the loss blank check to spend in Iraq. Now we meet domestic priorities, I would of their kids who were killed in this are seeing the consequences of this agree. But having given our troops all war, are standing tall. lack of planning, management, and re- they need and continuing to ignore cri- Now it is time for the President of sponsibility. ses at home would be irresponsible. the United States to stand tall. On Monday, the Special Inspector Veterans funding is one of the key Madam President, I yield the floor. General for Iraq Reconstruction re- parts of this bill. This bill adds an in- The PRESIDING OFFICER. The Sen- leased a report that details widespread crease in veterans funding that was ator from Massachusetts is recognized. failures in the most basic reconstruc- long overdue. In the last 2 years in my Mr. KERRY. Madam President, I ask tion projects. The report finds that, in State, veterans would come up to me— unanimous consent to proceed as in many cases, Iraq’s infrastructure and particularly from the Iraq and Afghani- morning business. utility systems are worse off than they stan wars—and they would tell me The PRESIDING OFFICER. Without were before the war. about how they had difficulty getting objection, it is so ordered. On closer inspection, it turns out treatment. They clearly had mental IRAQ that even projects which were declared health issues. I didn’t know if there Mr. KERRY. Madam President, 4 ‘‘success stories’’ were considerably was truth to this. I wasn’t sure, be- years ago today, as we know, the Presi- less than that. In fact, seven out of cause of the state of their minds, dent stood on an aircraft carrier under- eight of these projects which were whether this was true. Then I got here, neath a banner that read ‘‘Mission Ac- called success stories were not oper- and I started looking at the numbers. complished.’’ He declared that the ating properly due to plumbing and In 2005, the Department of Defense major combat operations in Iraq were electrical failures, improper mainte- estimated that about 24,000 soldiers over. When he spoke those words, 140

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00049 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.039 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5364 CONGRESSIONAL RECORD — SENATE May 1, 2007 American troops had been killed in As we know from our own intel- claimed that we would be greeted like Iraq. Since then, over 3,200 more Amer- ligence agencies, the war in Iraq has liberators, who told us the insurgency ican troops have given their lives. Just increased the threat of terrorism by was in its last throws, who continues today, we learned that April was the creating a breeding ground for terror- to insist that everything is on track deadliest month this year, with 104 ists that didn’t exist before the inva- and growing fine, I think we have Americans dead. sion and by serving as a rallying point grown used to this Vice President not With every passing day, it becomes for extremists around the world. In being candid with the American people. more obvious that the President really fact, the State Department’s annual Clearly, he didn’t hesitate to impugn should have said: My fellow Americans, terrorism report released yesterday the integrity of the Senate’s majority major combat operations in Iraq are shows that terrorist attacks worldwide leader who is standing for an appro- just beginning. On that day, he should were up 25 percent last year after in- priate new direction with respect to have had a plan to match the rhetoric creasing nearly fourfold the year before our policy in Iraq. with reality. But we are where we are, that. Certainly, we can disagree about as the saying goes, and it is even more How does the leadership come to the those tactics or strategies without im- tragically clear to all but a few that if country and suggest that this war is pugning the motives and challenging we want to accomplish our mission in accomplishing our larger goals? How the integrity of those who speak those Iraq—and we all do—if we want an Iraq does it help the war on terror to be cre- different possibilities. If the President insists on continuing that has any chance of stability and ating more terrorists? How can you tell down the wrong path, it seems to me some sense of democracy, any sense of the American people we have made you Congress has no choice but to be as res- it, we have to change course. safer, when the number of terrorist in- olute in demanding the right path for- In the past 4 years, we have lost at cidents have gone up and the number of ward for our troops, for our country, least 3,342 of our best young men and terrorists who want to kill Americans and for the Iraqis themselves. I believe women, and nearly 25,000 others have is larger today than it was on 9/11? we have to continue to fight for the been wounded and many wounded se- Any businessperson, any tourist, any- legislation that gives us the best verely. We have spent nearly $400 bil- body of any curiosity who has traveled chance of bringing our troops home lion, and the cost is rising at a rate of abroad and who has asked a few simple with some measure of success in the re- over $2 billion per week. There is no questions or read the newspapers and gion. end in sight. listened to the news knows that our Four years after ‘‘mission accom- ADM William Fallon, the top U.S. Nation, which we love passionately, is plished,’’ it is time for us to acknowl- commander in the Middle East, re- now less followed, less listened to, and edge the implications of what General cently said: less feared—less listened to by our Petraeus and every other military We are losing ground every day. friends and less feared by our enemies. commander, the Secretary of State and And even General Petraeus, the top The fact is, we are less safe as a result. even the President have told us. All of commander in Iraq, now says that we We are less unified at home, less re- them have said there is no military so- can expect the situation to get worse spected abroad, and we are less strong lution to the violence in Iraq. I don’t before it gets better. as a result. know how many times I have heard We were treated to a spectacle a Obviously, there is no way we can that on Sunday shows, I hear it out week and a half ago with news reports, make up for what has happened in the here in the corridors with individual a front-page story, I think, in the last few years, certainly not in terms Senators talking to the press. Every- Washington Post, that Stephen Hadley, of the lives lost and the pain and suf- body mouths the words: ‘‘There is no the President’s security adviser, was fering endured by those wounded and military solution.’’ But if there is no casting about to find a general to be by families who have suffered those military solution and we are all agreed the sort of supreme organizer, if you losses, but the fact is, we can find a re- on that, then what is the military will, of the war in Afghanistan and the sponsible strategy to try to deal with doing? Why is the military and an esca- war in Iraq. not just Iraq but the whole Middle East lation in the number of troops so crit- What struck me about that story is and, indeed, releverage America’s posi- ical if there is no military solution? here is our Nation at war, here is a se- tion in the world. The administration, even after tell- ries of four-star generals whose lives The President today, tonight, is ing you there is no military solution, are committed to Nation, to service, to going to veto crucial funding for the then gives you a rationale for a mili- duty, and to military, who under nor- troops passed by both Houses of Con- tary solution, which is: We have to put mal circumstances would be honored to gress, legislation that gives our sol- additional troops in to have the secu- be asked to become the point person to diers all they need to complete the rity, in order to have the compromises. organize our Nation’s efforts in two mission and receive the care they de- But the fact is, the security which, wars in a front that is of serious con- serve once they get home. The Presi- first of all, is proving illusive and prob- sequence to this Nation. Yet all four dent is going to veto it, but that is not ably impossible to secure with the retired four-star generals said no. One all he is going to do. Then he is going troops alone, cannot be secured with- was even quoted publicly as saying to try to pin the blame on those who out the political compromises. This is they don’t know what the hell they are have pushed for a new direction. He is a classic chicken-and-egg situation: doing, or they don’t know what direc- going to try to pin the blame for his Which comes first? You are not going tion they are going in. failures, for his lack of planning, for to get the security until the stake- That is a pretty remarkable state- his lack of leadership on those who are holders in this civil struggle feel con- ment for a career military person to providing the only way to try to re- fident enough that what they are make about the current effort. But we solve what is happening in Iraq. struggling about can be resolved to also know the history of what has Instead of pressuring Iraqi politi- their safety and future security. That brought us here with retired generals— cians, this administration is practicing is sort of a fundamental issue. You are a whole host of them—who publicly re- the politics of division at home, a not going to change the on-the-ground belled postservice against the leader- brand of American sectarianism that security situation and stop people from ship of Secretary Rumsfeld, who is now undermines our national unity, a unity bombing and militias from killing un- gone. required to make decisions in time of less those fundamental stakes are prop- It is a rather remarkable statement war. erly addressed and defined. about the lack of planning, about the Last week, Vice President CHENEY It is long since time that we started lack of candor, about the scapegoating accused Senator HARRY REID of putting to measure progress on the ground in that has gone on, about the unwilling- politics ahead of our national security. Iraq by the one metric that will ulti- ness of people’s careers to be judged I suppose we have grown used to this mately determine our success or our not by their ability to tell the truth Vice President, who has pioneered the failure, and that metric is this: Are the but, rather, their willingness to tell politics of fear, who oversaw the Iraqis making the tough political com- the civilian leaders what they want to politicization of the intelligence used promises necessary to keep their coun- hear. to mislead the country into war, who try together?

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00050 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.040 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5365 It has been nearly a year since the We are no closer to a political solu- to force them, there is no way to actu- Maliki Government took power. At tion today than we were when the ally determine that we can make the that time, General Casey and Ambas- Maliki Government took power 1 year progress we need to make. Since Janu- sador Khalilzad said that the Maliki ago, but there were more than 940 addi- ary, when the President decided to dis- Government had 6 months to make the tional American troops who gave their regard key elements of the Iraq Study political compromises necessary to win lives in that process to wait for the Group and announced the escalation, the public confidence. Iraqis to procrastinate. over 340 American troops have died, So here we have the commanding Did the President actually hold the and there is still no fundamental general of our forces and our trusted Iraqi Government to those benchmarks progress. Ambassador to Iraq both saying they as promised? No. I hope the President The legislation we have sent to the have 6 months to make the com- tonight, when he addresses us after the President would change this dynamic. promises. But guess what. The 6 veto, will address the benchmarks and It would force the Iraqis to either months went by and nothing hap- where we are with respect to the fail- stand up for Iraq and meet the political pened—nothing happened in Iraq to ure of the Government to make the benchmarks they have agreed to or de- make those compromises happened, choices they said they had to make cide they can’t do it and have their and nothing happened afterwards be- while our soldiers continue to die. fight. cause the compromises didn’t happen. The administration still refuses to It calls for a flexible timetable for That sends a message that there is no get genuinely tough with Iraqi politi- the redeployment in 2008, and I under- consequence to delay, there is no con- cians. They keep moving the goalposts, score ‘‘flexible.’’ Every time we try to sequence to procrastination. deflect the criticism of a failed strat- do something, we get into this totally After that, the Iraqi Government egy which they refuse to abandon. In- phony, polarized debate where the agreed to a set of benchmarks because stead, we get more vague assertions President and his henchmen go out and people were growing frustrated and that our presence is not open-ended talk about reckless abandonment and those benchmarks, guess what, were and outright rejection of any proposal surrender and defeatism when, in fact, pegged to specific dates for making that would leverage that threat. what we are proposing gives the Presi- progress toward national reconcili- The administration, it seems to me, dent all the discretion in the world—to ation. has reached a point where it has to leave troops there to finish the train- In January, the President announced stop pretending the lack of political ing of Iraqis, which is the fundamental the troop escalation, and he told the will in America is the problem. It is reason we are there; to leave troops American people the following: not the lack of political will in Amer- there to chase al-Qaida, to prosecute America will hold the Iraqi Government to ica that is the problem, it is the lack of the war on terror, which is in our inter- the benchmarks it has announced. Now is political will in Iraq that is the prob- ests, and to leave troops to protect the time to act. The Prime Minister under- lem. American forces and protect American stands this. It is impossible to make any other facilities. After 6 years of the war, But, once again, no real con- judgment when you look at that entire what other fundamental mission sequences, no real leverage, no real di- series of benchmarks. I remember Sec- should there be for American forces? plomacy. The result is, those bench- retary Rice coming before the Foreign marks proved meaningless. You can Relations Committee, I believe, several It seems to me the real debate is one take a look at the benchmarks the months ago now, and I asked her the that should center around the failures Iraqis agreed to. What did they agree question about the oil law. She said: of this administration to face that re- to do at that point in time? Oh, yes, the oil law is almost done, just ality and the few choices we have now October 2006, over 6 months ago, that about done; wrapped up, we are about to try to achieve success. The most im- was the deadline for Iraqis to approve a to proceed forward, we are confident it portant choice that has to be made to new oil law and a provincial election is going to be done in a few days. Here achieve success is to engage in full- law. As of today, the oil law has yet to we are, several months later, and there throated diplomacy, not dissimilar to even be introduced in Parliament, and is no oil law. It is not even before the the kind of meeting that will be held in that is an improvement over the pro- Parliament yet. Sharm el-Sheikh this week. We hope vincial election law which hasn’t even The administration needs to accept Secretary Rice will take advantage of been drafted yet. the basic reality that the Congress has that and that the countries of the re- November 2006 was the deadline for acknowledged: Iraqi politicians, if they gion will come together around a new new debaathification law to help bring are capable, if they are capable of mak- security arrangement and a new under- Sunnis into the Government. A draft ing these decisions, have shown they standing of what has to happen. proposal was recently denounced by will not do it without a reason to do it, The timetable for the redeployment Ayatollah Sistani and a national com- without a rationale that feels some in the legislation sent to the President mission to oversee the process, and heat. A deadline is the only thing they is not arbitrary, and it is not precipi- guess what. It is nowhere near comple- have responded to so far. It took a tous. It is consistent with the Iraq tion. In fact, 5 months after the dead- deadline to be able to get them to do a Study Group’s recommendations and line, the Shiite leader of the SCIRI constitution. It took a deadline to have with the timeframe for transferring Party recently described the Baathists each of their elections. control of Iraq to the Iraqis that was as ‘‘the first enemy of the Iraqi peo- Incidentally, they protested against set forth by General Casey. It also has ple.’’ So much for debaathification and each of the deadlines. Each time they the schedule agreed upon by the Iraqi reconciliation. said: Don’t do this to us; we can’t meet Government itself. There is nothing ar- December 2006 was the deadline for it; we can’t make it; it is too much. bitrary in a schedule to which your the Iraqis to approve legislation to ad- But each time, because we set the own commanding general and the Iraqi dress the militias. To date, absolutely deadline and kept pushing, they did Government have agreed. no progress has been made on this cru- meet it. Even the President has said, under cial legislation, and the militias con- American security is not a security his new strategy, responsibility for se- tinue to wreak havoc. blanket for Iraqis who want to pro- curity would be transferred to Iraqis January 2007 was the deadline for crastinate while American soldiers die. before the end of this year. So they are Iraqis to complete a constitutional re- The longer the President continues to willing to set a date. The administra- view process. There was supposed to be give them the sense that he is not tion can set a date for the transfer of a referendum on constitutional amend- going to change, he is not going to the security, but it is unwilling to set ments by March. Guess what. The con- move on them, the more they are se- a date for the beginning of the draw- stitutional committee hasn’t even cure in the sense that they can just down of some troops so you guarantee drafted the proposed amendments, and continue to jockey and play their polit- that date for the transfer of security is the Iraqis remain far apart on key ical game at the expense of American actually meaningful. The President has issues such as federalism and the fate dollars and American interests and said it. Our generals have said it. The of the divided city of Kirkut. American lives. Without real deadlines Iraq Study Group has said it. Now it is

VerDate Aug 31 2005 01:47 May 02, 2007 Jkt 059060 PO 00000 Frm 00051 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.042 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5366 CONGRESSIONAL RECORD — SENATE May 1, 2007 time for the President to embrace leg- greater ineffectiveness. In the process, forward. Putting Mr. Maliki’s personal islation that makes those words re- Iraq is spiraling deeper and deeper into political future on the line is perhaps ality. its sectarian divide. one of the few ways left to try to cre- Instead of accepting the change that It is not just the Iraqis. Last week we ate the leverage necessary to find out is necessary, we keep hearing we need learned that several prominent Sunni if he is capable of moving the reconcili- more of the same; we have to give the countries are balking at complete debt ation procession forward. If he proves surge time to work; the Iraqis need relief for Iraq because of the lack of unwilling or unable, then clearly some- just a little more breathing space to progress in political reconciliation. one else should be given a chance—if start making political progress. This past weekend the Saudis refused there is someone else. General Petraeus has said, however, to allow Prime Minister Maliki to visit This is the moment to put that to the that he won’t be able to make any their country because he has not deliv- test. I recognize that Iraqis must take progress assessment on the ground ered on his promise to seek real rec- responsibility for their own future and until September. Guess what. We hear onciliation with Iraqi Sunnis. How can that any government we impose will that Iraq’s Parliament, which has only we expect progress and political rec- lack legitimacy with their fellow been able to muster a quorum to even onciliation if the Iraqis have lost con- Iraqis. But we can use our own influ- consider legislation about once every fidence in the Maliki government? How ence behind the scenes to encourage week or two—the Iraqi Parliament can we expect diplomatic progress the Iraqis to make the leadership plans to take a 2-month vacation this when Iraq’s neighbors have lost con- changes so clearly needed in order to summer, a vacation in the middle of a fidence in Iraqi leadership? This is a give their Government a chance to suc- civil war. You sort of wonder what very serious issue. ceed. We certainly have a right to Abraham Lincoln would think of that. The administration has finally done make that request, given the degree to Iraq is descending further into chaos as what they should have done years ago: which that Government is dependent thousands of Iraqis die each month. If engaged, this week, in the kind of di- on our troops and our money and our the Iraqis go on vacation without mak- plomacy that is desperately needed. On presence. ing the key political compromises, it the eve of the summit, we learned that Congress has finally done what this will absolutely guarantee that there is some of the major players have no con- administration has stubbornly refused not going to be any meaningful polit- fidence in the political process. So if to do. I am proud of my fellow Mem- ical progress until next fall. I do not we really want to bring about the po- bers of this body who had the courage believe that America should be sending litical and diplomatic solution that is to vote for this legislation. I know how our troops to die for somebody else’s the only solution, the time has come divisive it can be. I know how the other vacation. now for new leadership in Iraq. side uses it and how people tend to try How many more American soldiers When I was in Iraq in December, to personalize and even denigrate peo- are going to give their lives without Prime Minister Maliki told me he was ple’s patriotism and concern for the any hope of achieving a real political working on forming a new coalition Nation. The fact is, the Congress has solution? 300? 400? 500? How many more that would isolate extremists unwilling done what needed to be done because doors are going to be knocked on and to compromise and empower moderates this administration has not done it. phone calls made? How many more vis- who were. Since then we have heard People say don’t micromanage. its to Arlington and other cemeteries from time to time that these negotia- Someone has to manage. They have across America, while the Iraqis pro- tions continue behind the scenes. But clearly mismanaged every step of this crastinate and refuse to settle their nothing has happened. It is time to get war, and they have been absent from differences? out from behind the scenes. It is time the diplomacy necessary. It is time to How can any of us in the Chamber to have a government that can put the have a new strategy, time to hold Iraqi look in the eyes of the parents of any pieces back together. young American killed and tell them: As one Iraqi Minister said yesterday, politicians responsible for their coun- Your son or daughter died so the Iraqis Mr. Maliki ‘‘said he was going to ap- try’s future, time to get deadly serious can take the summer off? point new Ministers; he needs to do about finding a political solution, and With every passing day it becomes that. . . . What is he waiting for?’’ finding it now. clearer this Iraqi Government is not That is a question the U.S. Congress Somehow this President still chooses going to get the job done. It is not should echo. We simply cannot go on to take a different tack. If President truly a unity government, it is a figleaf like this, day after day, news cycle Bush vetoes this bill, which we under- for politicians who are pursuing sec- after news cycle—more bombs, more stand he will, then he is the one stand- tarian interests instead of protecting murders, more assassinations, more ing in the way of a bipartisan strategy the nation they are charged with sav- suicide bombings, more killings, more on Iraq. The Iraq Study Group was bi- ing. Now it is starting to crumble American soldiers dead. We can’t go on partisan. The Iraq Study Group had under the weight of its own ineffective- like this and expect the situation to former Secretary of State Jim Baker, a ness and corruption. miraculously get better. Time is not on Republican, a great friend of President Last week some prominent Iraqi leg- our side. Time is not on anyone’s side Bush’s father. It had Secretary of State islators came out and said publicly in the end because if this does go down- Larry Eagleburger. It had Al Simpson, that they have lost confidence in the ward into greater sectarian violence, former Senator from Wyoming and Re- Maliki government. That is not sur- all of the Iraqis will lose. publican leader in the Senate. It had prising since we recently learned that If we are serious about a political so- Bill Perry, former Secretary of De- Prime Minister Maliki was responsible lution, we need a fresh start. That is fense; Chuck Robb; it had Ed Meese, for a politically motivated purge of why I believe it is time for Prime Min- former Attorney General and Chief of Iraqi military leaders who had the ister Maliki to make wholesale Staff to a Republican President. All of gumption to actually act against the changes in his Cabinet. He already has these are moderate, thoughtful, re- Mahdi militia. to replace the six Muqtada al-Sadr spected, trusted voices in foreign pol- Yesterday the largest block of Sunni Ministers, the Sadrist Ministers who icy and in the affairs of our country. Arabs in the Parliament threatened to recently resigned. He should use that They all came together in a consensus. withdraw its Ministers from the Shiite- as an opportunity to fire any other That consensus was summarily re- dominated Cabinet in frustration over Minister who is not committed to po- jected by the President, just pushed the Government’s failure to deal with litical reconciliation and replace them aside. Sunni concerns. As one Sunni legis- with Ministers who are. The President decided to go his own lator said: We should make it clear this truly is road, which even the generals and even The problem is not just with sectarian his last chance. If reshuffling the Cabi- Prime Minister Maliki did not want to practices but with the Government’s ineffec- net does not produce meaningful polit- do. I read one Senator’s comment that tiveness. ical progress within a relatively short there is no plan B, that there is just This Government we are supporting period of time, then he should step plan A, which is the surge. I disagree is spiraling downward into greater and down and allow a new leader to step with that. Plan B is what plan B should

VerDate Aug 31 2005 03:06 May 02, 2007 Jkt 059060 PO 00000 Frm 00052 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.043 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5367 have been all the time, which is to en- only to drugs like Thalidomide that timeline for the orderly, responsible, gage in the legitimate kind of inter- could not otherwise be approved. We and safe withdrawal of our forces from vention on a diplomatic level and to can understand why it is important Iraq. He was wrong to lead us into the put on the table all of the issues of the that the FDA probably would not have war, wrong to conduct it so poorly, and region in a way that proves the kind of approved Thalidomide, for all of the wrong to refuse to change course. sincerity and seriousness of purpose dangers it has, but it has now approved We cannot continue business as usual that raises the level of credibility of it to deal with some of the problems of in Iraq. It is time for America to end the discussion so people can trust that leprosy. We want to make sure it is not its participation in the brutal civil we, in fact, are going to be moving in going to be out there and be utilized in war. The message from the American a common direction, which is in their terms of expectant mothers. So we people couldn’t be louder or clearer: In- interests. have worked this out. I thank Senator stead of defying the will of the Amer- The reason Saudi Arabia is sending COBURN for his help on this issue. ican people, President Bush should lis- such public messages of discontent for We also make sure the FDA takes ten to their plea and begin working the policies of this administration into account concerns of rural commu- with Congress to bring this tragic war today is because, given what has hap- nities in setting safety policies. We to an end. pened, that is the way they have to have given enhanced authority to the The PRESIDING OFFICER. The Sen- play it in order to deal with their own FDA in terms of safety policies. We ator from Wyoming. politics of the region and their own want to make sure in the implementa- Mr. ENZI. Madam President, I am politics of the street and their nation. tion of those, particularly in rural going to make even briefer remarks It is our absence from a creative, diplo- areas, they are not going to be so re- than the Senator from Massachusetts matic effort, it is our absence from a strictive as to limit the opportunities did. credible and legitimate diplomatic lift to get the necessary prescription drugs. One of the questions I had been asked that has left no choice even to our I thank Senator HARKIN and Senator over the weekend was: Why hasn’t the friends than to begin to distance them- MURKOWSKI, who were enormously President already vetoed the supple- selves from our country. helpful in working through that issue. mental appropriations bill? He prom- With this veto, the President will This also adds a Web portal for FDA ised he would veto the bill because it deny our troops the vehicles they need, so consumers will have a single point has all this extra spending in it, with for the time being; he will deny them of access, via the Internet, to drug directions on the war from people who the basic care they deserve, for the safety information. I thank Senator really are not even involved in admin- time being, because all of us know the GREGG for that. That will be very im- istering the war. Congress will come back and we will portant for consumers who are con- Of course, what I found out is the bill fund those things. But the most signifi- cerned about the safety issues. All of has not even been sent to the President cant thing he will deny us is the kind those changes and alterations are very yet. He cannot veto a bill until he re- of leadership and the kind of consensus helpful and valuable in terms of the ceives a bill. So to chastise him for not legislation itself. the country deserves in order to move having already vetoed the bill when I wish to speak for 3 minutes as in forward in our policy in Iraq. there is a hold card keeping him from morning business and not under the We honor the lives lost in Iraq, not being able to veto the bill I think is un- time on the bill. conscionable. Hanging on to that bill with words but with lives saved. We The PRESIDING OFFICER. Without and not getting it there so the deci- honor the lives lost in Iraq not with objection, it is so ordered. words and with the political partisan- sions can be made on it one way or the ship here but with a policy that is f other just is not right. That is not the right for them and for the region. We SUPPLEMENTAL APPROPRIATIONS way to run the Senate. It is not the honor their sacrifice by creating a situ- Mr. KENNEDY. Madam President, way to run the country. And it is not ation in the region where we protect the President is going to be making up the President’s fault if he does not America’s and the region’s interests at his mind on the issue of the supple- have the bill to make the decision. the same time and begin to recognize mental and making a judgment in the There can be a lot of debate on what the degree to which our presence in next several hours. President Bush that decision ought to be made and Iraq is playing into the hands of the stubbornly clings to the false hope that how to carry them out. I am certain terrorists, is advancing the very cause success is just around the corner and the President will veto the bill; he has we seek to fight, which is diminishing that the mission will be accomplished. been very clear on that. There is a dif- the ability of the United States to be We have heard it all before. Ending the fering philosophy on how a war ought able to leverage, not just the Middle rule of Saddam Hussein was supposed to be run. There are a lot of people East issues, but a host of other issues to lessen violence and bring a new wave throwing in the towel. It is kind of in the world. of democracy into the Middle East. It hard to win at anything if your oppo- I believe we need to change course, has not. Saddam Hussein’s capture was nent knows the point at which you are and it is only by changing course that supposed to quell the violence. It going to give up. we will honor their sacrifice, respect didn’t. Free elections and the drafting That is where we are in this battle, our interests, and bring our troops of the constitution were supposed to be with the complete direction to give up, home with honor. a breakthrough. They weren’t. The to throw in the towel, to say what has Madam President, I yield the floor, surge was supposed to bring stability, been done over there has not done any and suggest the absence of a quorum. essential to political reconciliation and good, won’t do any good, and to keep The PRESIDING OFFICER. The economic reconstruction. It has not calling it a civil war. It is not a civil clerk will call the roll. and it will not. war. It is a religious war that is brew- The legislative clerk proceeded to Only the Iraqi people can save Iraq ing. There is a tremendous difference. call the roll. and it is time for them to do so. Amer- It is a religious war that involves the The PRESIDING OFFICER. The Sen- ican military force cannot solve the entire Middle East, not just Iraq. And ator from Massachusetts is recognized. problems of the Iraqi people. It is time in preparation, for what the other peo- Mr. KENNEDY. Madam President, I for the President to put the Iraqis on ple in the Middle East have heard said ask unanimous consent that the order notice that our military will begin to on the Senate floor, armies are gearing for the quorum call be rescinded. withdraw. No one in the administra- up in Saudi Arabia and Syria and Israel The PRESIDING OFFICER. Without tion can honestly tell the American and Iran, ready to move into the vacu- objection, it is so ordered. people we are making progress in Iraq. um that would be caused by a U.S. de- Mr. KENNEDY. I want to let our It is time the President listened to the parture. Members know about the substitute Iraq Study Group, Congress, and the That will not be the first time there that has been included, that is before American people, and work with us to has been a religious war in the world. If us now. It essentially clarifies the bring our troops home. we do not step in, it would probably be FDA’s authority to place restrictions The President is wrong to veto the the first time we had the chance to on drugs with safety problems; applies Iraq spending bill and reject its needed stop a religious war and did not help.

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00053 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.044 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5368 CONGRESSIONAL RECORD — SENATE May 1, 2007 So we could leave, have a regional reli- that it is not a civil war. My under- $1.7 billion a year in a Federal budget gious war, and then try to decide what standing of a civil war is when people is not a huge amount of money. There we are going to do about that. of the same nation are at war with one are many other agencies with less re- Religious wars are not easy things to another. sponsibility and more resources. The solve. We have seen that with Kosovo That, sadly, is the reality of what is Food and Drug Administration is re- with religious genocide. We got to see going on in Iraq today—Iraqis killing sponsible for really determining the what happened in Kosovo. We helped one another while Americans stand in safety of so many things American out in Kosovo just as we are helping in the midst of the crossfire. Had the families take for granted: when you are Iraq. President of the United States come to buying food, when you are buying So, Madam President, I hope we this Congress in October of 2002 and drugs, when you are buying over-the- would actually debate the Food and suggested we send 150,000 soldiers into counter medicines. Many of the appli- Drug Administration bill, which is Iraq for the purpose of refereeing a ances you buy really have to be tested what we were set out to do this week. civil war or a religious war that had its to be safe by the Food and Drug Ad- I hope people who have amendments origins in 14 centuries of anger, had he ministration. We count on this small would bring the amendments to the said to us we must stay as long as 5 agency to do a very big job and a job floor. years and spend $500 billion and risk that gets bigger by the year. The PRESIDING OFFICER. The Sen- thousands of American lives, with no The bill that is before us is basically ator from Massachusetts. end in sight, what were the chances we the law which authorizes the Food and Mr. KENNEDY. Madam President, as would have passed that resolution? Drug Administration to do its business. we know, the supplemental passed last None. That is not what the President I am glad we brought it to the floor. I Thursday. It is Tuesday today. So the told us. salute Senator ENZI on the Republican comments I made were directed to the He told us Iraq was a threat to the side and Senator KENNEDY on the fact that the President has announced United States of America with weapons Democratic side for their leadership. he is going to veto it. I just wanted to of mass destruction, and nuclear weap- The Food and Drug Administration is comment about that issue. ons, that somehow they had been in an essential guardian of the public’s Although we differ on that issue, we concert with al-Qaida, that led to 9/11. health and safety in America. In recent are together in wanting to get the Sen- None of those things turned out to be years, their reputation has been at risk ate to both debate and dispose of true—not one of them. because of incidents of drug safety amendments. The afternoon is moving On that basis, we authorized the problems and questions about their along. We had statements yesterday President to go to war, and he decided independence. The FDA has been fault- from Senator ENZI and myself on this to take a preventive course of action— ed for neglecting its drug safety re- legislation, spelling this out. We had not preemptive but preventive course sponsibilities and for failing to respond an opportunity in our caucus today—I of action—and invade this country be- to concerns raised by its own drug safe- imagine the Senator did as well—to go fore they threatened the United States. ty specialists. through the details of the legislation. That is what we are in today. Experts have warned that the FDA So we have addressed many of the con- Within 2 hours, the President will does not have adequate authority to cerns. But there are still some con- pick up a pen and have a chance to pull dangerous drugs off the market, cerns that are out there, and this is an start bringing this to an end. If he mandate changes in drug labels, or extremely important piece of legisla- signs this bill we have sent to him, it sanction drug companies that do not tion. So we are asking our colleagues will mean that American soldiers can monitor drug safety. to come to the floor to let us know start coming home and that, equally The most glaring example of a drug their amendments, to see if we can important, the Iraqis understand it is safety problem is the handling of work those out. If not, we would like to now their country, their war, and their Vioxx, a painkiller that was found to have the debate on those measures and future, that they have to put their increase the risk of heart attack and let the Senate exercise its will. We are lives on the line and not rely on the stroke and was used by 20 million peo- ready for those amendments, and we bravery of our soldiers to keep their ple across America. Merck was aware— urge our colleagues to bring them to country intact. the company that made Vioxx—that our attention at the earliest possible If the President vetoes this bill, ex- product raised the risk of cardio- time. actly the opposite message goes to the vascular problems, and they continued The PRESIDING OFFICER (Ms. Iraqis. Its message: Continue business to market it, nevertheless, long before KLOBUCHAR). The Senator from Illinois. as usual. Continue waiting out the po- it stopped selling the drug in 2004. The Mr. DURBIN. Madam President, I ask litical opposition, not resolving your episode has raised serious questions unanimous consent to speak as in differences, really allowing this reli- about FDA’s ability to react quickly to morning business before addressing the gious or civil war to become even signs of safety problems with drugs al- pending legislation. worse. ready on the market. The PRESIDING OFFICER. Without The month of April was the deadliest Listen to what one of FDA’s own objection, it is so ordered. month for American soldiers this year. drug safety experts said in testimony Mr. DURBIN. Madam President, We continue to see thousands of Iraqis before the Senate Finance Committee. there have been comments on the floor killed each month in this country. The I quote: about the fact that in just 2 hours the President, though he is limited in sup- I would argue that the FDA, as currently President of the United States will port for this position, continues to configured, is incapable of protecting Amer- have an opportunity to sign or veto a argue that with just a few more Amer- ica against another Vioxx. We are virtually bill which literally will affect the lives ican soldiers, a little longer period of defenseless. of 150,000 soldiers and their families, if time, some more money, everything is That is quite a statement. It troubles not every American. It is a bill that going to get better. Many of us are me. was passed by the House and Senate, skeptical. The American people be- That concern of that individual does with bipartisan votes in both bodies, lieve—and I concur with their belief— not stand alone. A survey of FDA sci- and sent to the President. It fully we do need a timetable to start bring- entists conducted last year by the funds the troops in Iraq, giving them ing American troops home on a respon- Union of Concerned Scientists found all the resources they need, and more, sible, reasonable basis. the following: 47 percent of FDA sci- so they can execute this war and their I hope the President will reconsider. entists said their FDA office is less ef- duties in a safe manner. I hope he will sign this bill. I hope the fective than it was 5 years ago; nearly But it also does something signifi- troops will be funded and the direction 40 percent said the FDA is not acting cant; it starts to change the mission in of this war will change. effectively to protect public health; Iraq. We are in the fifth year of this Madam President, this bill is for the more than one-third of FDA scientists war. We have lost 3,351 American lives. Food and Drug Administration’s reau- said FDA officials care more about ap- I respect very much the Senator from thorization. This is an agency which is proving new drugs and devices than en- Wyoming. He tries to make a point often overlooked. Madam President, suring they are safe; and 15 percent

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00054 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.046 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5369 said they personally have been inappro- I think our system has broken down. nitrogen levels, therefore they argue priately asked to exclude or alter infor- Now is the time for an appropriate higher protein levels, therefore they mation or conclusions for nonscientific amendment to close some of the gaps argue they should be paid more. So it reasons. That is a horrible comment on we have in our current system. is an economic fraud. They have argued an agency with the responsibility of In the larger picture, I have been that this is a product that doesn’t hurt the Food and Drug Administration. working on this issue for a long time. people. We are not sure of that, but we Our priority must be to take this re- I said, over 10 years ago, we need a sin- do know that the animals that died as authorization as an opportunity to gle food safety system. a result of contaminated pet food, some change the FDA. The bill does that. It I see Senator LIEBERMAN from Con- of them were found to have melamine restores balance between timely ap- necticut on the floor. His House col- in their system. It is a serious question proval of innovative drugs and safety league, Congresswoman ROSA as to whether it is toxic. and effectiveness. DELAURO, herself a victim of food poi- We know now that this pet food con- Problems with drug safety in recent soning at an early age, has been my tamination has resulted in the deaths years highlight the limits of FDA’s ally in this effort. We believe a single of more than 4,000 animals across ability to monitor and respond to safe- food safety system, based on science America. This contaminated product ty problems that arise after approval. and not on politics, is the only answer. came into America without inspection Safety problems may not be detected We need to do that and do it soon. or without suspicion. The FDA did not prior to FDA approval because the clin- The amendment which I am going to have a memorandum of understanding ical trials FDA relies upon often in- offer does not reach that level. It does with China or a certification that their volve only a few thousand people. not achieve all of the goals we wanted standards for food safety were even This bill, S. 1082, responds to this to on a legal basis, but it moves us for- close to those of the United States. The problem by making postapproval moni- ward. product made its way from the im- toring of drugs a core responsibility of How important an issue is food safe- porter ChemNutra into various manu- the FDA, strengthening and clarifying ty? The Centers for Disease Control es- facturers of pet food. Menu Foods is a the tools it has to make their products timates that as many as 76 million peo- Canadian company. They make pet safer. The bill requires active moni- ple suffer from food poisoning each food under a dozen different labels. toring for drug safety problems year. Thirty-two thousand Americans They learned on February 20 there was through the use of Federal and private will be hospitalized each year for food a problem. How did they know there databases. It creates a system for ap- poisoning; 5,000 will die. With emerging was a problem? The cats and dogs told proving drugs with a specific strategy pathogens, an aging population, and an them. They stopped eating their food for evaluating and mitigating their increasing volume of food imports, this and they started getting sick. risks. It promotes greater transparency situation isn’t going to improve with- So you own a company that has doz- by disclosing information on clinical out decisive action. ens of different pet food labels, and you trials. I agree with Chairman KENNEDY and notice that animals are getting sick. These and other provisions in this bi- Senator ENZI that we should proceed What is the responsible thing for a partisan bill will help to restore public with the broad issue of food safety company to do at that time? Pull the confidence in the FDA. S. 1082 will help within general order, and I appreciate product off the shelf and notify the FDA fulfill its crucial and complex their willingness to work with me. The Federal Government. They waited 3 mission. I look forward to supporting amendment is not what I hoped for in weeks before they sent out a notifica- it. creating a single food safety agency, tion. By the time the Food and Drug One of the things most people do not but it is a step forward. Administration learned about this, realize is the major responsibility the The most recent news, of course, is there were millions of cans of pet food Food and Drug Administration has for about pet food, but believe me, it and other products under different la- the food we eat. hasn’t been that long ago when we bels spread all across America with Now, let me tell you at the outset, I talked about salmonella-contaminated this contaminated product. Three am not capable, having served on Cap- peanut butter and E. coli-contaminated weeks they waited. Why? Because the itol Hill for a few years, to describe to spinach. If it seems as if these food cri- law does not currently require them to the people who follow this debate what ses are occurring more frequently, they report on a timely basis. we call the food safety system in Amer- are. We may have the safest food sup- I asked the FDA last week: What is ica. Imagine, if you will, that we have ply in the world, but the fact is, every the penalty against Menu Foods for 12 to 15 different Federal agencies re- parent, every family wants to have waiting 3 weeks? They said: Well, we sponsible for food safety. Imagine 30 peace of mind that when they buy are considering. We are talking to our different laws and legal standards for something at the grocery store, they counsel. We will get back to you. food safety, 40 or 50 different commit- can put it on the table, feed it to their Months have passed. Nothing has hap- tees on Capitol Hill with jurisdiction, family, and no one will get sick. There pened. Menu Foods waited 3 weeks in- hundreds, if not thousands, of lobbyists are questions that are being raised al- stead of reporting on a timely basis. By and special interest groups hovering most on a daily basis about whether we then, the product was all across Amer- over this whole scene. Add to that can have that confidence. ica. thousands of Government workers and The issue that came up recently was In the case of rice protein con- bureaucrats who are protecting their on pet food. Batches of wheat gluten centrate, there is less certainty. Im- turf, and we have a system that is vir- and rice protein concentrate contami- porter Wilbur Ellis purchased product tually out of control—not just when it nated with a chemical called melamine from the Binzhou Futian Company in comes to drugs, as important as they were imported from China by several China. It then distributed the product are, but when it comes to the food we shipping companies. We just learned to a host of companies that produce pet eat. over the last few days from stories food. These brands and labels have been I thank Chairman KENNEDY and Sen- printed in the press that melamine is recalled in a haphazard way over the ator ENZI and others for partnering regularly added to animal feed in past 3 weeks—again, delays in report- with me on an amendment which I will China. ing. The FDA has even refused to name offer as soon as I am given the green Why would they add a chemical several companies for more than a light by the chairman and the ranking called melamine to something they are week trying to get to the bottom of member on the issue of food safety. I going to feed to livestock? Well, it is a this investigation because the records thank them for working with my staff way to increase the value of the prod- process is so broken down at this agen- for several months to come up with uct. If there is more protein in the cy. language to the deal with some serious feed, then they can charge a higher One or more of the manufacturers challenges. price. When the food product is tested sold some refuse pet food that it pro- For too long, we have gone without to see if there is protein, you look for duced using contaminated product to updating the resources and authorities the presence of nitrogen. The chemical, hog farms in California and other of the FDA in the area of food safety. melamine, when added, tests for higher States. These farms fed their hogs the

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00055 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.047 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5370 CONGRESSIONAL RECORD — SENATE May 1, 2007 contaminated feed, some of which was these events might have caught some- Are we surprised at what has hap- sold to consumers and much more of it thing like melamine earlier. So the pened? The FDA doesn’t have the re- has been quarantined and is slated for amendment creates an early warning sources or the authority to make sure destruction. and surveillance system for companion what we are bringing in from overseas In addition, we just learned this week animals and directs the Secretary to is safe. We need to tackle it in a larger that 38 poultry farms in Indiana re- work with professional organizations, bill. ceived contaminated feed. So the plot veterinarians, and others to dissemi- What our amendment does is close thickens, and the safety issue grows as nate information. the loophole by improving data collec- we wonder if what was originally pet While we are at it, the amendment tion and reporting. It creates an FDA food is now being fed to livestock, and would direct the FDA, in cases of both database of food adulterants that if humans consume the food what im- pet food and human food, to keep up- would be filled by FDA inspectors as pact it will have. to-date, comprehensive, searchable re- well as importers of food. The extra se- There is a mystery importer involved call lists on their Web site. ries of data points would better pick as well from China that we have heard Second, the amendment closes the out trends and help FDA do a better about but we can’t identify yet. Sup- gap that FDA itself identified in an risk-based inspection job. It also cre- posedly this second importer purchased earlier draft framework posted on its ates a system in which adulterations rice protein from the Chinese firm in Web site in December of 2006. The guid- are reported quickly so as to prevent question in larger quantities than the ances and practices that govern the pet contamination from spreading. This firm Wilbur Ellis. food industry are currently generated would have helped in this most recent In terms of the investigation in by the American Association of Feed case, but because of delays in reporting China, the FDA said: We want to send Control Officers, known as AAFCO. it led to an expansion of recalled prod- inspectors to China to see what they The guidelines on best practices and in- uct into dozens of different companies are sending to us. Well, first the Chi- gredient lists are updated annually and and got perilously close to the human nese said: We deny you the visas for implemented on a voluntary basis by food chain. The data would then be your FDA inspectors. Imagine that. manufacturers and State departments used by the Secretary to issue import Millions of dollars worth of foodstuffs of agriculture. However, there is no re- alerts, blocking similar risky products. coming in from China, contaminated quirement under the law for States to I have also pursued a separate track and poisoned, killing off pets, threat- adopt these practices, and they don’t on the issue of resources for FDA by ening human consumption, and when have the force of Federal guidelines. sending a letter to Chairman KOHL of we say to the Chinese that we want to Inspections are not coordinated State Wisconsin and Senator BENNETT of take a look at their production facili- to State, and some States have dif- Utah requesting additional resources ties, they denied us visas. I joined with ferent standards. While the FDA par- for food inspection at the Food and Congresswoman DELAURO and sent a ticipates in the AAFCO process, it does Drug Administration. I hope my col- letter to the Chinese Embassy, and not provide a list of ingredients and ad- leagues will join me in that effort. they reversed their position, offering ditives. AAFCO’s list is more com- Also, I am filing an amendment that the visas. We have to make it clear to prehensive than the FDA’s. Our amend- would authorize a study on user fees China and every other country that if ment would direct the FDA to work for food producers. It is vital that we they want to do business with the with AAFCO and other stakeholders to explore various revenue streams for the United States, they will do it on our give these guidelines the force of law. FDA in light of the shortage of re- terms when it comes to health and Third, the amendment closes a loop- sources they have for inspection. safety. We will never allow them to hole that this contamination has ex- The last two items in my amendment compromise the safety and health of posed with regard to our imports of are a sense of the Senate and a clari- American citizens in the process. food. The source of the contamination fication that companies are required to The amendment I am going to offer— we know of was wheat gluten and rice maintain records and make them ac- and I hope it will be accepted—does protein concentrate originating in cessible to the FDA as part of an inves- several things based on what we have China. Neither shipment was inspected tigation. This latter item would pre- learned over the last 6 weeks. First, by the FDA. If you have some peace of vent delays that keep contaminations during this recall, consumers, veteri- mind or belief that a Federal inspector from being known as quickly as pos- narians, and retailers, among others, is watching food as it comes into the sible. In the case of recalled peanut expressed concern about the scope of United States, the odds are 99 to 1 you butter this past winter, an FDA report the recall, what products were in- are wrong. Only about 1 or 1.5 percent showed that inspectors were denied cluded, or what not to feed to domestic of all the shipments of food products documents when they were requested. animals. The FDA was slow, uneven, coming into the United States are ac- The language would clarify that when and inconsistent in sharing informa- tually inspected. the FDA makes the inspection, it will tion on the recall. While there are As imports have increased the num- have access to those documents needed mechanisms in place to proactively ber of inspectors have decreased. This for purposes of safeguarding the food track human food-borne illnesses and is an indication of U.S. food imports by supply. then share information, no similar sys- country. As you can see, there have The sense-of-the-Senate language tem exists for companion animals. been dramatic increases in these fiscal goes beyond this amendment and this I visited the FDA pet food recall Web years showing that the amount of food bill, stating that it is vital to update site the day before the March 12 Agri- coming into the United States is in- resources, direction, and authorities of culture appropriations hearing and creasing in volume. The number of in- the FDA to better safeguard our food found a jumble of corporate press re- spectors who watch for this food to supply. The sense of the Senate directs leases. It was virtually unintelligible. I protect our families and consumers the FDA to work with our trading part- said to the FDA: Can’t you make this across America just hasn’t kept pace. ners to establish cooperative agree- information clearer so consumers can In 2003, the United States imported ments. have the information they need to pur- $45.6 billion worth of agricultural prod- Several weeks ago, Robert Brackett, chase these products? They took it to ucts—in 2003; today, $64 billion. Agri- Director of the FDA’s food arm, said: heart and made the changes. That is cultural imports from China have al- These outbreaks point to a need to com- good. most doubled in that period of time, pletely overhaul the way the agency does In addition, following the recall, the from $1.2 billion to $2.1 billion. Due to business. FDA checked the records of companies flat budgets and increasing responsibil- I am thankful the sponsors of this such as Banfield, the largest privately ities, the overall number of FDA in- legislation for the reauthorization of owned veterinary hospital chain in the spectors looking at these shipments the Food and Drug Administration un- United States. The records kept and at domestic food processors has ac- derstand that expanding the scope of showed a statistically significant in- tually decreased from 2003 to the our debate on this bill to include food crease in the instances of renal failures present time; imports up, inspectors safety is overdue. of cats. A system in place to track down. Mr. Brackett went on to say:

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00056 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.049 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5371 We have 60,000 to 80,000 facilities that we not worth fighting for, then what they That has been documented not by rep- are responsible for in any given year. We ought to do is act to end the war. This resentatives of the administration or have to get out of the 1950s paradigm. legislation would do no such thing. It people who support the current policy Dr. Stephen Sundlof, Director of the would not end the war in Iraq. It will but on the front pages of the New York Center for Veterinary Medicine of not require the withdrawal of all Amer- Times and USA Today in the last few FDA, which has jurisdiction for pet ican troops from Iraq. It will not cut days. food, implied as much when he was off funding for the war in Iraq. At a moment when Sunnis in Anbar quoted last month as saying: On the contrary, what this legisla- are finally helping us in targeting al- In this case, we’re going to have to look at tion proposes to do is something far Qaida terrorists, this legislation would this after the dust settles and determine if worse. It would handcuff our soldiers require us to abandon them. there is something from a regulatory stand- with an inflexible and arbitrary set of Madam President, what message are point that we could have done differently to restrictions—restrictions that would we sending to our friends and our foes prevent this incident from occurring. take life-and-death decisions about with this ill-advised legislation? We I couldn’t agree more. This is a situa- how, when, and where our troops can have heard from some that we need to tion where we need one food safety fight away from those troops and their abandon Iraq because it is not part of agency, not driven by the politics of commanders. It would substitute the the war on terror. But here again, lis- Washington but driven by science, to judgment of politicians in Washington ten to General Petraeus, who is on the make sure the food fed to our children, for the judgment of our military com- ground, one of the most outstanding the food fed to our pets, or any food manders on the ground. That is wrong. generals of our military that I have served in America is as safe as possible. What is more, this legislation will met since I have been a Senator, con- As we import more food with fewer in- impose on our soldiers in Iraq a binding firmed unanimously by the Senate a spectors, the risk increases. deadline of October 1, 2007—5 months short while ago. Here is what General I might add that we have looked at from today—to begin withdrawal. That Petraeus warned us: the pet food contamination and others withdrawal would be required to begin Iraq is, in fact, the central front of al- from the aspect of greed and neg- regardless of conditions on the ground, Qaida’s global campaign against us. ligence. In the instance of China, they regardless of the recommendations of Let me repeat that. General Petraeus were adulterating their product with a our military leaders, regardless of the said: chemical so that it was worth more in opinions of our allies in the region—in Iraq is, in fact, the central front of al- the marketplace. That is economic short, regardless of reality—on October Qaida’s global campaign against us. fraud. In the instance of spinach and 1, 2007. If we withdraw, as this legislation peanut butter, we are dealing with neg- This is a deadline as arbitrary as it is would require us to begin to do, al- ligence—negligence that results in a inflexible. It is a deadline for defeat— Qaida wins—the same al-Qaida that at- deadly product being sold across Amer- defeat for America and a defeat for the tacked America on September 11, 2001, ica. But we can’t stop there, unfortu- hopes of the majority of the Iraqi peo- killing 3,000 innocents, the same al- nately. In the world we live in, with ple for a better, freer future. Qaida that intends to attack us again, the vulnerabilities we have, food could I know we have heard from some sup- the same al-Qaida that has made very also become a terrorist weapon. That porters of this legislation that by or- clear to us what its plans for domina- may sound far-fetched to some, but dering a withdrawal we will encourage tion and control of large sectors of the when Governor Tommy Thompson left the Iraqis to make political com- world are. the Bush Cabinet, he said in parting promises. Where is the evidence of Madam President, the violence we that he found it hard to imagine why this? are seeing in Iraq today, the suicide the terrorists had not attacked our According to the legislation this Con- bombings in Baghdad, the chemical food supply. He said he worried about gress has now sent to the President, weapons attacks in Anbar Province, it on a regular basis. the withdrawal must begin regardless the targeted assassinations of Iraq’s We have to have inspection standards of what the Iraqi Government does. leaders—these are all primarily the in place that mitigate against greed Where, then, is the incentive for the work of al-Qaida. So the big question, and negligence and the possibility of Iraqis to reconcile? On the contrary, then, for me—and I ask my colleagues someone intentionally contaminating there is every reason to conclude this to consider it—is whether we respond our food supply, causing terrible suf- legislation will have exactly the oppo- to al-Qaida’s terrorism by pulling out, fering and death across America. site effect that its sponsors claim for as it hopes we do, and as this legisla- That is why this amendment is a step it. tion would require us to do—aban- in the direction for a safer food supply. Listen to the latest National Intel- doning the future of Iraq, the Middle I sincerely hope my colleagues on both ligence Estimate on Iraq, which has East, and ultimately our own Amer- sides of the aisle will support my ef- been saluted by Members of this Cham- ican security, to the very people re- forts. ber on both sides of the question of sponsible for the terrible atrocities and I yield the floor. what to do now in Iraq. That latest Na- suicide bombings we see in Iraq today. The PRESIDING OFFICER. The Sen- tional Intelligence Estimate predicted The alternative to pulling out is ator from Connecticut is recognized. that a withdrawal of American troops standing up and fighting. That is what Mr. LIEBERMAN. Madam President, in the months ahead would ‘‘almost we are doing now in Iraq and doing I ask unanimous consent that I be able certainly lead to a significant increase with some success in Baghdad and to speak as in morning business. in the scale and scope of sectarian vio- Anbar Province. Rather than under- The PRESIDING OFFICER. Without lence, intensify Sunni resistance, and mining General Petraeus and handing objection, it is so ordered. have adverse effects on national rec- al-Qaida a victory, Congress should SUPPLEMENTAL APPROPRIATIONS onciliation.’’ take swift and responsible action to get Mr. LIEBERMAN. Madam President, How do the supporters of this legisla- General Petraeus and our troops in the I rise this afternoon to encourage tion explain that National Intelligence field the support they need to prevail. President Bush to go ahead and veto Estimate? For that matter, how do The Iraq war is not lost. But if this the supplemental appropriations bill they justify this legislation, in light of supplemental became law, it would be that Congress has sent him this after- what we all heard directly from GEN lost and America would suffer the con- noon because of the language in that David Petraeus, the commander of our sequences of that defeat for genera- bill on Iraq that I consider to be bad forces in Iraq, when we spoke with him tions. for our troops and dangerous for our and he spoke with us last week? President Bush, veto this bill. country. General Petraeus told us very clearly I yield the floor, and I suggest the ab- The legislation that Congress has that we have achieved progress since sence of a quorum. passed, in my opinion, represents the our new strategy in Iraq—the so-called The PRESIDING OFFICER. The worst of all worlds. As I have said be- surge—began. Consider the situation in clerk will call the roll. fore, if people feel the war in Iraq is Anbar Province to the West of Bagh- The assistant legislative clerk pro- lost, or if people feel it is not lost but dad, which has dramatically improved. ceeded to call the roll.

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00057 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.051 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5372 CONGRESSIONAL RECORD — SENATE May 1, 2007 Mr. KENNEDY. Madam President, I ing things cleared up. We would like to a prompt but safe procedure for getting ask unanimous consent that the order get it done tonight and tomorrow, if drugs approved in this country, some- for the quorum call be rescinded. possible. I think we are getting a long thing called PDUFA, which basically The PRESIDING OFFICER. Without way down the list now on problems allows drug companies to pay a fairly objection, it is so ordered. that people had with it, and we are get- significant portion of the cost of the Mr. KENNEDY. Madam President, we ting those cleared up in a way that I approval of new drugs, which has expe- are still looking for amendments. It is think both sides can agree on. dited dramatically the rate of approval true that there are probably four im- So that is why this is not quite as of new drugs. That means pharma- portant areas where negotiations are controversial as some people might ex- ceuticals and biologics come to the going on with the principals in a bipar- pect or perhaps even want. I thank the market, which help people, which save tisan way, and progress is being made. Senator from Massachusetts, Mr. KEN- lives, which basically makes life bet- It does seem to us that we ought to NEDY, for all his cooperation on this ter. That is the good news. continue that progress. We will de- and the tremendous effort of all the In addition, there is, for devices, the scribe in greater detail those proce- staff. We need people to come down MDUFMA proposals, which deal with dures tomorrow. with amendments, particularly if they devices, medical devices the way we We are urging our colleagues who have something new that we have not deal with pharmaceuticals, setting up a have amendments to get in touch with heard about. fee system for the approval of medical us. We know this is complex legisla- I yield the floor and suggest the ab- devices. This is something, when I was tion, but it is enormously important, sence of a quorum. chairman of this committee, I had the and we have a lot of business in the The PRESIDING OFFICER. The good fortune to be involved in devel- Senate. Our leaders have indicated that clerk will call the roll. oping. These two initiatives are the es- they wanted us to be ready to move The assistant legislative clerk pro- sence of how we maintain a vibrant ahead on amendments. Senator ENZI ceeded to call the roll. drug and medical device approval proc- and I are quite prepared to do so. Mr. GREGG. Mr. President, I ask ess in this country. It is absolutely I understand the Senator from Michi- unanimous consent the order for the critical they be reauthorized, and this gan, Ms. STABENOW, has an amendment quorum call be rescinded. bill does it in an effective way. she is going to speak to and offer later The PRESIDING OFFICER (Mr. In addition, the bill takes on a num- on. We will look forward to her pres- SALAZAR). Without objection, it is so ence. ordered. ber of other issues which are timely We want to again underline the im- Mr. GREGG. Mr. President, I rise to and appropriate. The most significant, portance that if Members have amend- speak today on this FDA bill that has from my perspective, although there ments, notify us as soon as possible, so been brought forward by Chairman are a lot of significant ones here, is the we can work on them and accept them KENNEDY and Senator ENZI. I begin by issue of drug safety and how we make if we can. We want to be able to con- thanking them for their cooperative, sure the drugs which do come to the clude this legislation in a timely way collegial, and inclusive approach over market are safe. This involves not in the not-too-distant future. the last couple of weeks to get this bill guesswork but finding out what the I yield the floor. in a form that makes it much more ef- science is and what happens when peo- The PRESIDING OFFICER. The Sen- fective, accomplishing the goals we all ple start using these drugs and medical ator from Wyoming is recognized. have. devices. The concept behind that in Mr. ENZI. Madam President, I thank Senator KENNEDY and Senator ENZI this bill is that we should set up a re- the Senator from Massachusetts for his for a long time have been great advo- gime that basically collects informa- comments. I’ll make a slight addition cates of making sure we have a strong tion from all sorts of different sources. to what he said. For some, it may not and effective FDA. Senator KENNEDY, There are literally thousands of dif- look as if there is a lot of progress of course, has been involved in this for ferent sources, but there are some very being made, but I assure you there is a many years and has played a huge role big ones that we develop information lot of progress being made. One of the in the success of the FDA, which is, as about the reactions people have when secrets to our committee operation— we know, one of the extraordinarily they take drugs. We have the tremen- which used to be one of the most con- successful agencies in the Federal Gov- dous database of the Medicare system, tentious committees in the Senate, and ernment. It gives the American people for example. We have the tremendous now it works productively on issues confidence, when they go into a gro- database of provider groups, such as such as this to get things done—is that cery store and purchase food or when the Kaiser Permanente fund out in we recognize if somebody brings an they go into a pharmacy and purchase California. These different provider amendment to the floor and we have a pharmaceutical product or have a groups have a huge amount of informa- not heard about it before, it creates prescription filled, that they are going tion on what is happening when some- difficulty. When the amendment is to receive goods which are safe and ef- body takes some form of medication. filed, we don’t have a real good process fective and that they are not going to But what happens is that information, for amending an amendment. Tech- be at risk of harm as a result of adul- although it is collected, is not effec- nically, we can, but it requires a lot of teration, fraud, abuse, or misuse of tively screened and is not effectively time and votes. In the meantime, it po- those goods. evaluated. larizes people. Instead, we take a look It is one of the most amazing suc- What this bill does, essentially, is at them, talk about them, and we use cesses of our Federal Government in create a regime that allows us to more the body of knowledge we have gained the area of protecting consumers. It effectively, first, collect the data; sec- from a lot of hearings on the issue to arose out of the early 1900 period when ond, when there are red flags popping show where there could be inconsist- there were serious issues relative to up on that data that say there is a re- encies and problems with the amend- food safety in this country, and has action here or reaction there or some- ment. We get the problems ironed out evolved into clearly one of the finest thing occurs here that was not ex- so the amendment can have a logical agencies, not only in our Government pected, that information becomes more chance for inclusion if it adds to what but in the world. It is respected around visible under this regime and more we are doing. the world as the gold standard for pro- available; and then, third, if it is clear That is what is going on as we are tecting American citizens and citizens there is something that is not going speaking. The Kennedy staff and the who use the products made by Amer- right here, that there is a series of ab- Enzi staff, and those Senators with ican companies. errations nobody expected, then it sets amendments are meeting together and This bill builds on that success. I up a process where we take that infor- working out difficulties. We will accept congratulate the Senator from Massa- mation out and we give it to selected many of them. Some of them are al- chusetts and the Senator from Wyo- groups of specialists in the academic ready in the substitute bill we have. So ming for doing such a strong job of and private world who have the ability a lot of progress has already been made building on that success. This bill con- to evaluate that information and tell on this bill. We want to get the remain- tinues the effort to make sure we have us what is going on.

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00058 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.053 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5373 There are centers at MIT and I be- change for your testing this and mak- fortable with dealing with the Internet lieve at Duke, for example, that do ex- ing sure it will work effectively, or on a variety of different levels, but cer- actly this. The idea, of course, is to finding out if it will not work effec- tainly senior citizens as people age into first collect the information effec- tively, on children. The practical effect their senior citizenship years who had tively; second, make sure when those of that, of giving that incentive, has been dealing with the Internet for aberrations or red flags start to show been that hundreds of new drugs have quite a few years and are comfortable up they are noted; and, third, when been made available to children which with it—I believe it is critical we have there is a certain critical mass of infor- were not available before. This has had in place a system which allows people, mation that reflects something that a very positive impact on children and when they look at the site on the may not be correct or is out of kilter, the ability of children to get pharma- Internet, to know whether that Inter- it makes sure we have that informa- ceuticals. net pharmacy is selling the product tion evaluated in a very science-based, With the BSE program, we also de- they say they are selling and whether professional way by people who spe- veloped a program called the Pediatric the product they say they are selling cialize in this and who have the ability Research Equity Act, which essentially has received FDA approval. to do it—something which FDA does takes the opposite approach from the The problem we have here is a lot of not have the resources, necessarily, to BSE program. It creates a mandate these pharmacies will represent that do right now. where, in certain instances, certain they are selling some sort of pharma- With that information in hand, with medications have to be tested on chil- ceutical good and it turns out that that science in hand, then you can dren. They have to go through a proc- product is, in many cases, adulterated make decisions. This bill creates a new ess of seeing if they will work for chil- or inappropriately made, in which case regime for making those decisions—as dren. The two together basically work people end up getting a pharmaceutical to what a company must tell people or in tandem and the idea is they will feed product which is bad for them. In some tell providers when they are using off of each other, and you will create cases it can actually lead to death. So these different drugs and medications. an atmosphere out there where the two it is critical that we have a way so But it will be a science-based decision, different approaches—one basically when somebody goes on the Internet and looks at a site on the Internet, and that is the key here. All of this being a carrot and the other being a they know that Internet pharmacy will key off of science that is hard and stick—will lead to better medications they are looking at is legitimate and that is effectively reviewed and evalu- being available for children. the products they sell are legitimate ated in order to come to the conclusion It has worked amazingly well. The and have been through the FDA ap- that certain actions must be taken in key to this, of course, is to keep these two in tandem. In order to accomplish proval process. how you distribute this medication and In order to accomplish that, we need that, they both, in my opinion—and how you communicate what the impli- to set up a whole new regime, basi- fortunately in the opinion of the chair- cations of this medication are. So this cally, and we need to pay for it. This man and the ranking member of the new safety and surveillance regime, amendment which I have put in accom- committee now, at least—have to be on which is known as mining the informa- plishes that. It essentially gives the tion, and then pulling it together and the same wavelength. They have to be FDA the authority to review pharmacy taking advantage of it, validating it dealt with the same way relative to sites on line, to meet with the people and integrating it—this new regime is things such as their sunsets, when they who have set up those sites, to make at the essence of the safety concerns get reviewed and when they don’t get sure to set up a certification process which are involved in this bill. reviewed, because if you were to have where they are guaranteed the sites are It is very positive. It opens a new one sunsetted at a different time than meeting the conditions of selling phar- world of review in the area of pharma- the other or one sunset and the other maceutical products or medications ceuticals and medicines, a postmarket not sunset, you wouldn’t get an effec- which have met the FDA approval, and review process which will be based on tive review of the two together, and then to put sort of a Good House- science and which will be very healthy they both work, as I said, together. keeping seal on that site, which is to the system as a whole. I congratu- This bill makes sure they are treated tamperproof, which says this site has late and thank both Senator KENNEDY the same way in that area, and that is FDA-approved products. It would be a and Senator ENZI for evolving this a major step in the right direction to- huge step forward in safety for Amer- process in this bill. ward making sure children get proper ican citizens using Internet phar- In addition, there is the pediatric pediatric care. There is still going to be macies. language in this bill. There is the BSE an issue tomorrow, I understand, on ex- It is complicated, though, in its en- program, which is the program which clusivity, which is going to be brought forcement. It is simple to state but basically rewards companies that are up by another Senator; that is, the complicated to enforce because it willing to go out and do extra research length of the exclusivity that is nec- means the FDA needs the resources to to see how a drug might affect a child. essary in order to get pharmaceutical deal with these sites and also to deal Historically, drugs will be brought to companies to pursue proper research on directly with these pharmaceutical the market and you would never children is an issue. But I happen to Internet sales places which may be know—because all the clinical exams think what we have now has been somewhere other than the United have been done on adults—how they shown to work, and why fix something States. Second, you have to have in the would affect children. Some of these that is not broken, in my opinion. So I United States a point at which you can drugs, obviously, if given to a child, believe we should stay with what we deal with the site if something goes could have a significant negative im- have for the 6-month exclusivity pe- wrong, a responsible representative on pact and, if given in the wrong doses, riod. the ground in the United States who might have an extraordinarily adverse In addition, there are a number of has the economic wherewithal to basi- effect. Some could actually be very other issues floating around this bill. cally bond the site, for all intents and positive if given in the right dosage. So This bill, obviously being a major purposes. it became a guessing game as to when health care bill, attracts a lot of other Setting up that type of regime will these pharmaceuticals, when these concerns. One of them that I have filed be expensive. The language of this medications, were good for children, in as an amendment—but I don’t intend amendment puts in place a fee system many instances. As a result, doctors to bring it up unless we move into the which allows that to be paid for so we and prescribers simply didn’t know issue of reimportation, which may be can be assured that the FDA has the whether to make them available, in brought up on the floor—is the ques- resources necessary to review these many instances, to children. tion of safety of Internet pharmacies. I sites and accomplish this goal of mak- This BSE pharmaceutical procedure believe very strongly, when somebody ing sure these Internet pharmacy sites said essentially, We will give you, the goes on line and purchases a pharma- are safe for Americans to use. I think producer of this pharmaceutical, of ceutical product over the Internet— this would be a tremendous step for- this medication—we will give you an which is happening more and more ward in safety for all Americans, espe- extra 6 months of exclusivity in ex- often as people become more com- cially as we move toward a much more

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00059 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.057 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5374 CONGRESSIONAL RECORD — SENATE May 1, 2007 Internet-oriented purchasing process in You will also need very aggressive ciate his submitting it in case we need this country. postmarket surveillance in this area to have that debate. Another issue which is going to be because you do not know, in many in- I also appreciate the explanation he discussed here, and which I understand stances—you hope you know, but you gave on the follow-on biologics. It is a from the chairman may be held over do not necessarily know—how individ- hard thing for people on the committee for conference or come into play in uals will react to taking this type of who have been through a number of some area, is a crucial issue of follow- medication, which is developed as a hearings to understand. I am sure the on biologics or similar biologics. similar medication, as versus the basic public as a whole has an even greater We know we can produce a generic medication which is trying to be rep- difficulty with it. But it is a whole new pharmaceutical and do it with a fair licated. phase of medications. By the name, amount of predictability. We know This area of biologics is a complex ‘‘biologics,’’ it is alive. That makes it a that if a generic company brings on a one. It should not be rushed into. I lot more complicated than a set of pharmaceutical product which has run know there is a great desire to step for- chemicals that are ground up and put its course, it has proper patent cov- ward and say: We have a huge victory together in a particular order. Even erage, that that generic is going to be for the American people, we can now with the chemicals that are ground up safe and effective and be essentially have generic biologics. But if we rush and put together in a particular order, the same thing as the pharmaceutical into this exercise and create a process if they aren’t done quite right, they because they are chemical compounds. with approval which does not ade- would not dissolve and people do not In the biologics area, this is not the quately account for the significantly, get any benefit from them. That is why case because you are dealing with a the exponentially more complex proc- we are doing the bill. Then we will be much more complex process of pro- ess of bringing online a biologic when working on biologic similars to see if ducing the biological medication. It is compared to a chemical pharma- there is some way that that can be a fermentation process, it involves pro- ceutical, then we will not have done done effectively and safely. I thank the teins, it involves mutation of proteins, our job as policy people but will simply Senator for his comments and his tre- which depends to a great extent on a have given ourselves a good press re- mendous work. huge number of factors which are very lease and in the end probably have I yield the floor. uniquely identified with the way that given ourselves a very dangerous proc- The PRESIDING OFFICER. The Sen- that vat of medication was evolved ess relevant to protecting the Amer- ator from Massachusetts. through the process. ican people in the area of biologics. Mr. KENNEDY. Mr. President, I Anyone who has been to one of these As we move down this road of would add a note of thanks to the Sen- facilities can see how complex it is to generics, I do hope we will move in a ator as well. We are strongly com- maintain consistency, even within the way that understands there is a signifi- mitted to information technology, the facility that is producing the medica- cant difference in pharmaceuticals and use of information technology eventu- tion. If you stepped out of that facility that those differences are going to re- ally. We have that on our list. We and tried to reproduce that medication, quire a much more detailed and a much passed it unanimously through this the complexities would even be more more complex approval process than we body a couple of years ago, but the difficult to replicate. presently have in moving in the ge- House didn’t act and we are going to It is critical that as we move into neric pharmaceutical area. this biologic area, we understand we act further. Those are some of the concerns I But what we are talking about in the are not dealing with generic pharma- have relative to other issues that ceuticals. You know, when you put the database, which the Senator from New might be brought up in this bill. But I Hampshire talked about, is using the title ‘‘generic pharmaceuticals’’ on do again wish to congratulate the Sen- something that is sort of a motherhood information technology and database ator from Wyoming, I wish to con- in terms of the postmarketing or ap- term, that is a good idea. It is a good gratulate the chairman from Massa- idea if it works. But if you put the ge- proval surveillance. This makes a great chusetts for once again bringing to the deal of sense. That is a key aspect of neric title on biologics, you are prob- floor a very strong piece of legislation, safety in the legislation. The Senator ably going to mislead a lot of people which will significantly improve the from New Hampshire is very interested and, in the process, potentially produce capacity of the FDA to continue its ex- in shaping that. medicines which can be extremely traordinary record of protecting the harmful or could not accomplish the The second is to make sure we are American people relevant to food and going to bring the latest information purposes. drug safety. on drug safety to the consumers; that So as we move down this road of I yield the floor. looking at biologics and how we give The PRESIDING OFFICER. The Sen- is more scattered at the present time the opportunity to produce similar bio- ator from Wyoming is recognized. than it should be. logics to people after the patent life Mr. ENZI. Mr. President, I wish to We have accepted the recommenda- has run, we have to be very careful thank the Senator from New Hamp- tion of Senator GREGG to include one that we don’t oversimplify the exercise shire, Mr. GREGG, for the tremendous what they call portal in the Internet to in the name of getting something, as effort he put into this bill. He spent make sure that that information will ‘‘motherhoodish’’ as generics; rather, years on the committee. He became be collected and available to the con- we have to make sure we put in place chairman of the committee. He used sumers on safety, which is a useful ad- a process which allows those biologics, those years with the institutional dition. So these are important. I thank when they are produced as similar bio- memory and the experience with a him for his strong support for this leg- logics, to have been properly reviewed great deal of diligence and creativity islation. This is very helpful. to be sure they accomplish what they which he has always used on that com- Now we are beginning to see, we have claim they are going to accomplish. mittee to provide us with fuller expla- got broad support on our side and on This means that almost in every in- nations and wording for several of the both sides of the aisle for this legisla- stance of an individual biologic, you provisions that are in this bill. tion. We are working hard to clear up are going to have to have clinical trials I thank him for helping us to perfect some of the—still a few of the out- for the similar biologic. There are those and the diligence he always has standing items, but we are moving going to be very rare instances where on all of the issues we bring up in the ahead. We want to indicate to our col- you can actually bring to the market committee. I also appreciate the work leagues again that we want to try and something that doesn’t go through he has done on Internet safety. This is respond to many of their amendments, clinical trials in this area, in my opin- not something he just developed now. but we want to do it in a timely way. ion, and you have to be very sure that He has been working on it for at least We were in here yesterday afternoon you demonstrate safety and effective- 3 years that I am aware, to make that with the presentation. We welcomed ness of the similar product before you as safe a system as possible if we ever suggestions during the course of the step into this arena of awarding the au- have to put it into place. evening last night, and we have done so thority to go ahead and sell that prod- I am hoping we will not have to have during the course of the day. We are uct in the market generally. that full debate at this time and appre- moving along we hope that anyone who

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00060 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.058 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5375 has any other further amendments (2) such State or territory requires certifi- So there is a group of farmers, turtle would be in close touch with us because cation of sanitization that is signed by a vet- farmers, in Louisiana particularly, but we are giving every opportunity to our erinarian who is licensed in the State or ter- I am sure there are others around the colleagues to make any recommenda- ritory, and approved by the State or terri- country, who have maintained their tory agency in charge of regulating the sale business by selling overseas. Recently, tions they have or would like to move of pet turtles; along to conclusion at a reasonably (3) the certification of sanitization re- because of the competition and devel- swift time. quires each turtle to be sanitized or treated opment of overseas markets, they are I yield the floor. for diseases, including salmonella, and is de- getting very constricted in what they The PRESIDING OFFICER. The Sen- pendant upon using the Siebeling method, or can sell because they have now gotten ator from Louisiana. other such proven method, which uses an an- competition from the countries in AMENDMENT NO. 1004 tibiotic to make the turtle salmonella-free; which most of these sales occur. Ms. LANDRIEU. Taking that advice and There has been a great deal of pres- to heart, Mr. President, I call up (4) the turtle farmer or commercial retail sure to try to reopen the domestic mar- seller includes, with the sale of such a turtle, ket. That is what this amendment will amendment No. 1004. a disclosure to the buyer that includes— I would like to speak about that (A) information regarding— do. It will open a domestic market amendment now. (i) the possibility that salmonella can re- again because the science has caught The PRESIDING OFFICER. The colonize in turtles; up with the regulations. We now have clerk will report. (ii) the dangers, including possible severe developed a vaccine, universally-tested The legislative clerk read as follows: illness or death, especially for at-risk people and proven, that can keep those small The Senator from Louisiana [Ms. who may be susceptible to salmonella poi- turtles nearly free of salmonella, and LANDRIEU] proposes an amendment num- soning, such as children, pregnant women, with the right licensing procedures this bered 1004. and others who may have weak immune sys- amendment calls for and the right in- The amendment is as follows: tems, that could result if the turtle is not formation that is required when these properly handled and safely maintained; (Purpose: To require the Food and Drug Ad- (iii) the proper handling of the turtle, in- turtles are sold for pets, either to a ministration to permit the sale of baby cluding an explanation of proper hygiene wholesaler or retailer or to a family turtles as pets so long as the seller uses such as handwashing after handling a turtle; who might purchase them, I believe the proven methods to effectively treat sal- and safeguards are in place, as the science monella) (iv) the proven methods of treatment that, and technology have caught up with At the end of the bill, add the following: if properly applied, keep the turtle safe from the problem. TITLE ll—DOMESTIC PET TURTLE salmonella; There are many wonderful aspects MARKET ACCESS (B) a detailed explanation of how to prop- about technology. Sometimes we can SEC. ll. SHORT TITLE. erly treat the turtle to keep it safe from sal- think our way through a problem. That This title may be cited as the ‘‘Domestic monella, using the proven methods of treat- is basically what has been done over ment referred to under subparagraph (A), Pet Turtle Market Access Act of 2007’’. the last 35 years. I am proud of the role SEC. ll. FINDINGS. and how the buyer can continue to purchase Congress makes the following findings: the tools, treatments, or any other required that LSU, Louisiana State University, (1) Pet turtles less than 10.2 centimeters in item to continually treat the turtle; and has played in developing these treat- diameter have been banned for sale in the (C) a statement that buyers of pet turtles ments. I am proud the industry sur- United States by the Food and Drug Admin- should not abandon the turtle or abandon it vived through a very difficult time and istration since 1975 due to health concerns. outside, as the turtle may become an proud they are now proposing very (2) The Food and Drug Administration does invasive species to the local community, but strict rules and regulations. not ban the sale of iguanas or other lizards, should instead return them to a commercial I might add that when this ban went snakes, frogs, or other amphibians or rep- retail pet seller or other organization that into place for this particular reptile, tiles that are sold as pets in the United would accept turtles no longer wanted as pets. there was no such ban for other rep- States that also carry salmonella bacteria. tiles that also can carry salmonella, The Food and Drug Administration also does (b) FDA REVIEW OF STATE PROTECTIONS.— not require that these animals be treated for The Food and Drug Administration may, which are still continuing to be sold on salmonella bacteria before being sold as pets. after providing an opportunity for the af- the domestic market. So on behalf of (3) The technology to treat turtles for sal- fected State to respond, restrict the sale of a this industry, which is small but im- monella, and make them safe for sale, has turtle only if the Secretary of Health and portant, mainly in Louisiana, and I am greatly advanced since 1975. Treatments Human Services determines, that the actual certain there are turtle farmers in exist that can nearly eradicate salmonella implementation State health protections de- many places, I offer this amendment to from turtles, and individuals are more aware scribed in subsection (a) are insufficient to repeal this 1975 ban in light of the new of the causes of salmonella, how to treat sal- protect consumers against infectious dis- eases acquired from such turtles at the time technology and new opportunities that monella poisoning, and the seriousness asso- are out there to give protection to our ciated with salmonella poisoning. of sale. general public. (4) University research has shown that The PRESIDING OFFICER. The Sen- That is the essence of the amend- these turtles can be treated in such a way ator from Louisiana is recognized. ment. I would like to set it aside now that they can be raised, shipped, and distrib- Ms. LANDRIEU. This amendment, I and speak to it at a later time when uted without having a recolonization of sal- will discuss briefly at this time, and monella. votes are scheduled. (5) University research has also shown that then according to the leaders on how Mr. KENNEDY. Mr. President, I pet owners can be equipped with a treatment they would like to go ahead and pro- thank the Senator. regiment that allows the turtle to be main- ceed with these amendments, it can be We are reviewing the proposal. I un- tained safe from salmonella. voted on at another time. derstand the State of Louisiana has (6) The Food and Drug Administration Mr. President, sometimes we offer had a very strong regulatory process in should allow the sale of turtles less than 10.2 amendments that affect large indus- terms of safety, which has been recog- centimeters in diameter as pets as long as tries and millions and millions of peo- nized and commended for some period the sellers are required to use proven meth- ple in large industries. Sometimes they ods to treat these turtles for salmonella. of time. are smaller industries but very impor- SEC. ll. SALE OF BABY TURTLES. Ms. LANDRIEU. Mr. President, the Notwithstanding any other provision of tant industries that we have to stand Senator is correct, because I under- law, the Food and Drug Administration shall for as well. stand, as I am learning more about this not restrict the sale by a turtle farmer, or One of them is a small, relatively industry, it is more robust in the State wholesaler commercial retail seller of a tur- small industry in my State. That is the of Louisiana than elsewhere. So I think tle that is less than 10.2 centimeters in di- industry of turtle farmers who grow our legislature has put the appropriate ameter as a pet if— and produce and trade and sell turtles restrictions, licensing, information, as (1) the State or territory in which such to be used in a variety of different well as keeping the research going, farmer is located has developed a regulatory ways. One of the ways is by selling process by which pet turtle farmers are re- that could develop the appropriate quired to have a State license to breed, them for pets. In 1975, the FDA banned ways to treat these reptiles so we can hatch, propagate, raise, grow, receive, ship, the sale of small turtles for pets do- maintain an industry, allow people to transport, export, or sell pet turtles or pet mestically but allowed those sales to make a living, and keep our population turtle eggs; continue internationally. safe as well.

VerDate Aug 31 2005 03:06 May 02, 2007 Jkt 059060 PO 00000 Frm 00061 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.060 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5376 CONGRESSIONAL RECORD — SENATE May 1, 2007 Mr. KENNEDY. Mr. President, I American innovation. They are true ceutical advertising is allowed, because thank the Senator. We are reviewing world leaders in their industry. we have limited knowledge about the proposal. We will work very closely The changes made in the last reau- drugs, especially when they come on with the Senator, and we will be back thorization at my request, along with the market. in touch making a recommendation, the new structure of the user fee in Those who make such arguments fail working with her. We thank the Sen- FDARA and the improved trigger pro- to recognize that FDARA will guar- ator very much. vision satisfy me that the manufactur- antee that consumers have access to Ms. LANDRIEU. Mr. President, I ers are being fairly treated by the user greater clinical and safety information thank the Senator from Massachusetts. fee program in this bill. And, indeed, about medications because it gives the Mr. KENNEDY. Mr. President, I sug- this is a serious concern. FDA more authority to review and gest the absence of a quorum. In February of 2006, the Lewin Group react to drug safety data. User fees cre- The PRESIDING OFFICER. The prepared a report for the FDA entitled ated by S. 1082 will bolster the FDA of- clerk will call the roll. ‘‘Medical Device Industry Perspectives fice responsible for reviewing drug ad- The legislative clerk proceeded to on MDUFMA. That report revealed vertisements. call the roll. that senior industry experts felt FDA The FDA has told my office and oth- Mr. HATCH. Mr. President, I rise in is generally doing an excellent job in ers that drug manufacturers cooperate support of S. 1082, the Food and Drug premarket regulation of medical de- fully with the FDA when a concern is Administration Revitalization Act. vices and that the industry was gen- raised about an advertisement. That This legislation addresses many crit- erally supportive of the purpose and would be my preference for how these ical issues, including the need for pro- goals of MDUFMA. However, key ads should be handled. vide proper incentives and support for among the findings was the fact that I am hopeful we will be able to ad- the development and review of pharma- the industry perceived little or no evi- dress this issue and I am encouraged by ceuticals and medical devices, includ- dence of attaining the main intent of recent discussions involving the Sen- ing products for children, and the need the program or in realizing a favorable ator from Kansas and others members for heightened efforts to assure the return on investment from user fees. In of the Senate HELP Committee. safety of medications. fact, whenever I return to Utah to The bill’s drug safety provisions are As we debate this legislation, let us meet with medical device executives, I probably its most important compo- remember we all have the same goals hear the same concern. And it is a con- nent. Indeed, shortly after the Insti- in mind. cern I share. tute of Medicine issued its report on We want Americans to benefit from Indicative of that concern is the as- this issue, we all began to see a floor of life-saving, life-enhancing drug and de- tounding fact that 70 percent of re- letters in support of efforts to improve vice products. sponding device manufacturers per- the drug safety program. We want Americans to have access to ceived that MDUFMA goals have not Members of the HELP Committee un- drugs that are safe and effective. resulted in meaningful improvements dertook serious discussions on how to We want Americans to have all the in either the predictability or timeli- address the problems that have been relevant safety information available ness of reviews. In fact, when I re- identified, and the result is this legis- on their drugs. viewed the device approval times, I un- lation developed by Senator ENZI and And, indeed, we want Americans to derstood those concerns. For some Chairman KENNEDY. The Enzi-Kennedy know that the Food and Drug Adminis- classes of devices, FDA had made great bill has benefited from the guidance of tration, the agency responsible for en- progress. For others not. This was dis- our colleagues, former Chairman suring drug and device safety, has the turbing to me, since we would all hope GREGG and Senator BURR, who have resources to do its job. that progress would have been made pointed out the necessity for more That is what this bill is all about across the board. flexibility in determining when a risk protecting Americans and giving the It is my hope with the new fee struc- evaluation mitigation plan—or FDA the tools to do its job. ture embodied in S. 1082, we will make REMS—is needed. Senator COBURN The legislation before us reauthorizes better progress in achieving the ap- added greatly to the discussion by rais- both the Prescription Drug User Fee proval time goals. I am pleased that ing issues relating to the access of our Act, better known as PDUFA, and the Chairman KENNEDY and Senator ENZI constituents in rural areas to needed Medical Device User Modernization Fee included provisions at my request pharmaceuticals. Act, better known as MDUFMA. which make certain the fees for small- I believe the product of these discus- It is of critical importance that both er companies are affordable. sions strikes the appropriate balance. programs be authorized by the end of Let me turn to the issue of direct-to- It requires, for example, that deter- the fiscal year. This legislation em- consumer advertising, or DTC. This is mining whether the FDA should fur- bodies the agreements reached by both an issue on which our colleague, the ther assess the safety of a drug should industries and the FDA, along with re- senior Senator from Kansas, Mr. PAT be based on scientific evidence. To me, finements added by the Congress. ROBERTS, has shown great leadership, that is probably the most integral part Let me make clear that I am sup- both in the HELP Committee, and here of this bill—when concerns are raised portive of these reauthorizations. It is in the Senate Chamber. Senator ROB- about drugs, these concerns must be fair to say that I had reservations ERTS has led the charge to eliminate based on scientific evidence and not on about PDUFA when it was enacted in the 2-year moratorium on prescription innuendos or hearsay. This approach 1992, questioning the wisdom of wheth- advertising for newly approved drugs. allows proper evaluation of relevant in- er an industry should be required to He has expressed constitutional con- formation and gives the FDA greater support a governmental function. To a cerns about such a moratorium. I share authority to warn consumers when certain extent, I still have those res- those concerns. He is right to bring there are problems. ervations. That being said, it has be- this up. In addition, the drug safety title come abundantly clear that there are In general, I believe we should be strengthens the FDA’s existing author- not the resources in the Agriculture guided by a very simple rule. Adver- ity to monitor drugs once they have Appropriations bill to support these re- tising about products the FDA regu- been approved by making it clear that view functions absent a user fee, and lates should be truthful and not mis- evaluation must occur before and after thus I recognize their necessity. leading. approval. One of the most important With regard to MDUFMA, I have I do understand the arguments that components of this legislation is that been particularly concerned about the some in this body make with respect to more drug safety information will be impact that user fees could have on pharmaceutical advertising. Some made more available to the public. I small medical device manufacturers, nights, when I watch television, those believe that is an important victory for many of which are located in Utah. In- ads do become tiresome. But I could the American consumer. deed, I am proud that there are over 100 say that about a lot of ads. I also want to take a few minutes to medical device companies in Utah, Some have argued we need to be par- talk about the pediatric testing and re- companies that represent the best in ticularly careful about what pharma- search provisions included in this bill.

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00062 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.061 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5377 I have supported both the Best Phar- sideration of this bill that would ad- must be mindful of the fact that we maceuticals for Children Act and the dress another important issue. My need to encourage and nurture the in- Pediatric Research Improvement Act. amendment had several provisions novation that provides the biologics In fact, I have supported these efforts which encouraged innovation and de- that the generic companies seek to since our former colleague from Ohio, velopment of safe antibiotics, required copy. This is a tremendously com- Senator MIKE DEWINE, brought the the FDA to convene a meeting to de- plicated task, but it is one worth need for additional pediatric testing of termine how the Orphan Drug Act doing. prescription drugs to our attention should be applied to antibiotics, and re- In 1984, when Chairman WAXMAN and during consideration of the FDA Mod- authorized the grant programs for the I undertook a series of negotiations ernization Act of 1997. He fought long Orphan Drug Act. Finally, my amend- that led to approval of the Drug Price and hard to encourage drug companies ment provided for a 5-year exclusivity Competition and Patent Term Restora- to conduct clinical trials on pediatric for enantiomers of previously approved tion Act, it was a very different time. uses of their drugs. His efforts paid off racemic drugs if and only if, one, they There were no cell phones, no DVDs, and this program has been extremely are approved for new therapeutic uses almost no one had a personal com- successful. and, two, a completely new data set puter, and a stamp cost 20 cents My good friend and colleague from has been created for approval of this It was a much less complicated time. Connecticut, subcommittee Chairman enantiomer. It is my expectation that Generic drugs were a small, struggling CHRIS DODD, has also shown great lead- our current discussions on these provi- industry, with no discernible footprint ership on this issue when FDAMA was sions will lead toward their adoption in the pharmaceutical world. The being considered in 1997. He held a later in the week. innovators had yet to respond to their hearing on this issue earlier this year I also want to point out that there first paragraph IV certification. In with his ranking Republican member, have been many discussions on ways to 1984, brands versus generics largely an Senator LAMAR ALEXANDER. That hear- ensure that citizens’ petitions do not American endeavor. Today, the phar- ing was very insightful and I believe unfairly delay generic drug approvals. I maceutical market—both innovator that many of us are trying to do the believe this is a problem, although I do and generic—is an international mark- right thing as we reauthorize both pro- not believe it is of a magnitude as some er—for research, development and mar- grams. would suggest. I do not oppose making keting. I urge my colleagues not to lose sight changes to ensure that any abuses in Biological products were not an issue of the purpose of these two programs as this area are stopped, as long as FDA in 1984. Today, they are becoming an we make decisions on this part of the still has the ability to do the appro- increasingly larger part of pharma- bill. We want good, solid information priate scientific and legal review of ab- ceutical spending. about the safest way to prescribe drugs breviated new drug approval applica- It is my strong belief that we can for children. And by giving companies tions in the timeframe it desires. learn from this experience and build market exclusivity to conduct clinical Let me turn now to one provision another solid law that will help con- trials, we will know the safest dosage which is not in the bill: language au- sumers—both by supporting the incen- levels for children. So let us not lose thorizing a pathway for the Food and tive to discover and develop new bio- sight of the original propose of these Drug Administration to approve copies logics, and by fostering a climate that programs—to help children have the of biologics. This is commonly referred will lead to lower prices. This is a clas- safest dosages for prescriptions. I am to as the ‘‘biosimilars,’’ ‘‘biogenerics,’’ sic win-win situation. hopeful that we will be able to work or ‘‘follow-on biologics’’ legislation. And why is that so important? out our differences on these provisions Senator GREGG spoke so well about A February report by the Center for on these very important issues. Medicare and Medicaid Services paints Food safety is another issue that is this subject just a few minutes ago. While language on this issue is not the picture very well: America’s health on nearly everyone’s mind these days. included in the bill we consider today, care spending in the next 10 years will When I was a kid, we were always told I want to make perfectly clear that it double to $4.1 trillion. Or, to look at it to eat our spinach so we could grow is my intention to work toward devel- another way, that is 20 cents out of muscles like Popeye. Peanut butter is opment of an acceptable compromise every dollar spent. We spend about almost a staple for most Americans. that can be included in the final And yet these ordinary, common foods $7,500 per capita on health care in the version of FDARA and signed into law. have harmed rather than helped. Pets U.S. Yet in 2016, that will rise to an as- are getting sick and we have discovered It is my hope Senators will refrain tounding $12,800 per person. Greater that their food has been contaminated. from offering any amendments on this spending for pharmaceuticals is ex- Something needs to be done. issue until we have time to develop pected to fuel much of the increase, the I have worked with Senators KEN- consensus. And I do believe consensus report’s authors concluded. NEDY, ENZI, DURBIN and ALLARD to fig- can be developed without delay. It is And there it is in a nutshell. The ure out a constructive approach to my intention to do so. good news and the bad news. these important issues. I think that we As my colleagues are aware, I am the Not much worries Congress more have made a lot of progress and I look Hatch of Hatch-Waxman. I have a seri- than the costs of medical care—both forward continuing those discussions ous interest in making certain the law from the perspective of a balanced as the bill progresses toward enact- Chairman WAXMAN and I developed in budget, and from the view of our con- ment. 1984, the Drug Price Competition and stituents’ pocketbooks. One factor that is not discussed Patent Term Restoration Act, is used In many ways, it is an embarrass- enough is the need to appropriate more as the basis for development of legisla- ment of riches. funding for inspectors and inspector tion to provide an abbreviated pathway We have exciting new therapies to training, especially abroad. I can recall for approval of follow-on biological treat our medical ills—new drugs, new over a decade though when Jim Phil- products. In so doing, we must make devices, stem cell treatments. Their lips, a former investigator for the FDA, certain we include the appropriate in- potential to improve human health and brought to our attention the woefully centives for development of those prod- well-being is almost limitless. lacking FDA resources for foreign in- ucts. Indeed, that is my high priority. And yet the cost of those treatments, spections. We were shocked then, and By any estimate, the Hatch-Waxman the impact they have on the budget, at unfortunately, we are shocked now. law has done consumers tremendous times seems equally limitless. In fact, Today, only one percent of imported good by fostering today’s modern ge- in 2005, prescription drug spending was food is inspected. I believe this issue neric drug industry. It has saved pa- estimated at $214 billion, a healthy needs to be carefully reviewed by Con- tients literally billions of dollars. amount by anyone’s measure. That gress so people no longer have to worry Similarly, using it as a basis for devel- same year, spending on biologics was about whether food for them or their opment of a pathway for follow-on bio- estimated at $32 billion. pets is safe. logics will help consumers with access Since biologicals are generally more I offered and withdrew an amend- to the innovative, life-affirming bio- expensive products, ways to reduce ment during the HELP Committee con- logic products. But in so doing, we their costs interest policymakers and

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00063 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.064 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5378 CONGRESSIONAL RECORD — SENATE May 1, 2007 other stakeholders in expenditure of good at advancing science—stem cell the agency to evaluate pure, safe and the health care dollar, foremost among research is one example that comes potent copies of biotech products, but them employers, insurers, pharmacy readily to mind—we must hold open we must all recognize that there must benefits managers, and of course, the the possibility that one day there will be a bright line that separates a safe government. be true biogenerics. copy from a new product which should Comes now the generic drug indus- And we must also develop a pathway be subject to a full biologic license ap- try, which has been proven to provide so that biosimilar products can be ap- plication. alternative, safe and effective thera- proved without a full biologics license We need to free the agency and pro- pies in a much more cost beneficial application, a time-consuming and ex- vide it with the flexibility to evaluate manner. We look to them to be part of pensive process. the adequacy of a biosimilar submis- the solution to this problem. And they, But whatever policy we develop, it sion based on good science, but we in turn, look to us to help them be part must be based on soundness of science, must also recognize that, as Commis- of that solution. rather than the practicalities of poli- sioner von Eschenbach has said, there It is no secret that several senators tics. may be some products which cannot be have been meeting to develop a bill Fourth, we must take into account copied safely with today’s science. that would establish a pathway for bio- the unique nature of today’s industry. Eighth, we must make certain the re- similar products to be approved by the This is so much more than an exercise sources are there for the FDA to do the Food and Drug Administration. We had between big Pharma and the generics, job right. I must note that negotia- hoped to have it ready for inclusion in or even between big bio and the tions between the agency and the phar- FDARA, but it was not, despite the generics. maceutical industry on the Prescrip- talks of the four Senators. I am refer- Indeed, there are about 1,400 biotech tion Drug User Fee Act reauthoriza- ring to Health, Education, Labor, and companies in the United States. How tion, or PDUFA, took over one year. many of them are profitable? Astound- Pensions Committee Chairman TED Every indication I have is that review ingly, only 20. KENNEDY, the committee’s ranking Re- of a biosimilar application is very like- Many of these companies are small, publican, MIKE ENZI, Senator HILLARY ly to be more complex and time con- with revenues of under a million dol- CLINTON, and me. All members of the suming than that for a new biologics li- lars per year. Many do not even have a HELP Committee, we have worked to cense application. product on the market. There must be authority for a fee to develop consensus on what legislation We must examine closely the issue of would include. be collected that reflects this complex who will be making biosimilars? Will it workload. If we do not provide ade- Senator KENNEDY and I began these be the Barr Labs and Tevas of the quate resources to the FDA, then re- talks several months ago. He is com- world? Undoubtedly. mitted to developing a bill on a pri- view of new products could suffer at But it may also be generic subsidi- the expense of cheaper copies as re- ority basis. Our staffs literally have aries of innovator companies. been working night and day. viewers become siphoned off from new It is also very likely to be companies products to the biosimilars. We should Our work has been aided immeas- in India and China. As we have seen urably by the leadership of Chairman not design a system in which this oc- with the recent concerns over pet food, curs. WAXMAN, and in the Senate, Senator inspecting foreign manufacturing And I must digress at this point to CHUCK SCHUMER and Senator CLINTON, plants has historically been a problem underscore that the FDA is already who have introduced the companion to for the resource-constrained Food and cash-strapped and that situation sim- the Waxman bill. Their legislation, the Drug Administration. ply must be corrected. The dire FDA Access to Life-Saving Medicine Act, Fifth, we must use the framework of resources issue appears to have mani- H.R. 1038/S. 623, provides a solid start- Hatch-Waxman where we can, but we fested iself in such recent revelations ing point for discussions. It is an im- must recognize there may be ways to as to the inadequacy of food inspec- portant work that has added immeas- improve it. tions for some of the most ubiquitous urably to the congressional dialogue. There are obvious differences be- products in American life, including It is my hope that our discussions tween regulating a pathway for pet food and peanut butter. will also be informed by the work of biosimilars and for copies of chemical Federal policymakers must take this Representatives JAY INSLEE, GENE drugs. For example, as I mentioned, to- into account when legislating, and the GREEN and TAMMY BALDWIN, who re- day’s science will probably not allow Food and Drug Administration Revital- cently introduced the Patient Protec- identical copies of today’s biologics. ization Act is a good place to start. tion and Innovative Biologic Medicines So, the concept of bioequivalence can- Enacting follow-on biologics legisla- Act of 2007, H.R. 1956, and by the views not be imported into this debate. In- tion is a top priority for me. I want us of the many, many stakeholders in this stead, we must work carefully to define to finalize a bill on a priority basis, legislative effort. biosimilarity. and it is my hope it can be included in The time to develop a pathway for Another difference today is the fact the final version of FDARA that approval of biosimilar products is long that process patents are much more in- emerges from the conference com- past overdue. It should be our priority, tegrally tied to the manufacture of bio- mittee. and it should be our high priority, to logics. Current law does not require Before I close, I want to talk about get it done this year. But, we should listing of process patents in the orange one other issue that is often debated get it done right. Our deliberations book. when FDA-related legislation is consid- must be based on science. The original Waxman-Hatch is inherently a liti- ered on the floor: importation of pre- balance of the law must be maintained, gious process. But its framework—the scription drugs. This morning, I lis- but we must also recognize the emerg- patent holder or drug manufacturer—v. tened to our colleague, the Senator ing realities of this new world. the generic—does not easily translate from North Dakota, Mr. DORGAN, talk And what are those realities? First, to a system in which multiple patent about his legislation which allows pre- biotechnology products are not drugs; holders may exist, including, for exam- scription drugs from other countries to they are very complicated molecules ple, major universities and research be imported into the United States that are not easily reproduced. An in- centers. from other countries. My colleague re- advertent change in the structure of Sixth, the incentives for development fers to this as drug reimportation that molecule can lead to very dev- of biotech products must be main- which I believe gives people the false astating consequences. tained, enhanced where it advances impression that these drugs are origi- Second, today, it is unlikely that any public policy. But at the same time, we nally manufactured in the United follow-on company will be able to cannot seed a new generation of road- States, exported to another country produce an exact copy of a biotech blocks that preclude biosimilar entry. and then imported back to the United molecule, a generic biologic if you will, This is the nub of the key, crucial bal- States. I just want to clarify that is at least at first. ance. not typically the case. Third, because science advances, and Seventh, the role of the FDA must be In addition, I saw the Senator from because American researchers are very carefully evaluated. We must empower North Dakota hold up two bottles of

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00064 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.065 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5379 Lipitor and say that there is no dif- standards. When consumers take such medi- ality is one this Nation and the world ference between a drug manufactured cations, they face risks of dangerous drug did not have to experience. It is a trag- in Ireland and a drug manufactured in interactions and/or of suffering adverse ic reality, brought on by a war of events, some of which can be life-threat- the United States. He suggested that ening. More commonly, if the drugs are sub- choice and an occupation that has the pills may be different colors but potent or ineffective, they may suffer com- yielded neither stability nor reconcili- the bottles are the same and the medi- plications from the illnesses that their pre- ation. cine in the bottle is the same. scriptions were intended to treat, without Four years ago today, the President That may be true for the two bottles ever knowing the true cause. landed on the deck of the USS Abraham of drugs that he had on the Senate Mr. President, this was a sobering Lincoln to declare, ‘‘Mission accom- floor. But how could we be assured that hearing and I urge my colleagues, espe- plished.’’ Four years ago—it feels like is always the case? Can we always cially those who support the importa- an age. For thousands of our soldiers guarantee that pills in a bottle labeled tion of prescription drugs into this and their families, and likely for the from Ireland are actually manufac- country, to take the time to review the Iraqi people, it feels like a lifetime. tured in Ireland? I don’t think so. testimony from the July 14, 2004, hear- How wrong our President was then, and This issue is the crux of the prob- ing. We had many witnesses who pro- how wrong our President continues to lem—unless the FDA has approved vided valuable insights on this issue. be today. these medications, we have no way of To address Senator DORGAN’s other Ralph Waldo Emerson said: knowing what is actually in the bottle. point regarding the cost of prescription A foolish consistency is the hobgoblin of In fact, when I served as chairman of drugs, I want to make one thing per- little minds, adored by little statesmen and the Senate Judiciary Committee, I fectly clear—I want Americans to have philosophers and divines. held a hearing on drug importation and access to affordable drugs, but I also No matter how many times the this issue was raised by one of the want these drugs to be safe and effec- President wishes it were so, peace in members of the committee. At that tive. As one of the authors of Hatch- Iraq will not be found at the barrel of July 14, 2004, hearing, one Senator spe- Waxman, I understand the problem of an American gun. No matter how hard cifically asked about a prescription pharmaceutical costs, and I have a the President hopes that it will hap- drug bottle labeled as being from Can- record of working to find solutions. pen, sectarian violence will not be ada. William Hubbard, the Associate But bringing potentially unsafe medi- quelled with U.S. forces occupying the Commissioner for Policy and Planning cines, medicines uncertified by the Iraqi nation. Cross your fingers, pull for the FDA, told her that even though FDA, into the United States is not a out your lucky rabbit’s foot, even nail the label said the bottle was from Can- solution. a horseshoe over the Oval Office door, ada, the FDA had no idea where that In conclusion, I ask my colleagues but hoping for luck will never change bottle had originated. who are skeptical about this bill to re- the deadly dynamic in Iraq. In fact, at that hearing, Mr. Hubbard serve judgment and listen carefully to Peace demands an Iraqi-led political said: the debate. While I supported this bill solution to transcend the ethnic and Although some purchasers of drugs from when it was considered by the Senate sectarian divisions that are splitting foreign sources may receive genuine product, HELP Committee 2 weeks ago, I hon- the country apart—a political effort others may unknowingly buy counterfeit estly believe that members of the which, to date, the Iraqi Government copies that contain only inert ingredients, HELP Committee have worked hard to- has been unable or unwilling to take legitimate drugs that are outdated and have gether to make the reported bill even on. Our legislation could have spurred been diverted to unscrupulous resellers, or better. So I urge my colleagues to take that progress, but President Bush has dangerous sub-potent or super-potent prod- ucts that were improperly manufactured. the time to review the bill because defiantly said no. This White House Furthermore, in the case of foreign-based there are a lot of good provisions in it. clings to its ‘‘foolish consistency.’’ sources, if a consumer has an adverse drug I would like to take this opportunity When he took office as President reaction or any other problem, the consumer to recognize the hard work of the staffs more than 6 years ago, George W. Bush may have little or no recourse either because of both our committee chairman, Sen- issued a call for renewed responsibility the operator of the pharmacy often is not ator KENNEDY, and our ranking minor- in government. Where are the echoes of known, or the physical location of the seller ity member, Senator ENZI. I would spe- that call today? What is responsible is unknown or beyond the consumer’s reach. cifically like to thank Amy Muhlberg about clinging to this failed course in FDA has only limited ability to take action and David Dorsey for their dedication Iraq and refusing to consider a new against these foreign operators. and hard work on this issue—they have path? What is responsible about the On a related issue, I would like to been working on drug safety legislation President continuing to foster and ma- share Mr. Hubbard’s insights on the for over 2 years and I want both of nipulate the fears of the American peo- safety of drugs that have been im- them to know how much all of us ap- ple? ported from other countries. preciate their efforts. I also want to Faced with the tragic consequences FDA remains concerned about the public recognize Shana Christrup and David of its misjudgments in Iraq, the Bush health implications of unapproved prescrip- Bowen for their leadership in helping administration is paralyzed, unwilling tion drugs from entities seeking to profit by their bosses get this bill to the floor to acknowledge, much less remedy, its getting around U.S. legal standards for drug safety and effectiveness. Many drugs ob- under very difficult time constraints. catastrophic blunders. President Bush tained from foreign sources that either pur- All of the HELP Committee members’ has gone so far as to say that the way port to be or appear to be the same as U.S.- staff have worked long hours and many out of Iraq will be decided by future approved prescription drugs are, in fact, of weekend hours and I just want you to Presidents. unknown quality. Consumers are exposed to know how much I appreciate all of you. What an outrageous abdication of re- a number of potential risks when they pur- Mr. President, I yield the floor. sponsibility. It is unacceptable to pass chase drugs from foreign sources or from The ACTING PRESIDENT pro tem- this buck to future leaders while our sources that are not operated by pharmacies pore. The Senator from West Virginia brave troops fight and die today in the properly licensed under state pharmacy laws. is recognized. These outlets may dispense expired, sub- crosshairs of this Iraqi civil war. The potent, contaminated or counterfeit product, IRAQ time to begin rectifying this dreadful the wrong or a contraindicated product, an Mr. BYRD. Mr. President, 4 years blunder is now, not in 2 years, not with incorrect dose, or medication unaccom- ago, I stood in this very spot and the next President but now. panied by adequate directions for use. The warned against an ill-advised invasion With the supplemental bill, Congress labeling of the drug may not be in English of Iraq. Today, the situation in Iraq responded to the call of the American and therefore important information regard- has spiraled out of control, into a people. We offered a new beginning in ing dosage, warnings and side effects may bloody, deadly, sectarian civil war. Yet reconstruction and stability for Iraq. not be available to the consumer. The drugs the President and his team continue to Our proposal could have generated po- may not have been packaged and stored under appropriate conditions to prevent deg- hold fast to their ‘‘stay the course’’ litical reconciliation and economic se- radation, and there is no assurance that nonsense. While they do, thousands of curity in Iraq. Our bipartisan plan these products were manufactured under cur- brave young Americans place their shifted the responsibility for the Iraqi rent good manufacturing practice (cGMP) lives in jeopardy every day. That re- nation’s long-term success to the Iraqi

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00065 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.066 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5380 CONGRESSIONAL RECORD — SENATE May 1, 2007 people themselves. But plainly Con- The PRESIDING OFFICER. S. 1082 is was sent to Canada and one was sent to gress offered a plan that could have before the Senate. The Landrieu the United States. meant a brighter future for Iraq, a fu- amendment is currently pending. The one sent to the United States ture controlled by the Iraqi people Mr. DORGAN. Mr. President, I ask was priced nearly double the price of themselves with continued support unanimous consent that the Landrieu the medicine sent to Canada. But that from the United States. But the Presi- amendment be set aside and that I may is not unusual. The same thing would dent has flatly rejected that plan. It is be able to offer an amendment. be true with respect to medicine that a sad day for our Nation and for the The PRESIDING OFFICER. Without was sold in Germany or Italy or France world. objection, it is so ordered. or Spain or England. They all pay Before the war began, I urged the AMENDMENT NO. 990 much lower prices for the same pre- President to think through the con- Mr. DORGAN. I have amendment No. scription drug, the identical drug made sequences. There was no doubt as to 990 at the desk. I ask for its consider- in the identical plant—FDA-approved, the military outcome of the war be- ation. sold all around the world, except the tween the United States and Iraq. Our The PRESIDING OFFICER. The U.S. consumer is given the privilege of military might was certainly unques- clerk will report. paying the highest prices in the world, tioned. I was very concerned about the The assistant legislative clerk read in some cases 80 or 90 percent higher, repercussions that would follow this as follows: in some cases 120 percent higher than others pay for the identical prescrip- certain military victory. Tragically, The Senator from North Dakota [Mr. DOR- the repercussions I feared all have GAN], for himself, Ms. SNOWE, Mr. GRASSLEY, tion drug. come to pass. Oh, how I wish, yes, how Mr. MCCAIN, Ms. STABENOW, Mr. NELSON of Our point with this amendment sim- I wish that I had been wrong. Florida, Mr. PRYOR, Mr. SANDERS, Mr. ply is that if the global economy is Once again, I urge the President to WHITEHOUSE, and Mrs. MCCASKILL, proposes going to work, why doesn’t it work for think through the consequences of his an amendment number 990. everybody? How about the little guy choices, the consequences of his rejec- Mr. DORGAN. Mr. President, I ask who is buying prescription drugs and is tion of this new plan for Iraq, the con- unanimous consent that the reading of paying the highest prices in the world. sequences of clinging to false hopes, for the amendment be dispensed with. We have put together a piece of legis- that is what this veto does. This veto The PRESIDING OFFICER. Without lation with very significant safety pre- endorses the falsehoods that took us to objection, it is so ordered. cautions so that there are no safety war. It cements failed policy in place. (The amendment is printed in today’s issues at all. I mentioned today that Europe does this routinely. They have This veto ensures that hundreds, RECORD under ‘‘Text of Amendments.’’) a parallel trading system in Europe. maybe thousands, more will die in Iraq Mr. DORGAN. I offer this amendment They have had it for a couple of dec- without any true plan for peace. It on behalf of myself and Senator SNOWE ades. If you are in Germany and want forces our military to continue to pur- and other cosponsors, including Sen- to buy a prescription drug from sue a mission impossible, creating de- ator STABENOW, Senator GRASSLEY, France, no problem. If you are in Italy mocracy at the point of a gun. Senator MCCAIN, Senator PRYOR, Sen- and want to buy it from Germany, no I am sorry this day has come to pass. ator SANDERS, Senator WHITEHOUSE, and Senator MCCASKILL. problem. I am so sorry the horrors of this deadly They have a parallel trading system and mishandled occupation have be- This amendment comes from a piece of legislation we have previously intro- that allows the consumers to access come the stuff of political gamesman- the best prices. It is only the American ship. There is ample blame to go duced dealing with the reimportation of prescription drugs, FDA-approved, consumer that is disadvantaged by a around for that fact. sweetheart deal that allows the pre- I have seen clashes between the legis- lower priced prescription drugs that scription drug industry to engage their lative and executive branches. I have are sold in other parts of the world for own price controls, which means that seen Presidents make mistakes in the much lower prices than they are priced in the United States. There are 33 co- we pay the highest prices in the world. past. Everyone, yes everyone, makes We have offered an amendment. We mistakes. I certainly have made mis- sponsors on the bill as it was intro- duced in the Senate. It seems clear to have 33 cosponsors on the underlying takes, but I have never seen such arro- legislation. The amendment I offer on gance in a White House that seals its me that the best approach to advanc- ing this legislation is to offer it as an behalf of myself and Senator SNOWE, eyes and ears and blindly sends so bipartisan legislation, as I indicated— many people to their doom. I pray for amendment to the legislation that re- Senators GRASSLEY and MCCAIN, our troops, for our President—yes, I authorizes the Food and Drug Adminis- STABENOW, PRYOR, SANDERS, do—and I pray for our country, yes, for tration. Inasmuch as this subject deals with the FDA, it would provide funding WHITEHOUSE, MCCASKILL. our country, and for the people of Iraq. This is a good amendment. It is good for the FDA, guidelines for the FDA on President Bush has chosen to hold public policy. I know the prescription reimportation of drugs. I am not going hostage $100 billion for our troops to drug industry, the pharmaceutical in- to speak at length today. I spoke ear- his, President Bush’s, policies, his dustry doesn’t like it. I understand lier today. I intend to come back to- failed policies. But his choice, his that. I do not come here with a griev- morrow morning to speak at some choice, is not the last word. Congress ance against that industry. I just do greater length. will get to work on a new version of not like their pricing policy. I do not I know my colleagues, Senator the supplemental appropriations con- like the fact that they say to the SNOWE and Senator GRASSLEY and Sen- ference report. We, with the Lord’s American people: You pay the highest ator STABENOW and Senator SANDERS— will, will not delay, but we also will prices in the world. not stop our efforts to stand for what is I have talked to him—I know others That is not fair. It ought to change. right and to craft policies that reflect will wish to come and speak as well. Our amendment is aiming to change it. the true strength of America: humility, But suffice it to say, we have a situa- Mr. President, I will speak at greater modesty, honesty. tion in this country today in which the length on the subject tomorrow. We will continue to press for a U.S. consumer is charged the highest I yield the floor. strong, intelligent foreign policy that prices in the world for prescription The PRESIDING OFFICER. The Sen- does not rely on military might alone. drugs. That is just a fact. Today I held ator from Utah is recognized. And we will not stop in our efforts to up two pill bottles on the floor of the Mr. HATCH. As usual, my dear friend bring peace to Iraq and our troops Senate, identical bottles that con- from North Dakota is articulate, and home from war, so help me God. tained the same prescription drug med- he deserves to be listened to, but I dis- I yield the floor. icine made in Ireland. It was called agree with him. The PRESIDING OFFICER (Mr. Lipitor, for controlling cholesterol. The Dorgan amendment allows indi- MENENDEZ). The Senator from North The tablets were made in a manufac- viduals to import a qualifying drug, Dakota is recognized. turing plant, FDA-approved plant in and this will pose an overwhelming set Mr. DORGAN. Mr. President, what is Ireland. The two bottles I held up of resource burdens for the FDA, Cus- the pending business? today were different only in that one toms, and other agencies, especially

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00066 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.068 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5381 the FDA. It would, as I have mentioned testimony before the Senate Judiciary lion unapproved and potentially unsafe and before, create very significant safety Committee on July 14, 2004, entitled ineffective Ovulen–2l ‘‘birth control’’ tablets concerns. ‘‘Examining the Implications of Drug from Panama were distributed into the U.S. This amendment establishes a com- Importation,’’ of Mr. William Hubbard, as ‘‘American goods returned.’’ In another plicated system for the regulation of case, a counterfeit version of Ceclor, a wide- Associate Commissioner for Policy and ly used antibiotic at the time, found its way imported drugs. Now this system that Planning of the U.S. FDA. into the U.S. drug distribution from a for- he suggests is so vast, it would take There being no objection, the mate- eign source. Over the years, FDA has em- and require a lot of money, more than rial was ordered to be printed in the ployed PDMA and other authorities to build all of the proposed fees could support. RECORD, as follows: a drug safety infrastructure to ensure that Where would an already strapped TESTIMONY: UNITED STATES SENATE Americans enjoy the highest-quality drug Federal agency such as FDA get these COMMITTEE ON THE JUDICIARY supply in the world. Unfortunately, the drug supply is under additional dollars? So far we have not EXAMINING THE IMPLICATIONS OF DRUG unprecedented attack from a variety of in- given it to them. There have been esti- IMPORTATION, JULY 14, 2004 creasingly sophisticated threats. This is evi- mates that these dollars would amount Mr. William Hubbard, Associate Commis- dent in the recent significant increase in ef- to so much that there is no way that sioner for Policy and Planning, U.S. Food forts to introduce counterfeit drugs into the we could give them enough money. and Drug Administration U.S. market. FDA has seen its number of This amendment allows foreign-im- INTRODUCTION counterfeit drug investigations increase ported products to be approved for dis- Mr. Chairman and Members of the Sub- four-fold since the late 1990s. Although coun- tribution in the United States even committee, I am Mr. William K. Hubbard, terfeiting was once a rare event, we are in- when they may not be bioequivalent to Associate Commissioner for Policy and Plan- creasingly seeing large supplies of counter- the FDA-approved products. Now the ning at the U.S. Food and Drug Administra- feit versions of finished drugs being manu- tion (FDA or the Agency). With me is John factured and distributed by well-funded and reason I cite that is because the letter M. Taylor, Associate Commissioner for Reg- elaborately organized networks. At the same from the FDA, this letter was sent to ulatory Affairs at FDA. We appreciate hav- time, inadequately regulated foreign Inter- the Honorable BYRON L. DORGAN, Sen- ing this opportunity to discuss with you the net sites have also become portals for unsafe ator DORGAN. This letter was sent April issues relating to the importation of pre- and illegal drugs. For example, FDA recently 10, 2007. scription drugs into the United States and worked with domestic and international au- I ask unanimous consent that this the use of the Internet to facilitate the sale thorities to shut down a website that was ad- letter be printed at the conclusion of of these drugs. vertising ‘‘FDA-approved’’ and safe ‘‘Euro- my remarks. At FDA, our statutory responsibility is to pean’’ birth control pills and other drugs, The PRESIDING OFFICER. Without assure the American public that the drug but was actually responsible for importing supply is safe, secure, and reliable. For more ineffective, counterfeit drugs. Evidence objection, it is so ordered. than 60 years, the Federal Food, Drug, and (See exhibit 1.) strongly suggests that the volume of these Cosmetic (FD&C) Act has ensured that foreign drug importations is increasing Mr. HATCH. In that letter, just to Americans can be confident that, when they steadily, presenting an increasingly difficult mention a couple of things, the Acting use an FDA-approved drug, the medicine will challenge for Agency field personnel at Deputy Commissioner for Policy, Ran- be safe and effective and will work as in- ports-of-entry, mail facilities, and inter- dall W. Lutter, Ph.D.—let me just men- tended in treating their illness and pre- national courier hubs, and our laboratory tion a couple of sentences. venting complications. In carrying out this analysts and border and law enforcement He said: responsibility, FDA is working to do all we partners. Nevertheless, the Agency continues to can under the law to make medicines acces- FDA is doing its best to use its limited re- have concerns with enacting such a sweeping sible and help doctors and patients to use sources and international authorities to stop importation program and fears that inter- them as effectively as possible, through such the increasing flow of violative drugs into mediaries would likely swallow the bulk of steps as expanding access to generic medi- this country, but the task is daunting. FDA’s cost-savings, preventing the American con- cines, reducing the time and cost of showing Office of Regulatory Affairs has inspectors sumers from enjoying much, if any, practical that new medicines are safe and effective, working in the field who perform investiga- benefit from such a program. and providing up-to-date information for tions pertaining to imported prescription health professionals and patients to obtain drugs, a job that is not limited to inspec- On safety concerns, he said: the benefits and avoid the risks associated tions at ports-of-entry. Each day, however, We have safety concerns related to both with powerful medicines. That is the pri- thousands of individual packages containing the identification of unsafe or non-complaint mary mission of the thousands of dedicated prescription drugs are imported illegally drug products and about the substitutability staff, including leading health care experts, into the U.S., simply because the sheer vol- for domestic products. doctors, economists and scientists who work ume has grown to exceed the capability of On identifying unsafe/noncompliant tirelessly at FDA in public service for the FDA field personnel to properly process. drug products, he said: American people. FDA remains strongly con- SAFETY CONCERNS RELATING TO IMPORTATION The section of the bill that would allow in- cerned about counterfeit, and/or illegally im- FDA remains concerned about the public dividuals to import a qualifying drug from a ported pharmaceuticals whose safety (and ef- health implications of unapproved prescrip- registered exporter would likely pose an fectiveness cannot be assured because they tion drugs from entities seeking to profit by overwhelming resource burden for the Agen- are distributed outside the legal structure getting around U.S. legal standards for drug cy and create significant safety concerns. and regulatory resources provided by Con- safety and effectiveness. Many drugs ob- gress. Just reading at random: tained from foreign sources that either pur- IMPORTATION OF PRESCRIPTION DRUGS S.242 would establish a complicated system port to be or appear to be the same as U.S.- Sixty-five years ago, Congress responded to for the regulation of imported drugs. This approved prescription drugs are, in fact, of widespread instances of unsafe drugs by di- complex system is so vast that it would be unknown quality. Consumers are exposed to recting FDA to implement a system for as- enormously resource-intensive, likely much a number of potential risks when they pur- suring that Americans have a drug supply greater than the proposed registration fees chase drugs from foreign sources or from they can trust will not harm them. Over and inspection fees could support. sources that are not operated by pharmacies forty years ago, Congress required that legal properly licensed under state pharmacy laws. On a lack of substitutability, he said: drugs be proven to be effective as well, be- These outlets may dispense expired, sub- The proposed bill provides a mechanism for cause modern medicines—when they are pro- potent, contaminated or counterfeit product, foreign imported products to be approved for duced, distributed, prescribed, and used prop- the wrong or a contraindicated product, an distribution in the U.S. even though these erly—should not only be safe but effective in incorrect dose, or medication unaccom- products may not be bioequivalent to the the treatment of disease. More recently, in panied by adequate directions for use. The FDA-approved product. 1988, Congress enacted the Prescription Drug labeling of the drug may not be in English This letter is a serious letter. I don’t Marketing Act (PDMA) to establish addi- and therefore important information regard- think we should ignore letters such as tional safeguards to prevent substandard, in- ing dosage, warnings and side effects may these in our zeal to resolve problems. I effective, or counterfeit drugs from entering not be available to the consumer. The drugs believe the distinguished Senator from the U.S. Under PDMA, it is illegal for any- may not have been packaged and stored North Dakota is very well intentioned. one other than the drug’s original manufac- under appropriate conditions to prevent deg- turer to re-import a prescription drug into radation, and there is no assurance that I have a tremendous regard for him and the U.S. that was manufactured in the U.S. these products were manufactured under cur- for his ability to explain things on the This law was enacted with strong bipartisan rent good manufacturing practice (cGMP) floor of the Senate. support because of high-profile cases of un- standards. When consumers take such medi- I also ask unanimous consent to have safe and ineffective drugs entering the U.S. cations, they face risks of dangerous drug printed in the RECORD excerpts of the in large volumes. In one instance, over 2 mil- interactions and/or of suffering adverse

VerDate Aug 31 2005 02:25 May 02, 2007 Jkt 059060 PO 00000 Frm 00067 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.069 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5382 CONGRESSIONAL RECORD — SENATE May 1, 2007 events, some of which can be life-threat- Field Operations at the Bureau of Customs seizure detention rate was nearly 7 percent ening. More commonly, if the drugs are sub- and Border Protection. of the number of individuals inspected, potent or ineffective, they may suffer com- Today I’d like to discuss with you CBP’s which was significant enough to warrant ad- plications from the illnesses that their pre- efforts to address the ever-increasing trend ditional enforcement efforts at our land bor- scriptions were intended to treat, without of personal and bulk importation of pharma- ders. ever knowing the true cause. ceutical products and controlled substances Based on an operation nicknamed ‘‘Oper- Patients also are at greater risk because into the United States. ation Safeguard’’ that we have carried out there is no certainty about what they are Although the main focus of the CBP has over the last couple of years, we have found getting when they purchase some of these shifted to protecting the United States from the volume of pharmaceuticals shipped drugs. Although some purchasers of drugs terrorist attacks, we also enforce over 400 re- through international mail to be enormous. from foreign sources may receive genuine quirements for more than 40 other federal We have also found a significant number of product, others may unknowingly buy coun- agencies at U.S. borders. These include the these products do not contain an active terfeit copies that contain only inert ingre- laws that prohibit the importation of illegal pharmaceutical ingredient, but merely con- dients, legitimate drugs that are outdated or unapproved pharmaceuticals that fall tain substances such as starch or sugar. and have been diverted to unscrupulous re- under the jurisdiction of the Food and Drug Other problems include expired materials, sellers, or dangerous subpotent or super-po- Administration, as well as those controlled unapproved products, improper use instruc- tent products that were improperly manufac- substances that are under the jurisdiction of tions and products made in facilities not tured. Furthermore, in the case of foreign- the Drug Enforcement Administration. under proper regulation. The vast majority based sources, if a consumer has an adverse The issue of U.S. consumers buying pre- of the pharmaceuticals that enter the United drug reaction or any other problem, the con- scription drugs from foreign sources has be- States via the mail do so in a manner that sumer may have little or no recourse either come a significant concern. A growing num- according to FDA violates present FDA and because the operator of the pharmacy often ber of Americans obtain their medications other requirements. is not known, or the physical location of the from foreign locations. However, the safety It is clear that the importation of pharma- seller is unknown or beyond the consumer’s of drugs purchased from these sources can- ceuticals and controlled substances remains reach. FDA has only limited ability to take not be insured. Drugs produced outside the an overwhelming problem for CBP. We are action against these foreign operators. United States may be counterfeit. Counter- working with the FDA, the DEA, ICE and The Agency has responded to the challenge feiting can apply to both brand name and ge- other regulatory agencies to develop a more of importation by employing a risk-based en- neric drugs where the identity of the source practical and workable approach to solve forcement strategy to target our existing en- is deliberately and fraudulently mislabeled this huge problem. forcement resources effectively in the face of in a way that suggests that it is the authen- I want to thank you and the members of multiple priorities, including homeland secu- tic approved product. the committee for considering Customs and rity, food safety and counterfeit drugs. How- The CBP is concerned with three avenues Border Protection in your review of the im- ever, this system, as it works today, is al- that pharmaceuticals are imported: Those portation of pharmaceuticals and controlled ready overwhelmed by the number of incom- that are purchased through the Internet and substances. This is an issue that speaks di- ing packages, and this presents a significant shipped through our international mail ex- rectly to our mission. We will continue to ongoing challenge for the Agency. press courier facilities; those carried into Recent spot examinations of mail ship- make every effort possible to work with the the States by individuals transiting our land Congress and our fellow inspection agencies ments of foreign drugs to U.S. consumers re- borders; and bulk shipments of adulterated vealed that these shipments often contain to address the health and safety concerns of or counterfeit pharmaceuticals. During the dangerous or unapproved drugs that pose po- the American people. course of the past year we have taken sev- tentially serious safety problems. In 2003, in- Thank you, Mr. Chairman, I look forward eral steps to address each of these areas. to responding to any questions today. spectors found that the majority of the pack- Millions of packages come through the ages examined in these ‘‘blitzes’’ contained mail and express courier facilities every Mr. HATCH. It was a startling state- illegal drugs. Last summer, FDA and the year. Thousands of packages, particularly in ment. I know at least one Democratic U.S. Customs and Border Protection agency the mail, are found to contain illegal and ap- Senator, who takes matters very seri- (CBP) conducted blitz examinations on mail proved pharmaceuticals. We also estimate ously and who was for importation or shipments at the Miami and New York (JFK that 10 million people cross the land border Airport) mail facilities in July, and the San reimportation of drugs, was shocked at annually carrying unapproved products. some of the testimony because she did Francisco and Carson, California, mail facili- Additionally, we have found bulk pharma- ties in August. In each location, the agencies not believe things could be as bad as ceutical shipments that were attempted to examined packages shipped by international be imported through the mail potentially in- they represented and was kind of mail over a 3–day time span. Of the 1,153 dicating that these products could be mak- shocked that they made a pretty darn shipments examined, the overwhelming ma- ing their way to pharmacy shelves. good case that these matters are much jority (1,019 packages, or 88 percent) con- In order to address what is clearly a grow- more serious than some are taking tained unapproved drugs. The drugs arrived ing threat to this public health, CBP has from many countries. For example, 16 per- them. been working cooperatively with the DEA, cent entered the U.S. from Canada; 14 per- I don’t have anything more to say at the FDA, our own U.S. Immigration and Cus- cent were from India 14 percent came from this time, but I hope we will think this toms Enforcement, ONDCP and the Depart- Thailand, and 8 percent were shipped from through before we saddle the American ment of Justice attorneys in an interagency the Philippines. working group directed at addressing issues people with something that can be dis- Mr. HATCH. These are serious state- related to the importation of prescription astrous in their lives. I am familiar ments by serious people. I don’t think drugs and miscellaneous pharmaceuticals. with how some of these drugs that peo- we should ignore them. It is one thing The working group has conducted regular ple think are good drugs that come to argue that you don’t like the phar- meetings since January 2004 and has into this country are adulterated. maceutical companies, and many don’t. achieved several key accomplishments since Some are made with contaminated It is another thing to argue that these its inception, including conducting a joint water, do not have any efficacy in drugs that are going to be imported or interagency enforcement operation known as Operation Safety Cap, which was designed to them at all. Yet they look identical to reimported are absolute identical cop- look at passenger importations of pharma- what our U.S. manufacturers are mak- ies of what they represent. I would pay ceuticals from Mexico. ing or what other qualified manufac- attention to what these people are say- Operation Safety Cap was an interagency turers are doing. We can’t ignore these ing. plan to enforce laws related to the importa- things. I think even if we could give I also ask unanimous consent to tion of prescription drugs at the border. Both FDA all the money—and it would print in the RECORD the statement of a FDA and ICE participated in the enforce- amount to trillions of dollars, cer- Customs officer who came and testified ment operation. The plan began with a pub- tainly hundreds of billions of dollars lic outreach, followed by an enforcement ef- on the 14th. but I think trillions of dollars—to han- There being no objection, the mate- fort at the Ports of Andrade, Yuma, Tecate, San Luis and Calexico. The purpose was to dle this, there is still no way FDA can rial was ordered to be printed in the evaluate compliance with laws related to the take care of all the problems that RECORD, as follows: importation of prescription drugs. would come up. U.S. SENATOR ORRIN G. HATCH (R–UT) HOLDS During the course of the operation there We have a pretty good system here. I HEARING ON DRUG IMPORTATION were several troubling instances of returning have to admit, I wish we could get drug Mr. HATCH. Ms. Durant. U.S. residents receiving different medica- prices down. As the author of the tions than the ones they thought they were Ms. Durant. Mr. Chairman, members of the Hatch-Waxman Act, we worked hard to committee, thank you for this opportunity being prescribed. to testify. In one instance there was no active ingre- get the generic business into action. At I’m Elizabeth Durant, director of trade dient in the unmarked, undeclared bottle the time we did Hatch-Waxman, compliance and facilitation in the Office of that was brought into the U.S. The overall generics were no more than 17 or 18

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00068 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.016 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5383 percent of the total marketplace. that. One was drug price competition, children’s programs in, I would hate to Today they are over 50 percent. Hatch- to make sure we could get drugs in ge- see this bill vetoed, but I would not Waxman is the reason they are there. neric form immediately, once they blame the President one bit if he ve- In every case, every year we have saved come off patent, which we did. The toes it based upon the testimony of sci- at least $10 billion for the consumers. other, of course, is the patent term res- entists who have testified before our What many in this body seem to ignore toration so that we could give inno- committees. is that it costs these innovator compa- vator companies some restoration of Frankly, I would think he would be nies upwards of $1 billion to create one patent life or market exclusivity so right if he vetoed it. But be that as it of these drugs. Most of them go they could recoup the moneys, the ex- may, I am only one Senator, and I through at least 6,000 failed experi- traordinary costs that are involved. think most people know I am very sin- ments before they arrive at one of When I say I have heard some in the cere in this area. I work very hard in these drugs. We can’t ignore that fact. Congress who I think have exploited these areas. I have a record of accom- The only way they can recoup that this for political purposes, I would plishment in these areas. I just want to money is within the few years that are never say that about my friend from make sure that our consuming public left of their patent life. North Dakota. I don’t particularly has every protection they possibly can. This is the only industry I know of— want to disparage anybody else, but I Unfortunately, it costs a lot of money there may be others, but I can’t think can say this: There have been some to give them that protection. I wish of any—where if you create a widget, who have used this issue politically, there was some way we could bring you have 20 years of patent life, mar- and there is no doubt about it. I believe those prices down. Having said that, back in the early ket exclusivity. In this industry, a lot the Senator from North Dakota is ar- 1990s, I helped put through this body of that is eaten up by the FDA process. ticulate and means what he says and is doing so for the right reasons. Having the FDA Revitalization Act. Among It means that the innovator companies the purposes of that act was to create have very few years in which to recoup said that, I don’t think we should ig- nore the testimony of these top people a unitary campus for FDA rather than that billion dollars, upwards of a bil- have over 30 different locations in the lion dollars. A few years ago, it was in the administration who say this could be a disaster for the American greater metropolitan area around the $800 million, which was astounding to District of Columbia, to have a central consuming public. I don’t think you me. Now it is approaching a billion; in campus, state-of-the-art equipment, can ignore those comments. I am sug- some cases, maybe even more. the highest technology we can, with an gesting that I hope people will read It is one thing to throttle the phar- incentive to bring the very best sci- these comments, and I will put more maceutical companies in the interest entific minds we can into FDA. We all into the record before we are through of politics. It is another thing to ignore know the White Oak complex is being with this debate. We are all interested reality and ignore what happens here. built now. It didn’t start until about 5 in getting drug prices down. There is One reason for Hatch-Waxman was or 6 years ago. It is going to take an- no question about it. I don’t think because one side wanted all drug price other 10 years and probably cost a lot there is anybody in this Congress who competition. They wanted 100 percent more than it would have had we done generics if they could get them. The has done more to bring drug prices what that bill said we could do imme- problem is, there would not be any down than I have, through Hatch-Wax- diately. It was only an authorizing bill. generics if you don’t have the inno- man and my friend HENRY WAXMAN The appropriators did not appropriate vator companies doing the innovative over in the House and others who sup- the funds to develop that campus. But drugs. ported that bill. There is no question we have to find a way of helping FDA. Mr. DORGAN. Will the Senator yield about it. I am as interested as anybody The sooner we get that campus and for a question? in making sure the consumer public is they have all of the integral online Mr. HATCH. Sure. not ripped off. services and equipment and top-of-the- Mr. DORGAN. My friend from Utah On the other hand, these innovative line approaches that they can bring to did not mean to suggest those of us drugs cost a lot of money to develop. bear, we should be able to bring drug who are offering this amendment on a When we get into follow-on biologics, it prices down through that. But we are a bipartisan basis are doing so for the apparently costs even more for these long way from the completion of White purpose of politics, as he said. My ex- large-molecule drugs that may not be Oak, as we stand here today. pectation is, he would think this would readily duplicated. In fact, under cur- Frankly, at least we are doing it. At be a serious and thoughtful amendment rent science, they are not readily du- least we are going somewhere. I wish to that he disagrees strongly with, but I plicated. I am very concerned about attribute some of that to the distin- hope he would not suggest the motive this whole issue. I am very concerned guished Senator from Maryland, BAR- is politics. CBO has suggested this bill about making sure that the record BARA MIKULSKI, and others in the will save $50 billion for the American shows that we have brought out how House who have worked very hard to consumer, $5 billion of which is for the serious this issue is and how serious make sure that the FDA revitalization Federal Government. This is a serious the consequences are if people are approach finally comes to fruition. issue and a thoughtful issue. One might wrong, if they happen to get this type One of the biggest problems we have disagree, but I hope that one would not of legislation through. in Government today is to get top sci- ascribe motives of politics to those of Let me add one other thing. I would entists at FDA. We can’t pay them us on a bipartisan basis who are offer- suggest to my friend from North Da- commensurate with scientists at the ing this amendment. kota that the President has already major pharmaceuticals or even the Mr. HATCH. I have heard some who I said that if this language is in this bill, major generic companies. In fact, they believe are using it politically in the he is going to veto it. I believe that can start at three times or more what Congress. But I would never ascribe veto would be sustained. I think it we pay at FDA. So we have a very dif- that type of attitude to the distin- should be sustained. It is one thing to ficult time continuously getting top guished Senator from North Dakota. I come out and argue for something such scientists to come and work at FDA. believe he is very sincere. I believe he as this, but I would hope that he will That is a big problem. It is a blessing is truly trying to represent the con- withdraw his amendment because I that we do have some of the best sci- sumers in the best possible way. I just would hate to see a bill as important to entists in the world working there who believe he is ignoring some of these our country as this drug safety bill, a are willing to sacrifice to do what they comments and statements made under bill that has brought together Demo- consider to be the important work of oath before committees of the Senate crats and Republicans from the left to the Food and Drug Administration. that fly in the face of what is being the right, a bill that would help to save This bill will help the Food and Drug said here. I would like to see drug as many lives as this bill will do, a bill Administration to do a better job, to prices reduced. There is no question that will help bring to the forefront the go forward with more backing from the about it. I worked hard to get them re- FDA in a way that it should be Congress and, in the end, benefit all of duced. That is what Hatch-Waxman is brought, a bill that has the MDUFA us who benefit so much from the work all about. But there are two sides to and PDUFA moneys in, a bill that has of the Food and Drug Administration.

VerDate Aug 31 2005 03:03 May 02, 2007 Jkt 059060 PO 00000 Frm 00069 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.072 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5384 CONGRESSIONAL RECORD — SENATE May 1, 2007 I yield the floor. entered the U.S. in 2003. Even if a lower level tially, the high pro rata share of fees may EXHIBIT 1 of examination were considered adequate, actually discourage participation and make the costs to FDA would still be very high. it difficult for FDA to collect fees at the des- DEPARTMENT OF HEALTH AND HUMAN Despite its registration and inspection fee ignated levels. Even once a program is devel- SERVICES, FOOD AND DRUG ADMIN- provisions, the bill likely provides inad- oped, the bill is not likely to provide the nec- ISTRATION equate resources to conduct such examina- essary funds to continue an adequate regu- Rockville, MD, April 10, 2007. tion on a routine basis. Resources are lim- latory program if inspection fees are low be- Hon. BYRON L. DORGAN, ited to 2.5 percent of the total price of quali- cause imports do not reach the anticipated Chairman, Subcommittee on Interstate Com- fying drugs imported by registered exporters, levels. merce, Trade and Tourism, Committee on an amount likely to be a small fraction of SUPPLY CHAIN SECURITY Commerce, Science, and Transportation, the cost of inspecting packages at inter- We are proud of FDA’s efforts with supply U.S. Senate, Washington, DC. national mail facilities. This is a particular DEAR SENATOR DORGAN: Thank you for the chain stakeholders and states to maintain a concern because, once personal importation safe and secure drug supply in the U.S. that opportunity to testify at the March 7, 2007, is given the appearance of legality, con- hearing entitled, ‘‘Policy Implications of is premised on a closed, tightly regulated sumers may be less vigilant in scrutinizing system. The type of drug importation pro- Pharmaceutical Importation for U.S. Con- the drug shipments they receive from sumers,’’ before the Senate Subcommittee gram in the bill would increase the number abroad. of foreign entities FDA would have to mon- on Interstate Commerce, Trade, and Tour- S. 242 would establish a complicated sys- itor and regulate. It can be difficult for FDA ism. The Food and Drug Administration tem for the regulation of imported drugs. enforcement to reach foreign entities vio- (FDA or the Agency) is responding to address This complex system is so vast that it would lating our laws and regulations. This bill the March 9, 2007, correspondence you sent in be enormously resource-intensive, likely would open the door to more entities outside follow-up to that hearing. much greater than the proposed registration our domestic legal framework. We also have Your correspondence included statements fees and inspection fees could support. The grave concerns for consumers who may be made by former FDA Commissioner, David bill and its associated fees also do not appear harmed from products from these foreign Kessler, at an April 19, 2005, hearing entitled, to account for the costs of the increased vol- sources. The bill does not take into account ‘‘Examining S. 334, to amend the Federal ume of packages likely to inundate the U.S., protecting the rights of the consumer if they Food, Drug, and Cosmetic Act with respect or address the accompanying and likely sub- are injured after using one of these products. to the importation of prescription drugs,’’ stantial enforcement work that will arise as held by the Senate Committee on Health, As we all agree, counterfeit drugs must be a result of legalized importation as more un- kept out of the U.S. drug supply chain. FDA Education, Labor, and Pensions. Dr. scrupulous vendors set up shop to cir- Kessler’s statements focused on the issues of is currently using its resources and authori- cumvent the new U.S. system. ties as efficiently as possible to secure the safety, resources, supply chain security, and Lack of substitutability standards for approval of foreign versions of drug supply chain and protect American con- FDA-approved drugs. You asked that I ex- The proposed bill provides a mechanism for sumers from counterfeit and diverted drugs. plain my views on the ‘‘Pharmaceutical Mar- foreign imported products to be approved for Opening the U.S. drug distribution system to ket Access and Drug Safety Act’’ in the con- distribution in the U.S. even though these foreign markets would provide more oppor- text of these issues. The bulk of this re- products may not be bioequivalent to the tunity for counterfeit drugs to enter our cur- sponse details our views about these issues. FDA-approved product. This mechanism rently closed system and would significantly I would like to start, however, by com- seems to by-pass the existing drug approval complicate FDA’s efforts to investigate mending you for your efforts to address process for drug products that are not bio- irregularities in the drug supply chain. American consumers’ concerns regarding ac- equivalent to an FDA-approved product, Conducting foreign investigations and cess to affordable prescription medications. which is through the submission of a new prosecutions is inherently costly and dif- Nevertheless, the Agency continues to have drug application (NDA) that is thoroughly ficult and often is complicated by language concerns with enacting such a sweeping im- reviewed for safety and efficacy. Ultimately, barriers and issues of extraterritorial juris- portation program and fears that inter- the bill appears to establish for imported diction and extradition. We are concerned mediaries would likely swallow the bulk of drugs an alternative to FDA’s existing ge- that the bill does not provide sufficient en- cost-savings, preventing American con- neric drugs program. forcement tools and penalties to deter for- The bill would allow non-bioequivalent sumers from enjoying much, if any, practical eign entities from introducing counterfeit or products to be sold in the U.S. as approved benefit from such a program. We expect such otherwise substandard drugs into the U.S. ‘‘variations’’ of the innovator product under a result might lead consumers to continue to drug supply chain. the existing NDA, which would create confu- look for substantial savings on their pre- APPROVAL OF FOREIGN VERSIONS sion for doctors and pharmacists in pre- scription medications by seeking products We believe the bill creates complicated ap- scribing or dispensing, respectively. Dr. Todd outside the legalized importation system, plication and inspection requirements for Cecil of the U.S. Pharmacopeia testified at just as some do now. We continue to observe imported ‘‘foreign’’ versions of FDA-ap- the April 2005 Senate HELP hearing regard- that many consumers buy drugs from foreign proved products. These requirements would ing pharmaceutical equivalence and bio- Internet sources even though generic be difficult to implement, as each foreign equivalence and his concerns with this bill. versions of those products are approved by country has its own regulatory scheme and In addition, doctors cannot anticipate which FDA and such products are generally cheap- requirements for the information necessary version of a drug product their patients will er in the United States than abroad. to approve a drug product. FDA would essen- receive, and pharmacists may not know We note that legalizing commercial impor- tially have to review foreign information in which version of a drug the doctor intended tation may have unintended effects on pro- a foreign format, all in less time than is re- to prescribe. The possibility of confusion is tection of intellectual property and may re- quired for review of traditional NDAs. In ad- significant and poses a real public health duce incentives for research and develop- dition, the bill would require imported ‘‘for- concern as this increases the chance of error ment, as noted in the 2004 report issued by eign’’ versions of a drug bear the labeling as- in prescribing and/or dispensing of medica- the Health and Human Services’ (HHS) Task sociated with the original FDA-approved tions. In addition, the domestic and foreign Force Report on Drug Importation. product. This practice would essentially le- versions of prescription drugs may become SAFETY CONCERNS galize the misbranding of these products, and commingled in the drug supply chain. It is raises concerns for FDA not only in the ap- We have safety concerns related to both unclear whether a patient will be able to proval context but also in the counterfeits the identification of unsafe and or non-com- specify if he wants the foreign version or the context. It is difficult enough for FDA and pliant drug products and about the substi- original FDA-approved version when he gets other federal enforcement agencies to detect tutability of foreign products for domestic his prescription filled at the pharmacy or re- counterfeit drug products and packaging; products. ceives medication at a hospital or other creating a mechanism that would allow per- Identifying unsafe/non-compliant drug products medical treatment facility. sons to label foreign drugs with reproduc- The section of the bill that would allow in- INADEQUATE RESOURCES tions of FDA-approved labeling would make dividuals to import a qualifying drug from a It is uncertain whether the anticipated fee it even harder to distinguish between ‘‘legal’’ registered exporter would likely pose an revenues will be realized because the market foreign products and counterfeits. overwhelming resource burden for the Agen- response to legalization of importation can- U.S. consumers currently have a number of cy and create significant safety concerns. not be accurately predicted. This uncer- options available to them when looking for Under such a program, the anticipated high tainty could pose problems for FDA’s pro- affordable medications within the closed volume of products would make it extremely gram, because large costs of starting and de- U.S. drug distribution system. Many essen- difficult for FDA and U.S. Customs and Bor- veloping a program to regulate imports will tial drugs have a generic alternative and der Protection officials to examine ade- have to be incurred even if the volume of le- some even have many generics, which are quately all of the personally imported drug galized imports is initially low. Although the generally less expensive than the brand prod- products to ensure that they comply. In fact, bill does assume certain sales volumes in the uct. We continue to find that many con- the HHS Task Force estimated that it would first several years for purposes of collecting sumers currently buying foreign products have cost $3 billion annually to examine and inspection fees, with only a few registered are actually trying to purchase, or are un- process each of the 10 million packages that importers and exporters participating ini- knowingly receiving, a foreign product that

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00070 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.073 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5385 often is more expensive than the U.S. prod- years. But worse still is the silence The controversy surrounding his involve- uct. In addition, the consumers are at risk that so often greets the vindication of ment in health care was a perennial bugaboo when receiving foreign drug products, as the accused. for Dr. Frist. For years he was harassed by there are documented cases where the wrong I remember the rush to judgment such liberal lobbies as Public Citizen, and medication was received (the haloperidol that followed the allegations. I remem- Citizens for Responsibility and Ethics in case mentioned in my testimony). Many Washington, which alleged conflicts of inter- pharmaceutical companies and Pharma- ber the memo Democrats sent out at- est. These groups objected even to those ceutical Research and Manufacturers Asso- tacking Bill on ethical grounds. The stocks he held in the blind trust he had cre- ciation of America offer discounts and some- authors were later forced to apologize, ated to avoid the appearance of a conflict of times even free medications for consumers but the piece had its intended effect. interest. Yet when he sold those stocks, with who cannot afford them. Medicare Part D Republicans knew then—and every- a possible eye on higher office, he was pil- has also helped some seniors cut their pre- one now knows—those allegations were loried for doing what the ethicists had asked scription costs. Consumers should not feel absolutely false. But the damage, of him to do all along. restricted to higher priced innovator (brand) course, was already done. As the Jour- Today, even this muted absolution is sure- products. nal writers put it today: ly a relief to Dr. Frist. Yet it’s impossible to Consumers must also understand that if a undo the damage to his political career. De- Despite flimsy evidence, the media storm medication is costly, they should discuss spite flimsy evidence, the media storm cast cast a shadow over [Frist’s] office . . . [and] other treatment options with their doctor a shadow over his office, derailing any the Nashville heart surgeon chose . . . to and pharmacist, as most often there are thought of a Presidential bid this year. The take a sabbatical from public life.— lower-cost alternatives available. We will [And] Dr. Frist now joins a long line of Nashville heart surgeon chose instead to continue to strive to make more affordable public servants to be smeared on page one ‘‘take a sabbatical from public life.’’ medicines available to consumers, but we re- and [then] exonerated next to the classifieds, Democrats naturally cared less about the main concerned about the implications of le- only to wonder if anyone noticed. actual facts than about pinning another galizing drug importation as one of those op- scandal on Congressional Republicans in the tions. Well, his friends noticed. Still, it is run-up to the fall elections. But what about In conclusion, I would like to reiterate hard not to lament the damage these others who thought it clever or funny or per- concerns about the economic implications of reckless claims have caused—caused haps mandatory to get their share of media prescription drug importation, as stated in for Bill, his family, and potentially our attention by confusing accusation with proof the 2004 HHS Task Force Report on Drug Im- political system. of wrongdoing? portation. Even if all the safety concerns The Founders envisioned a nation in American University Professor James could be allayed, these concerns would re- which citizen legislators would be will- Thurber got his name in the paper for main: that savings to U.S. consumers would ing to leave the plow and the work- quipping that Senator Frist ‘‘came in like be small as a percent of total drug spending; Jimmy Stewart and was leaving like Martha that implementing such a program would bench to serve. Stewart.’’ What a card. As for the press incur significant costs; and that legalized Bill embodied this ideal by leaving corps, it ran off in a braying stampede in importation would likely adversely affect his profession and the comforts of pri- pursuit of the theme dujour, which was the future development of new drugs for vate life for a career of public service. Abramoff-DeLay-GOP corruption. The accu- American consumers. In 2004, the HHS Task He graced this body with his intel- sations against Dr. Frist fit that template, Force Report noted that generic drugs ac- ligence, his thoughtfulness, and his vi- so there was no need for the herd of inde- count for most prescription drugs used in the sion. pendent minds to inspect the evidence and U.S. and that these are usually less expen- We can only hope that future citizen make distinctions. A Washington Post edi- sive in the U.S. than abroad. We thus have a legislators, and judges, are not de- torial from the day now looks especially em- well-functioning system of intellectual prop- terred from entering and elevating pol- barrassing—and unfair. erty rights that balances the short-term in- As a medical professional with strong Ten- terests of consumers with the long-term re- itics because of the threat of similar nessee roots, Bill Frist was the kind of per- search incentives. treatment. son we’d hope would occasionally choose to Thank you for the opportunity to address A great American statesman once participate in politics, as opposed to the per- some of our concerns with S. 242. said: manent political class that now dominates Sincerely, Reputation is like fine china and glass— Congress. That his previous engagement in RANDALL W. LUTTER, easy to crack, but hard to mend. the real world, even carefully and trans- Acting Deputy Commissioner for Policy. We hope a political culture that al- parently managed, made him an unfair tar- lowed the abuse of Bill Frist’s good get of political attacks shows why so few The ACTING PRESIDENT pro tem- people of accomplishment run for office. name for political gain does not deter These are the kind of people that the goo-goo pore. The Republican leader is recog- others from choosing the same path nized. Naderites and their media acolytes end up that he chose—and so honorably fol- driving from public life. Mr. MCCONNELL. Mr. President, I lowed. Dr. Frist now joins a long line of public ask unanimous consent to proceed as Mr. President, I ask unanimous con- servants to be smeared on page one and ex- in morning business. sent that the editorial entitled ‘‘Frist’s onerated next to the classifieds, only to won- The ACTING PRESIDENT pro tem- Vindication’’ from today’s Wall Street der if anyone noticed. As former U.S. Sec- pore. Without objection, it is so or- Journal be printed in the RECORD. retary of Labor Ray Donovan asked after his dered. There being no objection, the mate- legal ordeal, ‘‘Which office do I go to to get my reputation back?’’ EXONERATION OF SENATOR FRIST rial was ordered to be printed in the Mr. MCCONNELL. Mr. President, a RECORD, as follows: Mr. MCCONNELL. Mr. President, I yield the floor. great injustice has come to an end. I [From the Wall Street Journal, May 1, 2007] The ACTING PRESIDENT pro tem- rise to recognize the clearing of a good FRIST’S VINDICATION pore. The assistant majority leader is man’s name. When insider-trading allegations against Former Senator Bill Frist, with former Senate Majority Leader Bill Frist recognized. whom I and my Republican colleagues surfaced back in 2005, they were splashed on IRAQ SUPPLEMENTAL had the honor of serving for 12 years in the pages of major newspapers from coast to Mr. DURBIN. Mr. President, about 1 the Senate, was cleared last week of coast. Now that Dr. Frist has been vindi- hour ago, the President of the United every allegation of wrongdoing related cated, the silence is instructive. Is anybody States vetoed the supplemental appro- out there? to his ownership and sale of stock Senator Frist was alleged to have received priations bill for the war in Iraq. It was while serving as majority leader. an insider tip and then sold shares in a hos- a bill that we have worked on in Con- I rise because, with the exception of pital company run by members of his family. gress since its arrival in the middle of an editorial in this morning’s Wall The Securities and Exchange Commission February. It was the subject of lengthy Street Journal, the clearing of this and Justice Department investigated for 18 deliberations. There were long debates good and honorable man’s name has months, and last week the SEC announced on the floor of the House and Senate. gone largely unreported. that it had closed its probe without taking There was a lot of compromise that led It is a sad fact of political life in action—that is, the doctor was cleared. to the final work product and a bipar- Thanks in part to his meticulous email ar- America that the mere allegation of chives, Dr. Frist was able to show that he tisan vote which sent it to the Presi- wrongdoing—the mere allegation of had begun the process of selling his HCA dent. wrongdoing—has the power to tarnish stock in April of 2005, months before he was There were people who were skeptical someone’s name and dog them for alleged to have received the inside whispers. as to whether the Senate and the House

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00071 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.035 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5386 CONGRESSIONAL RECORD — SENATE May 1, 2007 of Representatives could rise to this Iraqi people will be inspired enough to did not spell out to the President what challenge. In a nation that is so divided ask their Government for leadership? was in that bill before he vetoed it. on so many political issues, in a nation Mr. President, 3,351 American sol- Well, the President knows—and he where the war in Iraq is the biggest diers have fought and died in Iraq, as I said as much—we do not have the votes issue by far, there were serious doubts stand here today. Mr. President, 3,351 to override his veto. That is a reality. as to whether this Congress, with scant American lives should be enough to in- It takes 67 votes in the Senate. We majorities of Democrats in both the spire the Iraqi people and their Govern- have been able to rally 51 or 52 votes on House and the Senate, could produce a ment. How many more American lives a good day to question the President’s bill for President Bush to consider. will it take for that inspiration the policies in Iraq. Two or three Repub- Congress rose to that occasion. With President is looking for? lican Senators have stood by our side the leadership of Speaker PELOSI and I am troubled by this notion that un- on the Democratic side of the aisle. the leadership of our majority leader, less we will sacrifice our treasure and Few others have been willing to do so. Harry Reid of Nevada, we produced a the lives of our brave soldiers, the So the thought of reaching 67 votes is bill which attracted not only the over- Iraqis cannot rise to the occasion and probably a bridge too far. I think we whelming support of the Democratic lead themselves out of this morass. know that reality. caucus but also the support of Repub- I also listened to the President when But this much I will say: Congress lican Senators who joined us in passing he characterized the money that we cannot override the President’s veto, this bill. added in Congress to his budget re- but the President cannot override the It was our hope that our work prod- quest. He called it—and I will quote— reality of Iraq. The reality of Iraq is uct would be considered seriously by ‘‘billions in nonemergency spending this: We are in the fifth year of a war. the President. It was sent to him this that has nothing to do with fighting We have seen 3,351 American lives sac- afternoon. A few hours after receiving the war on terror.’’ rificed, 25,000 or more injured, 7,000 or it, the President vetoed it and an- I wonder if the President’s staff put 8,000 seriously injured with traumatic nounced his veto in a public press con- the bill in front of him for him to take brain injury and amputations. ference. a close look at, in the few hours he had Americans have sacrificed from their I am disappointed. The President had it before vetoing the bill. hard work and earnings $500 billion for a chance to sign a bill that would have Is the President arguing to the Amer- this war and for rebuilding Iraq. That funded the troops in this war. More im- ican people that providing $2 billion is the reality of Iraq today. portantly, it was a bill he could have more in equipment to keep our troops The reality is, this last month of signed which could have changed the safe in Iraq has nothing to do with April was the deadliest month this course of this war—something that is fighting the war on terror? year for American soldiers. The reality long overdue. Is the President arguing that the $1 is, this President has no plan to exit I listened in my office as the Presi- billion in our supplemental appropria- that country and bring our troops dent gave his veto message to the tions bill—the $1 billion to replenish home. That is the reality. We may not American people. It was short, direct National Guard equipment destroyed be able to override this veto, but the but, in many ways inadequate when and lost in the war in Iraq—that $1 bil- President cannot override those reali- you consider the awesome responsi- lion has nothing to do with the war on ties. bility we face in Congress and in the terror? Now it is time for the American peo- White House. Is the President arguing that the $2 ple to understand what happens next. The President referred to our time- billion in this bill for military hos- We will fund these troops. We have table to start bringing American pitals—such as Walter Reed, so we do made that promise, and we will keep it. troops home as a date for failure. It is not relegate our fallen soldiers and They will not be bargaining chips in ironic the President would make that those who were injured to a flophouse our policy debate in Washington. But statement on the fourth anniversary of motel across Georgia Avenue from we will continue, through this bill and his appearance on the USS Lincoln air- Walter Reed Hospital—is he arguing through other legislation this year, to craft carrier under a banner announc- that the $2 billion that is in the bill for continue to put the issue of the Iraq ing, 4 years ago, that our mission was military hospitals has nothing to do war in front of the President, in front accomplished. For the President to an- with the war on terror? of the American people. They expect nounce success and failure, accom- Perhaps the President is not aware of nothing less. plishment and lack of accomplishment, the fact there was $2 billion in this bill For those who are frustrated by the leaves something to be desired after for veterans hospitals all across Amer- President’s veto today, I join them in that experience 4 years ago. ica, for those who have come home that frustration. But I join them, as I am particularly troubled as well by with post-traumatic stress disorder, well, in believing that as the American the President’s notion of what this bill traumatic brain injury, and amputa- people speak out on this issue, the like- was all about. You see, he said, at one tions who need the services of the VA lihood that Republicans will cross this point, for us to set a timetable to bring hospitals. Is the President arguing that aisle and join us increases. American troops home would—in the money for VA hospitals has ‘‘nothing The time will come—I am not sure President’s words—‘‘demoralize the to do with the war on terror’’? That is when but I hope soon—that tipping Iraqi people.’’ Those were his words. what he said. That is an exact quote. point will be reached where the Repub- Mr. President, excuse me, but I am This bill has add-ons that relate to licans finally say to their President: not as interested in building up the real emergencies in America. I have Enough. We cannot ignore the reality morale of the Iraqi people as I am in outlined a few related directly to the of this war and what it has done to inspiring the leaders of the nation to war on terror, directly to our troops, America. Then they will join us. Then stand up and lead. For too long now, directly to our national security. this will truly become a bipartisan ef- with the protection of the U.S. troops, There is money, as well, for the base fort. Then we will be able to override this Iraqi Government has failed to closing commission, which it is my un- vetoes and pass legislation that will make even basic progress in taking derstanding the President wanted in- make a meaningful change in the pol- control of their country. They have cluded. There is money, as well, for icy of this war. failed to address the key political Hurricane Katrina. Here we are, a year I encourage those across America issues that would lead to stability. and a half after that terrible tragedy, seeking a new direction in Iraq, do not So the President is arguing that if we still trying to put New Orleans back on be discouraged by this veto. There will continue to send 150,000 or more Amer- its feet and rebuild Louisiana and Mis- be another day. There will be another ican soldiers to risk their lives, it will sissippi and areas affected by Katrina bill. There will be another chance for build up the morale of the Iraqi people and Rita. Yes, there is money in the us to change this policy. We need to to seek nationhood, stability, and bill for those emergency purposes. keep our forces together—the forces for peace. So we expect American soldiers For the President to dismiss this as change in Iraq on the Democratic side to stand in this crossfire of a bitter re- billions in nonemergency spending sug- and on the Republican side. We cannot ligious and civil war, hoping that the gests his staff did not do their job, they allow the President’s veto pen to be the

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00072 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.075 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5387 last word on this war in Iraq. We have terrorism and directing counterterror- Mr. REID. Mr. President, I ask unan- to stand together, and we have to work ism and not simply policing a civil war. imous consent that the order for the together. The next few weeks will be momen- quorum call be rescinded. The President comes up with rosy re- tous in our history. Frankly, when The ACTING PRESIDENT pro tem- ports on what is happening in Iraq. But these few weeks began, the President, pore. Without objection, it is so or- we know the reality. Sectarian deaths with his bully pulpit, his harsh rhet- dered. are down, he said. Well, I guess they oric, his idea that he was trying to per- SENATOR FRIST’S VINDICATION are down slightly, a small percentage, suade people we didn’t support the Mr. REID. Mr. President, I had the of those innocent civilians killed last troops, many thought he would win the good fortune of working with Senator month. There were fewer this month. I fight—the fight here in this Chamber Bill Frist for 4 years as a leader. He guess that is progress. But those who and in the minds of public opinion. But was a leader. There were times he and are there say the violence is subsiding that hasn’t happened at all. In fact, the I had some political disagreements, while the surge is underway, and they American people are so disgruntled by and that is an understatement, but on are afraid it will return. I am, too. this war in Iraq, that the old name- a personal basis we had no misunder- We need to pass a bill for the troops, calling, the old kneecapping, the old standings. He was in public service for and sometime soon. We will work hard attempts to instill fear in people who the right reason. He was a very fine, to try to find a way with the President. disagreed with him don’t work for this outstanding, nationally recognized He has invited the leadership of the President anymore. He has only one transplant surgeon. He comes from a Senate and the House to meet with him choice. That choice is a simple one, good family. He and I had many discus- tomorrow in the White House. I have which is to change the course of the sions, personal in nature. He was al- been to those meetings before. There war in Iraq. It is inevitable. It will hap- ways available to anyone in the Sen- have been little results to point to for pen. It will happen sooner or it will ate. When there were any medical prob- the time we have met and the dialog happen later, but it must happen be- lems involved, he was always there to we have exchanged. But I go tomorrow cause failed policies can never continue give advice and counsel. I went to him with the hope that things will be dif- on and on and on. on many occasions about situations in- ferent. I hope this President, after his They have asked us to have faith in volving my friends and he would lay moment in the sun with this veto, will the surge. If it won’t work with 150,000 things out for me and head me in the now understand that we face the grim troops, it won’t work with 180,000 right direction. reality of Iraq, and the reality that we troops, and it won’t work because the have no exit plan. This failed policy in Government in Iraq does not have the Senator Frist had a situation arise Iraq must come to an end. We will con- support of the people, is unable to ac- front page in many of the newspapers, tinue to fight, with this democratic complish any goals, is unable to bring problems with the Securities and Ex- Congress, to make a change in that Sunnis, Shiites, and Kurds together. It change Commission. Senator Frist policy. We will stand by our soldiers, doesn’t matter how many troops we comes from a family that has done but we will not stand by a failed policy. have there; the bottom line is simple. well. They have been involved in health I am encouraged by the fact that so Our President is in the twilight days of care for many years. He and I had con- many of my colleagues are ready to his administration, and he has only versations about this and he said at the continue this fight, and I encourage two choices. One is to do what his pred- time it was unfair. He had to spend a the American people: Don’t give up. ecessor Ronald Reagan did: See that lot of money hiring lawyers and ac- Don’t lose heart. This democracy things have gone off course and seek a countants and consultants. works when you work with us to bring correction. Ronald Reagan did that in This matter was closed yesterday, the will of the people to the law of the 1986, and by 1988 the wall came down but the closing of this in the news- land. and Ronald Reagan had restored the papers and on the news was certainly Mr. President, I yield the floor. faith of the American people. Why this not the top story, not at the top of the The ACTING PRESIDENT pro tem- President can’t see the necessity to do newspaper. It was buried some place in pore. The senior Senator from New the same when his policies, if anything, the back. At no time during my con- York is recognized. are in far worse shape than those of versations with Senator Frist or in my IRAQ SUPPLEMENTAL President Reagan, speaks either to an dealings with Senator Frist did I ever Mr. SCHUMER. Mr. President, to- inability to sense what is going on or a have any doubt about his integrity. night is a sad night for America, but stubbornness despite the facts. We His wife Karen and my wife are good what the President’s veto indicated can’t tolerate that. friends. They worked together on a was not that Democrats don’t want to We here tonight make a pledge to the number of activities that Senate support the troops—we do—but that he American people. We will continue this spouses work on. They had to do things does not want a change in direction, a struggle to change our direction in because Senator Frist and I were the change in mission, a change in course. Iraq. We will not run away from fight- two leaders of the Senate and they did It indicates the President is still in his ing terrorism. We believe it every bit them together based on our relation- bunker thinking everything is going as fervently as anybody else, but we ship. fine in Iraq, and it clearly isn’t. will also not run away from fighting I extend to Senator Frist my con- The bottom line is very simple: We terrorism smartly, which is what we gratulations on getting this put behind can do two things at once. We can sup- are not doing here. him. I want the RECORD to be spread port the troops and at the same time So we will continue to try to reach a with the fact that I know this was a we can change our mission. The bottom compromise with this President, to try difficult time for him on occasion, but line is simple, and that is that the to figure out a way we can both sup- never at any time did I doubt his integ- present policies have failed. Everyone port the troops and change the course rity, his honesty. I will long remember except a handful of supporters of the of the war in Iraq in maybe a different Senator Frist and I appreciate my deal- President, and the President and the way, but we will not give up on our ings with him over these many years. Vice President themselves, know that, mission. The American people demand CLOTURE MOTION but unfortunately they stubbornly no less and we will not disappoint Mr. REID. Mr. President, I send a cling to staying on the same course, to them. cloture motion to the desk. the detriment of about everybody else Mr. President, I yield the floor, and I The ACTING PRESIDENT pro tem- in this country and the world. suggest the absence of a quorum. pore. The cloture motion having been The bottom line is very simple: that The ACTING PRESIDENT pro tem- presented under rule XXII, the Chair President Bush, when he asked Ameri- pore. The clerk will call the roll. directs the clerk to read the motion. cans to go to war, never talked about The legislative clerk proceeded to policing a civil war, and yet that is the call the roll. The legislative clerk read as follows: largest part of our efforts in Iraq. We The ACTING PRESIDENT pro tem- CLOTURE MOTION on this side of the aisle hope to change pore. The majority leader is recog- We, the undersigned Senators, in ac- that direction so that we are fighting nized. cordance with the provisions of rule

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00073 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.076 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5388 CONGRESSIONAL RECORD — SENATE May 1, 2007 XXII of the Standing Rules of the Sen- 1953, they came to the United States I am pleased to commend this impor- ate, hereby move to bring to a close de- and were welcomed with open arms. In tant program today before the Senate. bate on the Dorgan amendment No. 990 the years that followed, Steven and his I know I speak for every member of the to S. 1082, the FDA Revitalization bill. brother rose to become prominent and Senate in expressing our gratitude for Byron L. Dorgan, Dick Durbin, Claire successful businessmen, overcoming their valuable work in our commu- McCaskill, John Kerry, Ted Kennedy, great suffering to live the American nities. Amy Klobuchar, Sherrod Brown, Ken dream. Salazar, Mark Pryor, Daniel K. Inouye, Steven Schwarz embodies the grace f Chuck Schumer, Harry Reid, Ron and fortitude of all those who wrested NORTHERN NEVADA CENTER FOR Wyden, Dianne Feinstein, Carl Levin, triumph from despair. I am honored to Blanche L. Lincoln. INDEPENDENT LIVING have shared that day of remembrance Mr. REID. Mr. President, this is a with him and pleased to now pay trib- Mr. REID. Mr. President, I wish to honor the Northern Nevada Center for cloture motion on Senator DORGAN’s ute to his life story in the RECORD of longstanding endeavor to allow Ameri- the U.S. Congress as a powerful and Independent Living, NNCIL. I am hon- cans to go to other countries for the poignant example of the unbreakable ored to congratulate this organization importation of cheaper drugs. We know human spirit. for their 25 years of dedicated service to the people of northern Nevada. people are going to Canada now from f around the country who live on the NNCIL has helped disabled citizens in border, and it works pretty well. But if AAA SCHOOL SAFETY Nevada in all aspects of their lives. you are someone who lives in Nevada, PATROLLERS They have empowered disabled citizens you certainly need these drugs as well Mr. REID. Mr. President, I wish to to become more independent and have as someone living in Minnesota, and it recognize several young people who given disabled people a stronger voice makes it much more difficult. Nevad- were recently selected by the American in matters that directly affect their ans go to Mexico a lot of times for Automobile Association to receive spe- lives. With the skills taught by NNCIL, cheaper drugs. It is unfortunate. cial awards for their work as school disabled people who were benefactors Senator DORGAN is right. He has safety patrollers. of this program are now participating worked on this very hard for a number More than 560,000 students in 52,000 fully in the community by volun- of years. This is an effort to bring this schools across the country participate teering in the center and in other serv- matter to a close. I hope the Senate in AAA’s School Safety Patrol Pro- ice agencies across Nevada. votes to invoke cloture so we can have gram. These young people have taken NNCIL has helped disabled citizens a vote on this amendment. It is impor- on the important responsibility of thrive socially as well. The center has tant. I am confident it will pass if clo- making the streets around their instituted ‘‘recreation night’’ that has ture is invoked. It is something that schools safer for their classmates. helped disabled people form peer sup- has been needed for such a long time to Though their responsibilities are often port groups. They have incorporated help in one way to lower the cost of routine, the patrollers on occasion game night and movie night into their medicine for the American public. must place themselves in harm’s way organization to build communities in order to save lives. It is my honor throughout Nevada. f today to recognize two students who The efforts of NNCIL have garnered MORNING BUSINESS were selected to receive the AAA Life- broad respect and support from the Mr. REID. Mr. President, I ask unan- saver Award for their selfless and he- community as a whole. NNCIL has in- imous consent there now be a period of roic actions in fulfilling their duties as corporated multiple programs to edu- morning business with Senators al- patrollers. cate the public concerning issues con- Taylor Pitzer and Caleb Jarrell par- lowed to speak therein for a period of cerning disabled citizens. They have ticipate in the AAA School Safety Pa- up to 10 minutes each. encouraged Nevada residents to get in- trol Program at Southdale Elementary The ACTING PRESIDENT pro tem- volved in their communities, and the in Kettering, OH. On November 8, 2006, pore. Without objection, it is so or- citizens of northern Nevada have re- Taylor and Caleb pulled a younger dered. sponded by volunteering in a home- child to safety when a speeding van ran modification program that has helped f the red light at the intersection they install ramps, handrails, and other im- HONORING STEVEN SCHWARZ were patrolling. The younger child was provements to make life easier for dis- watching carefully for the ‘‘walk’’ sig- Mr. REID. Mr. President, last week I abled people. nal. When the light changed, she began I would like to commend NNCIL for attended a ceremony in the Capitol Ro- crossing the street and did not notice tunda to commemorate the 2007 Holo- their many years of dedicated service the oncoming vehicle approaching the to the people of Nevada. They have caust Days of Remembrance. intersection. Responding to an adult Fred Zeidman and Joel Geiderman, been an important part of improving guard’s ‘‘hold back’’ indication, Taylor the lives of disabled members of our Chairman and Vice Chairman of the and Caleb reacted quickly by locking U.S. Holocaust Memorial Council, community, and I wish them continued arms so the child could not cross the success. spoke eloquently about the horror and street, which allowed the van to speed courage, the unspeakable tragedy and by without incident or injury to the f unimaginable heroism that even 62 child. RECOGNIZING NEVADA’S 45TH years later we cannot begin to com- I would also like to thank AAA for ANNUAL RENO JAZZ FESTIVAL prehend. making the school safety program pos- Sara Bloomfield, Director of the U.S. sible. This program has helped save Mr. REID. Mr. President, I wish to Holocaust Memorial Museum, as well many lives over the years and has recognize the 45th annual Reno Jazz as my colleague, Senator JOE made our schools safer for our stu- Festival. Hosted by the University of LIEBERMAN, added their own powerful dents, though, as the story of the Life Nevada, Reno, the Festival has grown words. Saver Award recipients demonstrate, into one of the largest of its kind in I was privileged to sit beside Steven the streets around our schools are not the United States, with over 10,000 peo- Schwarz. As we sat together, Steven safe enough. That is why I worked to ple attending last year’s event. listened silently, tears streaming down create the national Safe Routes to The competition portions are one the his face. Afterward, he told me his School Program, which was adopted as highlights of the festival. Musical story. part of the Federal transportation bill groups and individuals from junior Born in Poland, Steven lost both par- on July 29, 2005. Funds for this program highs, high schools, and colleges from ents and a brother in the Holocaust. can help communities construct new throughout the country are invited to Forged with sheer willpower and bless- bike lanes, pathways, and sidewalks, as participate. The festival winner and ings from God, he, his late wife Tina, well as launch Safe Routes education other highly acclaimed musical groups and his brother Henryk managed to and promotion campaigns in elemen- will perform at the festival’s showcase survive by hiding out in Poland. In tary and middle schools. on its concluding day.

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00074 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.078 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5389 Clinics will also be offered at the fes- Lieutenant Gaspers was a para- ony obstruction of justice for lying tival to help developing musicians im- trooper with the Army’s historic 82nd about his relationship with disgraced prove their abilities and talents. Jazz Airborne Division based at Fort Bragg, lobbyist Jack Abramoff. And we dis- students have a unique opportunity to N.C. He had been serving in Iraq since covered that the Minerals Management meet with and learn from some of the August 2006. Service, an agency within the Interior most talented musicians and educators Lieutenant Gaspers is survived by his Department, has known for years in the Nation. parents, John and Pam, and sisters about flawed drilling leases that allow Jazz has come a long way since I first Katie and Audrey. We are proud of his companies to pay no royalties on valu- listened to the music as a boy on the service to our country. able oil and gas they take from Federal radio in Searchlight. This distinct mu- I ask my colleagues to join me and land in the Gulf of Mexico, but the sical form has developed from its hum- all Americans in honoring 1LT Kevin MMS did nothing until news reports ble origins in early 20th century New Gaspers. brought the facts to the public last Orleans to touch music fans of all ages f year. Indeed, the MMS has silenced and backgrounds today. The personal- VOTE EXPLANATION auditors on its staff who tried to blow ities of the early days of Jazz continue the whistle on companies not paying Mr. BROWNBACK. Mr. President, I to influence today’s artists across the their fair share. musical spectrum. regret that on April 25, I was unable to I wish the host and participants of vote on certain provisions and passage ‘‘Simply stated, short of a crime, the Reno Jazz Festival continued suc- of S. 761, the America Creating Oppor- anything goes at the highest levels of cess in bringing Jazz to all members of tunities to Meaningfully Promote Ex- the Interior Department,’’ the Interior the community. cellence in Technology, Education, and Department’s inspector general has f Science Act. I wish to address these warned us. HONORING OUR ARMED FORCES votes, so that the people of the great Last year, when Dirk Kempthorne State of Kansas, who elected me to STAFF SERGEANT KENNETH LOCKER was nominated to be Secretary of the Mr. HAGEL. Mr. President, I rise to serve them as U.S. Senator, may know Interior and he appeared before the express my sympathy over the loss of my position. Senate Energy and Natural Resources U.S. Army SSG Kenneth Locker of Regarding vote No. 142, on amend- Committee for confirmation, I secured Burwell, NE. Sergeant Locker was ment No. 930, I would not have voted in from him a pledge. He told me that he killed on April 23 in Diyala province, favor of this amendment. My vote would reform that troubled department Iraq. He was 28 years old. would not have altered the final result and introduce a higher ethical stand- Sergeant Locker graduated from of this vote. ard. The scandals would stop coming. Regarding vote No. 143, on amend- Burwell High School in 1997. He en- However, in late March, the inspector ment No. 918, I would not have voted in listed with the Army while he was still general once again released a scath- favor of this amendment. My vote in high school. Bob Lee, his high school ingly critical report warning us about would not have altered the final result math teacher, said that after he en- bad things happening at the Interior listed, Sergeant Locker became a much of this vote. Regarding vote No. 144, on amend- Department. This time the subject was more focused young man whose grades Julie MacDonald, Deputy Assistant shot up. ment No. 921, I would have voted in favor of this amendment. My vote Secretary for Fish, Wildlife and Parks. After high school, Sergeant Locker Mr. Laverty would be the immediate spent 3 years in the Army, 2 years with would not have altered the final result of this vote. supervisor of the position Ms. Mac- the National Guard, and eventually re- Donald held. enlisted with the Army. He had been in Regarding vote No. 145, on amend- Iraq since August 2006 with the Army’s ment No. 922, I would have voted in In detail, the inspector general told historic 82nd Airborne Division. favor of this amendment. My vote us two things about Ms. MacDonald. Sergeant Locker was previously in- would not have altered the final result One, she violated Federal rules by jured in Iraq by a land mine. He was of this vote. leaking internal Fish and Wildlife awarded a Purple Heart and lived with Regarding vote No. 146, on passage of Service records to business groups ac- shrapnel in his neck. Thousands of S. 761, the America Creating Opportu- tively challenging the Government’s brave men and women like Sergeant nities to Meaningfully Promote Excel- environmental rulemaking process. In Locker are serving in Iraq. lence in Technology, Education, and the process, she has been undermining In addition to his life as a soldier, Science Act, I would have voted in her own agency’s cases in court. Two, Sergeant Locker was father to three favor of passage of this act. My vote without any formal education in the young sons and believed he was making would not have altered the final result natural sciences, she has bullied and a safer world for his children. He is also of this vote. threatened FWS scientists and forced survived by his father Ken, two sisters, f changes in their reports to suit her and a half sister and half brother. We HOLD ON INTERIOR DEPARTMENT own political and personal agendas. are proud of his service to our country. NOMINATION FWS attorneys no longer will sign off I ask my colleagues to join me and on reports if they know the reports all Americans in honoring SSG Ken- Mr. WYDEN. Mr. President, today I passed through her hands because they neth Locker. have placed a hold on the nomination no longer are certain of the accuracy. FIRST LIEUTENANT KEVIN GASPERS of R. Lyle Laverty to be Assistant Sec- I rise to express my sympathy over retary for Fish, Wildlife and Parks at This sort of conduct is simply unac- the loss of U.S. Army 1LT Kevin Gasp- the U.S. Interior Department. Con- ceptable. If you agree to work in the ers of Hastings, NE. Lieutenant Gasp- sistent with my policy of publicly an- Interior Department, your loyalty ers was killed on Apri1 23 in Diya1a nouncing whenever I place a hold on a should be with the Interior Department province, Iraq. He was 26 years old. nomination, I want to notify my col- and protecting this country’s natural Lieutenant Gaspers was a 2000 grad- leagues of my objection to allowing treasures. Ms. MacDonald’s loyalty lay uate of St. Cecilia High School in Mr. Laverty’s nomination to be consid- elsewhere. Hastings, where he wrestled and played ered under a unanimous-consent agree- The inspector general sent his report football. After graduation, he attended ment. and to take a few minutes to ex- on Ms. MacDonald to the Interior De- the University of Nebraska at Lincoln plain to my colleagues why I am doing partment for administrative action and enrolled in the ROTC program. As so. more than a month ago. The Interior a senior at UNL, Lieutenant Gaspers The Interior Department has suffered Department had no public comment. was selected to lead the ROTC cadet’s no shortage of scandals in recent years. Only after I announced that I would battalion. His colleagues remember To name just two of the most egre- place a hold on Mr. Laverty’s nomina- him as low-key and professional in his gious: Its former No. 2 official, a Dep- tion did Ms. MacDonald resign. That leadership style. He earned his Army uty Interior Secretary who previously removes her from the equation, but not officer’s commission in 2005, along with had been a coal industry lobbyist, the atmosphere that allowed her to op- a degree from UNL in accounting. pleaded guilty earlier this year to fel- erate as she did for so long.

VerDate Aug 31 2005 04:38 May 02, 2007 Jkt 059060 PO 00000 Frm 00075 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.038 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5390 CONGRESSIONAL RECORD — SENATE May 1, 2007 In case I wasn’t perfectly clear last plateaus that surround the base. The ending September 30, 2007, and for other pur- year at his confirmation hearing, I 366th Fighter Wing is a force to be poses. want to be sure that Secretary Kemp- reckoned with when it comes to the na- The enrolled bill was subsequently thorne knows that I am serious. The tional security of the United States. signed by the President pro tempore Interior Department has been a source The missions currently headquartered (Mr. BYRD). of shame to this government for too at Mountain Home comprise a vital f long. It is failing in its mission to pro- component of our comprehensive mili- MEASURES PLACED ON THE tect the public land and balance the tary defensive and offensive force. CALENDAR needs of the American people with wis- Idaho is fortunate to be host and home dom and integrity. It has stumbled to these defenders of freedom. The following bill was read the sec- from one misstep to another, from one Idaho benefits from Mountain Home ond time, and placed on the calendar: scandal to another, and I have to ques- Air Force Base, not just when the mili- H.R. 1332. An act to improve the access to tion who is in charge over there. tary men and women serving out their capital programs of the Small Business Ad- I want to hear from Secretary Kemp- assignments there call our State ministration, and for other purposes. thorne what action he plans to take to ‘‘home’’ for a time in their military ca- f be certain that we won’t see this sort reers but also when some return to call INTRODUCTION OF BILLS AND of problem again. I want to hear from Idaho home permanently in retire- JOINT RESOLUTIONS Mr. Laverty what he would do, if he is ment. The following bills and joint resolu- confirmed to the post of Assistant Sec- I offer my sincere congratulations to tions were introduced, read the first retary, to end the politicization of the the Gunfighters and my heartfelt grati- and second times by unanimous con- Fish and Wildlife Service. We cannot tude for their service to our great sent, and referred as indicated: continue to have government scientists country, in defense of my freedom and whose work is manipulated and conclu- that of my family. By Ms. MIKULSKI (for herself, Mr. sions are rewritten by political ap- VOINOVICH, and Mr. HARKIN): f S. 1254. A bill to amend title II of the So- pointees. We cannot continue to have ADDITIONAL STATEMENTS cial Security Act to provide that the reduc- federal officials working secretly with tions in social security benefits which are re- groups challenging their own agencies. quired in the case of spouses and surviving Until I receive these assurances, I spouses who are also receiving certain gov- TRIBUTE TO BOB HUDSON will object to any unanimous consent ernment pensions shall be equal to the agreement to allow Mr. Laverty’s nom- ∑ Mr. DOMENICI. Mr. President, I amount by which two-thirds of the total ination to come to a vote in the Sen- would like to pay tribute to the public amount of the combined monthly benefit ate. service of Bob Hudson, city manger of (before reduction) and monthly pension ex- Farmington, NM. ceeds $1,200, adjusted for inflation; to the f Committee on Finance. Bob first came to New Mexico in 1982 IDAHO GUNFIGHTERS HONORED By Mr. McCAIN (for himself, Mr. KYL, to take on the job as director of parks, Mr. THOMAS, and Mr. DOMENICI): Mr. CRAPO. Mr. President, on March recreation & cultural affairs in Farm- S. 1255. A bill to protect Indian arts and 30, Secretary of Defense Robert Gates ington. Since that time he has served crafts through the improvement of applica- announced that Mountain Home Air the citizens of Farmington faithfully, ble criminal proceedings, and for other pur- Force Base in my home State of Idaho eventually becoming city manager in poses; to the Committee on Indian Affairs. had earned the coveted 2007 Com- 1999. By Mr. KERRY (for himself, Ms. mander in Chief’s Annual Award for In- Bob’s commitment to the community SNOWE, and Mr. LEVIN): stallation Excellence. This Presi- S. 1256. A bill to amend the Small Business of Farmington did not end with his of- Act to reauthorize loan programs under that dential honor is given only to a single ficial duties. He has also served on the Act, and for other purposes; to the Com- installation in each of the military boards of several local organizations mittee on Small Business and Entrepreneur- branches for outstanding and innova- including the Boys & Girls Club, the ship. tive efforts by installation personnel. I Farmington Inter-tribal Indian Organi- By Mr. LIEBERMAN (for himself, Mr. am honored to be able to publicly her- zation, and the Chamber of Commerce. HATCH, and Mr. BENNETT): ald this tremendous achievement by The citizens of Farmington are well S. 1257. A bill to provide the District of Co- Colonel Rock and all the men and aware of Bob’s contributions to their lumbia a voting seat and the State of Utah women of Mountain Home Air Force an additional seat in the House of Represent- community and have honored him with atives; to the Committee on Homeland Secu- Base. numerous awards, including the New rity and Governmental Affairs. This high honor reflects a sustained Mexico Distinguished Public Service By Ms. CANTWELL (for herself, Mr. level of excellence by all the Gun- Award in 1991 and the Elks Citizen of HATCH, Mr. WYDEN, Mr. ALLARD, and fighters of Mountain Home. Installa- the Year award in 1995. Bob was also in- Mr. SMITH): tion of the Year can only be achieved if ducted into the History Makers Hall of S. 1258. A bill to amend the Reclamation everyone, from the wing commander to Fame by the Farmington Chamber of Safety of Dams Act of 1978 to authorize im- airmen working in all aspects of oper- Commerce in 2001 and the recipient of provements for the security of dams and ations and support, has their priorities other facilities; to the Committee on Energy the 2005 Public Employee of the Year and Natural Resources. straight and expectations for personal award. By Mrs. CLINTON (for herself and Mr. duty performance at the highest level. Bob is retiring in April to devote SMITH): Improving the structures that protect more time to his family, but I am sure S. 1259. A bill to amend the Foreign Assist- valuable aircraft, creative and respon- his dedication to the community of ance Act of 1961 to provide assistance for de- sible financial management with re- Farmington will not end. I wish him veloping countries to promote quality basic gard to improving facilities, and a the best in retirement and thank him education and to establish the achievement of universal basic education in all developing commitment to Air Force families are for his long years of service.∑ just some of the ways in which Moun- countries as an objective of United States f foreign assistance policy, and for other pur- tain Home Air Force Base dem- MESSAGE FROM THE HOUSE poses; to the Committee on Foreign Rela- onstrated its excellence this year. The tions. Gunfighters have maintained this By Mr. CARPER (for himself and Mr. strong tradition of superiority and ex- BENNETT): cellence for over half a century. The ENROLLED BILL SIGNED S. 1260. A bill to protect information relat- missions have changed over the years, At 3:20 p.m., a message from the ing to consumers, to require notice of secu- but Gunfighter commitment and per- House of Representatives, delivered by rity breaches, and for other purposes; to the formance has not. one of its clerks, announced that the Committee on Banking, Housing, and Urban Affairs. Idahoans can be very proud of their Speaker has signed the following en- By Ms. CANTWELL (for herself, Mr. Gunfighters. Mountain Home Air Force rolled bill: HARKIN, and Mr. BROWN): Base is as much a part of Idaho history H.R. 1591. An act making emergency sup- S. 1261. A bill to amend title 10 and 38, as the magnificent valleys, rivers, and plemental appropriations for the fiscal year United States Code, to repeal the 10-year

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00076 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.021 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5391 limit on use of Montgomery GI Bill edu- (Mrs. FEINSTEIN) was added as a co- from South Dakota (Mr. JOHNSON) were cational assistance benefits, and for other sponsor of S. 329, a bill to amend title added as cosponsors of S. 604, a bill to purposes; to the Committee on Veterans’ Af- XVIII of the Social Security Act to amend title 10, United States Code, to fairs. provide coverage for cardiac rehabilita- limit increases in the certain costs of f tion and pulmonary rehabilitation health care services under the health SUBMISSION OF CONCURRENT AND services. care programs of the Department of SENATE RESOLUTIONS S. 339 Defense, and for other purposes. The following concurrent resolutions At the request of Mr. BAYH, the name S. 609 and Senate resolutions were read, and of the Senator from Rhode Island (Mr. At the request of Mr. ROCKEFELLER, referred (or acted upon), as indicated: REED) was added as a cosponsor of S. the name of the Senator from Min- By Mr. BINGAMAN: 339, a bill to promote the national secu- nesota (Ms. KLOBUCHAR) was added as a S. Res. 178. A resolution expressing the rity and stability of the United States cosponsor of S. 609, a bill to amend sec- sympathy of the Senate to the families of economy by reducing the dependence of tion 254 of the Communications Act of women and girls murdered in Guatemala, the United States on oil through the 1934 to provide that funds received as and encouraging the United States to work use of alternative fuels and new tech- universal service contributions and the with Guatemala to bring an end to these nology, and for other purposes. universal service support programs es- crimes; to the Committee on Foreign Rela- tablished pursuant to that section are tions. S. 543 By Mr. BOND: At the request of Mr. NELSON of Ne- not subject to certain provisions of S. Res. 179. A resolution welcoming the braska, the names of the Senator from title 31, United States Code, commonly Prime Minister of Singapore on the occasion Idaho (Mr. CRAIG), the Senator from known as the Antideficiency Act. of his visit to the United States and the 40th Florida (Mr. NELSON) and the Senator S. 624 anniversary of the Association of Southeast from Rhode Island (Mr. WHITEHOUSE) At the request of Ms. MIKULSKI, the Asian Nations (ASEAN), expressing grati- name of the Senator from Washington tude to the Government of Singapore for its were added as cosponsors of S. 543, a strong cooperation with the United States in bill to improve Medicare beneficiary (Mrs. MURRAY) was added as a cospon- the campaign against terrorism, and re- access by extending the 60 percent sor of S. 624, a bill to amend the Public affirming the commitment of the United compliance threshold used to deter- Health Service Act to provide waivers States to the continued expansion of friend- mine whether a hospital or unit of a relating to grants for preventive health ship and cooperation between the United hospital is an inpatient rehabilitation measures with respect to breast and States and Singapore; to the Committee on facility under the Medicare program. cervical cancers. Foreign Relations. S. 689 By Mr. CRAPO (for himself and Mr. S. 578 CRAIG): At the request of Mr. KENNEDY, the At the request of Mr. LUGAR, the S. Res. 180. A resolution recognizing the name of the Senator from New Jersey name of the Senator from North Da- 70th anniversary of the Idaho Potato Com- (Mr. LAUTENBERG) was added as a co- kota (Mr. DORGAN) was added as a co- mission and designating May 2007 as ‘‘Idaho sponsor of S. 578, a bill to amend title sponsor of S. 689, a bill to amend the Potato Month’’; to the Committee on the Ju- XIX of the Social Security Act to im- Internal Revenue Code of 1986 to per- diciary. prove requirements under the Medicaid manently extend and expand the chari- By Mr. ALLARD (for himself, Mr. table deduction for contributions of PRYOR, and Mr. CRAIG): program for items and services fur- S. Res. 181. A resolution honoring and rec- nished in or through an educational food inventory. ognizing the achievements of the United program or setting to children, includ- S. 691 States Air Force Academy football program ing children with developmental, phys- At the request of Mr. CONRAD, the over the last 27 years; considered and agreed ical, or mental health needs, and for name of the Senator from Mississippi to. other purposes. (Mr. LOTT) was added as a cosponsor of By Mrs. FEINSTEIN (for herself, Mr. S. 579 S. 691, a bill to amend title XVIII of the SPECTER, Mr. LEAHY, Mr. HATCH, Mrs. BOXER, Mr. CORNYN, Mr. KENNEDY, At the request of Mr. HATCH, the Social Security Act to improve the Mr. DURBIN, Mr. DODD, Mr. KERRY, name of the Senator from Minnesota benefits under the Medicare program Ms. STABENOW, Ms. CANTWELL, Mr. (Mr. COLEMAN) was added as a cospon- for beneficiaries with kidney disease, HARKIN, Ms. LANDRIEU, Mr. MENEN- sor of S. 579, a bill to amend the Public and for other purposes. DEZ, and Mr. COLEMAN): Health Service Act to authorize the Di- S. 695 S. Res. 182. A resolution honoring the life rector of the National Institute of En- of Jack Valenti; considered and agreed to. At the request of Ms. SNOWE, the By Ms. LANDRIEU (for herself, Mr. AL- vironmental Health Sciences to make name of the Senator from South Da- EXANDER, Mr. LIEBERMAN, Mr. CAR- grants for the development and oper- kota (Mr. JOHNSON) was added as a co- PER, Mr. BURR, Mr. DEMINT, Mr. ation of research centers regarding en- sponsor of S. 695, a bill to amend the VITTER, Mrs. DOLE, and Mr. GREGG): vironmental factors that may be re- International Claims Settlement Act S. Res. 183. A resolution supporting the lated to the etiology of breast cancer. of 1949 to allow for certain claims of goals and ideals of National Charter Schools S. 588 nationals of the United States against Week, April 30, 2007, through May 4, 2007; Turkey, and for other purposes. considered and agreed to. At the request of Mr. NELSON of Flor- By Mr. CHAMBLISS (for himself and ida, the name of the Senator from S. 721 Mr. CASEY): Maine (Ms. COLLINS) was added as a co- At the request of Mr. ENZI, the name S. Res. 184. A resolution expressing the sponsor of S. 588, a bill to amend title of the Senator from Vermont (Mr. sense of the Senate with respect to childhood XVIII of the Social Security Act to in- SANDERS) was added as a cosponsor of stroke and designating May 5, 2007, as ‘‘Na- crease the Medicare caps on graduate S. 721, a bill to allow travel between tional Childhood Stroke Awareness Day’’; medical education positions for States considered and agreed to. the United States and Cuba. with a shortage of residents. S. 725 f S. 589 At the request of Mr. LEVIN, the ADDITIONAL COSPONSORS At the request of Mr. ALLARD, the name of the Senator from Michigan S. 242 name of the Senator from Alaska (Mr. (Ms. STABENOW) was added as a cospon- At the request of Mr. DORGAN, the STEVENS) was added as a cosponsor of sor of S. 725, a bill to amend the Non- name of the Senator from Missouri S. 589, a bill to provide for the transfer indigenous Aquatic Nuisance Preven- (Mrs. MCCASKILL) was added as a co- of certain Federal property to the tion and Control Act of 1990 to reau- sponsor of S. 242, a bill to amend the United States Paralympics, Incor- thorize and improve that Act. Federal Food, Drug, and Cosmetic Act porated, a subsidiary of the United S. 755 with respect to the importation of pre- States Olympic Committee. At the request of Mr. SCHUMER, the scription drugs, and for other purposes. S. 604 name of the Senator from Ohio (Mr. S. 329 At the request of Mr. LAUTENBERG, BROWN) was added as a cosponsor of S. At the request of Mr. CRAPO, the the names of the Senator from Michi- 755, a bill to amend title XIX of the So- name of the Senator from California gan (Ms. STABENOW) and the Senator cial Security Act to require States to

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00077 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.052 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5392 CONGRESSIONAL RECORD — SENATE May 1, 2007 provide diabetes screening tests under vide for the treatment of Individual (Mr. CARPER), the Senator from Mary- the Medicaid program for adult enroll- Development Accounts, and for other land (Mr. CARDIN), the Senator from ees with diabetes risk factors, to en- purposes. Ohio (Mr. BROWN) and the Senator from sure that States offer a comprehensive S. 886 South Dakota (Mr. JOHNSON) were package of benefits under that program At the request of Mr. BINGAMAN, the added as cosponsors of S. 999, a bill to for individuals with diabetes, and for name of the Senator from Texas (Mr. amend the Public Health Service Act other purposes. CORNYN) was added as a cosponsor of S. to improve stroke prevention, diag- S. 774 886, a bill to amend chapter 22 of title nosis, treatment, and rehabilitation. At the request of Mr. DURBIN, the 44, United States Code, popularly S. 1040 names of the Senator from New Mexico known as the Presidential Records Act, At the request of Mr. SHELBY, the (Mr. BINGAMAN), the Senator from to establish procedures for the consid- name of the Senator from New Hamp- Washington (Ms. CANTWELL), the Sen- eration of claims of constitutionally shire (Mr. SUNUNU) was added as a co- ator from New York (Mrs. CLINTON), based privilege against disclosure of sponsor of S. 1040, a bill to repeal the the Senator from Massachusetts (Mr. Presidential records. current Internal Revenue Code and re- KERRY), the Senator from New Jersey S. 897 place it with a flat tax, thereby guar- (Mr. MENENDEZ), the Senator from At the request of Ms. MIKULSKI, the anteeing economic growth and greater Washington (Mrs. MURRAY) and the name of the Senator from Washington fairness for all Americans. Senator from Nevada (Mr. REID) were (Mrs. MURRAY) was added as a cospon- S. 1092 added as cosponsors of S. 774, a bill to sor of S. 897, a bill to amend the Inter- At the request of Mr. HAGEL, the amend the Illegal Immigration Reform nal Revenue Code of 1986 to provide name of the Senator from New Hamp- more help to Alzheimer’s disease care- and Immigrant Responsibility Act of shire (Mr. SUNUNU) was added as a co- 1996 to permit States to determine givers. sponsor of S. 1092, a bill to temporarily State residency for higher education S. 898 increase the number of visas which purposes and to authorize the cancella- At the request of Ms. MIKULSKI, the may be issued to certain highly skilled tion of removal and adjustment of sta- name of the Senator from Washington workers. (Mrs. MURRAY) was added as a cospon- tus of certain alien students who are S. 1149 sor of S. 898, a bill to amend the Public long-term United States residents and At the request of Mr. KOHL, the name Health Service Act to fund break- who entered the United States as chil- of the Senator from Wisconsin (Mr. throughs in Alzheimer’s disease re- dren, and for other purposes. FEINGOLD) was added as a cosponsor of search while providing more help to S. 805 S. 1149, a bill to amend the Federal caregivers and increasing public edu- At the request of Mr. DURBIN, the Meat Inspection Act and the Poultry cation about prevention. name of the Senator from California Products Inspection Act to authorize S. 901 (Mrs. FEINSTEIN) was added as a co- the interstate distribution of State-in- At the request of Mr. KENNEDY, the sponsor of S. 805, a bill to amend the spected meat and poultry if the Sec- names of the Senator from Illinois (Mr. Foreign Assistance Act of 1961 to assist retary of Agriculture determines that DURBIN) and the Senator from Wash- countries in sub-Saharan Africa in the the State inspection requirements are ington (Ms. CANTWELL) were added as effort to achieve internationally recog- at least equal to Federal inspection re- cosponsors of S. 901, a bill to amend the nized goals in the treatment and pre- quirements and to require the Sec- Public Health Service Act to provide vention of HIV/AIDS and other major additional authorizations of appropria- retary to reimburse State agencies for diseases and the reduction of maternal tions for the health centers program part of the costs of the inspections. and child mortality by improving under section 330 of such Act. S. 1164 human health care capacity and im- At the request of Mr. CARDIN, the S. 903 proving retention of medical health name of the Senator from Rhode Island At the request of Mr. DURBIN, the professionals in sub-Saharan Africa, name of the Senator from California (Mr. WHITEHOUSE) was added as a co- and for other purposes. (Mrs. FEINSTEIN) was added as a co- sponsor of S. 1164, a bill to amend title S. 831 sponsor of S. 903, a bill to award a Con- XVIII of the Social Security Act to im- At the request of Mr. DURBIN, the gressional Gold Medal to Dr. Muham- prove patient access to, and utilization name of the Senator from Maryland mad Yunus, in recognition of his con- of, the colorectal cancer screening ben- (Ms. MIKULSKI) was added as a cospon- tributions to the fight against global efit under the Medicare Program. sor of S. 831, a bill to authorize States poverty. S. 1183 and local governments to prohibit the S. 968 At the request of Mr. HARKIN, the investment of State assets in any com- At the request of Mrs. BOXER, the name of the Senator from Washington pany that has a qualifying business re- name of the Senator from Washington (Mrs. MURRAY) was added as a cospon- lationship with Sudan. (Mrs. MURRAY) was added as a cospon- sor of S. 1183, a bill to enhance and fur- S. 847 sor of S. 968, a bill to amend the For- ther research into paralysis and to im- At the request of Mrs. MURRAY, the eign Assistance Act of 1961 to provide prove rehabilitation and the quality of name of the Senator from Vermont increased assistance for the prevention, life for persons living with paralysis (Mr. SANDERS) was added as a cospon- treatment, and control of tuberculosis, and other physical disabilities, and for sor of S. 847, a bill to extend the period and for other purposes. other purposes. of time during which a veteran’s mul- S. 969 S. 1202 tiple sclerosis is to be considered to At the request of Mr. DODD, the name At the request of Mr. SESSIONS, the have been incurred in, or aggravated of the Senator from New Jersey (Mr. name of the Senator from Arizona (Mr. by, military service during a period of LAUTENBERG) was added as a cosponsor KYL) was added as a cosponsor of S. war. of S. 969, a bill to amend the National 1202, a bill to require agencies and per- S. 848 Labor Relations Act to modify the defi- sons in possession of computerized data At the request of Mrs. MURRAY, the nition of supervisor. containing sensitive personal informa- name of the Senator from Vermont S. 970 tion, to disclose security breaches (Mr. SANDERS) was added as a cospon- At the request of Mr. SMITH, the where such breach poses a significant sor of S. 848, a bill to amend title 38, name of the Senator from South Caro- risk of identity theft. United States Code, to provide im- lina (Mr. GRAHAM) was added as a co- S. 1204 proved benefits for veterans who are sponsor of S. 970, a bill to impose sanc- At the request of Mr. DODD, the name former prisoners of war. tions on Iran and on other countries for of the Senator from Ohio (Mr. BROWN) S. 871 assisting Iran in developing a nuclear was added as a cosponsor of S. 1204, a At the request of Mr. LIEBERMAN, the program, and for other purposes. bill to enhance Federal efforts focused name of the Senator from Michigan S. 999 on public awareness and education (Ms. STABENOW) was added as a cospon- At the request of Mr. COCHRAN, the about the risks and dangers associated sor of S. 871, a bill to establish and pro- names of the Senator from Delaware with Shaken Baby Syndrome.

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00078 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.045 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5393 S. 1210 land of the United States should pro- suggests it is the product of an indi- At the request of Mrs. FEINSTEIN, the vide from renewable resources not less vidual Indian or Indian Tribe. name of the Senator from South Da- than 25 percent of the total energy con- Unfortunately, the law is written so kota (Mr. JOHNSON) was added as a co- sumed in the United States and con- that only the Federal Bureau of Inves- sponsor of S. 1210, a bill to extend the tinue to produce safe, abundant, and tigation, FBI, acting on behalf of the grant program for drug-endangered affordable food, feed, and fiber. Attorney General, can investigate and children. S. RES. 125 make arrests in cases of suspected In- S. 1211 At the request of Mrs. FEINSTEIN, the dian art counterfeiters. The bill we are introducing would amend the law to At the request of Mrs. FEINSTEIN, the name of the Senator from Ohio (Mr. expand existing Federal investigative name of the Senator from South Da- BROWN) was added as a cosponsor of S. authority by authorizing other Federal kota (Mr. JOHNSON) was added as a co- Res. 125, a resolution designating May sponsor of S. 1211, a bill to amend the 18, 2007, as ‘‘Endangered Species Day’’, investigative bodies, such as the BIA Controlled Substances Act to provide and encouraging the people of the Office of Law Enforcement, in addition to the FBI, to investigate cases of mis- enhanced penalties for marketing con- United States to become educated representation of Indian arts and trolled substances to minors. about, and aware of, threats to species, crafts. This bill is similar to provisions S. 1232 success stories in species recovery, and the opportunity to promote species included in the Native American Omni- At the request of Mr. DODD, the name bus Act, S. 536, and S. 1375, which conservation worldwide. of the Senator from Ohio (Mr. BROWN) passed the Senate at the end of the last was added as a cosponsor of S. 1232, a S. RES. 146 Congress but were not acted on by the bill to direct the Secretary of Health At the request of Mr. ALEXANDER, the House. and Human Services, in consultation name of the Senator from Iowa (Mr. A major source of tribal and indi- with the Secretary of Education, to de- GRASSLEY) was added as a cosponsor of vidual Indian income is derived from velop a voluntary policy for managing S. Res. 146, a resolution designating the sale of handmade Indian arts and the risk of food allergy and anaphy- June 20, 2007, as ‘‘American Eagle crafts. Yet millions of dollars are di- laxis in schools, to establish school- Day’’, and celebrating the recovery and verted each year from these original based food allergy management grants, restoration of the American bald eagle, artists and Indian tribes by those who and for other purposes. the national symbol of the United reproduce and sell counterfeit Indian S. 1237 States. goods. Few, if any, criminal prosecu- At the request of Mr. LAUTENBERG, S. RES. 162 tions have been brought in Federal the name of the Senator from Massa- At the request of Mr. LEAHY, the court for such violations. It is under- chusetts (Mr. KENNEDY) was added as a name of the Senator from New York standable that enforcing the criminal cosponsor of S. 1237, a bill to increase (Mr. SCHUMER) was added as a cospon- law under the Indian Arts and Crafts public safety by permitting the Attor- sor of S. Res. 162, a resolution com- Act is often stalled by the other re- ney General to deny the transfer of memorating and acknowledging the sponsibilities of the FBI including in- firearms or the issuance of firearms dedication and sacrifice made by the vestigating terrorism activity and vio- and explosives licenses to known or men and women who have lost their lent crimes in Indian country. There- suspected dangerous terrorists. lives while serving as law enforcement fore, expanding the investigative au- thority to include other Federal agen- S. 1243 officers. cies is intended to promote the active At the request of Mr. KERRY, the S. RES. 171 investigation of alleged misconduct. It name of the Senator from Maryland At the request of Ms. COLLINS, the is my hope that this much needed (Ms. MIKULSKI) was added as a cospon- names of the Senator from Arkansas change will deter those who choose to sor of S. 1243, a bill to amend title 10, (Mr. PRYOR), the Senator from Wash- ington (Mrs. MURRAY), the Senator violate the law. United States Code, to reduce the age I urge my colleagues to support this from Connecticut (Mr. LIEBERMAN), and for receipt of military retired pay for bill. nonregular service from 60 years of age the Senator from Maine (Ms. SNOWE) to 55 years of age. were added as cosponsors of S. Res. 171, By Mr. KERRY (for himself, Ms. S. 1244 a resolution memorializing fallen fire- SNOWE, and Mr. LEVIN): fighters by lowering the United States At the request of Mr. KENNEDY, the S. 1256. A bill to amend the Small name of the Senator from Vermont flag to half-staff on the day of the Na- Business Act to reauthorize loan pro- tional Fallen Firefighter Memorial (Mr. LEAHY) was added as a cosponsor grams under that Act, and for other of S. 1244, a bill to amend the Occupa- Service in Emmitsburg, Maryland. purposes; to the Committee on Small tional Safety and Health Act of 1970 to f Business and Entrepreneurship. Ms. SNOWE. Mr. President, as rank- expand coverage under the Act, to in- STATEMENTS ON INTRODUCED ing member of the Senate Committee crease protections for whistleblowers, BILLS AND JOINT RESOLUTIONS to increase penalties for certain viola- on Small Business and Entrepreneur- By Mr. MCCAIN (for himself, Mr. tors, and for other purposes. ship, I rise today to join with Senator KYL, Mr. THOMAS, and Mr. KERRY in introducing, the Small Busi- S. 1250 DOMENICI): ness Lending Reauthorization and Im- At the request of Ms. SNOWE, the S. 1255. A bill to protect Indian arts provement Act of 2007. This bill is espe- name of the Senator from Maine (Ms. and crafts through the improvement of cially timely considering the Nation COLLINS) was added as a cosponsor of S. applicable criminal proceedings, and recently celebrated National Small 1250, a bill to direct the United States for other purposes; to the Committee Business Week, and this body just Trade Representative to conduct an in- on Indian Affairs. passed the America COMPETES Act, a vestigation of the personal exemption Mr. MCCAIN. Mr. President, I am bill that invests in innovation and edu- allowance that Canada provides for pleased to be joined by my colleagues cation to improve the competitiveness merchandise purchased abroad by Ca- Senator THOMAS, Senator KYL, and of the United States in the global econ- nadian residents, and for other pur- Senator DOMENICI in introducing a bill omy. poses. to amend the Indian Arts and Crafts The impact small businesses have on S. CON. RES. 3 Act. This legislation would improve our country’s economy and the techno- At the request of Mr. SALAZAR, the Federal laws that protect the integrity logical innovations they create simply name of the Senator from Vermont and originality of Native American cannot be overstated. Small hi-tech (Mr. SANDERS) was added as a cospon- arts and crafts. firms represent the most innovative sor of S. Con. Res. 3, a concurrent reso- The Indian Arts and Crafts Act pro- sector in America. According to the lution expressing the sense of Congress hibits the misrepresentation in mar- Small Business Administration’s Office that it is the goal of the United States keting of Indian arts and crafts prod- of Advocacy, these businesses hold over that, not later than January 1, 2025, ucts, and makes it illegal to display or 40 percent of the Nation’s patents, ob- the agricultural, forestry, and working sell works in a manner that falsely tain 13 to 14 times more patents per

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00079 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.047 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5394 CONGRESSIONAL RECORD — SENATE May 1, 2007 employee than large businesses, and se- a strong and vibrant Small Business taxes just like everyone else. In fact, cure patents which are twice as techno- Administration. The Small Business they pay more: Per capita, District logically significant as larger firms. Lending Reauthorization and Improve- residents have the second highest Fed- With American jobs and our security at ment Act of 2007 will build on the pre- eral tax obligation. And yet they have stake, it is essential that we support vious success of the Agency, and help no voice in how high those taxes will innovation programs to meet national to ensure the success of tomorrow’s en- be or how they will be spent. The Dis- challenges in defense, healthcare, en- trepreneurs. trict is also the only jurisdiction in the ergy, and information technology. country that must seek congressional A critical partner for small busi- By Mr. LIEBERMAN (for himself, approval, through the appropriations nesses is the Small Business Adminis- Mr. HATCH, and Mr. BENNETT): process, before spending locally-gen- tration, SBA, whose fundamental pur- S. 1257. A bill to provide the District erated tax dollars. When Congress fails pose is to ‘‘aid, counsel, assist, and pro- of Columbia a voting seat and the to pass appropriations bills before the tect the interests of small-business State of Utah an additional seat in the beginning of the fiscal year, the Dis- concerns.’’ The SBA’s methods for car- House of Representatives; to the Com- trict’s budget is essentially frozen. And rying out this mandate vary widely, mittee on Homeland Security and Gov- yet DC has no say in that appropria- but the agency’s primary tool is found ernmental Affairs. tions process. in its small business lending programs. Mr. LIEBERMAN. Mr. President, I DC residents fight and die for our de- The SBA’s 7(a), 504, and Microloan pro- rise today with my colleague from mocracy but they cannot participate grams are tailored to encourage small Utah, Senator HATCH, to introduce bi- fully in it. I ask you, how can we effec- business growth and expansion. With partisan legislation that I believe is tively promote democracy abroad small businesses representing 99 per- the breakthrough we have been search- while denying it to hundreds of thou- cent of all employers, creating nearly ing for to bring House voting represen- sands of citizens in our Nation’s Cap- 75 percent of all net new jobs, and em- tation to the residents of the District ital? ploying 51 percent of the private-sector of Columbia, who have historically There is no good reason why DC resi- workforce, it is essential that Congress been denied this fundamental birth- dents have been denied congressional affirms long-term stability in the lend- right. representation. In 1800, when the na- ing programs the SBA provides to the I am proud to join with, DC Delegate tion’s capital was established as the small business community. ELEANOR HOLMES NORTON and Rep- District of Columbia, an oversight left As it has in the past, the SBA con- resentative TOM DAVIS, and the many the area’s residents without congres- tinues to meet the demands of small others from both parties and both sional representation. Maryland and businesses, both in my home state of houses who have worked without rest Virginia ceded land for the capitol in Maine and across the county. In fiscal to remedy the disenfranchisement of 1788 and 1789, respectively, but it took Year 2006, the SBA backed a net 100,197 District residents since the capital was another 10 years for Congress to estab- loans totaling over $19.1 billion under established in Washington in 1800. I es- lish the District of Columbia. In the in- the 7(a) and 504 programs. In fact, both pecially want to thank my friend Sen- terim, residents continued to vote ei- the number of loans and the dollar ator HATCH for his influential support ther in Maryland or Virginia, but Con- amount represent record amounts for of this voting rights proposal, which gress withdrew those voting rights the agency—dramatically highlighting would bring to an end a gross incon- once the District was founded. Unfortu- the significance of the SBA and the sistency with the founding principles of nately, apparently by omission, Con- critical role it plays in our nation’s our Nation. gress neglected to establish new voting economy. Mr. President, we have a historic op- rights for the citizens of the new dis- The foundation for the bill Senator portunity today to finally bestow upon trict. KERRY and I are introducing today the citizens of the District of Columbia The right to be counted, to have your started during the 109th Congress under the civic entitlement every other tax- voice heard by your government is cen- an extensive reauthorization process paying American citizen enjoys no tral to a functioning democracy and which I led. This process ultimately matter where he or she resides, democ- fundamental to a free society. If we are culminated in the unanimous Small racy’s most essential right, voting rep- willing to sacrifice our young men and Business Committee passage of a com- resentation in Congress. women in the name of freedom, we prehensive SBA reauthorization bill. I The bill is simple. It would increase must be willing to protect their free- firmly believe that the Small Business the number of voting representatives doms as well. This legislation would do Lending Reauthorization and Improve- in the House from 435 to 437 by pro- just that. ment Act of 2007 will help the SBA con- viding the District with a voting rep- In 2002, 10 cosponsors and I intro- tinue its legacy of achievement. resentative and by adding another con- duced the No Taxation without Rep- The SBA’s loan and investment pro- gressional seat for Utah, the next State resentation Act. I held a hearing on the grams have produced success story in line to increase its representation bill in the Governmental Affairs Com- after success story, which include as- based on the 2000 Census. mittee, which I then chaired. It was sisting the founders of Intel, Staples, Working cooperatively in the spirit the first hearing in Congress on DC and Federal Express, as well as thou- of service to the people of Washington, voting rights since 1994. We reported sands of other successful businesses. DC, and Utah, Congresswoman NORTON the bill out of committee, but the Sen- Our bipartisan measure will build upon and Congressman DAVIS shepherded a ate never took action on it. these past successes and make the SBA similar proposal through the House Today, the tide has changed. Mem- even more effective. As former Chair Government Reform Committee on bers from both parties have come to- and now ranking member of the Small March 13 by a vote of 24–5. The full gether to find a solution to break the Business Committee, I believe we must House approved the measure April 20 stalemates of the past that have denied do everything possible to sustain pros- by a vote of 241–177, a historic day un- DC residents equal representation in perity and job creation throughout the like any other since 1978 when Congress Congress. The State of Utah has united United States. To achieve that goal, I approved a constitutional amendment in favor of a fourth congressional seat, have long fought to solidify and expand to give District residents voting rights and Senator HATCH has lent his consid- the reach of the SBA’s programs that in the House and Senate. Of course, erable support to this effort. Mr. Presi- have helped millions of aspiring entre- that amendment came to naught when dent, this legislation represents an un- preneurs and existing small businesses. too few States ratified it. common victory for fairness and a rare Small businesses yearn to grow, The people of this city have waited but hopefully increasingly more com- flourish, and thrive, and the SBA has far too long for this right. They have mon example of what we can do if we the experience and the resources to be been the direct target of terrorist at- work together to accomplish our mu- their bridge to success. It is essential tacks, and yet they have no representa- tual goals. that we upgrade the SBA’s core lending tive to vote in Congress on policies to The essence of our work in the legis- programs for the 21st century entre- protect their homeland security. Citi- lative branch is compromise, and the preneur. The American economy needs zens of Washington, DC, pay income compromise reached by Senator HATCH

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00080 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.054 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5395 and I will bring partial voting rep- United States Code, is amended by striking SEC. 5. CONFORMING AMENDMENTS. resentation to the District while ensur- ‘‘come into office;’’ and inserting the fol- (a) REPEAL OF OFFICE OF DISTRICT OF CO- ing Utah receives the additional rep- lowing: ‘‘come into office (subject to the LUMBIA DELEGATE.— (1) REPEAL OF OFFICE.— resentation it is due. twenty-third article of amendment to the Constitution of the United States in the case (A) IN GENERAL.—Sections 202 and 204 of I know there are those who believe of the District of Columbia);’’. the District of Columbia Delegate Act (Pub- this bill is unconstitutional. But the lic Law 91–405; sections 1–401 and 1–402, D.C. SEC. 3. INCREASE IN MEMBERSHIP OF HOUSE OF District clause of the Constitution, REPRESENTATIVES. Official Code) are repealed, and the provi- which gives Congress the power to leg- sions of law amended or repealed by such (a) PERMANENT INCREASE IN NUMBER OF sections are restored or revived as if such islate ‘‘in all cases whatsoever’’ per- MEMBERS.—Effective with respect to the taining to the District, provides ample sections had not been enacted. 111th Congress and each succeeding Con- (B) EFFECTIVE DATE.—The amendments authority for the legislative branch to gress, the House of Representatives shall be made by this subsection shall take effect on give DC residents voting rights. composed of 437 Members, including the the date on which a Representative from the Mr. President, this is our moment to Member representing the District of Colum- District of Columbia takes office for the do right here at home, just as we have bia pursuant to section 2(a). 111th Congress. done throughout our history for our (b) REAPPORTIONMENT OF MEMBERS RESULT- (2) CONFORMING AMENDMENTS TO DISTRICT democratic allies abroad. By giving the ING FROM INCREASE.— OF COLUMBIA ELECTIONS CODE OF 1955.—The citizens of the District of Columbia a (1) IN GENERAL.—Section 22(a) of the Act District of Columbia Elections Code of 1955 is entitled ‘‘An Act to provide for the fifteenth vote in the House, we will ensure not amended as follows: and subsequent decennial censuses and to (A) In section 1 (sec. 1–1001.01, D.C. Official only that their voices will finally be provide for apportionment of Representa- Code), by striking ‘‘the Delegate to the heard. We will be following the impera- tives in Congress’’, approved June 28, 1929 (2 House of Representatives,’’ and inserting tive of our history and moral values. U.S.C. 2a(a)), is amended by striking ‘‘the ‘‘the Representative in Congress,’’. The Framers of our Constitution in ef- then existing number of Representatives’’ (B) In section 2 (sec. 1–1001.02, D.C. Official fect placed with Congress the solemn and inserting ‘‘the number of Representa- Code)— responsibility of assuring that the tives established with respect to the 111th (i) by striking paragraph (6); and rights of DC citizens would be pro- Congress’’. (ii) in paragraph (13), by striking ‘‘the Del- (2) EFFECTIVE DATE.—The amendment egate to Congress for the District of Colum- tected in the future, just as it is our re- made by paragraph (1) shall apply with re- bia,’’ and inserting ‘‘the Representative in sponsibility to protect the rights of all spect to the regular decennial census con- Congress,’’. citizens throughout this great country. ducted for 2010 and each subsequent regular (C) In section 8 (sec. 1–1001.08, D.C. Official Congress has failed to meet this obliga- decennial census. Code)— tion for more than 200 years, and I am (c) TRANSMITTAL OF REVISED APPORTION- (i) in the heading, by striking ‘‘Delegate’’ not prepared to make DC citizens wait MENT INFORMATION BY PRESIDENT.— and inserting ‘‘Representative’’; and another 200 years. (1) STATEMENT OF APPORTIONMENT BY PRESI- (ii) by striking ‘‘Delegate,’’ each place it appears in subsections (h)(1)(A), (i)(1), and Mr. President, the tax-paying citi- DENT.—Not later than 30 days after the date of the enactment of this Act, the President (j)(1) and inserting ‘‘Representative in Con- zens of the District of Columbia have gress,’’. been without congressional voting rep- shall transmit to Congress a revised version of the most recent statement of apportion- (D) In section 10 (sec. 1–1001.10, D.C. Offi- resentation for too long. The House has ment submitted under section 22(a) of the cial Code)— acted. Now it is time for the Senate to Act entitled ‘‘An Act to provide for the fif- (i) in subsection (a)(3)(A)— act. I urge my colleagues to join Sen- teenth and subsequent decennial censuses (I) by striking ‘‘or section 206(a) of the Dis- ator HATCH and me in support of this and to provide for apportionment of Rep- trict of Columbia Delegate Act’’; and essential legislation. resentatives in Congress’’, approved June 28, (II) by striking ‘‘the office of Delegate to 1929 (2 U.S.C. 2a(a)), to take into account the House of Representatives’’ and inserting Mr. President, I ask unanimous con- ‘‘the office of Representative in Congress’’; sent that the text of the bill be printed this Act and the amendments made by this Act and identifying the State of Utah as the (ii) in subsection (d)(1), by striking ‘‘Dele- in the RECORD. State entitled to one additional Representa- gate,’’ each place it appears; and There being no objection, the text of tive pursuant to this section. (iii) in subsection (d)(2)— the bill was ordered to be printed in (2) REPORT BY CLERK.—Not later than 15 (I) by striking ‘‘(A) In the event’’ and all the RECORD, as follows: calendar days after receiving the revised that follows through ‘‘term of office,’’ and S. 1257 version of the statement of apportionment inserting ‘‘In the event that a vacancy oc- curs in the office of Representative in Con- Be it enacted by the Senate and House of Rep- under paragraph (1), the Clerk of the House of Representatives shall submit a report to gress before May 1 of the last year of the resentatives of the United States of America in Representative’s term of office,’’; and Congress assembled, the Speaker of the House of Representatives identifying the State of Utah as the State (II) by striking subparagraph (B). SECTION 1. SHORT TITLE. entitled to one additional Representative (E) In section 11(a)(2) (sec. 1–1001.11(a)(2), This Act may be cited as the ‘‘District of pursuant to this section. D.C. Official Code), by striking ‘‘Delegate to Columbia House Voting Rights Act of 2007’’. the House of Representatives,’’ and inserting SEC. 2. TREATMENT OF DISTRICT OF COLUMBIA SEC. 4. EFFECTIVE DATE; TIMING OF ELECTIONS. ‘‘Representative in Congress,’’. AS CONGRESSIONAL DISTRICT. The general election for the additional (F) In section 15(b) (sec. 1–1001.15(b), D.C. (a) IN GENERAL.—Notwithstanding any Representative to which the State of Utah is Official Code), by striking ‘‘Delegate,’’ and other provision of law, the District of Colum- entitled for the 111th Congress and 112th inserting ‘‘Representative in Congress,’’. bia shall be considered a Congressional dis- Congress and the general election for the (G) In section 17(a) (sec. 1–1001.17(a), D.C. trict for purposes of representation in the Representative from the District of Colum- Official Code), by striking ‘‘the Delegate to House of Representatives. bia for the 111th Congress and the 112th Con- Congress from the District of Columbia’’ and (b) CONFORMING AMENDMENTS RELATING TO gress shall be subject to the following re- inserting ‘‘the Representative in Congress’’. APPORTIONMENT OF MEMBERS OF HOUSE OF quirements: (b) REPEAL OF OFFICE OF STATEHOOD REP- REPRESENTATIVES.— (1) The additional Representative from the RESENTATIVE.— (1) INCLUSION OF SINGLE DISTRICT OF COLUM- State of Utah will be elected pursuant to a (1) IN GENERAL.—Section 4 of the District BIA MEMBER IN REAPPORTIONMENT OF MEMBERS redistricting plan enacted by the State, such of Columbia Statehood Constitutional Con- AMONG STATES.—Section 22 of the Act enti- as the plan the State of Utah signed into law vention Initiative of 1979 (sec. 1–123, D.C. Of- tled ‘‘An Act to provide for the fifteenth and on December 5, 2006, which— ficial Code) is amended as follows: subsequent decennial censuses and to provide (A) revises the boundaries of Congressional (A) By striking ‘‘offices of Senator and for apportionment of Representatives in Con- districts in the State to take into account Representative’’ each place it appears in sub- gress’’, approved June 28, 1929 (2 U.S.C. 2a), is the additional Representative to which the section (d) and inserting ‘‘office of Senator’’. amended by adding at the end the following State is entitled under section 3; and (B) In subsection (d)(2)— new subsection: (B) remains in effect until the taking ef- (i) by striking ‘‘a Representative or’’; ‘‘(d) This section shall apply with respect fect of the first reapportionment occurring (ii) by striking ‘‘the Representative or’’; to the District of Columbia in the same man- after the regular decennial census conducted and ner as this section applies to a State, except for 2010. (iii) by striking ‘‘Representative shall be that the District of Columbia may not re- (2) The additional Representative from the elected for a 2-year term and each’’. ceive more than one Member under any re- State of Utah and the Representative from (C) In subsection (d)(3)(A), by striking ‘‘and apportionment of Members.’’. the District of Columbia shall be sworn in 1 United States Representative’’. (2) CLARIFICATION OF DETERMINATION OF and seated as Members of the House of Rep- (D) By striking ‘‘Representative or’’ each NUMBER OF PRESIDENTIAL ELECTORS ON BASIS resentatives on the same date as other Mem- place it appears in subsections (e), (f), (g), OF 23RD AMENDMENT.—Section 3 of title 3, bers of the 111th Congress. and (h).

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00081 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.031 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5396 CONGRESSIONAL RECORD — SENATE May 1, 2007 (E) By striking ‘‘Representative’s or’’ each 2007. Our colleagues in the House of 14,000 Utah missionaries from the place it appears in subsections (g) and (h). Representatives recently passed simi- Church of Jesus Christ of Latter-day (2) CONFORMING AMENDMENTS.— lar legislation, H.R. 1905, that would Saints living abroad. Utah took its (A) STATEHOOD COMMISSION.—Section 6 of provide a fourth congressional seat for fight for a fourth seat all the way to such Initiative (sec. 1–125, D.C. Official Code) the Supreme Court, but lost. Instead, is amended— my home state of Utah and the first (i) in subsection (a)— voting member for the District of Co- North Carolina gained another seat in (I) by striking ‘‘27 voting members’’ and in- lumbia. No doubt, this is a historic the House by 856 residents. Since then, serting ‘‘26 voting members’’; time for the citizens of the District of I have heard from many Utahns and (II) by adding ‘‘and’’ at the end of para- Columbia and a unique opportunity for share their frustrations about the out- graph (5); and Utah to receive a long overdue fourth come of the 2000 Census. (III) by striking paragraph (6) and redesig- congressional seat. Why push for an additional seat now? nating paragraph (7) as paragraph (6); and The Founding Fathers made clear in Under normal circumstances, Utah (ii) in subsection (a-1)(1), by striking sub- article 1, section 8 of the Constitution would have to wait until the 2010 Cen- paragraph (H). that the District of Columbia would be sus to see if its growing population jus- (B) AUTHORIZATION OF APPROPRIATIONS.— tifies another congressional seat. How- Section 8 of such Initiative (sec. 1–127, D.C. the seat of the national government Official Code) is amended by striking ‘‘and and granted Congress the power ‘‘[t]o ever, the proposed legislation provides House’’. exercise exclusive Legislation, in all Utah a chance to receive another vot- (C) APPLICATION OF HONORARIA LIMITA- Cases whatsoever, over such District ing member of Congress 5 years early. TIONS.—Section 4 of D.C. Law 8–135 (sec. 1– (not exceeding ten Miles square) as That is equivalent to two and a half 131, D.C. Official Code) is amended by strik- may, by Cession of particular States, terms for a Member of Congress and ing ‘‘or Representative’’ each place it ap- and the Acceptance of Congress become places the new Member well on his or pears. the Seat of the Government of the her way in establishing seniority and (D) APPLICATION OF CAMPAIGN FINANCE influence for the benefit of Utah’s citi- LAWS.—Section 3 of the Statehood Conven- United States . . .’’ This clause became effective in 1790 when Congress accept- zens. I don’t think this is an offer we tion Procedural Amendments Act of 1982 should dismiss. (sec. 1–135, D.C. Official Code) is amended by ed land that Maryland and Virginia I have some constitutional concerns striking ‘‘and United States Representa- ceded to the United States to create with H.R. 1905’s attempt to impose an tive’’. the national capital. Ten years later, at-large seat upon my State of Utah. In (E) DISTRICT OF COLUMBIA ELECTIONS CODE in December 1800, jurisdiction over the States with more than one seat in the OF 1955.—The District of Columbia Elections District of Columbia was vested in the Code of 1955 is amended— House, Members are expected to rep- Federal Government. Since then, Dis- (i) in section 2(13) (sec. 1–1001.02(13), D.C. resent insular constituencies. Under trict residents have not had the right Official Code), by striking ‘‘United States H.R. 1905, residents of one State would to vote for Members of Congress. Addi- Senator and Representative,’’ and inserting be represented by two House Members tionally, article 1, section 2 and section ‘‘United States Senator,’’; and while citizens in other States would (ii) in section 10(d) (sec. 1–1001.10(d)(3), D.C. 3 of the Constitution provides that citi- have one. In addition, in our constitu- Official Code), by striking ‘‘United States zens of States shall have voting rep- Representative or’’. tional system, States are responsible resentation in the House and Senate. for elections and Utah has chosen the (3) EFFECTIVE DATE.—The amendments During my time in the Senate, I have approach it wants to take by redis- made by this subsection shall take effect on heard from many District residents the date on which a Representative from the tricting. I see no warrant for Congress who believe strongly that their voice District of Columbia takes office for the to undermine this balance and impose should be heard in Congress. They pay 111th Congress. upon Utah a scheme it has not chosen taxes, vote in presidential elections, (c) CONFORMING AMENDMENTS REGARDING for itself. For this reason, in the pro- APPOINTMENTS TO SERVICE ACADEMIES.— and serve in the military. Yet these posed Senate legislation, I insisted (1) UNITED STATES MILITARY ACADEMY.— nearly 600,000 Americans do not have a that Utah be required to redistrict to Section 4342 of title 10, United States Code, voting representative in Congress. is amended— provide for the new seat. I believe that Many, including myself, have been re- Utah’s legislators deserve the freedom (A) in subsection (a), by striking paragraph luctant to support previous proposals (5); and to determine their representatives’ dis- (B) in subsection (f), by striking ‘‘the Dis- based upon the constitutional principle tricts without unjustified intrusion or trict of Columbia,’’. that States, not territories, are af- mandate of the Federal Government. (2) UNITED STATES NAVAL ACADEMY.—Such forded congressional representation. I Additionally, the House bill would re- title is amended— understand the argument that congres- quire Utah to hold a special election in (A) in section 6954(a), by striking para- sional representation is dependent on 2007 if the bill passes. The Senate graph (5); and statehood and, therefore, the Constitu- version requires that both seats be (B) in section 6958(b), by striking ‘‘the Dis- tion would need to be amended before elected in the November 2008 general trict of Columbia,’’. the District is given a voting rep- (3) UNITED STATES AIR FORCE ACADEMY.— election. Thereafter, both new Mem- Section 9342 of title 10, United States Code, resentative in Congress. While the Con- bers would begin their service at the is amended— stitution does not affirmatively grant start of the 111th Congress in 2009. (A) in subsection (a), by striking paragraph District residents the right to vote in In conclusion, let me say that I rec- (5); and congressional elections, it does affirm- ognize there are many who strongly op- (B) in subsection (f), by striking ‘‘the Dis- atively grant Congress plenary power pose this legislation. There are many trict of Columbia,’’. to govern the District’s affairs. Indeed, who wish the District voting rights (4) EFFECTIVE DATE.—This subsection and the Constitution grants Congress ex- issue would simply go away. The the amendments made by this subsection clusive authority to legislate all mat- shall take effect on the date on which a Rep- Democratic-controlled Congress could resentative from the District of Columbia ters concerning the District, and I be- have simply pushed forward with legis- takes office for the 111th Congress. lieve this authority extends to the lation giving the District of Columbia SEC. 6. NONSEVERABILITY OF PROVISIONS. granting of congressional voting rights a seat without balancing a ‘‘Democrat’’ If any provision of this Act or any amend- for District residents. seat with a ‘‘Republican’’ seat. I am ment made by this Act is declared or held in- I support this legislation not only be- pleased that this was not the case. The valid or unenforceable, the remaining provi- cause it rectifies the District’s un- House of Representatives has already sions of this Act or any amendment made by democratic political status, but it voted in favor of moving this legisla- this Act shall be treated and deemed invalid gives my home State of Utah a long tion forward. Now it is up to the Sen- and shall have no force or effect of law. overdue fourth voting Member in the ate. Let me be clear, the proposed leg- Mr. HATCH. Mr. President, I rise House of Representatives. islation does not provide Senate rep- today to join with Senate Committee During the 2000 Census count, Utah resentation for the District of Colum- on Homeland Security and Govern- missed out on a fourth House seat by bia. I am not in favor of granting two mental Affairs Chairman JOSEPH only 857 people. The Census Bureau Senators for the District and would not LIEBERMAN and Senator ROBERT BEN- counted members of the military serv- support such a proposal. NETT in introducing the District of Co- ing abroad as residents of their home As one who represents Utah, I have lumbia Voting House Rights Act of State, but did not count an estimated an important responsibility to ensure

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00082 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.051 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5397 that my State is dealt with properly cation. The bill that I am introducing In 2000, at the World Education and fairly. And, in light of the House’s today will make a tangible difference Forum in Dakar, Senegal, the United recent legislative action, I am deter- in the lives of children around the States was one of 180 countries to com- mined to do all that I can to ensure world, by helping them to attend mit to the goal of universal basic edu- that Utah’s fourth seat configuration school and receive a quality education. cation by 2015. Since then, we have en- is done right. I want my fellow Utahns And its impact will go far beyond the hanced our efforts to provide basic edu- to know that the window of oppor- individual, but will also benefit fami- cation overseas. From fiscal years 2001 tunity is quickly closing. In fact, I dare lies, communities, and countries. to 2006, USAID, the Departments of say there won’t be another opportunity A 2004 report by Barbara Herz and State and Defense and the Millennium like this again. For this reason, I in- Gene Sperling from the Center on Uni- Challenge Corporation allocated $2.2 tend to make the most of it and hope versal Education at the Council on billion to support our basic inter- that my Senate colleagues will support Foreign Relations detailed the gains national education efforts. During this me in this endeavor. that are to be made when we invest in same period, the Departments of Agri- education, particularly for girls. A sin- culture and Labor further allocated an By Mrs. CLINTON (for herself gle year of primary education cor- estimated $1 billion to programs with and Mr. SMITH): relates with a 10–20 percent increase in basic education as a component. I am S. 1259. A bill to amend the Foreign women’s wages later in life. An extra proud of our country’s generosity and Assistance Act of 1961 to provide assist- year of a woman’s education has been commitment to this important goal. ance for developing countries to pro- shown to reduce the risk that her chil- Our bill will ensure the United States mote quality basic education and to es- dren will die in infancy by 5–10 percent, provides the resources and leadership tablish the achievement of universal and a study of South Asia and Sub-Sa- necessary to supply all children with a basic education in all developing coun- haran Africa found that from 1960 to quality basic education. It calls on the tries as an objective of United States 1992, equality in education between President to establish a comprehensive foreign assistance policy, and for other men and women could have led to near- strategy for achieving universal basic purposes; to the Committee on Foreign ly 1 percent higher annual per capita education by 2015. This strategy should Relations. GDP growth. include actions toward improving co- We have the data to show that edu- Mrs. CLINTON. Mr. President, today, ordination, reducing duplication, ex- cation is the path to good jobs, strong I am proud to introduce, along with panding public-private partnerships, democracies, and stable societies. We Senator GORDON SMITH, the Education leveraging resources and maximizing for All Act of 2007. This bill would en- have the capacity, responsibility, and opportunity to help millions of chil- the use of American technical experts. able us to increase our spending on The bill also establishes a U.S. Edu- global education initiatives in order to dren worldwide. All it takes now is the will to expand access to educational cation for All Coordinator, an ambas- help millions of children around the sador-level position appointed by the world have the opportunity to receive opportunity. I believe with bipartisan support we President and confirmed by the Senate. an education. The Coordinator will manage U.S. ef- Worldwide, more than 77 million chil- can turn this bill into law, and lead the world in meeting the goal of universal forts to ensure aid dollars are used in dren do not have access to primary the most effective manner possible. school education. The majority of basic education, and I look forward to working with my colleagues in Con- The bill further establishes a fellow- these—approximately 44 million—are ship program at USAID which allows girls. Approximately half of the school- gress in making education for all a re- ality. qualified individuals to serve 3-year age children who start primary school Mr. SMITH. Mr. President, I rise terms as Basic Education fellows, help- do not complete it. And there are hun- today to introduce the Education for ing establish and carry out basic edu- dreds of millions more children who All Act of 2007 with my colleague from cation policy and programming. This are denied the opportunity to complete New York, Senator HILLARY CLINTON. fellowship will broaden U.S. capabili- a secondary school education—to be- This legislation will focus U.S. efforts ties in the areas of technical assistance come the next generation of doctors, to help provide all children worldwide and training. Finally, the bill author- nurses, lawyers, scientists, and teach- with a basic education. At this time, at izes $1 billion for fiscal year 2008, $1.5 ers. These statistics represent a uncon- least 77 million children of primary billion for fiscal year 2009, $2 billion for scionable misuse of human potential— school age around the world are not in fiscal year 2010, $2.5 billion for fiscal a misuse that we can and must remedy. school. year 2011, and $3 billion for fiscal year In 2000, the United States, along with Basic education is a critical part of a 2012 for international basic education other governments around the world, child’s development. In addition to pro- programs. committed to the goal of achieving viding children the tools necessary to I hope my colleagues will join us in universal basic education by 2015. succeed in life, education provides a supporting the noble ambition of Through some of the initiatives and secondary purpose of helping to reduce achieving universal basic education by partnership in which our government is poverty and inequality. A strong basic endorsing the Education for All Act of participating, such as the Education education system also lays the founda- 2007. for All Fast Track Initiative, we have tion for sound governance, civic par- made progress. Since the Fast Track ticipation, and strong familial institu- By Ms. CANTWELL (for herself, Initiative was launched in 2002, ap- tions. Without an education, children Mr. HARKIN, and Mr. BROWN): proximately 4 million children each are less able to contribute to a coun- S. 1261. A bill to amend title 10 and year have gained access to school. try’s development, often becoming a 38, United States Code, to repeal the Yet despite such gains, we are not on burden on society. 10–year limit on use of Montgomery GI track to meet our 2015 goal. In order to A recent Government Accountability Bill educational assistance benefits, do so, we would need to help millions Office concluded there are seven U.S. and for other purposes; to the Com- more children enter school each year— Federal agencies providing inter- mittee on Veterans’ Affairs. requiring a global financial commit- national basic education services in ap- Ms. CANTWELL. Mr. President, I ment of more than $7 billion every proximately 70 countries. Unfortu- rise today to speak about an invest- year. nately, the GAO also found instances ment program in lifelong education for The Education for All Act of 2007 when agencies did not coordinate the our service members and veterans. The would authorize $10 billion in spending planning or delivery of international Montgomery GI Bill is consistently over the next 5 years, enabling the U.S. basic education activities. To maxi- cited as an important reason people Government to make a significant mize the impact of U.S. aid dollars, we join the military and continues to be commitment to reach the 2015 goal, must efficiently coordinate between one of the most important benefits pro- and help children in developing coun- government agencies to decrease re- vided for military service today. There tries, particularly areas experiencing dundant spending on overlapping pro- is no reason why 100 percent of our ac- conflict or humanitarian emergencies, grams. The Education for All Act will tive duty, selected reserve, and veteran have access to a quality basic edu- help achieve this. servicemembers should not have the

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00083 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.054 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5398 CONGRESSIONAL RECORD — SENATE May 1, 2007 opportunity to take advantage of their ods of time due to disability associated that the GI Bill of the future must in- earned education benefits. with military service, but are now clude the following: Provide veterans That is why I’m reintroducing the ready to move forward in their lives, with access to post-secondary edu- Montgomery GI Bill for Life Act of and going back to school is their first cation that they use; assist the Armed 2007, which would allow Montgomery step. In some cases, due to random life forces in recruiting the high quality GI Bill participants an unlimited circumstances, some people just lost high school graduates needed; enhance amount of time to use their earned track of time. Additionally, because of the Nation’s competitiveness by fur- benefits. misinformation and bureaucratic lan- ther educating American veterans, a I am pleased that my colleague, Sen- guage, the GI Bill is known as a com- population that is already self-dis- ator TOM HARKIN, is again joining me plicated program to navigate. ciplined, goal oriented, and steadfast; in sponsoring this legislation and that A constituent of mine, Ruben and attract the kind of service mem- Senator SHERROD BROWN has also Ruelas—who is a Local Veterans Em- bers who will go on to occupy leader- signed on to further extend MGIB bene- ployment Representative, LVER, for ship positions in government and the fits. the WorkSource in Wenatchee, Wash- private sector. The MGIB is a program that provides ington, wrote to me saying, ‘‘It’s been Eliminating the GI Bill 10 and 14 year up to 36 months of education benefits my experience that most people don’t limitation for service members, vet- for educational opportunities ranging know what they want to do in life or erans, and Selected Reserve moves one from college to apprenticeship and job are placed in situations where, due to step toward improving the MGIB. The training, and even flight training. changing economic times, they are dis- Montgomery GI Bill for Life would Upon enlistment, the GI Bill also re- placed and need further education and allow MGIB members, including quali- quires service members to contribute training to compete for jobs. But most fied Vietnam Era Veterans, the flexi- $100 per month for their first 12 months don’t have access to training resources bility to access their earned education of services. to do so.’’ benefits at any time. Basically, the MGIB is divided into In terms of Vietnam Era veterans, As the nation’s economy continues to two programs. One program targets ac- Mr. Ruelas goes on to say, ‘‘many 50 recover and grow stronger, the GI Bill tive duty and veteran members, paying year olds are unemployed, untrained will continue to be the primary vehicle over $1,000 per month to qualified stu- and uneducated and could use their keeping our active duty service mem- dents. That’s more than $36,000 for educational benefits to improve their bers and veterans of military service school. The other is directed at the Se- skills to compete for better jobs. Many on track, helping to ensure our coun- lected Reserve. This program provides have come to realize, too late, that try’s prosperity. educational benefits of $288 per month, they need college or retraining and f for a total of $10,368. don’t have the resources to do so.’’ SUBMITTED RESOLUTIONS If recruits are overwhelmingly de- While times have changed remark- claring that education opportunity ably, one thing remains constant: edu- under the GI Bill is the key incentive cation is critical to employment oppor- SENATE RESOLUTION 178—EX- for them to join the military, then it tunity. In the 21st Century global labor PRESSING THE SYMPATHY OF makes sense that most—if not all—of market, enhancing skills through edu- THE SENATE TO THE FAMILIES our troops, who signed up for the pro- cation and job training is now more OF WOMEN AND GIRLS MUR- gram, would also be cashing in on their important than ever. The need for re- DERED IN GUATEMALA, AND EN- benefits. But reports show that the ma- training is even more underscored for COURAGING THE UNITED STATES jority, 40 to 60 percent, do not actually our military service members and vet- TO WORK WITH GUATEMALA TO use the benefits they have earned. erans. BRING AN END TO THESE Currently, MGIB participants have My legislation, the Montgomery GI CRIMES up to 10 years from their release date Bill for Life, would ensure that edu- Mr. BINGAMAN submitted the fol- from the military to use their earned cational opportunities are lifelong, al- lowing resolution; which was referred education benefits. Members of the Se- lowing service members and veterans to the Committee on Foreign Rela- lected Reserve are able to use their the flexibility to seek education and tions: MGIB benefit for 14 years. However, job training opportunities when it is S. RES. 178 that means your earned education ben- the right time for them to do so. Whereas, since 2001, more than 2,000 women efits expire if you don’t use the within Higher education not only serves as and girls have been murdered in Guatemala; the required timeframe, closing your an individual benefit, but positive Whereas most of the victims are women window of opportunity to go to school externalities have transpired: the GI ranging in age from 18 to 30, with many of or finish your college education. Plus, Bill was instrumental in building our the cases involving abduction, sexual vio- you lose the $1,200 dedicated for your country’s middle class and continues to lence, or brutal mutilation; GI Bill during your first year of enlist- help close the college education gap. Whereas, from 2001 to 2006, the rate at ment. Today, employers are requiring high- which women have been murdered in Guate- Originally, the intent of 1944 GI Bill er qualifications from the workforce. mala has almost doubled, increasing at a higher rate than the murder rate of men in of Rights was to help veterans success- The Bureau of Labor Statistics reports Guatemala during the same period; fully transition back into civilian life that six of the ten fastest-growing oc- Whereas, according to data from Guate- as education is the key to employment cupations require an associate’s degree mala’s Public Prosecutors Office, few arrests opportunities. Looking back now, we or bachelor’s degree. By 2010, 40 percent and fewer convictions have occurred, and know that the GI Bill opened the door of all job growth will require some prosecutors, forensics experts, and other to higher education, helping millions form of postsecondary education. While state justice officials have not brought the of service members and veterans who a highly skilled workforce is one char- perpetrators to justice; wouldn’t otherwise have had the acteristic of the new economy, working Whereas, from 2001 to 2006, there were only 20 convictions for the murders of women and chance to pay for college. That is, for one employer throughout a lifetime girls; servicemembers benefited from the GI is no longer routine, but rather an eva- Whereas the Human Rights Ombudsman of Bill because they used the payments nescent feature. According to findings the Government of Guatemala has reported within the 10 and 14 year limitation. by Brigham Young University, the av- that in 1 year alone police officers were im- But there are many others who did erage person changes jobs or careers plicated on 10 separate occasions in the mur- not use their earned education benefits eight times in his or her lifetime. To der of women in Guatemala, and rec- within that timeframe. For example, keep up with these trends, expanding ommended that such officers and other offi- after leaving the military, some access to education and training is a cials be held accountable for their acts; servicemembers postponed going to Whereas an effective, transparent, and im- must do in the 21st Century global partial judicial system is key to the admin- school because they had to go straight marketplace. istration of justice, and the failure to ensure to work in order to support their fam- A 1999 report by the Congressional proper investigations and prosecutions ham- ily. Others unfortunately, were either Commission on Service members and pers the ability to solve crimes and punish homeless or incarcerated for long peri- Veterans Transition Assistance stated perpetrators;

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00084 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.056 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5399 Whereas inadequate financial, human, and nizes their courageous struggle in seeking to submit a resolution urging increased technical resources, as well as a lack of fo- justice for the victims; U.S. involvement in addressing this se- rensic and technical expertise, have impeded (2) expresses the solidarity of the people of rious issue. the arrest and prosecution of suspects; the United States with the people of Guate- Whereas the Special Prosecutor for Crimes mala in the face of these tragic and senseless Since 2001, more than 2,000 women Against Women of the Government of Guate- acts; and girls have been murdered in Guate- mala has reported that her office has re- (3) condemns the ongoing murders of mala. The murder rate of these women viewed approximately 800 incidents of do- women and girls in Guatemala, and encour- almost doubled from 2001 to 2006, in- ages the Government of Guatemala to act mestic violence per month, with some of creasing at a higher rate than the mur- those cases ending in murder, and that with due diligence in order to promptly in- deaths could have been prevented if the legal vestigate these killings, prosecute those re- der rate of men. While these killings system of Guatemala provided for prison sen- sponsible, and continue to work toward may be due to a variety of factors, tences in cases of domestic violence; eliminating violence against women; what clearly unifies these cases is the Whereas the murders of women and girls in (4) urges the Government of Guatemala to fact that very few of the perpetrators Guatemala have brought pain to the families recognize domestic violence and sexual har- have been brought to justice. Indeed, it and friends of the victims as they struggle to assment as criminal acts and to provide the is my understanding that as of 2006 resources and commitment necessary to cope with the loss of their loved ones and the there have been only 20 convictions for fact that the perpetrators of these heinous strengthen the integrity of the prosecutorial acts remain unknown to the proper authori- and judicial systems; these killings. In some of the cases po- ties; (5) urges the President and the Secretary lice have been implicated in the Whereas many countries in Latin America of State to incorporate the investigative and crimes. face significant challenges in combating vio- preventative efforts of the Government of Guatemala regarding the murder of women The lack of respect for the rule of lence against women, and international co- law, inadequate legal protections for operation is essential in addressing this seri- and girls into the bilateral agenda between ous issue; the Governments of Guatemala and the women, ongoing violence in the coun- Whereas the United States Agency for United States; try, corruption, insufficient resources, International Development (USAID) has pro- (6) encourages the Secretary of State to substandard investigations, and the vided assistance to the Government of Gua- support efforts by the Government of Guate- lack of independent and effective judi- temala to implement judicial reform and mala to train and equip the special police cial and prosecutorial systems, all con- rule of law programs, and in fiscal year 2006, and prosecutorial units of the Government of tribute to the inability of the Govern- Congress provided $1,500,000 for programs to Guatemala to conduct thorough and proper investigations of crimes of violence against ment of Guatemala to hold those re- combat impunity, corruption, and crimes of sponsible for these killings accountable violence, of which $500,000 is to be allocated women, and to implement judicial reform to strengthen the special prosecutorial units and rule of law programs; for their crimes. The result is a general charged with investigating the murders of (7) encourages the Secretary of State and sense of impunity for crimes against women in Guatemala; the Attorney General to provide assistance women in the country. Whereas the Government of Guatemala has in establishing a comprehensive missing per- sons system and an effective state protection The Government of Guatemala has undertaken efforts to prevent violence taken some steps to address these against women, as evidenced by its ratifica- program for witnesses, victims’ relatives, tion of the United Nations Convention and human rights defenders; killings. Guatemala has created special Against Torture and Other Cruel, Inhuman (8) urges the Government of Guatemala to police and prosecutorial units to inves- or Degrading Treatment or Punishment, hold accountable those law enforcement and tigate these murders, and repealed the done at New York December 10, 1984, the judicial officials whose failure to investigate so called ‘‘Rape Law’’ which had ab- United Nations Convention on the Elimi- and prosecute the murders adequately, solved perpetrators of criminal respon- nation of All Forms of Discrimination whether through negligence, omission, or sibility for rape upon the perpetrator’s Against Women, done at New York December abuse, has led to impunity for these crimes; (9) encourages the Secretary of State to marriage with the victim. The Govern- 18, 1979, the Inter-American Convention on ment also recently entered into an the Prevention, Punishment, and Eradi- support efforts to identify perpetrators and cation of Violence Against Women, done at unknown victims through forensic analysis, agreement with the United Nations to Belem do Para, Brazil June 9, 1994, and other including assisting the Government of Gua- establish the International Commis- international human rights treaties, and the temala in adequately funding the National sion Against Impunity in Guatemala, enactment of laws and the creation of state Institute for Forensic Science (INACIF) and CICIG, which has a mandate to inves- institutions to promote and protect the training lab personnel in investigatory and tigate and prosecute illegal security rights of women; evidence gathering protocols; groups operating with impunity. And Whereas the Government of Guatemala has (10) urges the Secretary of State— (A) to express support for the efforts of the Guatemala established the National In- created special police and prosecutorial stitute for Forensic Sciences to im- units to address the brutal murders of victims’ families and loved ones to seek jus- women in Guatemala; tice for the victims, prove investigatory and evidence gath- Whereas, in June 2006, the Government of (B) to express concern relating to any har- ering efforts. Guatemala successfully abolished the ‘‘Rape assment of these families and the human The resolution I am submitting Law’’ which had absolved perpetrators of rights defenders with whom they work, and (C) to express concern with respect to im- today is aimed at raising awareness of criminal responsibility for rape and certain this issue and encouraging the govern- other crimes of violence upon the perpetra- pediments in the ability of the families to tor’s marriage with the victim; receive prompt and accurate information in ments of Guatemala and the United Whereas legislators from various parties in their cases; States to work together to stop these Guatemala have joined lawmakers from (11) encourages the Secretary of State to killings. Among other things, the reso- Mexico and Spain to form the ‘‘Inter- continue to include in the Department of lution: condemns these murders and parliamentary Network against ‘Femicide’’’; State’s annual Country Reports on Human expresses the sympathy of the Senate Whereas the Government of Guatemala Rights Practices all instances of improper to the families of women and girls mur- and the United Nations recently entered into investigatory methods, threats against human rights activists, and the use of tor- dered in Guatemala; encourages the an agreement to establish the International Government of Guatemala to act with Commission Against Impunity in Guatemala ture with respect to cases involving the mur- (CICIG), which has a mandate to investigate der and abduction of women and girls in due diligence in investigating and pros- and promote the prosecution of illegal secu- Guatemala; ecuting those responsible for these rity groups and clandestine security organi- (12) recommends that the United States crimes; urges the Government of Gua- zations that function with impunity and are Ambassador to Guatemala continue to meet temala to recognize domestic violence suspected of attacking human rights defend- with the families of the victims, women’s as a criminal act and to provide ade- ers, justice officials, and other civil society rights organizations, and the officials of the quate resources necessary to strength- actors; and Government of Guatemala who are respon- sible for investigating these crimes; and en the integrity of the prosecutorial Whereas continuing impunity for crimes and judicial systems; urges the Presi- against women is a threat to the rule of law, (13) recommends that the Secretary of democracy, and stability in Guatemala: Now, State develop a comprehensive plan to ad- dent and the Secretary of State to in- therefore, be it dress and combat the growing problem of vi- corporate this issue into the bilateral olence against women in Latin America. Resolved, That the Senate— agenda between the governments of (1) expresses its sincerest condolences and Mr. BINGAMAN. Mr. President, I rise Guatemala and the United States; and deepest sympathy to the families of women today to speak about the tragic deaths encourages the Secretary of State to and girls murdered in Guatemala, and recog- of women and girls in Guatemala, and provide assistance in training and

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00085 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.058 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5400 CONGRESSIONAL RECORD — SENATE May 1, 2007 equipping special police units to inves- Whereas Singapore has joined the United popular brand for the Russet Burbank potato tigate these crimes, implementing ju- States in the global struggle against ter- variety; and dicial reforms and rule of law pro- rorism, providing intelligence and offering Whereas Idaho’s potato industry contrib- grams, establishing a missing persons political and diplomatic support; utes approximately $2,700,000,000 to the State Whereas Singapore is the 15th largest trad- economy and employs 39,000 residents: Now, system, creating an effective witness ing partner of the United States and the first therefore, be it protection program, and supporting ef- free trade partner of the United States in the Resolved, That the Senate— forts to enhance forensic capabilities. Asia-Pacific region, and the United States is (1) recognizes the 70th anniversary of the Mr. President, I urge my colleagues the second largest trading partner of Singa- Idaho Potato Commission; and to support this important resolution pore; (2) designates May 2007 as ‘‘Idaho Potato and give this issue the attention it de- Whereas the relationship between the Month’’. serves. United States and Singapore extends beyond the current campaign against terrorism and f f is reinforced by strong ties of culture, com- merce, and scientific and technical coopera- SENATE RESOLUTION 181—HON- SENATE RESOLUTION 179—WEL- tion; and ORING AND RECOGNIZING THE COMING THE PRIME MINISTER Whereas the relationship between the ACHIEVEMENTS OF THE UNITED OF SINGAPORE ON THE OCCA- United States and Singapore encompasses al- STATES AIR FORCE ACADEMY SION OF HIS VISIT TO THE most every field of international coopera- FOOTBALL PROGRAM OVER THE UNITED STATES AND THE 40TH tion, including a common commitment to LAST 27 YEARS ANNIVERSARY OF THE ASSOCIA- fostering a stronger and more open inter- national trading system: Now, therefore, be Mr. ALLARD (for himself, Mr. TION OF SOUTHEAST ASIAN NA- it TIONS (ASEAN), EXPRESSING Resolved, That the Senate— PRYOR, and Mr. CRAIG) submitted the GRATITUDE TO THE GOVERN- (1) welcomes the Prime Minister of Singa- following resolution; which was consid- MENT OF SINGAPORE FOR ITS pore, His Excellency Lee Hsien Loong, to the ered and agreed to: STRONG COOPERATION WITH United States; S. RES. 181 (2) congratulates the Association of South- THE UNITED STATES IN THE Whereas, Fisher DeBerry, originally of east Asian Nations (ASEAN), and Singapore CAMPAIGN AGAINST TERRORISM, Cheraw, South Carolina, coached football at as one of its founding members, on the 40th the United States Air Force Academy for 27 AND REAFFIRMING THE COMMIT- anniversary of ASEAN; years, 23 of which as head coach; MENT OF THE UNITED STATES (3) expresses profound gratitude to the Whereas, Fisher DeBerry is the winningest TO THE CONTINUED EXPANSION Government of Singapore for promoting se- head coach of any United States service OF FRIENDSHIP AND COOPERA- curity and prosperity in Southeast Asia and academy with a record of 169–109–1; cooperating with the United States in the TION BETWEEN THE UNITED Whereas, Fisher DeBerry has amassed a 35– global campaign against terrorism; and STATES AND SINGAPORE 11 record against the United States Military (4) reaffirms the commitment of the Academy and the United States Naval Acad- Mr. BOND submitted the following United States to continue strengthening the emy, and led the U.S. Air Force Academy to resolution; which was referred to the friendship and cooperation between the 14 of its 16 Commander-in-Chief Trophy ti- Committee on Foreign Relations: United States, Singapore, and the other tles; countries of the ASEAN region. S. RES. 179 Whereas, Fisher DeBerry led his Air Force Whereas Singapore is a great friend of the f teams to 3 conference championships and 12 United States; SENATE RESOLUTION 180—RECOG- bowl games; Whereas the United States and Singapore NIZING THE 70TH ANNIVERSARY Whereas, Fisher DeBerry has been recog- share a common vision of promoting peace, nized numerous times for his coaching suc- stability, security, and prosperity in the OF THE IDAHO POTATO COMMIS- cess, including selection as National Coach Asia-Pacific region; SION AND DESIGNATING MAY of the Year for 1985; selection 3 times as Whereas Singapore was a founding member 2007 AS ‘‘IDAHO POTATO MONTH’’ Western Athletic Conference Coach of the of the Association of Southeast Asian Na- Mr. CRAPO (for himself and Mr. Year; induction into the South Carolina tions (ASEAN); CRAIG) submitted the following resolu- Sports Hall of Fame; induction into the Col- Whereas Singapore is a member of the Pro- tion; which was referred to the Com- orado Springs Sports Hall of Fame; induc- liferation Security Initiative, an initiative tion into the Independence Bowl Hall of launched by the United States in 2003 to re- mittee on the Judiciary: Fame; the 2001 State Farm Coach of Distinc- spond to the challenges posed by the pro- S. RES. 180 tion honor; an honorary doctorate of human- liferation of weapons of mass destruction, Whereas the State of Idaho produces ities from Wofford College; service as presi- and a committed partner of the United roughly one-third of all the potatoes grown dent of the American Football Coaches Asso- States in preventing the spread of weapons in the United States, harvesting an average ciation (AFCA); and service as Chairman of of mass destruction; of 12,000,000,000 to 14,000,000,000 pounds annu- the AFCA ethics committee; Whereas Singapore is a leader in the Radi- ally; Whereas, Fisher DeBerry has acted as a ation Detection Initiative, an effort by the Whereas the State of Idaho’s unique cli- pillar of the Colorado Springs, Colorado, United States to develop technology to safe- mate of warm days, cool nights, mountain- community during the past 27 years through guard maritime security by detecting traf- fed irrigation, and rich volcanic soil is con- his active involvement and volunteerism ficking of nuclear and radioactive material; ducive to growing world-renowned potatoes; with local church, charity, and community Whereas, in July 2005, Singapore became a Whereas Idaho potatoes are top-selling and organizations; partner of the United States in the Strategic highly recognized potatoes in the United Whereas, in 2004 Fisher DeBerry founded Framework Agreement for Closer Coopera- States due to their consistently great taste, the Fisher DeBerry Foundation, which is tion in Defense and Security, an agreement versatility, and nutritional content; dedicated to the support and education of which will build upon the already strong Whereas the Idaho potato ‘‘brand’’ is rec- single mothers and their children, as well as military relations between the United States ognized throughout the world for its high other charitable causes; and Singapore and expand the scope of de- quality and is an identifying characteristic Whereas, Fisher DeBerry has served as a fense and security cooperation between the 2 of the great State of Idaho; positive influence and role model to numer- countries; Whereas May 2007 marks the 70th consecu- ous future Air Force officers, including Whereas Singapore selected the F–15SG tive year that Idaho potatoes have been pro- coaching 3,375 players; having a graduation Fighter, built in the United States, for use moted by the Idaho Potato Commission, an success rate of 91.6 percent among his play- by the Air Force of Singapore, which will Idaho potato industry group responsible for ers; and producing 19 All-American players, greatly enhance the interoperability of the generating attention for the numerous at- 124 All-Conference players, 11 Academic All- Air Forces of Singapore and the United tributes of Idaho potatoes; Americans, and 9 Postgraduate Scholarship States; Whereas the Idaho Potato Commission is winners; Whereas Singapore responded quickly to recognized nationally and internationally as Whereas, Fisher DeBerry imparted to his provide generous humanitarian relief and fi- a top promotional authority for Idaho’s po- players the core values of the United States nancial assistance to the people affected by tatoes and potato products; Air Force: Integrity First, Service Before the tragic tsunami that struck Southeast Whereas the Idaho Potato Commission’s Self, and Excellence In All We Do; and Asia in December 2004; requirement, since 1959, that only potatoes Whereas, the United States Air Force Whereas Singapore responded quickly to grown in the State of Idaho are allowed to Academy football program under the leader- provide logistical support and assistance to wear the ‘‘Grown in Idaho’’ Federal certifi- ship of Fisher DeBerry has served as an ex- the relief efforts in the United States after cation mark contributed toward the creation ample of these values for its community and Hurricane Katrina; of a distinctive, enduringly successful, and the entire Nation: Now, therefore, be it

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00086 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.055 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5401 Resolved, That the United States Senate dustry, ushered movies into the digital era, Whereas charter schools give parents new honors and recognizes the numerous con- championed artists’ rights, and condemned freedom to choose public schools, routinely tributions made by the United States Air intellectual property theft; measure parental satisfaction levels, and Force Academy football program over the Whereas Jack Valenti authored 5 books, must prove their ongoing success to parents, last 27 years to Colorado Springs and the sur- including ‘‘A Very Human President’’, ‘‘Pro- policymakers, and communities; rounding communities, the United States tect and Defend’’, ‘‘The Bitter Taste Of Whereas nearly 56 percent of charter Air Force Academy, and the United States Glory’’, ‘‘Speak Up With Confidence’’, and, schools report having a waiting list, and the Air Force. his most recent, ‘‘This Time, This Place: My total number of students on all such waiting f Life in War, the White House, and Holly- lists is enough to fill over 1,100 average-sized wood’’, and wrote numerous essays for the charter schools; SENATE RESOLUTION 182—HON- New York Times, the Washington Post, the Whereas charter schools nationwide serve ORING THE LIFE OF JACK VA- Los Angeles Times, Reader’s Digest, Atlantic a higher percentage of low-income and mi- LENTI Monthly, Newsweek, Cox newspapers, and nority students than the traditional public Mrs. FEINSTEIN (for herself, Mr. other publications; school system; SPECTER, Mr. LEAHY, Mr. HATCH, Mrs. Whereas Jack Valenti was awarded with Whereas charter schools have enjoyed France’s highly-prized Legion d’Honneur, the broad bipartisan support from the President, BOXER, Mr. CORNYN, Mr. KENNEDY, Mr. French Legion of Honor, and has been hon- Congress, State governors and legislatures, DURBIN, Mr. DODD, Mr. KERRY, Ms. ored with his own star on the Hollywood educators, and parents across the United STABENOW, Ms. CANTWELL, Mr. HARKIN, Walk of Fame; and States; and Ms. LANDRIEU, Mr. MENENDEZ, and Mr. Whereas Jack Valenti will be remembered Whereas the eighth annual National Char- COLEMAN) submitted the following res- as a dedicated family man, a philanthropist, ter Schools Week, to be held April 30 through olution; which was considered and a voice for copyright owners, a true vision- May 4, 2007, is an event sponsored by charter agreed to: ary whose devotion, intelligence, creativity, schools and grassroots charter school organi- S. RES. 182 and wisdom transformed the film industry, zations across the United States to recognize and as Hollywood’s ultimate leading man: the significant impacts, achievements, and Whereas Jack Valenti was born September Now, therefore, be it innovations of charter schools: Now, there- 5, 1921, in Houston, Texas, the grandson of Resolved, That the Senate honors the life of fore, be it Sicilian immigrants, Joe and Josephine Va- Jack Valenti, a pioneer in the fields of mo- Resolved, That the Senate— lenti, and was the youngest high school grad- uate in the city at age 15; tion pictures and public service, a dedicated (1) acknowledges and commends charter Whereas Jack Valenti married his beloved family man, and a legendary figure in the schools and students, parents, teachers, and Mary Margaret in 1962, with whom he had 3 history of the United States. administrators of charter schools across the United States for their ongoing contribu- children, John, Alexandra, and Courtenay; f Whereas Jack Valenti joined the United tions to education and improving and States Army Air Forces in 1942 and flew 51 SENATE RESOLUTION 183—SUP- strengthening the public school system; combat missions as a pilot of a B–25 attack PORTING THE GOALS AND (2) supports the goals and ideals of the bomber with the 12th Air Force in Italy dur- IDEALS OF NATIONAL CHARTER eighth annual National Charter Schools ing World War II, obtained the rank of lieu- SCHOOLS WEEK, APRIL 30, 2007, Week; and (3) encourages the people of the United tenant, and received 4 decorations, including THROUGH MAY 4, 2007 the Distinguished Flying Cross, the Air States to conduct appropriate programs, Medal with 4 clusters, the Distinguished Ms. LANDRIEU (for herself, Mr. AL- ceremonies, and activities to demonstrate Unit Citation with one cluster, and the Euro- EXANDER, Mr. LIEBERMAN, Mr. CARPER, support for charter schools during this week- pean Theater Ribbon with 4 battle stars; Mr. BURR, Mr. DEMINT, Mr. VITTER, long celebration in communities throughout the United States. Whereas Jack Valenti received a B.A. de- Mrs. DOLE, and Mr. GREGG) submitted gree from the University of Houston in 1946 the following resolution; which was f after doing all of his undergraduate work at considered and agreed to: night and working during the day, and be- SENATE RESOLUTION 184—EX- came the first University of Houston grad- S. RES. 183 PRESSING THE SENSE OF THE uate to be admitted to Harvard Business Whereas charter schools deliver high-qual- SENATE WITH RESPECT TO School, receiving an M.B.A. degree in 1948; ity education and challenge students to CHILDHOOD STROKE AND DESIG- Whereas, in 1952, Jack Valenti cofounded reach their potential; NATING MAY 5, 2007, AS ‘‘NA- Weekley and Valenti, an advertising and po- Whereas charter schools provide thousands TIONAL CHILDHOOD STROKE litical consulting agency that worked on of families with diverse and innovative edu- Dwight D. Eisenhower’s presidential cam- cational options for their children; AWARENESS DAY’’ paign in Texas, Representative Albert Thom- Whereas charter schools are public schools Mr. CHAMBLISS (for himself and Mr. as’s run for Congress, and John Connally’s authorized by designated public entities to CASEY) submitted the following resolu- campaign for Governor of Texas; respond to the needs of communities, fami- tion; which was considered and agreed Whereas Jack Valenti met then-Senate lies, and students, and to promote the prin- to: Majority Leader Lyndon B. Johnson in 1957, ciples of quality, choice, and innovation; the two became close friends, and Valenti Whereas, in exchange for the flexibility S. RES. 184 worked on Lyndon Johnson’s presidential and autonomy given to charter schools, Whereas a stroke, also known as a ‘‘cere- campaign during the primaries of 1960; charter schools are held accountable by their brovascular accident’’, is an acute neurologic Whereas Weekley and Valenti handled sponsors for improving student achievement injury that occurs when the blood supply to press during President John F. Kennedy’s and for their finances and other operations; a part of the brain is interrupted by a clot in and Vice President Lyndon Johnson’s fateful Whereas 40 States and the District of Co- the artery or a burst of the artery; trip to Dallas, Texas, in November 1963; lumbia have passed laws authorizing charter Whereas a stroke is a medical emergency Whereas Jack Valenti became the first spe- schools; that can cause permanent neurologic damage cial assistant hired when Lyndon Johnson Whereas more than 4,000 charter schools or even death if not promptly diagnosed and ascended to the Presidency; operating across the United States serve treated; Whereas Jack Valenti resigned his White more than 1,140,000 students; Whereas 26 out of every 100,000 newborns House post in 1966 and went on to serve as Whereas, over the last 13 years, Congress and almost 3 out of every 100,000 children the president of the Motion Picture Associa- has provided more than $2,026,225,000 in sup- have a stroke each year; tion of America (MPAA) for the next 38 port to the charter school movement by pro- Whereas an individual can have a stroke years; viding facilities, financing assistance, and before birth; Whereas Jack Valenti, as president of the grants for planning, startup, implementa- Whereas stroke is among the top 10 causes MPAA, created the voluntary film rating tion, and dissemination of information; of death for children in the United States; system that is still in place today, which Whereas many charter schools improve the Whereas 12 percent of all children who ex- provides parents with advance information achievement of students and stimulate im- perience a stroke die as a result; they can use to determine which movies are provement in traditional public schools; Whereas the death rate for children who appropriate for their children; Whereas charter schools must meet the experience a stroke before the age of 1 year Whereas Jack Valenti’s persona and skill student achievement accountability require- is the highest out of all age groups; combined to give the motion picture indus- ments under section 1111 of the Elementary Whereas many children who experience a try a strong and enduring presence in the and Secondary Education Act of 1965 (20 stroke will suffer serious, long-term neuro- Nation’s capital, which grew year by year U.S.C. 6311) in the same manner as tradi- logical disabilities, including— during his nearly 4 decade tenure at the tional public schools, and often set higher (1) hemiplegia, which is paralysis of 1 side MPAA; and additional individual goals to ensure of the body; Whereas Jack Valenti presided over a that charter schools are of high quality and (2) seizures; worldwide change in the motion picture in- truly accountable to the public; (3) speech and vision problems; and

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00087 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.060 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5402 CONGRESSIONAL RECORD — SENATE May 1, 2007 (4) learning difficulties; SA 994. Mr. GRASSLEY submitted an section (a)(1) be used exclusively to authen- Whereas those disabilities may require on- amendment intended to be proposed by him ticate the pedigree of prescription drugs, in- going physical therapy and surgeries; to the bill S. 1082, supra; which was ordered cluding by— Whereas the permanent health concerns to lie on the table. (A) implementing inventory control; and treatments resulting from strokes that SA 995. Mr. GRASSLEY submitted an (B) tracking and tracing prescription occur during childhood and young adulthood amendment intended to be proposed by him drugs; have a considerable impact on children, fam- to the bill S. 1082, supra; which was ordered (C) verifying shipment or receipt of pre- ilies, and society; to lie on the table. scription drugs; Whereas very little is known about the SA 996. Mr. GRASSLEY submitted an (D) authenticating finished prescription cause, treatment, and prevention of child- amendment intended to be proposed by him drugs; and hood stroke; to the bill S. 1082, supra; which was ordered (E) electronically authenticating the pedi- Whereas medical research is the only to lie on the table. gree of prescription drugs. means by which the citizens of the United SA 997. Mr. GRASSLEY submitted an (2) PRIVACY PROTECTION.—The Secretary States can identify and develop effective amendment intended to be proposed by him shall prohibit technologies required by sub- treatment and prevention strategies for to the bill S. 1082, supra; which was ordered section (a)(1) from containing or transmit- childhood stroke; to lie on the table. ting any information that may be used to Whereas early diagnosis and treatment of SA 998. Mr. GRASSLEY submitted an identify a health care practitioner or the childhood stroke greatly improves the amendment intended to be proposed by him prescription drug consumer. chances that the affected child will recover to the bill S. 1082, supra; which was ordered (3) PROHIBITION AGAINST ADVERTISING.—The and not experience a recurrence; and to lie on the table. Secretary shall prohibit technologies re- Whereas the Children’s Hospital of Phila- SA 999. Mr. GRASSLEY submitted an quired by subsection (a)(1) from containing delphia should be commended for its initia- amendment intended to be proposed by him or transmitting any advertisement or infor- tive in creating the Nation’s first program to the bill S. 1082, supra; which was ordered mation about prescription drug indications dedicated to pediatric stroke patients: Now, to lie on the table. or off-label prescription drug uses. SA 1000. Mr. GRASSLEY submitted an therefore, be it (c) RECOMMENDED TECHNOLOGIES.—The Sec- Resolved, That the Senate— amendment intended to be proposed by him retary shall encourage the manufacturers (1) designates May 5, 2007 as ‘‘National to the bill S. 1082, supra; which was ordered and distributors of prescription drugs to in- Childhood Stroke Awareness Day’’; and to lie on the table. corporate into the packaging of such drugs, SA 1001. Mr. GRASSLEY submitted an (2) urges the people of the United States to in addition to the technologies required amendment intended to be proposed by him support the efforts, programs, services, and under subsection (a), overt optically variable to the bill S. 1082, supra; which was ordered advocacy of organizations that work to en- counterfeit-resistant technologies that— to lie on the table. hance public awareness of childhood stroke. (1) are visible to the naked eye, providing SA 1002. Mr. GRASSLEY submitted an for visual identification of prescription drug f amendment intended to be proposed by him authenticity without the need for readers, AMENDMENTS SUBMITTED AND to the bill S. 1082, supra; which was ordered microscopes, lighting devices, or scanners; to lie on the table. (2) are similar to technologies used by the PROPOSED SA 1003. Mr. GRASSLEY submitted an Bureau of Engraving and Printing to secure SA 983. Mr. VITTER submitted an amend- amendment intended to be proposed by him United States currency; ment intended to be proposed by him to the to the bill S. 1082, supra; which was ordered (3) are manufactured and distributed in a bill S. 1082, to amend the Federal Food, to lie on the table. highly secure, tightly controlled environ- Drug, and Cosmetic Act to reauthorize and SA 1004. Ms. LANDRIEU proposed an ment; and amend the prescription drug user fee provi- amendment to the bill S. 1082, supra. (4) incorporate additional layers of non- sions, and for other purposes; which was or- SA 1005. Mr. LEVIN submitted an amend- visible covert security features up to and in- dered to lie on the table. ment intended to be proposed by him to the SA 984. Mr. VITTER submitted an amend- bill S. 1082, supra; which was ordered to lie cluding forensic capability. (d) STANDARDS FOR PACKAGING.— ment intended to be proposed by him to the on the table. (1) MULTIPLE ELEMENTS.—For the purpose bill S. 1082, supra; which was ordered to lie SA 1006. Ms. MURKOWSKI submitted an of making it more difficult to counterfeit on the table. amendment intended to be proposed by her SA 985. Mr. BROWNBACK (for himself and to the bill S. 1082, supra; which was ordered the packaging of prescription drugs, the Sec- retary shall require manufacturers of pre- Mr. BROWN) submitted an amendment in- to lie on the table. tended to be proposed by him to the bill S. SA 1007. Mr. REID (for Mr. BUNNING) pro- scription drugs to incorporate the tech- 1082, supra; which was ordered to lie on the posed an amendment to the resolution S. nologies described in paragraphs (1), (2), and table. Res. 162, commemorating and acknowledging (3) of subsection (a), and shall encourage SA 986. Ms. LANDRIEU submitted an the dedication and sacrifice made by the manufacturers and distributors of prescrip- amendment intended to be proposed by her men and women who have lost their lives tion drugs to incorporate the technologies to the bill S. 1082, supra; which was ordered while serving as law enforcement officers. described in subsection (c), into multiple ele- ments of the physical packaging of the to lie on the table. f SA 987. Mr. INHOFE submitted an amend- drugs, including— ment intended to be proposed by him to the TEXT OF AMENDMENTS (A) blister packs, shrink wrap, package la- bill S. 1082, supra; which was ordered to lie bels, package seals, bottles, and boxes; and on the table. (B) at the item level. SA 988. Mr. INHOFE submitted an amend- SA 983. Mr. VITTER submitted an (2) LABELING OF SHIPPING CONTAINER.— ment intended to be proposed by him to the amendment intended to be proposed by Shipments of prescription drugs shall in- bill S. 1082, supra; which was ordered to lie him to the bill S. 1082, to amend the clude a label on the shipping container that on the table. Federal Food, Drug, and Cosmetic Act incorporates the technologies described in SA 989. Mr. HARKIN submitted an amend- to reauthorize and amend the prescrip- subsection (a)(1), so that members of the sup- ment intended to be proposed by him to the tion drug user fee provisions, and for ply chain inspecting the packages will be able to determine the authenticity of the bill S. 1082, supra; which was ordered to lie other purposes; which was ordered to on the table. shipment. Chain of custody procedures shall SA 990. Mr. DORGAN (for himself, Ms. lie on the table; as follows: apply to such labels and shall include proce- SNOWE, Mr. GRASSLEY, Mr. MCCAIN, Ms. At the end of subtitle E of title II, insert dures applicable to contractual agreements STABENOW, Mr. NELSON, of Florida, Mr. the following: for the use and distribution of the labels, PRYOR, Mr. SANDERS, Mr. WHITEHOUSE, and SEC. ll. COUNTERFEIT-RESISTANT TECH- methods to audit the use of the labels, and Mrs. MCCASKILL) submitted an amendment NOLOGIES FOR PRESCRIPTION database access for the relevant govern- intended to be proposed by him to the bill S. DRUGS. mental agencies for audit or verification of 1082, supra. (a) REQUIRED TECHNOLOGIES.—The Sec- the use and distribution of the labels. SA 991. Mr. KOHL (for himself, Mr. GRASS- retary of Health and Human Services shall (e) PENALTY.—A prescription drug is LEY, Mr. LEAHY, and Mr. SCHUMER) sub- require that the packaging of any prescrip- deemed to be misbranded for purposes of the mitted an amendment intended to be pro- tion drug incorporate— Federal Food, Drug, and Cosmetic Act (21 posed by him to the bill S. 1082, supra; which (1) radio frequency identification (RFID) U.S.C. 301 et seq.) if the packaging or label- was ordered to lie on the table. tagging technology, or similar trace and ing of the drug is in violation of a require- SA 992. Mr. KOHL submitted an amend- track technologies that have an equivalent ment or prohibition applicable to the drug ment intended to be proposed by him to the function; under subsection (a), (b), or (d). bill S. 1082, supra; which was ordered to lie (2) tamper-indicating technologies; and (f) TRANSITIONAL PROVISIONS; EFFECTIVE on the table. (3) blister security packaging when pos- DATES.— SA 993. Mr. GREGG submitted an amend- sible. (1) NATIONAL SPECIFIED LIST OF SUSCEP- ment intended to be proposed by him to the (b) USE OF TECHNOLOGIES.— TIBLE PRESCRIPTION DRUGS.— bill S. 1082, supra; which was ordered to lie (1) AUTHORIZED USES.—The Secretary shall (A) INITIAL PUBLICATION.—Not later than on the table. require that technologies described in sub- 180 days after the date of the enactment of

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00088 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.064 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5403 this Act, the Secretary shall publish in the care spending, which reached nearly evant governmental authority to engage in Federal Register a list, to be known as the $2,000,000,0000 in 2005, of which spending on the business of selling prescription drugs National Specified List of Susceptible Pre- prescription drugs amounted to that employs 1 or more pharmacists. scription Drugs, consisting of not less than $200,700,000,000. ‘‘(5) PRESCRIPTION DRUG.—The term ‘pre- 30 of the prescription drugs that are most (5) According to the Congressional Budget scription drug’ means a drug subject to sec- frequently subject to counterfeiting in the Office, American seniors alone will spend tion 503(b), other than— United States (as determined by the Sec- $1,800,000,000,000 on pharmaceuticals over the ‘‘(A) a controlled substance (as defined in retary). next 10 years. section 102 of the Controlled Substances Act (B) REVISION.—Not less than annually (6) Allowing open pharmaceutical markets (21 U.S.C. 802)); through the end of calendar year 2010, the could save American consumers at least ‘‘(B) a biological product (as defined in sec- Secretary shall review and, as appropriate, $635,000,000,000 of their own money. tion 351 of the Public Health Service Act (42 revise the National Specified List of Suscep- SEC. l03. PURPOSES. U.S.C. 262)); tible Prescription Drugs. The Secretary may The purposes of this title are to— ‘‘(C) an infused drug (including a peri- not revise the List to include fewer than 30 (1) give all Americans immediate relief toneal dialysis solution); prescription drugs. from the outrageously high cost of pharma- ‘‘(D) an intravenously injected drug; (2) EFFECTIVE DATES.—The Secretary shall ceuticals; ‘‘(E) a drug that is inhaled during surgery; implement the requirements and prohibi- (2) reverse the perverse economics of the or tions of subsections (a), (b), and (d)— American pharmaceutical market; ‘‘(F) a drug which is a parenteral drug, the (A) with respect to prescription drugs on (3) allow the importation of prescription importation of which pursuant to subsection the National Specified List of Susceptible drugs only if the drugs and facilities where (b) is determined by the Secretary to pose a Prescription Drugs, beginning not later than such drugs are manufactured are approved threat to the public health, in which case the earlier of— by the Food and Drug Administration, and to section 801(d)(1) shall continue to apply. (i) 1 year after the initial publication of exclude pharmaceutical narcotics; ‘‘(6) QUALIFYING DRUG.—The term ‘quali- such List; or (4) ensure continued integrity to the pre- fying drug’ means a prescription drug that— (ii) December 31, 2008; and scription drug supply of the United States ‘‘(A) is approved pursuant to an applica- (B) with respect to all prescription drugs, by— tion submitted under section 505(b)(1); and beginning not later than December 31, 2011. (A) requiring that imported prescription ‘‘(B) is not— (3) AUTHORIZED USES DURING TRANSITIONAL drugs be packaged and shipped using coun- ‘‘(i) a drug manufactured through 1 or PERIOD.—In lieu of the requirements speci- terfeit-resistant technologies; more biotechnology processes; fied in subsection (b)(1), for the period begin- (B) requiring Internet pharmacies to reg- ‘‘(ii) a drug that is required to be refrig- ning on the effective date applicable under ister with the United States Government for erated; or paragraph (2)(A) and ending on the com- Americans to verify authenticity before pur- ‘‘(iii) a photoreactive drug. mencement of the effective date applicable chases over the Internet; ‘‘(7) QUALIFYING INTERNET PHARMACY.—The under paragraph (2)(B), the Secretary shall (C) requiring all foreign sellers to register term ‘qualifying Internet pharmacy’ means a require that technologies described in sub- with United States Government and submit registered exporter that dispenses qualifying section (a)(1) be used exclusively to verify to facility inspections by the Government drugs to individuals over an Internet the authenticity of prescription drugs. without prior notice; and website. (g) DEFINITIONS.—In this Act: (D) limiting the eligible countries from ‘‘(8) QUALIFYING LABORATORY.—The term (1) The term ‘‘pedigree’’— which prescription drugs may be imported to ‘qualifying laboratory’ means a laboratory (A) means the history of each prior sale, Canada, member countries of the European in the United States that has been approved purchase, or trade of the prescription drug Union, and other highly industrialized na- by the Secretary for the purposes of this sec- involved to a distributor or retailer of the tions with safe pharmaceutical infrastruc- tion. drug (including the date of the transaction tures. ‘‘(9) REGISTERED EXPORTER.—The term ‘reg- and the names and addresses of all parties to istered exporter’ means a person that is in SEC. l04. AMENDMENTS TO SECTION 804 OF THE the transaction); and FEDERAL FOOD, DRUG, AND COS- the business of exporting a drug to persons (B) excludes information about the sale, METIC ACT. in the United States (or that seeks to be in purchase, or trade of the drug to the drug (a) DEFINITIONS.—Section 804(a) of the Fed- such business), for which a registration consumer. eral Food, Drug, and Cosmetic Act (21 U.S.C. under this section has been approved and is (2) The term ‘‘prescription drug’’ means a 384(a)) is amended to read as follows: in effect. drug subject to section 503(b)(1) of the Fed- ‘‘(a) DEFINITIONS.—In this section: ‘‘(10) WHOLESALER.— eral Food, Drug, and Cosmetic Act (21 U.S.C. ‘‘(1) IMPORTER.—The term ‘importer’ means ‘‘(A) IN GENERAL.—The term ‘wholesaler’ 353(b)(1)). a pharmacy, group of pharmacies, phar- means a person licensed as a wholesaler or (3) The term ‘‘Secretary’’ means the Sec- macist, or wholesaler. distributor of prescription drugs in the retary of Health and Human Services. ‘‘(2) PERMITTED COUNTRY.—The term ‘per- United States under section 503(e)(2)(A). mitted country’ means Australia, Canada, ‘‘(B) EXCLUSION.—The term ‘wholesaler’ SA 984. Mr. VITTER submitted an Israel, Japan, New Zealand, Switzerland, does not include a person authorized to im- amendment intended to be proposed by South Africa, Austria, Belgium, Denmark, port drugs under section 801(d)(1).’’. him to the bill S. 1082, to amend the Finland, France, Germany, Greece, Ireland, (b) REGULATIONS.—Section 804(b) of the Federal Food, Drug, and Cosmetic Act Italy, Luxemburg, Netherlands, Portugal, Federal Food, Drug, and Cosmetic Act (21 to reauthorize and amend the prescrip- Spain, Sweden, the United Kingdom, Iceland, U.S.C. 384(b)) is amended to read as follows: Liechtenstein, and Norway, except that the tion drug user fee provisions, and for ‘‘(b) REGULATIONS.—Not later than 180 days other purposes; which was ordered to Secretary— after the date of enactment of the Pharma- lie on the table; as follows: ‘‘(A) may add a country, union, or eco- ceutical Market Access Act of 2007, the Sec- nomic area as a permitted country for pur- retary, after consultation with the United At the appropriate place, insert the fol- poses of this section if the Secretary deter- lowing: States Trade Representative and the Com- mines that the country, union, or economic missioner of the Bureau of Customs and Bor- TITLE—IMPORTATION OF PRESCRIPTION area has a pharmaceutical infrastructure der Protection, shall promulgate regulations DRUGS that is substantially equivalent or superior permitting pharmacists, pharmacies, and SEC. l01. SHORT TITLE. to the pharmaceutical infrastructure of the wholesalers to import qualifying drugs from This Act may be cited as the ‘‘Pharma- United States, taking into consideration permitted countries into the United ceutical Market Access Act of 2007’’. pharmacist qualifications, pharmacy storage States.’’. SEC. l02. FINDINGS. procedures, the drug distribution system, the Congress finds as follows: drug dispensing system, and market regula- (c) LIMITATION.—Section 804(c) of the Fed- (1) Americans unjustly pay up to 1,000 per- tion; and eral Food, Drug, and Cosmetic Act (21 U.S.C. cent more to fill their prescriptions than ‘‘(B) may remove a country, union, or eco- 384(c)) is amended by striking ‘‘prescription consumers in other countries. nomic area as a permitted country for pur- drug’’ each place it appears and inserting (2) The United States is the world’s largest poses of this section if the Secretary deter- ‘‘qualifying drug’’. market for pharmaceuticals yet consumers mines that the country, union, or economic (d) INFORMATION AND RECORDS.—Section still pay the world’s highest prices. area does not have such a pharmaceutical in- 804(d)(1) of the Federal Food, Drug, and Cos- (3) An unaffordable drug is neither safe nor frastructure. metic Act (21 U.S.C. 384(d)(1)) is amended— effective. Allowing and structuring the im- ‘‘(3) PHARMACIST.—The term ‘pharmacist’ (1) by striking subparagraph (G) and redes- portation of prescription drugs ensures ac- means a person licensed by the relevant gov- ignating subparagraphs (H) through (N) as cess to affordable drugs, thus providing a ernmental authority to practice pharmacy, subparagraphs (G) through (M), respectively; level of safety to American consumers they including the dispensing and selling of pre- (2) in subparagraph (H) (as so redesig- do not currently enjoy. scription drugs. nated), by striking ‘‘telephone number, and (4) Prescription drug costs are a leading ‘‘(4) PHARMACY.—The term ‘pharmacy’ professional license number (if any)’’ and in- cause of the growth in United States health means a person that is licensed by the rel- serting ‘‘and telephone number’’; and

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00089 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.062 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5404 CONGRESSIONAL RECORD — SENATE May 1, 2007 (3) in subparagraph (L) (as so redesig- Administration and via a toll-free telephone SEC. l05. REGISTRATION FEES. nated), by striking ‘‘(J) and (L)’’ and insert- number; and Subchapter C of chapter VII of the Federal ing ‘‘(I) and (K)’’. ‘‘(C) update such list promptly after the Food, Drug, and Cosmetic Act (21 U.S.C. 397f (e) TESTING.—Section 804(e) of the Federal approval of a registration under this sub- et seq.) is amended by adding at the end the Food, Drug, and Cosmetic Act (21 U.S.C. section. following: 384(e)) is amended to read as follows: ‘‘(4) EDUCATION OF CONSUMERS.—The Sec- ‘‘PART 5—FEES RELATING TO ‘‘(e) TESTING.—The regulations under sub- retary shall carry out activities, by use of PRESCRIPTION DRUG IMPORTATION section (b) shall require that the testing de- the Internet website and toll-free telephone scribed under subparagraphs (I) and (K) of number under paragraph (3), that educate ‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION. subsection (d)(1) be conducted by the im- consumers with regard to the availability of ‘‘(a) REGISTRATION FEE.—The Secretary porter of the qualifying drug, unless the qualifying drugs for import for personal use shall establish a registration fee program qualifying drug is subject to the require- under this section, including information on under which a registered exporter under sec- ments under section 505C for counterfeit-re- how to verify whether an exporter is reg- tion 804 shall be required to pay an annual sistant technologies.’’. istered. (f) REGISTRATION OF EXPORTERS; INSPEC- fee to the Secretary in accordance with this ‘‘(5) INSPECTION OF IMPORTERS AND REG- TIONS.—Section 804(f) of the Federal Food, subsection. ISTERED EXPORTERS.—The Secretary shall in- Drug, and Cosmetic Act (21 U.S.C. 384(f)) is ‘‘(b) COLLECTION.— spect the warehouses, other facilities, and amended to read as follows: ‘‘(1) COLLECTION ON INITIAL REGISTRATION.— records of importers and registered exporters ‘‘(f) REGISTRATION OF EXPORTERS; INSPEC- A fee under this section shall be payable for as often as the Secretary determines nec- TIONS.— the fiscal year in which the registered ex- essary to ensure that such importers and ‘‘(1) IN GENERAL.—Any person that seeks to porter first submits a registration under sec- registered exporters are in compliance with be a registered exporter (referred to in this tion 804 (or reregisters under that section if this section.’’. subsection as the ‘registrant’) shall submit that person has withdrawn its registration (g) SUSPENSION OF IMPORTATION.—Section to the Secretary a registration that includes 804(g) of the Federal Food, Drug, and Cos- and subsequently reregisters) in a amount of the following: metic Act (21 U.S.C. 384(g)) is amended by— $10,000, due on the date the exporter first ‘‘(A) The name of the registrant and identi- (1) striking ‘‘and the Secretary determines submits a registration to the Secretary fication of all places of business of the reg- that the public is adequately protected from under section 804. istrant that relate to qualifying drugs, in- counterfeit and violative prescription drugs ‘‘(2) COLLECTION IN SUBSEQUENT YEARS.— cluding each warehouse or other facility being imported under subsection (b)’’; and After the fee is paid for the first fiscal year, owned or controlled by, or operated for, the (2) by adding after the period at the end the fee described under this subsection shall registrant; the following: ‘‘The Secretary shall reinstate be payable on or before October 1 of each ‘‘(B) An agreement by the registrant to— the importation by a specific importer upon year. ‘‘(i) make its places of business that relate a determination by the Secretary that the ‘‘(3) ONE FEE PER FACILITY.—The fee shall to qualifying drugs (including warehouses violation has been corrected and that the im- be paid only once for each registered ex- and other facilities owned or controlled by, porter has demonstrated that further viola- porter for a fiscal year in which the fee is or operated for, the exporter) and records tions will not occur. This subsection shall payable. available to the Secretary for on-site inspec- not apply to a prescription drug imported by ‘‘(c) FEE AMOUNT.— tions, without prior notice, for the purpose an individual, or to a prescription drug ‘‘(1) IN GENERAL.—Subject to subsection of determining whether the registrant is in shipped to an individual by a qualifying (b)(1), the amount of the fee shall be deter- compliance with this Act’s requirements; Internet pharmacy.’’. mined each year by the Secretary and shall ‘‘(ii) export only qualifying drugs; (h) WAIVER AUTHORITY FOR INDIVIDUALS.— be based on the anticipated costs to the Sec- ‘‘(iii) export only to persons authorized to Section 804(j) of the Federal Food, Drug, and retary of enforcing the amendments made by import the drugs; Cosmetic Act (21 U.S.C. 384(j)) is amended to the Pharmaceutical Market Access Act of ‘‘(iv) notify the Secretary of a recall or read as follows: 2007 in the subsequent fiscal year. withdrawal of a qualifying drug distributed ‘‘(j) IMPORTATION BY INDIVIDUALS.— ‘‘(2) LIMITATION.— in a permitted country to or from which the ‘‘(1) IN GENERAL.—Not later than 180 days ‘‘(A) IN GENERAL.—The aggregate total of registrant has exported or imported, or in- after the enactment of the Pharmaceutical fees collected under this section shall not ex- tends to export or import, to the United Market Access Act of 2007, the Secretary ceed 1 percent of the total price of drugs ex- States; shall by regulation permit an individual to ported annually to the United States by reg- ‘‘(v) monitor compliance with registration import a drug from a permitted country to istered exporters under this section. conditions and report any noncompliance the United States if the drug is— ‘‘(B) REASONABLE ESTIMATE.—Subject to promptly; ‘‘(A) a qualifying drug; the limitation described in subparagraph (A), ‘‘(vi) submit a compliance plan showing ‘‘(B) imported from a licensed pharmacy or a fee under this subsection for an exporter how the registrant will correct violations, if qualifying Internet pharmacy; shall be an amount that is a reasonable esti- any; and ‘‘(C) for personal use by an individual, or mate by the Secretary of the annual share of ‘‘(vii) promptly notify the Secretary of family member of the individual, not for re- the exporter of the volume of drugs exported changes in the registration information of sale; by exporters under this section. the registrant. ‘‘(D) in a quantity that does not exceed a ‘‘(d) USE OF FEES.—The fees collected ‘‘(2) NOTICE OF APPROVAL OR DIS- 90-day supply during any 90-day period; and under this section shall be used for the sole APPROVAL.— ‘‘(E) accompanied by a copy of a prescrip- purpose of administering this section with ‘‘(A) IN GENERAL.—Not later than 90 days tion for the drug, which— respect to registered exporters, including the after receiving a completed registration ‘‘(i) is valid under applicable Federal and costs associated with— from a registrant, the Secretary shall— State laws; and ‘‘(1) inspecting the facilities of registered ‘‘(i) notify such registrant of receipt of the ‘‘(ii) was issued by a practitioner who is exporters, and of other entities in the chain registration; authorized to administer prescription drugs. of custody of a qualifying drug; ‘‘(ii) assign such registrant a registration ‘‘(2) DRUGS DISPENSED OUTSIDE THE UNITED ‘‘(2) developing, implementing, and main- number; and STATES.—An individual may import a drug taining a system to determine registered ex- ‘‘(iii) approve or disapprove the applica- from a country that is not a permitted coun- porters’ compliance with the registration tion. try if— conditions under the Pharmaceutical Market ‘‘(B) DISAPPROVAL OF APPLICATION.— ‘‘(A) the drug was dispensed to the indi- Access Act of 2007, including when shipments ‘‘(i) IN GENERAL.—The Secretary shall dis- vidual while the individual was in such coun- of qualifying drugs are offered for import approve a registration, and notify the reg- try, and the drug was dispensed in accord- into the United States; and istrant of such disapproval, if the Secretary ance with the laws and regulations of such ‘‘(3) inspecting such shipments, as nec- has reason to believe that such registrant is country; essary, when offered for import into the not in compliance with a registration condi- ‘‘(B) the individual is entering the United United States to determine if any such ship- tion. States and the drug accompanies the indi- ment should be refused admission. ‘‘(ii) SUBSEQUENT APPROVAL.—The Sec- vidual at the time of entry; ‘‘(e) ANNUAL FEE SETTING.—The Secretary retary may subsequently approve a registra- ‘‘(C) the drug is approved for commercial shall establish, 60 days before the beginning tion that was denied under clause (i) if the distribution in the country in which the drug of each fiscal year beginning after Sep- Secretary finds that the registrant is in com- was obtained; tember 30, 2007, for that fiscal year, registra- pliance with all registration conditions. ‘‘(D) the drug does not appear to be adul- tion fees. ‘‘(3) LIST.—The Secretary shall— terated; and ‘‘(f) EFFECT OF FAILURE TO PAY FEES.— ‘‘(A) maintain an up-to-date list of reg- ‘‘(E) the quantity of the drug does not ex- ‘‘(1) DUE DATE.—A fee payable under this istered exporters (including qualifying Inter- ceed a 14-day supply.’’. section shall be paid by the date that is 30 net pharmacies that sell qualifying drugs to (i) REPEAL OF CERTAIN PROVISIONS.—Sec- days after the date on which the fee is due. individuals); tion 804 of the Federal Food, Drug, and Cos- ‘‘(2) FAILURE TO PAY.—If a registered ex- ‘‘(B) make such list available to the public metic Act (21 U.S.C. 384) is amended by strik- porter subject to a fee under this section on the Internet site of the Food and Drug ing subsections (l) and (m). fails to pay the fee, the Secretary shall not

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00090 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.063 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5405 permit the registered exporter to engage in tainer that incorporates the technologies de- ‘‘(F) cause there to be a difference (includ- exportation to the United States or offering scribed in subsection (b), so that officials in- ing a difference in active ingredient, route of for exportation prescription drugs under this specting the packages will be able to deter- administration, dosage form, strength, for- Act until all such fees owed by that person mine the authenticity of the shipment. mulation, manufacturing establishment, are paid. Chain of custody procedures shall apply to manufacturing process, or person that manu- ‘‘(g) REPORTS.— such labels and shall include procedures ap- factures the drug) between a prescription ‘‘(1) FEE ESTABLISHMENT.—Not later than plicable to contractual agreements for the drug for distribution in the United States 60 days before the beginning of each fiscal use and distribution of the labels, methods and the drug for distribution in a permitted year, the Secretary shall— to audit the use of the labels, and database country for the purpose of restricting impor- ‘‘(A) publish registration fees under this access for the relevant governmental agen- tation of the drug into the United States section for that fiscal year; cies for audit or verification of the use and under this section; ‘‘(B) hold a meeting at which the public distribution of the labels. ‘‘(G) refuse to allow an inspection author- may comment on the recommendations; and ‘‘(d) EFFECTIVE DATE.—This section shall ized under this section of an establishment ‘‘(C) provide for a period of 30 days for the take effect 180 days after the date of enact- that manufactures a prescription drug that public to provide written comments on the ment of the Pharmaceutical Market Access may be imported or offered for import under recommendations. Act of 2007.’’. this section; ‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be- SEC. l07. PROHIBITED ACTS. ‘‘(H) fail to conform to the methods used ginning with fiscal year 2007, not later than Section 301 of the Federal Food, Drug, and in, or the facilities used for, the manufac- 60 days after the end of each fiscal year dur- Cosmetic Act (21 U.S.C. 331) is amended by turing, processing, packing, or holding of a ing which fees are collected under this sec- inserting after subsection (k) the following: prescription drug that may be imported or ‘‘(l) The failure to register in accordance tion, the Secretary shall submit to the Com- offered for import under this section to good with section 804(f) or to import or offer to mittee on Health, Education, Labor, and manufacturing practice under this Act; Pensions of the Senate and the Committee import a prescription drug in violation of a suspension order under section 804(g).’’. ‘‘(I) become a party to a licensing or other on Energy and Commerce of the House of agreement related to a prescription drug SEC. l08. PATENTS. Representatives a report that describes— that fails to provide for compliance with all ‘‘(A) implementation of the registration Section 271 of title 35, United States Code, is amended— requirements of this section with respect to fee authority during the fiscal year; and such prescription drug or that has the effect ‘‘(B) the use by the Secretary of the fees (1) by redesignating subsections (h) and (i) as subsections (i) and (j), respectively; and of prohibiting importation of the drug under collected during the fiscal year for which the this section; or report is made.’’. (2) by inserting after subsection (g) the fol- lowing: ‘‘(J) engage in any other action that the SEC. l06. COUNTERFEIT-RESISTANT TECH- ‘‘(h) It shall not be an act of infringement Federal Trade Commission determines to NOLOGY. to use, offer to sell, or sell within the United discriminate against a person that engages (a) MISBRANDING.—Section 502 of the Fed- States or to import into the United States in, or to impede, delay, or block the process eral Food, Drug, and Cosmetic Act (21 U.S.C. any patented invention under section 804 (21 for, the importation of a prescription drug 352; deeming drugs and devices to be mis- U.S.C. 384) of the Federal Food, Drug, and under this section. branded) is amended by adding at the end the Cosmetic Act that was first sold abroad by ‘‘(2) AFFIRMATIVE DEFENSE.—It shall be an following: or under authority of the owner or licensee affirmative defense to a charge that a person ‘‘(z) If it is a drug subject to section 503(b), of such patent.’’. has discriminated under subparagraph (A), unless the packaging of such drug complies SEC. l09. OTHER ENFORCEMENT ACTIONS. (B), (C), (D), or (E) of paragraph (1) that the with the requirements of section 505C for (a) IN GENERAL.—Section 804 of the Federal higher price charged for a prescription drug counterfeit-resistant technologies.’’. Food, Drug, and Cosmetic Act (as amended sold to a person, the denial of supplies of a (b) REQUIREMENTS.—Chapter V of the Fed- in section l04) is amended by adding at the prescription drug to a person, the refusal to eral Food, Drug, and Cosmetic Act (21 U.S.C. end the following: do business with a person, or the specific re- 351 et seq.) is amended by inserting after sec- ‘‘(l) UNFAIR OR DISCRIMINATORY ACTS AND striction or delay of supplies to a person is tion 505B the following: PRACTICES.— not based, in whole or in part, on— ‘‘SEC. 505C. COUNTERFEIT-RESISTANT TECH- ‘‘(1) IN GENERAL.—It is unlawful for a man- ‘‘(A) the person exporting or importing a NOLOGIES. ufacturer, directly or indirectly (including prescription drug into the United States ‘‘(a) INCORPORATION OF COUNTERFEIT-RE- by being a party to a licensing or other under this section; or SISTANT TECHNOLOGIES INTO PRESCRIPTION agreement) to— ‘‘(B) the person distributing, selling, or DRUG PACKAGING.—The Secretary shall re- ‘‘(A) discriminate by charging a higher using a prescription drug imported into the quire that the packaging of any drug subject price for a prescription drug sold to a person United States under this section. to section 503(b) incorporate— in a permitted country that exports a pre- ‘‘(3) PRESUMPTION AND AFFIRMATIVE DE- ‘‘(1) overt optically variable counterfeit-re- scription drug to the United States under FENSE.— sistant technologies that are described in this section than the price that is charged to ‘‘(A) PRESUMPTION.—A difference (includ- subsection (b) and comply with the standards another person that is in the same country ing a difference in active ingredient, route of of subsection (c); or and that does not export a prescription drug administration, dosage form, strength, for- ‘‘(2) technologies that have an equivalent into the United States under this section; mulation, manufacturing establishment, function of security, as determined by the ‘‘(B) discriminate by charging a higher manufacturing process, or person that manu- Secretary. price for a prescription drug sold to a person factures the drug) created after January 1, ‘‘(b) ELIGIBLE TECHNOLOGIES.—Tech- that distributes, sells, or uses a prescription 2007, between a prescription drug for dis- nologies described in this subsection— drug imported into the United States under tribution in the United States and the drug ‘‘(1) shall be visible to the naked eye, pro- this section than the price that is charged to for distribution in a permitted country shall viding for visual identification of product another person in the United States that be presumed under paragraph (1)(H) to be for authenticity without the need for readers, does not import a prescription drug under the purpose of restricting importation of the microscopes, lighting devices, or scanners; this section, or that does not distribute, sell, drug into the United States under this sec- ‘‘(2) shall be similar to that used by the or use such a drug; tion. Bureau of Engraving and Printing to secure ‘‘(C) discriminate by denying supplies of a ‘‘(B) AFFIRMATIVE DEFENSE.—It shall be an United States currency; prescription drug to a person in a permitted affirmative defense to the presumption ‘‘(3) shall be manufactured and distributed country that exports a prescription drug to under subparagraph (A) that— in a highly secure, tightly controlled envi- the United States under this section or dis- ‘‘(i) the difference was required by the ronment; and tributes, sells, or uses a prescription drug country in which the drug is distributed; or ‘‘(4) should incorporate additional layers of imported into the United States under this ‘‘(ii) the Secretary has determined that the non-visible covert security features up to section; difference was necessary to improve the safe- and including forensic capability. ‘‘(D) discriminate by publicly, privately, or ty or effectiveness of the drug. ‘‘(c) STANDARDS FOR PACKAGING.— otherwise refusing to do business with a per- ‘‘(4) EFFECT OF SUBSECTION.— ‘‘(1) MULTIPLE ELEMENTS.—For the purpose son in a permitted country that exports a ‘‘(A) SALES IN OTHER COUNTRIES.—This sub- of making it more difficult to counterfeit prescription drug to the United States under section applies only to the sale or distribu- the packaging of drugs subject to section this section or distributes, sells, or uses a tion of a prescription drug in a country if the 503(b), manufacturers of the drugs shall in- prescription drug imported into the United manufacturer of the drug chooses to sell or corporate the technologies described in sub- States under this section; distribute the drug in the country. Nothing section (b) into multiple elements of the ‘‘(E) discriminate by specifically restrict- in this subsection shall be construed to com- physical packaging of the drugs, including ing or delaying the supply of a prescription pel the manufacturer of a drug to distribute blister packs, shrink wrap, package labels, drug to a person in a permitted country that or sell the drug in a country. package seals, bottles, and boxes. exports a prescription drug to the United ‘‘(B) DISCOUNTS TO INSURERS, HEALTH ‘‘(2) LABELING OF SHIPPING CONTAINER.— States under this section or distributes, PLANS, PHARMACY BENEFIT MANAGERS, AND Shipments of drugs described in subsection sells, or uses a prescription drug imported COVERED ENTITIES.—Nothing in this sub- (a) shall include a label on the shipping con- into the United States under this section; section shall be construed to—

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00091 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.063 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5406 CONGRESSIONAL RECORD — SENATE May 1, 2007 ‘‘(i) prevent or restrict a manufacturer of a ‘‘(I) to be heard with respect to any matter Clayton Act, except that it includes section prescription drug from providing discounts that arises in that action; and 5 of the Federal Trade Commission Act to to an insurer, health plan, pharmacy benefit ‘‘(II) to file a petition for appeal. the extent that such section 5 applies to un- manager in the United States, or covered en- ‘‘(C) CONSTRUCTION.—For purposes of bring- fair methods of competition. tity in the drug discount program under sec- ing any civil action under subparagraph (A), ‘‘(8) MANUFACTURER.—In this subsection, tion 340B in return for inclusion of the drug nothing in this subsection shall be construed the term ‘manufacturer’ means any entity, on a formulary; to prevent an attorney general of a State including any affiliate or licensee of that en- ‘‘(ii) require that such discounts be made from exercising the powers conferred on the tity, that is engaged in— available to other purchasers of the prescrip- attorney general by the laws of that State ‘‘(A) the production, preparation, propaga- tion drug; or to— tion, compounding, conversion, or processing ‘‘(iii) prevent or restrict any other meas- ‘‘(i) conduct investigations; of a prescription drug, either directly or in- ures taken by an insurer, health plan, or ‘‘(ii) administer oaths or affirmations; or directly by extraction from substances of pharmacy benefit manager to encourage con- ‘‘(iii) compel the attendance of witnesses natural origin, or independently by means of sumption of such prescription drug. or the production of documentary and other chemical synthesis, or by a combination of ‘‘(C) CHARITABLE CONTRIBUTIONS.—Nothing evidence. extraction and chemical synthesis; or in this subsection shall be construed to— ‘‘(D) ACTIONS BY THE COMMISSION.— ‘‘(B) the packaging, repackaging, labeling, ‘‘(i) prevent a manufacturer from donating ‘‘(i) IN GENERAL.—In any case in which an relabeling, or distribution of a prescription a prescription drug, or supplying a prescrip- action is instituted by or on behalf of the drug.’’. Commission for a violation of paragraph (1), tion drug at nominal cost, to a charitable or a State may not, during the pendency of that (b) REGULATIONS.—The Federal Trade Com- humanitarian organization, including the action, institute an action under subpara- mission shall promulgate regulations to United Nations and affiliates, or to a govern- graph (A) for the same violation against any carry out the enforcement program under ment of a foreign country; or defendant named in the complaint in that section 804(l) of the Federal Food, Drug, and ‘‘(ii) apply to such donations or supplying action. Cosmetic Act (as added by subsection (a)). of a prescription drug. ‘‘(ii) INTERVENTION.—An attorney general ‘‘(5) ENFORCEMENT (c) SUSPENSION AND TERMINATION OF EX- .— of a State may intervene, on behalf of the PORTERS.—Section 804(g) of the Federal ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC- residents of that State, in an action insti- Food, Drug, and Cosmetic Act (as amended TICE.—A violation of this subsection shall be tuted by the Commission. treated as a violation of a rule defining an by section l04(g)) (21 U.S.C. 384(g)) is amend- ‘‘(iii) EFFECT OF INTERVENTION.—If an at- unfair or deceptive act or practice prescribed torney general of a State intervenes in an ed by— under section 18(a)(1)(B) of the Federal Trade action instituted by the Commission, such (1) striking ‘‘SUSPENSION OF IMPORTA- Commission Act. attorney general shall have the right— TION.—The Secretary’’ and inserting ‘‘SUS- ‘‘(B) ACTIONS BY THE COMMISSION.—The ‘‘(I) to be heard with respect to any matter PENSION OF IMPORTATION.— Federal Trade Commission— that arises in that action; and ‘‘(1) IN GENERAL.—The Secretary’’; and ‘‘(i) shall enforce this subsection in the ‘‘(II) to file a petition for appeal. (2) adding at the end the following: same manner, by the same means, and with ‘‘(E) VENUE.—Any action brought under ‘‘(2) SUSPENSION AND TERMINATION OF EX- the same jurisdiction, powers, and duties as subparagraph (A) may be brought in the dis- PORTERS.— though all applicable terms and provisions of trict court of the United States that meets ‘‘(A) SUSPENSION.—With respect to the ef- the Federal Trade Commission Act were in- applicable requirements relating to venue fectiveness of a registration submitted under corporated into and made a part of this sec- under section 1391 of title 28, United States subsection (f) by a registered exporter: tion; and Code. ‘‘(i) Subject to clause (ii), if the Secretary ‘‘(ii) may seek monetary relief threefold ‘‘(F) SERVICE OF PROCESS.—In an action determines, after notice and opportunity for the damages sustained. brought under subparagraph (A), process a hearing, that the registered exporter has ‘‘(6) ACTIONS BY STATES.— may be served in any district in which the failed to maintain substantial compliance ‘‘(A) IN GENERAL.— defendant— with all registration conditions, the Sec- ‘‘(i) CIVIL ACTIONS.—The attorney general ‘‘(i) is an inhabitant; or retary may suspend the registration. of a State may bring a civil action on behalf ‘‘(ii) may be found. ‘‘(ii) If the Secretary determines that, of the residents of the State, and persons ‘‘(G) LIMITATION OF ACTIONS.—Any action under color of the registration, the reg- doing business in the State, in a district under this paragraph to enforce a cause of istered exporter has exported a drug that is court of the United States of appropriate ju- action under this subsection by the Federal not a qualifying drug, or a drug that does not risdiction for a violation of paragraph (1) Trade Commission or the attorney general of meet the criteria under this section, or has to— a State shall be forever barred unless com- exported a qualifying drug to an individual ‘‘(I) enjoin that practice; menced within 5 years after the Federal in violation of this section, the Secretary ‘‘(II) enforce compliance with this sub- Trade Commission, or the attorney general, shall immediately suspend the registration. section; as the case may be, knew or should have A suspension under the preceding sentence is ‘‘(III) obtain damages, restitution, or other known that the cause of action accrued. No not subject to the provision by the Secretary compensation on behalf of residents of the cause of action barred under existing law on of prior notice, and the Secretary shall pro- State and persons doing business in the the effective date of the Pharmaceutical vide to the registered exporter involved an State, including threefold the damages; or Market Access Act of 2007 shall be revived by opportunity for a hearing not later than 10 ‘‘(IV) obtain such other relief as the court such Act. days after the date on which the registration may consider to be appropriate. ‘‘(H) MEASUREMENT OF DAMAGES.—In any is suspended. ‘‘(ii) NOTICE.— action under this paragraph to enforce a ‘‘(iii) The Secretary may reinstate the reg- ‘‘(I) IN GENERAL.—Before filing an action cause of action under this subsection in istration, whether suspended under clause (i) under clause (i), the attorney general of the which there has been a determination that a or (ii), if the Secretary determines that the State involved shall provide to the Federal defendant has violated a provision of this registered exporter has demonstrated that Trade Commission— subsection, damages may be proved and as- further violations of registration conditions ‘‘(aa) written notice of that action; and sessed in the aggregate by statistical or sam- will not occur. ‘‘(bb) a copy of the complaint for that ac- pling methods, by the computation of illegal ‘‘(B) TERMINATION.—The Secretary, after tion. overcharges or by such other reasonable sys- notice and opportunity for a hearing, may ‘‘(II) EXEMPTION.—Subclause (I) shall not tem of estimating aggregate damages as the terminate the registration under subsection apply with respect to the filing of an action court in its discretion may permit without (f) of a registered exporter if the Secretary by an attorney general of a State under this the necessity of separately proving the indi- determines that the registered exporter has paragraph, if the attorney general deter- vidual claim of, or amount of damage to, per- engaged in a pattern or practice of violating mines that it is not feasible to provide the sons on whose behalf the suit was brought. 1 or more registration conditions, or if on 1 notice described in that subclause before fil- ‘‘(I) EXCLUSION ON DUPLICATIVE RELIEF.— or more occasions the Secretary has under ing of the action. In such case, the attorney The district court shall exclude from the subparagraph (A)(ii) suspended the registra- general of a State shall provide notice and a amount of monetary relief awarded in an ac- tion of the registered exporter. The Sec- copy of the complaint to the Federal Trade tion under this paragraph brought by the at- retary may make the termination perma- Commission at the same time as the attor- torney general of a State any amount of nent, or for a fixed period of not less than 1 ney general files the action. monetary relief which duplicates amounts year. During the period in which the reg- ‘‘(B) INTERVENTION.— which have been awarded for the same in- istration of a registered exporter is termi- ‘‘(i) IN GENERAL.—On receiving notice jury. nated, any registration submitted under sub- under subparagraph (A)(ii), the Commission ‘‘(7) EFFECT ON ANTITRUST LAWS.—Nothing section (f) by such exporter or a person who shall have the right to intervene in the ac- in this subsection shall be construed to mod- is a partner in the export enterprise or a tion that is the subject of the notice. ify, impair, or supersede the operation of the principal officer in such enterprise, and any ‘‘(ii) EFFECT OF INTERVENTION.—If the Com- antitrust laws. For the purpose of this sub- registration prepared with the assistance of mission intervenes in an action under sub- section, the term ‘antitrust laws’ has the such exporter or such a person, has no legal paragraph (A), it shall have the right— meaning given it in the first section of the effect under this section.’’.

VerDate Aug 31 2005 03:08 May 02, 2007 Jkt 059060 PO 00000 Frm 00092 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.063 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5407 SEC. l10. AUTHORIZATION OF APPROPRIATIONS. 505(b)(1) will be submitted after the date of centimeters in diameter as pets as long as There are authorized to be appropriated the approval of the tropical disease product. the sellers are required to use proven meth- such sums as may be necessary to carry out ‘‘(3) LIMITATION.—A sponsor of a tropical ods to treat the turtles for salmonella and this title (and the amendments made by this disease product may not receive a priority maintain a safe pet. title). review voucher under this section if the trop- SEC. ll. SALE OF BABY TURTLES. ical disease product was approved by the (a) IN GENERAL.—Notwithstanding any SA 985. Mr. BROWNBACK (for him- Secretary prior to the date of enactment of other provision of law, the Food and Drug self and Mr. BROWN) submitted an this section. Administration shall not restrict the sale by amendment intended to be proposed by ‘‘(c) PRIORITY REVIEW USER FEE.— a turtle farmer or other commercial retail ‘‘(1) IN GENERAL.—The Secretary shall es- seller of a turtle that is less than 10.2 centi- him to the bill S. 1082, to amend the tablish a user fee program under which a Federal Food, Drug, and Cosmetic Act meters in diameter as a pet if— sponsor of a drug that is the subject of a pri- (1) the turtle is raised, shipped, and sold to reauthorize and amend the prescrip- ority review voucher shall pay to the Sec- using methods that are proven to keep the tion drug user fee provisions, and for retary a fee determined under paragraph (2). turtle free of salmonella, using salmonella other purposes; which was ordered to Such fee shall be in addition to any fee re- safety standards that are comparable to such lie on the table; as follows: quired to be submitted by the sponsor under standards relating to other animals, includ- chapter VII. At the appropriate place, insert the fol- ing reptiles and amphibians, that are allowed ‘‘(2) FEE AMOUNT.—The amount of the pri- lowing: for sale as pets, or animal products that are ority review user fee shall be determined allowed for sale as food products; SEC. ll. PRIORITY REVIEW TO ENCOURAGE each fiscal year by the Secretary and based TREATMENTS FOR TROPICAL DIS- (2) the Administration has approved a plan EASES. on the anticipated costs to the Secretary of submitted by the turtle farmer or commer- Subchapter A of chapter V of the Federal implementing this section. cial retail seller involved relating to compli- Food, Drug, and Cosmetic Act (21 U.S.C. 351 ‘‘(3) ANNUAL FEE SETTING.—The Secretary ance with paragraph (1); and et seq.) is amended by adding at the end the shall establish, before the beginning of each (3) the farmer or other commercial retail following: fiscal year beginning after September 30, seller includes, with the sale of such a turtle, 2007, for that fiscal year, the amount of the a disclosure to the buyer that includes— ‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE priority review user fee. TREATMENTS FOR TROPICAL DIS- (A) information regarding— EASES. ‘‘(4) PAYMENT.— (i) the dangers, including possible severe ‘‘(A) IN GENERAL.—The fee required by this ‘‘(a) DEFINITIONS.—In this section: illness or death, especially for at-risk people ‘‘(1) AIDS.—The term ‘AIDS’ means the ac- subsection shall be due upon the filing of the who may be susceptible to salmonella poi- quired immune deficiency syndrome. new drug application under section 505(b)(1) soning, such as children, pregnant women, for which the voucher is used. ‘‘(2) AIDS DRUG.—The term ‘AIDS drug’ and others who may have weak immune sys- means a drug indicated for treating HIV. ‘‘(B) COMPLETE APPLICATION.—An applica- tems, that could result if the turtle is not ‘‘(3) HIV.—The term ‘HIV’ means the tion described under subparagraph (A) for properly handled and safely maintained; human immunodeficiency virus, the patho- which the sponsor requests the use of a pri- (ii) the proper handling of the turtle, in- gen that causes AIDS. ority review voucher shall be considered in- cluding an explanation of proper hygiene complete if the fee required by this sub- ‘‘(4) NEGLECTED OR TROPICAL DISEASE.—The such as handwashing after handling a turtle; term ‘neglected or tropical disease’ means— section is not included in such application.’’. and ‘‘(A) HIV, malaria, tuberculosis, and re- Ms. LANDRIEU submitted an (iii) the proven methods of treatment that, lated diseases; or SA 986. if properly applied, keep the turtle safe from ‘‘(B) any other infectious disease that dis- amendment intended to be proposed by salmonella; proportionately affects poor and her to the bill S. 1082, to amend the (B) a detailed explanation of how to prop- marginalized populations, including those Federal Food, Drug, and Cosmetic Act erly treat the turtle to keep it safe from sal- diseases targeted by the Special Programme to reauthorize and amend the prescrip- monella, using the proven methods of treat- for Research and Training in Tropical Dis- tion drug user fee provisions, and for ment referred to under subparagraph (A), eases cosponsored by the United Nations De- other purposes; which was ordered to and how the buyer can continue to purchase velopment Program, UNICEF, the World lie on the table; as follows: the tools, treatments, or any other required Bank, and the World Health Organization. item to continually treat the turtle; and At the end of the bill, add the following: ‘‘(5) PRIORITY REVIEW.—The term ‘priority (C) a statement that buyers of pet turtles review’, with respect to a new drug applica- TITLE—DOMESTIC PET TURTLE MARKET should not abandon the turtle or abandon it tion described in paragraph (6), means review ACCESS outside, as the turtle may become an and action by the Secretary on such applica- SEC. ll. SHORT TITLE. invasive species to the local community, but tion not later than 180 days after receipt by This title may be cited as the ‘‘Domestic should instead return them to a commercial the Secretary of such application, pursuant Pet Turtle Market Access Act of 2007’’. retail pet seller or other organization that to the Manual of Policies and Procedures of SEC. ll. FINDINGS. would accept turtles no longer wanted as the Food and Drug Administration. Congress makes the following findings: pets. ‘‘(6) PRIORITY REVIEW VOUCHER.—The term (1) Pet turtles less than 10.2 centimeters in (b) PLAN.— ‘priority review voucher’ means a voucher diameter have been banned for sale in the (1) IN GENERAL.—A turtle farmer or other issued by the Secretary to the sponsor of a United States by the Food and Drug Admin- commercial seller that desires to sell a tur- tropical disease product that entitles such istration since 1975 due to health concerns. tle as provided for under subsection (a) shall sponsor, or a person described under sub- (2) The Food and Drug Administration does submit a plan to the Food and Drug Admin- section (b)(2), to priority review of a new not ban the sale of iguanas or other lizards, istration that details the manner in which drug application submitted under section snakes, frogs, or other amphibians or rep- the farmer or seller will ensure compliance 505(b)(1) after the date of approval of the tiles that are sold as pets in the United with the requirements of subsection (a)(1) tropical disease product. States that also carry salmonella bacteria. with respect to the turtles involved. The ‘‘(7) TROPICAL DISEASE PRODUCT.—The term The Food and Drug Administration also does plan shall include use of non-antibiotic com- ‘tropical disease product’ means a product not require that these animals be treated for pounds that suppress or eliminate the pres- that— salmonella bacteria before being sold as pets. ence of salmonella in turtle hatchlings. ‘‘(A) is a new drug, antibiotic drug, biologi- (3) The technology to treat turtles for sal- (2) ACTION BY FDA.—Not later 30 days after cal product, vaccine, device, diagnostic, or monella, and make them safe for sale, has the date on which the Food and Drug Admin- other tool for treatment of a neglected or greatly advanced since 1975. Treatments istration receives a plan under paragraph (1), tropical disease; and exist that can nearly eradicate salmonella the Administration shall accept or reject ‘‘(B) is approved by the Secretary for use from turtles, and individuals are more aware such plan. If such plan is rejected, the Ad- in the treatment of a neglected or tropical of the causes of salmonella, how to treat sal- ministration shall provide clear, specific disease. monella poisoning, and the seriousness asso- guidance on the reasons for such rejection. ‘‘(b) PRIORITY REVIEW VOUCHER.— ciated with salmonella poisoning. The Administration may only reject such a ‘‘(1) IN GENERAL.—The Secretary shall (4) University research has shown that plan if it is determined that the plan fails to award a priority review voucher to the spon- these turtles can be treated in such a way achieve the same salmonella safety stand- sor of a tropical disease product upon ap- that they can be raised, shipped, and distrib- ards as such standards relating to other ani- proval by the Secretary of such tropical dis- uted without having a recolonization of sal- mals, including reptiles and amphibians, ease product. monella. that are allowed for sale as pets, or animal ‘‘(2) TRANSFERABILITY.—The sponsor of a (5) University research has also shown that products that are allowed for sale as food tropical disease product that receives a pri- pet owners can be equipped with a treatment products. ority review voucher under this section may regiment that allows the turtle to be main- (c) RULE OF CONSTRUCTION.—Nothing in transfer (including by sale) the entitlement tained safe from salmonella. this section shall be construed to permit the to such voucher to a sponsor of a new drug (6) The Food and Drug Administration Food and Drug Administration to hold the for which an application under section should allow the sale of turtles less than 10.2 sale of turtles less than 10.2 centimeters in

VerDate Aug 31 2005 04:14 May 02, 2007 Jkt 059060 PO 00000 Frm 00093 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.063 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5408 CONGRESSIONAL RECORD — SENATE May 1, 2007 diameter as a pet to any greater salmonella stance covered by section 202(c) of the Con- SA 990. Mr. DORGAN (for himself, safety standard applicable to other reptiles trolled Substances Act (21 U.S.C. 812(c)) or a Ms. SNOWE, Mr. GRASSLEY, Mr. MCCAIN, or amphibians sold as pets, animals sold as psychotropic drug for such individual’s child Ms. STABENOW, Mr. NELSON of Florida, pets, or food products regulated by such Ad- as the basis of a charge of child abuse, child Mr. PRYOR, Mr. SANDERS, Mr. ministration. neglect, education neglect, or medical ne- WHITEHOUSE, and Mrs. MCCASKILL) sub- glect until the agency or instrument dem- SA 987. Mr. INHOFE submitted an onstrates that it is no longer using such re- mitted an amendment intended to be amendment intended to be proposed by fusal as a basis of a child abuse, child ne- proposed by him to the bill S. 1082, to him to the bill S. 1082, to amend the glect, education neglect, or medical neglect amend the Federal Food, Drug, and Federal Food, Drug, and Cosmetic Act charge. Cosmetic Act to reauthorize and amend (b) DEFINITIONS.—In this section: to reauthorize and amend the prescrip- the prescription drug user fee provi- (1) CHILD.—The term ‘‘child’’ means any tion drug user fee provisions, and for sions, and for other purposes; as fol- person within the age limits for which the lows: other purposes; which was ordered to State provides free public education. At the appropriate place, insert the fol- lie on the table; as follows: (2) PSYCHOTROPIC DRUG.—The term ‘‘psy- lowing: At the appropriate place, insert the fol- chotropic drug’’ means a drug subject to sec- TITLE ll—IMPORTATION OF lowing: tion 505 of the Federal Food, Drug, and Cos- PRESCRIPTION DRUGS SEC. ll. HEAD START ACT AMENDMENT IMPOS- metic Act (21 U.S.C. 355) that is not a sub- ING PARENTAL CONSENT REQUIRE- stance covered by section 202(c) of the Con- SEC. l01. SHORT TITLE. MENT FOR NONEMERGENCY INTRU- trolled Substances Act (21 U.S.C. 812(c)) but This title may be cited as the ‘‘Pharma- SIVE PHYSICAL EXAMINATIONS. is— ceutical Market Access and Drug Safety Act The Head Start Act (42 U.S.C. 9831 et seq.) (A) used in the diagnosis, treatment, or of 2007’’. is amended by adding at the end the fol- prevention of a disease; and SEC. l02. FINDINGS. lowing: (B) intended to have an altering effect on Congress finds that— ‘‘SEC. 657A. PARENTAL CONSENT REQUIREMENT perception, emotion, or behavior. (1) Americans unjustly pay up to 5 times FOR NONEMERGENCY INTRUSIVE (3) STATE.—The term ‘‘State’’ means each more to fill their prescriptions than con- PHYSICAL EXAMINATIONS. of the 50 States, the District of Columbia, sumers in other countries; ‘‘(a) IN GENERAL.—A Head Start agency and the Commonwealth of Puerto Rico. (2) the United States is the largest market shall obtain written parental consent before (c) GAO STUDY AND REVIEW.— for pharmaceuticals in the world, yet Amer- administration of any nonemergency intru- (1) REVIEW.—The Comptroller General of ican consumers pay the highest prices for sive physical examination of a child in con- the United States shall conduct a review of— brand pharmaceuticals in the world; nection with participation in a program (A) the variation among States in defini- (3) a prescription drug is neither safe nor under this subchapter. tions of psychotropic medications as used in effective to an individual who cannot afford ‘‘(b) DEFINITION.—The term ‘nonemergency regard to State jurisdiction over public edu- it; intrusive physical examination’ means, with cation; (4) allowing and structuring the importa- respect to a child, a physical examination (B) the prescription rates of medications tion of prescription drugs to ensure access to that— used in public schools to treat children diag- safe and affordable drugs approved by the ‘‘(1) is not immediately necessary to pro- nosed with attention deficit disorder, atten- Food and Drug Administration will provide a tect the health or safety of the child in- tion deficit hyperactivity disorder, and other level of safety to American consumers that volved or the health or safety of another in- disorders or illnesses; they do not currently enjoy; dividual; and (C) which medications used to treat such (5) American spend more than ‘‘(2) requires incision or is otherwise children in public schools are listed under $200,000,000,000 on prescription drugs every invasive, or involves exposure of private the Controlled Substances Act; and year; body parts.’’. (D) which medications used to treat such (6) the Congressional Budget Office has children in public schools are not listed found that the cost of prescription drugs are SA 988. Mr. INHOFE submitted an under the Controlled Substances Act, includ- between 35 to 55 percent less in other highly- amendment intended to be proposed by ing the properties and effects of any such developed countries than in the United him to the bill S. 1082, to amend the medications, including the incidence of hal- States; and Federal Food, Drug, and Cosmetic Act lucinations, psychosis, violence, suicide, (7) promoting competitive market pricing heart problems, significant weight gain, or would both contribute to health care savings to reauthorize and amend the prescrip- diabetes that students may experience while and allow greater access to therapy, improv- tion drug user fee provisions, and for on these medications. ing health and saving lives. other purposes; which was ordered to (2) REPORT.—Not later than 1 year after SEC. l03. REPEAL OF CERTAIN SECTION RE- lie on the table; as follows: the date of enactment of this section, the GARDING IMPORTATION OF PRE- At the appropriate place, insert the fol- Comptroller General of the United States SCRIPTION DRUGS. lowing: shall prepare and submit a report that con- Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is SEC. ll. CHILD MEDICATION SAFETY. tains the results of the review under para- graph (1). amended by striking section 804. (a) REQUIRED POLICIES AND PROCEDURES.— SEC. l04. IMPORTATION OF PRESCRIPTION (1) IN GENERAL.—As a condition of receiv- SA 989. Mr. HARKIN submitted an DRUGS; WAIVER OF CERTAIN IM- ing funds under any program or activity ad- amendment intended to be proposed by PORT RESTRICTIONS. ministered by the Secretary of Education, him to the bill S. 1082, to amend the (a) IN GENERAL.—Chapter VIII of the Fed- not later than 1 year after the date of enact- eral Food, Drug, and Cosmetic Act (21 U.S.C. ment of this section, each State shall de- Federal Food, Drug, and Cosmetic Act 381 et seq.), as amended by section l03, is velop and implement policies and procedures to reauthorize and amend the prescrip- further amended by inserting after section prohibiting school personnel from requiring tion drug user fee provisions, and for 803 the following: a child to obtain a prescription for sub- other purposes; which was ordered to ‘‘SEC. 804. COMMERCIAL AND PERSONAL IMPOR- stances covered by section 202(c) of the Con- lie on the table; as follows: TATION OF PRESCRIPTION DRUGS. trolled Substances Act (21 U.S.C. 812(c)) or a At the appropriate place, insert the fol- ‘‘(a) IMPORTATION OF PRESCRIPTION psychotropic drug as a condition of attend- lowing: DRUGS.— N GENERAL ing school or receiving services. SEC. ll. REQUIRED INFORMATION IN DIRECT- ‘‘(1) I .—In the case of qualifying (2) RULE OF CONSTRUCTION.—Nothing in TO-CONSUMER TELEVISION AND drugs imported or offered for import into the paragraph (1) shall be construed to create a RADIO ADVERTISEMENTS. United States from registered exporters or Federal prohibition against teachers and Section 502(n) of the Federal Food, Drug, by registered importers— other school personnel consulting or sharing and Cosmetic Act (21 U.S.C. 352(n)) is amend- ‘‘(A) the limitation on importation that is classroom-based observations with parents ed by inserting after the first sentence the established in section 801(d)(1) is waived; and or guardians regarding a student’s academic following: ‘‘In addition to the requirements ‘‘(B) the standards referred to in section performance or behavior in the classroom or under the preceding sentence, in the case of 801(a) regarding admission of the drugs are school, or regarding the need for evaluation an advertisement of a prescription drug pre- subject to subsection (g) of this section (in- for special education or related services sented directly to consumers in television or cluding with respect to qualifying drugs to under section 612(a)(3) of the Individuals radio format that states the name of the which section 801(d)(1) does not apply). with Disabilities Education Act (20 U.S.C. drug and its medical indications, unless the ‘‘(2) IMPORTERS.—A qualifying drug may 1412(a)(3)). audio portion of such advertisement includes not be imported under paragraph (1) unless— (3) PROHIBITION OF PAYMENT OF FUNDS.—No a listing of all information in full about ad- ‘‘(A) the drug is imported by a pharmacy, Federal education funds may be paid to any verse reactions, contraindications, and pre- group of pharmacies, or a wholesaler that is local educational agency or other instru- cautions listed in the patient or professional a registered importer; or ment of government that uses the refusal of labeling of the drug approved under this ‘‘(B) the drug is imported by an individual a parent or legal guardian to provide a sub- Act.’’. for personal use or for the use of a family

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member of the individual (not for resale) ‘‘(bb) the importation of drugs to individ- ‘‘(b) REGISTRATION OF IMPORTERS AND EX- from a registered exporter. uals in the United States from the country PORTERS.— ‘‘(3) RULE OF CONSTRUCTION.—This section will not adversely affect public health. ‘‘(1) REGISTRATION OF IMPORTERS AND EX- shall apply only with respect to a drug that ‘‘(ii) The term ‘importer’ means a phar- PORTERS.—A registration condition is that is imported or offered for import into the macy, a group of pharmacies, or a wholesaler the importer or exporter involved (referred United States— that is in the business of importing a drug to in this subsection as a ‘registrant’) sub- ‘‘(A) by a registered importer; or into the United States or that, pursuant to mits to the Secretary a registration con- ‘‘(B) from a registered exporter to an indi- submitting a registration under subsection taining the following: vidual. (b), seeks to be in such business. ‘‘(A)(i) In the case of an exporter, the name ‘‘(4) DEFINITIONS.— ‘‘(iii) The term ‘pharmacist’ means a per- of the exporter and an identification of all ‘‘(A) REGISTERED EXPORTER; REGISTERED IM- son licensed by a State to practice phar- places of business of the exporter that relate PORTER.—For purposes of this section: macy, including the dispensing and selling of to qualifying drugs, including each ware- ‘‘(i) The term ‘registered exporter’ means prescription drugs. house or other facility owned or controlled an exporter for which a registration under ‘‘(iv) The term ‘pharmacy’ means a person by, or operated for, the exporter. subsection (b) has been approved and is in ef- that— ‘‘(ii) In the case of an importer, the name fect. ‘‘(I) is licensed by a State to engage in the of the importer and an identification of the ‘‘(ii) The term ‘registered importer’ means business of selling prescription drugs at re- places of business of the importer at which a pharmacy, group of pharmacies, or a tail; and the importer initially receives a qualifying ‘‘(II) employs 1 or more pharmacists. drug after importation (which shall not ex- wholesaler for which a registration under ‘‘(v) The term ‘prescription drug’ means a ceed 3 places of business except by permis- subsection (b) has been approved and is in ef- drug that is described in section 503(b)(1). sion of the Secretary). fect. ‘‘(vi) The term ‘wholesaler’— ‘‘(B) Such information as the Secretary de- ‘‘(iii) The term ‘registration condition’ ‘‘(I) means a person licensed as a whole- termines to be necessary to demonstrate means a condition that must exist for a reg- saler or distributor of prescription drugs in that the registrant is in compliance with istration under subsection (b) to be ap- the United States under section 503(e)(2)(A); registration conditions under— proved. and ‘‘(i) in the case of an importer, subsections ‘‘(B) QUALIFYING DRUG.—For purposes of ‘‘(II) does not include a person authorized (c), (d), (e), (g), and (j) (relating to the this section, the term ‘qualifying drug’ to import drugs under section 801(d)(1). sources of imported qualifying drugs; the in- means a drug for which there is a cor- ‘‘(E) PERMITTED COUNTRY.—The term ‘per- spection of facilities of the importer; the responding U.S. label drug. mitted country’ means— payment of fees; compliance with the stand- ‘‘(C) U.S. LABEL DRUG.—For purposes of ‘‘(i) Australia; ards referred to in section 801(a); and mainte- this section, the term ‘U.S. label drug’ ‘‘(ii) Canada; nance of records and samples); or means a prescription drug that— ‘‘(iii) a member country of the European ‘‘(ii) in the case of an exporter, subsections ‘‘(i) with respect to a qualifying drug, has Union, but does not include a member coun- (c), (d), (f), (g), (h), (i), and (j) (relating to the the same active ingredient or ingredients, try with respect to which— sources of exported qualifying drugs; the in- route of administration, dosage form, and ‘‘(I) the country’s Annex to the Treaty of spection of facilities of the exporter and the strength as the qualifying drug; Accession to the European Union 2003 in- marking of compliant shipments; the pay- ‘‘(ii) with respect to the qualifying drug, is cludes a transitional measure for the regula- ment of fees; and compliance with the stand- manufactured by or for the person that man- tion of human pharmaceutical products that ards referred to in section 801(a); being li- ufactures the qualifying drug; has not expired; or censed as a pharmacist; conditions for indi- ‘‘(iii) is approved under section 505(c); and ‘‘(II) the Secretary determines that the re- vidual importation; and maintenance of ‘‘(iv) is not— quirements described in subclauses (I) and records and samples). ‘‘(I) a controlled substance, as defined in (II) of clause (vii) will not be met by the date ‘‘(C) An agreement by the registrant that section 102 of the Controlled Substances Act on which such transitional measure for the the registrant will not under subsection (a) (21 U.S.C. 802); regulation of human pharmaceutical prod- import or export any drug that is not a ‘‘(II) a biological product, as defined in sec- ucts expires; qualifying drug. tion 351 of the Public Health Service Act (42 ‘‘(iv) Japan; ‘‘(D) An agreement by the registrant to— U.S.C. 262), including— ‘‘(v) New Zealand; ‘‘(i) notify the Secretary of a recall or ‘‘(aa) a therapeutic DNA plasmid product; ‘‘(vi) Switzerland; and withdrawal of a qualifying drug distributed ‘‘(bb) a therapeutic synthetic peptide prod- ‘‘(vii) a country in which the Secretary de- in a permitted country that the registrant uct; termines the following requirements are has exported or imported, or intends to ex- ‘‘(cc) a monoclonal antibody product for in met: port or import, to the United States under vivo use; and ‘‘(I) The country has statutory or regu- subsection (a); ‘‘(dd) a therapeutic recombinant DNA-de- latory requirements— ‘‘(ii) provide for the return to the reg- rived product; ‘‘(aa) that require the review of drugs for istrant of such drug; and ‘‘(III) an infused drug, including a peri- safety and effectiveness by an entity of the ‘‘(iii) cease, or not begin, the exportation toneal dialysis solution; government of the country; or importation of such drug unless the Sec- ‘‘(IV) an injected drug; ‘‘(bb) that authorize the approval of only retary has notified the registrant that expor- ‘‘(V) a drug that is inhaled during surgery; those drugs that have been determined to be tation or importation of such drug may pro- ‘‘(VI) a drug that is the listed drug referred safe and effective by experts employed by or ceed. to in 2 or more abbreviated new drug applica- acting on behalf of such entity and qualified ‘‘(E) An agreement by the registrant to en- tions under which the drug is commercially by scientific training and experience to sure and monitor compliance with each reg- marketed; or evaluate the safety and effectiveness of istration condition, to promptly correct any ‘‘(VII) a sterile opthlamic drug intended drugs on the basis of adequate and well-con- noncompliance with such a condition, and to for topical use on or in the eye. trolled investigations, including clinical in- promptly report to the Secretary any such ‘‘(D) OTHER DEFINITIONS.—For purposes of vestigations, conducted by experts qualified noncompliance. this section: by scientific training and experience to ‘‘(F) A plan describing the manner in ‘‘(i)(I) The term ‘exporter’ means a person evaluate the safety and effectiveness of which the registrant will comply with the that is in the business of exporting a drug to drugs; agreement under subparagraph (E). individuals in the United States from Canada ‘‘(cc) that require the methods used in, and ‘‘(G) An agreement by the registrant to en- or from a permitted country designated by the facilities and controls used for the manu- force a contract under subsection (c)(3)(B) the Secretary under subclause (II), or that, facture, processing, and packing of drugs in against a party in the chain of custody of a pursuant to submitting a registration under the country to be adequate to preserve their qualifying drug with respect to the authority subsection (b), seeks to be in such business. identity, quality, purity, and strength; of the Secretary under clauses (ii) and (iii) of ‘‘(II) The Secretary shall designate a per- ‘‘(dd) for the reporting of adverse reactions that subsection. mitted country under subparagraph (E) to drugs and procedures to withdraw ap- ‘‘(H) An agreement by the registrant to no- (other than Canada) as a country from which proval and remove drugs found not to be safe tify the Secretary not more than 30 days be- an exporter may export a drug to individuals or effective; and fore the registrant intends to make the in the United States if the Secretary deter- ‘‘(ee) that require the labeling and pro- change, of— mines that— motion of drugs to be in accordance with the ‘‘(i) any change that the registrant intends ‘‘(aa) the country has statutory or regu- approval of the drug. to make regarding information provided latory standards that are equivalent to the ‘‘(II) The valid marketing authorization under subparagraph (A) or (B); and standards in the United States and Canada system in the country is equivalent to the ‘‘(ii) any change that the registrant in- with respect to— systems in the countries described in clauses tends to make in the compliance plan under ‘‘(AA) the training of pharmacists; (i) through (vi). subparagraph (F). ‘‘(BB) the practice of pharmacy; and ‘‘(III) The importation of drugs to the ‘‘(I) In the case of an exporter— ‘‘(CC) the protection of the privacy of per- United States from the country will not ad- ‘‘(i) An agreement by the exporter that a sonal medical information; and versely affect public health. qualifying drug will not under subsection (a)

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00095 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.069 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5410 CONGRESSIONAL RECORD — SENATE May 1, 2007 be exported to any individual not authorized the Secretary shall update the Internet Code of Federal Regulations (or any cor- pursuant to subsection (a)(2)(B) to be an im- website and the information provided responding successor rule or regulation). porter of such drug. through the toll-free telephone number ac- ‘‘(2) The establishment is located in any ‘‘(ii) An agreement to post a bond, payable cordingly. country, and the establishment manufac- to the Treasury of the United States that is ‘‘(4) SUSPENSION AND TERMINATION.— tured the drug for distribution in the United equal in value to the lesser of— ‘‘(A) SUSPENSION.—With respect to the ef- States or for distribution in 1 or more of the ‘‘(I) the value of drugs exported by the ex- fectiveness of a registration submitted under permitted countries (without regard to porter to the United States in a typical 4- paragraph (1): whether in addition the drug is manufac- week period over the course of a year under ‘‘(i) Subject to clause (ii), the Secretary tured for distribution in a foreign country this section; or may suspend the registration if the Sec- that is not a permitted country). ‘‘(II) $1,000,000; retary determines, after notice and oppor- ‘‘(3) The exporter or importer obtained the ‘‘(iii) An agreement by the exporter to tunity for a hearing, that the registrant has drug— comply with applicable provisions of Cana- failed to maintain substantial compliance ‘‘(A) directly from the establishment; or dian law, or the law of the permitted country with a registration condition. ‘‘(B) directly from an entity that, by con- designated under subsection (a)(4)(D)(i)(II) in ‘‘(ii) If the Secretary determines that, tract with the exporter or importer— which the exporter is located, that protect under color of the registration, the exporter ‘‘(i) provides to the exporter or importer a the privacy of personal information with re- has exported a drug or the importer has im- statement (in such form and containing such spect to each individual importing a pre- ported a drug that is not a qualifying drug, information as the Secretary may require) scription drug from the exporter under sub- or a drug that does not comply with sub- that, for the chain of custody from the estab- section (a)(2)(B). section (g)(2)(A) or (g)(4), or has exported a lishment, identifies each prior sale, pur- ‘‘(iv) An agreement by the exporter to re- qualifying drug to an individual in violation chase, or trade of the drug (including the port to the Secretary— of subsection (i)(2)(F), the Secretary shall date of the transaction and the names and ‘‘(I) not later than August 1 of each fiscal immediately suspend the registration. A sus- addresses of all parties to the transaction); year, the total price and the total volume of pension under the preceding sentence is not ‘‘(ii) agrees to permit the Secretary to in- drugs exported to the United States by the subject to the provision by the Secretary of spect such statements and related records to exporter during the 6-month period from prior notice, and the Secretary shall provide determine their accuracy; January 1 through June 30 of that year; and to the registrant an opportunity for a hear- ‘‘(iii) agrees, with respect to the qualifying ‘‘(II) not later than January 1 of each fiscal ing not later than 10 days after the date on drugs involved, to permit the Secretary to year, the total price and the total volume of which the registration is suspended. inspect warehouses and other facilities, in- drugs exported to the United States by the ‘‘(iii) The Secretary may reinstate the reg- cluding records, of the entity for purposes of exporter during the previous fiscal year. istration, whether suspended under clause (i) determining whether the facilities are in ‘‘(J) In the case of an importer, an agree- or (ii), if the Secretary determines that the compliance with any standards under this ment by the importer to report to the Sec- registrant has demonstrated that further Act that are applicable to facilities of that retary— violations of registration conditions will not type in the United States; and ‘‘(i) not later than August 1 of each fiscal occur. ‘‘(iv) has ensured, through such contrac- year, the total price and the total volume of tual relationships as may be necessary, that ‘‘(B) TERMINATION.—The Secretary, after drugs imported to the United States by the the Secretary has the same authority re- notice and opportunity for a hearing, may importer during the 6-month period from garding other parties in the chain of custody terminate the registration under paragraph January 1 through June 30 of that fiscal from the establishment that the Secretary (1) of a registrant if the Secretary deter- year; and has under clauses (ii) and (iii) regarding such mines that the registrant has engaged in a ‘‘(ii) not later than January 1 of each fiscal entity. pattern or practice of violating 1 or more year, the total price and the total volume of ‘‘(4)(A) The foreign country from which the registration conditions, or if on 1 or more oc- drugs imported to the United States by the importer will import the drug is a permitted casions the Secretary has under subpara- importer during the previous fiscal year. country; or graph (A)(ii) suspended the registration of ‘‘(K) Such other provisions as the Sec- ‘‘(B) The foreign country from which the the registrant. The Secretary may make the retary may require by regulation to protect exporter will export the drug is the per- the public health while permitting— termination permanent, or for a fixed period mitted country in which the exporter is lo- ‘‘(i) the importation by pharmacies, groups of not less than 1 year. During the period in cated. of pharmacies, and wholesalers as registered which the registration is terminated, any ‘‘(5) During any period in which the drug importers of qualifying drugs under sub- registration submitted under paragraph (1) was not in the control of the manufacturer section (a); and by the registrant, or a person that is a part- of the drug, the drug did not enter any coun- ‘‘(ii) importation by individuals of quali- ner in the export or import enterprise, or a try that is not a permitted country. fying drugs under subsection (a). principal officer in such enterprise, and any ‘‘(6) The exporter or importer retains a ‘‘(2) APPROVAL OR DISAPPROVAL OF REG- registration prepared with the assistance of sample of each lot of the drug for testing by ISTRATION.— the registrant or such a person, has no legal the Secretary. ‘‘(A) IN GENERAL.—Not later than 90 days effect under this section. ‘‘(d) INSPECTION OF FACILITIES; MARKING OF after the date on which a registrant submits ‘‘(5) DEFAULT OF BOND.—A bond required to SHIPMENTS.— to the Secretary a registration under para- be posted by an exporter under paragraph ‘‘(1) INSPECTION OF FACILITIES.—A registra- graph (1), the Secretary shall notify the reg- (1)(I)(ii) shall be defaulted and paid to the tion condition is that, for the purpose of as- istrant whether the registration is approved Treasury of the United States if, after oppor- sisting the Secretary in determining whether or is disapproved. The Secretary shall dis- tunity for an informal hearing, the Sec- the exporter involved is in compliance with approve a registration if there is reason to retary determines that the exporter has— all other registration conditions— believe that the registrant is not in compli- ‘‘(A) exported a drug to the United States ‘‘(A) the exporter agrees to permit the Sec- ance with one or more registration condi- that is not a qualifying drug or that is not in retary— tions, and shall notify the registrant of such compliance with subsection (g)(2)(A), (g)(4), ‘‘(i) to conduct onsite inspections, includ- reason. In the case of a disapproved registra- or (i); or ing monitoring on a day-to-day basis, of tion, the Secretary shall subsequently notify ‘‘(B) failed to permit the Secretary to con- places of business of the exporter that relate the registrant that the registration is ap- duct an inspection described under sub- to qualifying drugs, including each ware- proved if the Secretary determines that the section (d). house or other facility owned or controlled registrant is in compliance with such condi- ‘‘(c) SOURCES OF QUALIFYING DRUGS.—A by, or operated for, the exporter; tions. registration condition is that the exporter or ‘‘(ii) to have access, including on a day-to- ‘‘(B) CHANGES IN REGISTRATION INFORMA- importer involved agrees that a qualifying day basis, to— TION.—Not later than 30 days after receiving drug will under subsection (a) be exported or ‘‘(I) records of the exporter that relate to a notice under paragraph (1)(H) from a reg- imported into the United States only if there the export of such drugs, including financial istrant, the Secretary shall determine is compliance with the following: records; and whether the change involved affects the ap- ‘‘(1) The drug was manufactured in an es- ‘‘(II) samples of such drugs; proval of the registration of the registrant tablishment— ‘‘(iii) to carry out the duties described in under paragraph (1), and shall inform the ‘‘(A) required to register under subsection paragraph (3); and registrant of the determination. (h) or (i) of section 510; and ‘‘(iv) to carry out any other functions de- ‘‘(3) PUBLICATION OF CONTACT INFORMATION ‘‘(B)(i) inspected by the Secretary; or termined by the Secretary to be necessary FOR REGISTERED EXPORTERS.—Through the ‘‘(ii) for which the Secretary has elected to regarding the compliance of the exporter; Internet website of the Food and Drug Ad- rely on a satisfactory report of a good manu- and ministration and a toll-free telephone num- facturing practice inspection of the estab- ‘‘(B) the Secretary has assigned 1 or more ber, the Secretary shall make readily avail- lishment from a permitted country whose employees of the Secretary to carry out the able to the public a list of registered export- regulatory system the Secretary recognizes functions described in this subsection for the ers, including contact information for the as equivalent under a mutual recognition Secretary randomly, but not less than 12 exporters. Promptly after the approval of a agreement, as provided for under section times annually, on the premises of places of registration submitted under paragraph (1), 510(i)(3), section 803, or part 26 of title 21, businesses referred to in subparagraph (A)(i),

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Markings under the tion (as defined in section 503(e)) of a quali- shipments are offered for import into the preceding sentence shall— fying drug that has been imported under sub- United States; and ‘‘(A) be designed to prevent affixation of section (a), to affix to each container of such ‘‘(iii) inspecting such shipments as nec- the markings to any shipping container that drug such markings or other technology as essary, when offered for import into the is not authorized to bear the markings; and the Secretary determines necessary to iden- United States to determine if such a ship- ‘‘(B) include anticounterfeiting or track- tify the shipment as being in compliance ment should be refused admission under sub- and-trace technologies, taking into account with all registration conditions, except that section (g)(5). the economic and technical feasibility of the markings or other technology shall not ‘‘(B) LIMITATION.—Subject to subparagraph those technologies. be required on a drug that bears comparable, (C), the aggregate total of fees collected ‘‘(3) CERTAIN DUTIES RELATING TO EXPORT- compatible markings or technology from the under paragraph (2) for a fiscal year shall not ERS.—Duties of the Secretary with respect to manufacturer of the drug. Markings or other exceed 2.5 percent of the total price of quali- an exporter include the following: technology under the preceding sentence fying drugs imported during that fiscal year ‘‘(A) Inspecting, randomly, but not less shall— into the United States by registered import- than 12 times annually, the places of busi- ‘‘(A) be designed to prevent affixation of ers under subsection (a). ness of the exporter at which qualifying the markings or other technology to any ‘‘(C) TOTAL PRICE OF DRUGS.— drugs are stored and from which qualifying container that is not authorized to bear the ‘‘(i) ESTIMATE.—For the purposes of com- drugs are shipped. markings; and ‘‘(B) During the inspections under subpara- plying with the limitation described in sub- ‘‘(B) shall include anticounterfeiting or paragraph (B) when establishing under sub- graph (A), verifying the chain of custody of track-and-trace technologies, taking into ac- a statistically significant sample of quali- paragraph (A) the aggregate total of fees to count the economic and technical feasibility be collected under paragraph (2) for a fiscal fying drugs from the establishment in which of such technologies. the drug was manufactured to the exporter, year, the Secretary shall estimate the total ‘‘(6) CERTAIN DUTIES RELATING TO IMPORT- which shall be accomplished or supple- price of qualifying drugs imported into the ERS.—Duties of the Secretary with respect to mented by the use of anticounterfeiting or United States by registered importers during an importer include the following: that fiscal year by adding the total price of track-and-trace technologies, taking into ac- ‘‘(A) Inspecting, randomly, but not less count the economic and technical feasibility qualifying drugs imported by each registered than 12 times annually, the places of busi- importer during the 6-month period from of those technologies, except that a drug ness of the importer at which a qualifying that lacks such technologies from the point January 1 through June 30 of the previous drug is initially received after importation. of manufacture shall not for that reason be fiscal year, as reported to the Secretary by ‘‘(B) During the inspections under subpara- excluded from importation by an exporter. each registered importer under subsection graph (A), verifying the chain of custody of ‘‘(C) Randomly reviewing records of ex- (b)(1)(J). a statistically significant sample of quali- ports to individuals for the purpose of deter- ‘‘(ii) CALCULATION.—Not later than March 1 fying drugs from the establishment in which mining whether the drugs are being imported of the fiscal year that follows the fiscal year the drug was manufactured to the importer, by the individuals in accordance with the for which the estimate under clause (i) is which shall be accomplished or supple- conditions under subsection (i). Such reviews made, the Secretary shall calculate the total mented by the use of anticounterfeiting or shall be conducted in a manner that will re- price of qualifying drugs imported into the track-and-trace technologies, taking into ac- sult in a statistically significant determina- United States by registered importers during tion of compliance with all such conditions. count the economic and technical feasibility that fiscal year by adding the total price of ‘‘(D) Monitoring the affixing of markings of those technologies, except that a drug qualifying drugs imported by each registered under paragraph (2). that lacks such technologies from the point importer during that fiscal year, as reported ‘‘(E) Inspecting as the Secretary deter- of manufacture shall not for that reason be to the Secretary by each registered importer mines is necessary the warehouses and other excluded from importation by an importer. under subsection (b)(1)(J). facilities, including records, of other parties ‘‘(C) Reviewing notices under paragraph ‘‘(iii) ADJUSTMENT.—If the total price of in the chain of custody of qualifying drugs. (4). qualifying drugs imported into the United ‘‘(F) Determining whether the exporter is ‘‘(D) Inspecting as the Secretary deter- States by registered importers during a fis- in compliance with all other registration mines is necessary the warehouses and other cal year as calculated under clause (ii) is less conditions. facilities, including records of other parties than the aggregate total of fees collected ‘‘(4) PRIOR NOTICE OF SHIPMENTS.—A reg- in the chain of custody of qualifying drugs. under paragraph (2) for that fiscal year, the istration condition is that, not less than 8 ‘‘(E) Determining whether the importer is Secretary shall provide for a pro-rata reduc- hours and not more than 5 days in advance of in compliance with all other registration tion in the fee due from each registered im- the time of the importation of a shipment of conditions. porter on April 1 of the subsequent fiscal qualifying drugs, the importer involved ‘‘(e) IMPORTER FEES.— year so that the limitation described in sub- agrees to submit to the Secretary a notice ‘‘(1) REGISTRATION FEE.—A registration paragraph (B) is observed. with respect to the shipment of drugs to be condition is that the importer involved pays ‘‘(D) INDIVIDUAL IMPORTER FEE.—Subject to imported or offered for import into the to the Secretary a fee of $10,000 due on the the limitation described in subparagraph (B), United States under subsection (a). A notice date on which the importer first submits the the fee under paragraph (2) to be paid on Oc- under the preceding sentence shall include— registration to the Secretary under sub- tober 1 and April 1 by an importer shall be an ‘‘(A) the name and complete contact infor- section (b). amount that is proportional to a reasonable mation of the person submitting the notice; ‘‘(2) INSPECTION FEE.—A registration condi- estimate by the Secretary of the semiannual ‘‘(B) the name and complete contact infor- tion is that the importer involved pays a fee share of the importer of the volume of quali- mation of the importer involved; to the Secretary in accordance with this sub- fying drugs imported by importers under ‘‘(C) the identity of the drug, including the section. Such fee shall be paid not later than subsection (a). established name of the drug, the quantity of October 1 and April 1 of each fiscal year in ‘‘(4) USE OF FEES.— the drug, and the lot number assigned by the the amount provided for under paragraph (3). ‘‘(A) IN GENERAL.—Subject to appropria- manufacturer; ‘‘(3) AMOUNT OF INSPECTION FEE.— tions Acts, fees collected by the Secretary ‘‘(D) the identity of the manufacturer of ‘‘(A) AGGREGATE TOTAL OF FEES.—Not later under paragraphs (1) and (2) shall be credited the drug, including the identity of the estab- than 30 days before the start of each fiscal to the appropriation account for salaries and lishment at which the drug was manufac- year, the Secretary, in consultation with the expenses of the Food and Drug Administra- tured; Secretary of Homeland Security and the Sec- tion until expended (without fiscal year limi- ‘‘(E) the country from which the drug is retary of the Treasury, shall establish an ag- tation), and the Secretary may, in consulta- shipped; gregate total of fees to be collected under tion with the Secretary of Homeland Secu- ‘‘(F) the name and complete contact infor- paragraph (2) for importers for that fiscal rity and the Secretary of the Treasury, mation for the shipper of the drug; year that is sufficient, and not more than transfer some proportion of such fees to the ‘‘(G) anticipated arrival information, in- necessary, to pay the costs for that fiscal appropriation account for salaries and ex- cluding the port of arrival and crossing loca- year of administering this section with re- penses of the Bureau of Customs and Border tion within that port, and the date and time; spect to registered importers, including the Protection until expended (without fiscal ‘‘(H) a summary of the chain of custody of costs associated with— year limitation). the drug from the establishment in which ‘‘(i) inspecting the facilities of registered ‘‘(B) SOLE PURPOSE.—Fees collected by the the drug was manufactured to the importer; importers, and of other entities in the chain Secretary under paragraphs (1) and (2) are

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only available to the Secretary and, if trans- ‘‘(iii) ADJUSTMENT.—If the total price of ‘‘(bb) any difference in labeling (except in- ferred, to the Secretary of Homeland Secu- qualifying drugs imported into the United gredient labeling). rity, and are for the sole purpose of paying States by registered exporters during a fiscal ‘‘(ii) INFORMATION IN NOTICE.—A notice the costs referred to in paragraph (3)(A). year as calculated under clause (ii) is less under clause (i)(I) shall include the informa- ‘‘(5) COLLECTION OF FEES.—In any case than the aggregate total of fees collected tion that the Secretary may require under where the Secretary does not receive pay- under paragraph (2) for that fiscal year, the section 506A, any additional information the ment of a fee assessed under paragraph (1) or Secretary shall provide for a pro-rata reduc- Secretary may require (which may include (2) within 30 days after it is due, such fee tion in the fee due from each registered ex- data on bioequivalence if such data are not shall be treated as a claim of the United porter on April 1 of the subsequent fiscal required under section 506A), and, with re- States Government subject to subchapter II year so that the limitation described in sub- spect to the permitted country that ap- of chapter 37 of title 31, United States Code. paragraph (B) is observed. proved the qualifying drug for commercial distribution, or with respect to which such ‘‘(f) EXPORTER FEES.— ‘‘(D) INDIVIDUAL EXPORTER FEE.—Subject to approval is sought, include the following: ‘‘(1) REGISTRATION FEE.—A registration the limitation described in subparagraph (B), condition is that the exporter involved pays the fee under paragraph (2) to be paid on Oc- ‘‘(I) The date on which the qualifying drug to the Secretary a fee of $10,000 due on the tober 1 and April 1 by an exporter shall be an with such difference was, or will be, intro- date on which the exporter first submits that amount that is proportional to a reasonable duced for commercial distribution in the per- mitted country. registration to the Secretary under sub- estimate by the Secretary of the semiannual ‘‘(II) Information demonstrating that the section (b). share of the exporter of the volume of quali- person submitting the notice has also noti- ‘‘(2) INSPECTION FEE.—A registration condi- fying drugs exported by exporters under sub- fied the government of the permitted coun- tion is that the exporter involved pays a fee section (a). try in writing that the person is submitting to the Secretary in accordance with this sub- ‘‘(4) USE OF FEES.— to the Secretary a notice under clause (i)(I), section. Such fee shall be paid not later than ‘‘(A) IN GENERAL.—Subject to appropria- which notice describes the difference in the October 1 and April 1 of each fiscal year in tions Acts, fees collected by the Secretary qualifying drug from a condition established the amount provided for under paragraph (3). under paragraphs (1) and (2) shall be credited in the approved application for the U.S. label ‘‘(3) AMOUNT OF INSPECTION FEE.— to the appropriation account for salaries and drug. ‘‘(A) AGGREGATE TOTAL OF FEES.—Not later expenses of the Food and Drug Administra- tion until expended (without fiscal year limi- ‘‘(III) The information that the person sub- than 30 days before the start of each fiscal mitted or will submit to the government of year, the Secretary, in consultation with the tation), and the Secretary may, in consulta- tion with the Secretary of Homeland Secu- the permitted country for purposes of ob- Secretary of Homeland Security and the Sec- taining approval for commercial distribution retary of the Treasury, shall establish an ag- rity and the Secretary of the Treasury, transfer some proportion of such fees to the of the drug in the country which, if in a lan- gregate total of fees to be collected under guage other than English, shall be accom- paragraph (2) for exporters for that fiscal appropriation account for salaries and ex- penses of the Bureau of Customs and Border panied by an English translation verified to year that is sufficient, and not more than be complete and accurate, with the name, necessary, to pay the costs for that fiscal Protection until expended (without fiscal year limitation). address, and a brief statement of the quali- year of administering this section with re- fications of the person that made the trans- ‘‘(B) SOLE PURPOSE.—Fees collected by the spect to registered exporters, including the lation. Secretary under paragraphs (1) and (2) are costs associated with— ‘‘(iii) CERTIFICATIONS.—The chief executive only available to the Secretary and, if trans- ‘‘(i) inspecting the facilities of registered officer and the chief medical officer of the ferred, to the Secretary of Homeland Secu- exporters, and of other entities in the chain manufacturer involved shall each certify in rity, and are for the sole purpose of paying of custody of a qualifying drug as necessary, the notice under clause (i) that— the costs referred to in paragraph (3)(A). under subsection (d)(3); ‘‘(I) the information provided in the notice ‘‘(5) COLLECTION OF FEES.—In any case ‘‘(ii) developing, implementing, and oper- is complete and true; and where the Secretary does not receive pay- ating under such subsection a system to ‘‘(II) a copy of the notice has been provided ment of a fee assessed under paragraph (1) or screen marks on shipments of qualifying to the Federal Trade Commission and to the (2) within 30 days after it is due, such fee drugs under subsection (a) that indicate State attorneys general. shall be treated as a claim of the United compliance with all registration conditions, ‘‘(iv) FEE.—If a notice submitted under when such shipments are offered for import States Government subject to subchapter II clause (i) includes a difference that would, into the United States; and of chapter 37 of title 31, United States Code. under section 506A, require the submission of ‘‘(iii) screening such markings, and in- ‘‘(g) COMPLIANCE WITH SECTION 801(a).— a supplemental application if made as a specting such shipments as necessary, when ‘‘(1) IN GENERAL.—A registration condition change to the U.S. label drug, the person offered for import into the United States to is that each qualifying drug exported under that submits the notice shall pay to the Sec- determine if such a shipment should be re- subsection (a) by the registered exporter in- retary a fee in the same amount as would fused admission under subsection (g)(5). volved or imported under subsection (a) by apply if the person were paying a fee pursu- ‘‘(B) LIMITATION.—Subject to subparagraph the registered importer involved is in com- ant to section 736(a)(1)(A)(ii). Subject to ap- (C), the aggregate total of fees collected pliance with the standards referred to in sec- propriations Acts, fees collected by the Sec- under paragraph (2) for a fiscal year shall not tion 801(a) regarding admission of the drug retary under the preceding sentence are exceed 2.5 percent of the total price of quali- into the United States, subject to paragraphs available only to the Secretary and are for fying drugs imported during that fiscal year (2), (3), and (4). the sole purpose of paying the costs of re- into the United States by registered export- ‘‘(2) SECTION 505; APPROVAL STATUS.— viewing notices submitted under clause (i). ers under subsection (a). ‘‘(A) IN GENERAL.—A qualifying drug that ‘‘(v) TIMING OF SUBMISSION OF NOTICES.— ‘‘(C) TOTAL PRICE OF DRUGS.— is imported or offered for import under sub- ‘‘(I) PRIOR APPROVAL NOTICES.—A notice ‘‘(i) ESTIMATE.—For the purposes of com- section (a) shall comply with the conditions under clause (i) to which subparagraph (C) plying with the limitation described in sub- established in the approved application applies shall be submitted to the Secretary paragraph (B) when establishing under sub- under section 505(b) for the U.S. label drug as not later than 120 days before the qualifying paragraph (A) the aggregate total of fees to described under this subsection. drug with the difference is introduced for be collected under paragraph (2) for a fiscal ‘‘(B) NOTICE BY MANUFACTURER; GENERAL commercial distribution in a permitted year, the Secretary shall estimate the total PROVISIONS.— country, unless the country requires that price of qualifying drugs imported into the ‘‘(i) IN GENERAL.—The person that manu- distribution of the qualifying drug with the United States by registered exporters during factures a qualifying drug that is, or will be, difference begin less than 120 days after the that fiscal year by adding the total price of introduced for commercial distribution in a country requires the difference. qualifying drugs exported by each registered permitted country shall in accordance with ‘‘(II) OTHER APPROVAL NOTICES.—A notice exporter during the 6-month period from this paragraph submit to the Secretary a no- under clause (i) to which subparagraph (D) January 1 through June 30 of the previous tice that— applies shall be submitted to the Secretary fiscal year, as reported to the Secretary by ‘‘(I) includes each difference in the quali- not later than the day on which the quali- each registered exporter under subsection fying drug from a condition established in fying drug with the difference is introduced (b)(1)(I)(iv). the approved application for the U.S. label for commercial distribution in a permitted ‘‘(ii) CALCULATION.—Not later than March 1 drug beyond— country. of the fiscal year that follows the fiscal year ‘‘(aa) the variations provided for in the ap- ‘‘(III) OTHER NOTICES.—A notice under for which the estimate under clause (i) is plication; and clause (i) to which subparagraph (E) applies made, the Secretary shall calculate the total ‘‘(bb) any difference in labeling (except in- shall be submitted to the Secretary on the price of qualifying drugs imported into the gredient labeling); or date that the qualifying drug is first intro- United States by registered exporters during ‘‘(II) states that there is no difference in duced for commercial distribution in a per- that fiscal year by adding the total price of the qualifying drug from a condition estab- mitted country and annually thereafter. qualifying drugs exported by each registered lished in the approved application for the ‘‘(vi) REVIEW BY SECRETARY.— exporter during that fiscal year, as reported U.S. label drug beyond— ‘‘(I) IN GENERAL.—In this paragraph, the to the Secretary by each registered exporter ‘‘(aa) the variations provided for in the ap- difference in a qualifying drug that is sub- under subsection (b)(1)(I)(iv). plication; and mitted in a notice under clause (i) from the

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00098 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.069 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5413 U.S. label drug shall be treated by the Sec- ‘‘(ii) If the Secretary has not made a deter- ‘‘(ii) may not order that the importation of retary as if it were a manufacturing change mination whether such a supplemental appli- the qualifying drug involved cease; and to the U.S. label drug under section 506A. cation regarding the U.S. label drug would be ‘‘(iii) shall promptly notify registered ex- ‘‘(II) STANDARD OF REVIEW.—Except as pro- approved or disapproved by the date on porters and registered importers. vided in subclause (III), the Secretary shall which the qualifying drug involved is to be ‘‘(F) DIFFERENCES IN ACTIVE INGREDIENT, review and approve or disapprove the dif- introduced for commercial distribution in a ROUTE OF ADMINISTRATION, DOSAGE FORM, OR ference in a notice submitted under clause permitted country, the Secretary shall— STRENGTH.— (i), if required under section 506A, using the ‘‘(I) order that the importation of the ‘‘(i) IN GENERAL.—A person who manufac- safe and effective standard for approving or qualifying drug involved from the permitted tures a drug approved under section 505(b) disapproving a manufacturing change under country not begin until the Secretary com- shall submit an application under section section 506A. pletes review of the notice; and 505(b) for approval of another drug that is ‘‘(III) BIOEQUIVALENCE.—If the Secretary ‘‘(II) promptly notify registered exporters, manufactured for distribution in a permitted would approve the difference in a notice sub- registered importers, the Federal Trade country by or for the person that manufac- mitted under clause (i) using the safe and ef- Commission, and the State attorneys general tures the drug approved under section 505(b) fective standard under section 506A and if of the order. if— the Secretary determines that the qualifying ‘‘(iii) If the Secretary determines that such ‘‘(I) there is no qualifying drug in commer- drug is not bioequivalent to the U.S. label a supplemental application regarding the cial distribution in permitted countries drug, the Secretary shall— U.S. label drug would not be approved, the whose combined population represents at Secretary shall— ‘‘(aa) include in the labeling provided least 50 percent of the total population of all ‘‘(I) order that the importation of the under paragraph (3) a prominent advisory permitted countries with the same active in- qualifying drug involved from the permitted that the qualifying drug is safe and effective gredient or ingredients, route of administra- country cease, or provide that an order but is not bioequivalent to the U.S. label tion, dosage form, and strength as the drug under clause (ii), if any, remains in effect; drug if the Secretary determines that such approved under section 505(b); and ‘‘(II) notify the permitted country that ap- an advisory is necessary for health care prac- ‘‘(II) each active ingredient of the other proved the qualifying drug for commercial titioners and patients to use the qualifying drug is related to an active ingredient of the distribution of the determination; and drug safely and effectively; or ‘‘(III) promptly notify registered exporters, drug approved under section 505(b), as de- ‘‘(bb) decline to approve the difference if registered importers, the Federal Trade fined in clause (v). the Secretary determines that the avail- Commission, and the State attorneys general ‘‘(ii) APPLICATION UNDER SECTION 505(b).— ability of both the qualifying drug and the of the determination. The application under section 505(b) required U.S. label drug would pose a threat to the ‘‘(iv) If the Secretary determines that such under clause (i) shall— public health. a supplemental application regarding the ‘‘(I) request approval of the other drug for ‘‘(IV) REVIEW BY THE SECRETARY.—The Sec- U.S. label drug would be approved, the Sec- the indication or indications for which the retary shall review and approve or dis- retary shall— drug approved under section 505(b) is labeled; approve the difference in a notice submitted ‘‘(I) vacate the order under clause (ii), if ‘‘(II) include the information that the per- under clause (i), if required under section any; son submitted to the government of the per- 506A, not later than 120 days after the date ‘‘(II) consider the difference to be a vari- mitted country for purposes of obtaining ap- on which the notice is submitted. ation provided for in the approved applica- proval for commercial distribution of the ‘‘(V) ESTABLISHMENT INSPECTION.—If review tion for the U.S. label drug; other drug in that country, which if in a lan- of such difference would require an inspec- ‘‘(III) permit importation of the qualifying guage other than English, shall be accom- tion of the establishment in which the quali- drug under subsection (a); and panied by an English translation verified to fying drug is manufactured— ‘‘(IV) promptly notify registered exporters, be complete and accurate, with the name, ‘‘(aa) such inspection by the Secretary registered importers, the Federal Trade address, and a brief statement of the quali- shall be authorized; and Commission, and the State attorneys general fications of the person that made the trans- ‘‘(bb) the Secretary may rely on a satisfac- of the determination. lation; tory report of a good manufacturing practice ‘‘(D) NOTICE; DRUG DIFFERENCE NOT REQUIR- ‘‘(III) include a right of reference to the ap- inspection of the establishment from a per- ING PRIOR APPROVAL.—In the case of a notice plication for the drug approved under section mitted country whose regulatory system the under subparagraph (B)(i) that includes a dif- 505(b); and Secretary recognizes as equivalent under a ference that would, under section ‘‘(IV) include such additional information mutual recognition agreement, as provided 506A(d)(3)(B)(ii), not require the approval of as the Secretary may require. under section 510(i)(3), section 803, or part 26 a supplemental application before the dif- ‘‘(iii) TIMING OF SUBMISSION OF APPLICA- of title 21, Code of Federal Regulations (or ference could be made to the U.S. label drug TION.—An application under section 505(b) re- any corresponding successor rule or regula- the following shall occur: quired under clause (i) shall be submitted to tion). ‘‘(i) During the period in which the notice the Secretary not later than the day on ‘‘(vii) PUBLICATION OF INFORMATION ON NO- is being reviewed by the Secretary, the au- which the information referred to in clause TICES.— thority under this subsection to import the (ii)(II) is submitted to the government of the ‘‘(I) IN GENERAL.—Through the Internet qualifying drug involved continues in effect. permitted country. website of the Food and Drug Administra- ‘‘(ii) If the Secretary determines that such ‘‘(iv) NOTICE OF DECISION ON APPLICATION.— tion and a toll-free telephone number, the a supplemental application regarding the The Secretary shall promptly notify reg- Secretary shall readily make available to U.S. label drug would not be approved, the istered exporters, registered importers, the the public a list of notices submitted under Secretary shall— Federal Trade Commission, and the State at- clause (i). ‘‘(I) order that the importation of the torneys general of a determination to ap- ‘‘(II) CONTENTS.—The list under subclause qualifying drug involved from the permitted prove or to disapprove an application under (I) shall include the date on which a notice is country cease; section 505(b) required under clause (i). submitted and whether— ‘‘(II) notify the permitted country that ap- ‘‘(v) RELATED ACTIVE INGREDIENTS.—For ‘‘(aa) a notice is under review; proved the qualifying drug for commercial purposes of clause (i)(II), 2 active ingredients ‘‘(bb) the Secretary has ordered that im- distribution of the determination; and are related if they are— portation of the qualifying drug from a per- ‘‘(III) promptly notify registered exporters, ‘‘(I) the same; or mitted country cease; or registered importers, the Federal Trade ‘‘(II) different salts, esters, or complexes of ‘‘(cc) the importation of the drug is per- Commission, and the State attorneys general the same moiety. mitted under subsection (a). of the determination. ‘‘(3) SECTION 502; LABELING.— ‘‘(III) UPDATE.—The Secretary shall ‘‘(iii) If the Secretary determines that such ‘‘(A) IMPORTATION BY REGISTERED IM- promptly update the Internet website with a supplemental application regarding the PORTER.— any changes to the list. U.S. label drug would be approved, the dif- ‘‘(i) IN GENERAL.—In the case of a quali- ‘‘(C) NOTICE; DRUG DIFFERENCE REQUIRING ference shall be considered to be a variation fying drug that is imported or offered for im- PRIOR APPROVAL.—In the case of a notice provided for in the approved application for port by a registered importer, such drug under subparagraph (B)(i) that includes a dif- the U.S. label drug. shall be considered to be in compliance with ference that would, under section 506A(c) or ‘‘(E) NOTICE; DRUG DIFFERENCE NOT REQUIR- section 502 and the labeling requirements (d)(3)(B)(i), require the approval of a supple- ING APPROVAL; NO DIFFERENCE.—In the case of under the approved application for the U.S. mental application before the difference a notice under subparagraph (B)(i) that in- label drug if the qualifying drug bears— could be made to the U.S. label drug the fol- cludes a difference for which, under section ‘‘(I) a copy of the labeling approved for the lowing shall occur: 506A(d)(1)(A), a supplemental application U.S. label drug under section 505, without re- ‘‘(i) Promptly after the notice is sub- would not be required for the difference to be gard to whether the copy bears any trade- mitted, the Secretary shall notify registered made to the U.S. label drug, or that states mark involved; exporters, registered importers, the Federal that there is no difference, the Secretary— ‘‘(II) the name of the manufacturer and lo- Trade Commission, and the State attorneys ‘‘(i) shall consider such difference to be a cation of the manufacturer; general that the notice has been submitted variation provided for in the approved appli- ‘‘(III) the lot number assigned by the man- with respect to the qualifying drug involved. cation for the U.S. label drug; ufacturer;

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00099 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.070 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5414 CONGRESSIONAL RECORD — SENATE May 1, 2007 ‘‘(IV) the name, location, and registration formed that the packaging does not comply dispense prescription drugs in sufficient number of the importer; and with such Act and that the exporter will pro- number to dispense safely the drugs exported ‘‘(V) the National Drug Code number as- vide the drug in packaging that is compliant by the exporter to individuals, and the ex- signed to the qualifying drug by the Sec- at no additional cost. porter assigns to those persons responsibility retary. ‘‘(iii) REQUEST FOR COPY OF SPECIAL LABEL- for dispensing such drugs to individuals. ‘‘(ii) REQUEST FOR COPY OF THE LABELING.— ING AND INGREDIENT LIST.—The Secretary ‘‘(i) INDIVIDUALS; CONDITIONS FOR IMPORTA- The Secretary shall provide such copy to the shall provide to the registered exporter in- TION.— registered importer involved, upon request of volved a copy of the special labeling, the ad- ‘‘(1) IN GENERAL.—For purposes of sub- the importer. visory, and the ingredient list described section (a)(2)(B), the importation of a quali- ‘‘(iii) REQUESTED LABELING.—The labeling under clause (i), upon request of the ex- fying drug by an individual is in accordance provided by the Secretary under clause (ii) porter. with this subsection if the following condi- shall— ‘‘(iv) REQUESTED LABELING AND INGREDIENT tions are met: ‘‘(I) include the established name, as de- LIST.—The labeling and ingredient list pro- ‘‘(A) The drug is accompanied by a copy of fined in section 502(e)(3), for each active in- vided by the Secretary under clause (iii) a prescription for the drug, which prescrip- gredient in the qualifying drug; shall— tion— ‘‘(II) not include the proprietary name of ‘‘(I) include the established name, as de- ‘‘(i) is valid under applicable Federal and the U.S. label drug or any active ingredient fined in section 502(e)(3), for each active in- State laws; and thereof; gredient in the drug; and ‘‘(ii) was issued by a practitioner who, ‘‘(III) if required under paragraph ‘‘(II) not include the proprietary name of under the law of a State of which the indi- (2)(B)(vi)(III), a prominent advisory that the the U.S. label drug or any active ingredient vidual is a resident, or in which the indi- qualifying drug is safe and effective but not thereof. vidual receives care from the practitioner bioequivalent to the U.S. label drug; and ‘‘(4) SECTION 501; ADULTERATION.—A quali- who issues the prescription, is authorized to ‘‘(IV) if the inactive ingredients of the fying drug that is imported or offered for im- administer prescription drugs. qualifying drug are different from the inac- port under subsection (a) shall be considered ‘‘(B) The drug is accompanied by a copy of tive ingredients for the U.S. label drug, in- to be in compliance with section 501 if the the documentation that was required under clude— drug is in compliance with subsection (c). the law or regulations of the permitted coun- ‘‘(aa) a prominent notice that the ingredi- ‘‘(5) STANDARDS FOR REFUSING ADMISSION.— try in which the exporter is located, as a ents of the qualifying drug differ from the in- A drug exported under subsection (a) from a condition of dispensing the drug to the indi- gredients of the U.S. label drug and that the registered exporter or imported by a reg- vidual. qualifying drug must be dispensed with an istered importer may be refused admission ‘‘(C) The copies referred to in subpara- advisory to people with allergies about this into the United States if 1 or more of the fol- graphs (A)(i) and (B) are marked in a manner difference and a list of ingredients; and lowing applies: sufficient— ‘‘(bb) a list of the ingredients of the quali- ‘‘(A) The drug is not a qualifying drug. ‘‘(i) to indicate that the prescription, and fying drug as would be required under sec- ‘‘(B) A notice for the drug required under the equivalent document in the permitted tion 502(e). paragraph (2)(B) has not been submitted to country in which the exporter is located, ‘‘(B) IMPORTATION BY INDIVIDUAL.— the Secretary. have been filled; and ‘‘(i) IN GENERAL.—In the case of a quali- ‘‘(C) The Secretary has ordered that impor- ‘‘(ii) to prevent a duplicative filling by an- fying drug that is imported or offered for im- tation of the drug from the permitted coun- other pharmacist. port by a registered exporter to an indi- try cease under paragraph (2) (C) or (D). ‘‘(D) The individual has provided to the vidual, such drug shall be considered to be in ‘‘(D) The drug does not comply with para- registered exporter a complete list of all compliance with section 502 and the labeling graph (3) or (4). drugs used by the individual for review by requirements under the approved application ‘‘(E) The shipping container appears dam- the individuals who dispense the drug. for the U.S. label drug if the packaging and aged in a way that may affect the strength, ‘‘(E) The quantity of the drug does not ex- labeling of the qualifying drug complies with quality, or purity of the drug. ceed a 90-day supply. all applicable regulations promulgated under ‘‘(F) The Secretary becomes aware that— ‘‘(F) The drug is not an ineligible subpart sections 3 and 4 of the Poison Prevention ‘‘(i) the drug may be counterfeit; H drug. For purposes of this section, a pre- Packaging Act of 1970 (15 U.S.C. 1471 et seq.) ‘‘(ii) the drug may have been prepared, scription drug is an ‘ineligible subpart H and the labeling of the qualifying drug in- packed, or held under insanitary conditions; drug’ if the drug was approved by the Sec- cludes— or retary under subpart H of part 314 of title 21, ‘‘(I) directions for use by the consumer; ‘‘(iii) the methods used in, or the facilities Code of Federal Regulations (relating to ac- ‘‘(II) the lot number assigned by the manu- or controls used for, the manufacturing, celerated approval), with restrictions under facturer; processing, packing, or holding of the drug section 520 of such part to assure safe use, ‘‘(III) the name and registration number of do not conform to good manufacturing prac- and the Secretary has published in the Fed- the exporter; tice. eral Register a notice that the Secretary has ‘‘(IV) if required under paragraph ‘‘(G) The Secretary has obtained an injunc- determined that good cause exists to pro- (2)(B)(vi)(III), a prominent advisory that the tion under section 302 that prohibits the dis- hibit the drug from being imported pursuant drug is safe and effective but not bioequiva- tribution of the drug in interstate com- to this subsection. lent to the U.S. label drug; merce. ‘‘(2) NOTICE REGARDING DRUG REFUSED AD- ‘‘(V) if the inactive ingredients of the drug ‘‘(H) The Secretary has under section 505(e) MISSION.—If a registered exporter ships a are different from the inactive ingredients withdrawn approval of the drug. drug to an individual pursuant to subsection for the U.S. label drug— ‘‘(I) The manufacturer of the drug has in- (a)(2)(B) and the drug is refused admission to ‘‘(aa) a prominent advisory that persons stituted a recall of the drug. the United States, a written notice shall be with an allergy should check the ingredient ‘‘(J) If the drug is imported or offered for sent to the individual and to the exporter list of the drug because the ingredients of import by a registered importer without sub- that informs the individual and the exporter the drug differ from the ingredients of the mission of a notice in accordance with sub- of such refusal and the reason for the refusal. U.S. label drug; and section (d)(4). ‘‘(j) MAINTENANCE OF RECORDS AND SAM- ‘‘(bb) a list of the ingredients of the drug ‘‘(K) If the drug is imported or offered for PLES.— as would be required under section 502(e); import from a registered exporter to an indi- ‘‘(1) IN GENERAL.—A registration condition and vidual and 1 or more of the following applies: is that the importer or exporter involved ‘‘(VI) a copy of any special labeling that ‘‘(i) The shipping container for such drug shall— would be required by the Secretary had the does not bear the markings required under ‘‘(A) maintain records required under this U.S. label drug been dispensed by a phar- subsection (d)(2). section for not less than 2 years; and macist in the United States, without regard ‘‘(ii) The markings on the shipping con- ‘‘(B) maintain samples of each lot of a to whether the special labeling bears any tainer appear to be counterfeit. qualifying drug required under this section trademark involved. ‘‘(iii) The shipping container or markings for not more than 2 years. ‘‘(ii) PACKAGING.—A qualifying drug offered appear to have been tampered with. ‘‘(2) PLACE OF RECORD MAINTENANCE.—The for import to an individual by an exporter ‘‘(h) EXPORTER LICENSURE IN PERMITTED records described under paragraph (1) shall under this section that is packaged in a unit- COUNTRY.—A registration condition is that be maintained— of-use container (as those items are defined the exporter involved agrees that a quali- ‘‘(A) in the case of an importer, at the in the United States Pharmacopeia and Na- fying drug will be exported to an individual place of business of the importer at which tional Formulary) shall not be repackaged, only if the Secretary has verified that— the importer initially receives the qualifying provided that— ‘‘(1) the exporter is authorized under the drug after importation; or ‘‘(I) the packaging complies with all appli- law of the permitted country in which the ‘‘(B) in the case of an exporter, at the facil- cable regulations under sections 3 and 4 of exporter is located to dispense prescription ity from which the exporter ships the quali- the Poison Prevention Packaging Act of 1970 drugs; and fying drug to the United States. (15 U.S.C. 1471 et seq.); or ‘‘(2) the exporter employs persons that are ‘‘(k) DRUG RECALLS.— ‘‘(II) the consumer consents to waive the licensed under the law of the permitted ‘‘(1) MANUFACTURERS.—A person that man- requirements of such Act, after being in- country in which the exporter is located to ufactures a qualifying drug imported from a

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00100 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.070 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5415 permitted country under this section shall drug to the United States under this section ‘‘(L) engage in any other action to restrict, promptly inform the Secretary— than the price that is charged, inclusive of prohibit, or delay the importation of a quali- ‘‘(A) if the drug is recalled or withdrawn rebates or other incentives to the permitted fying drug under this section; or from the market in a permitted country; country or other person, to another person ‘‘(M) engage in any other action that the ‘‘(B) how the drug may be identified, in- that is in the same country and that does Federal Trade Commission determines to cluding lot number; and not export a qualifying drug into the United discriminate against a person that engages ‘‘(C) the reason for the recall or with- States under this section; or attempts to engage in the importation of drawal. ‘‘(B) discriminate by charging a higher a qualifying drug under this section. ‘‘(2) SECRETARY.—With respect to each per- price for a prescription drug sold to a reg- ‘‘(2) REFERRAL OF POTENTIAL VIOLATIONS.— mitted country, the Secretary shall— istered importer or other person that distrib- The Secretary shall promptly refer to the ‘‘(A) enter into an agreement with the gov- utes, sells, or uses a qualifying drug im- Federal Trade Commission each potential ernment of the country to receive informa- ported into the United States under this sec- violation of subparagraph (E), (F), (G), (H), tion about recalls and withdrawals of quali- or (I) of paragraph (1) that becomes known to tion than the price that is charged to an- fying drugs in the country; or the Secretary. other person in the United States that does ‘‘(B) monitor recalls and withdrawals of ‘‘(3) AFFIRMATIVE DEFENSE.— not import a qualifying drug under this sec- qualifying drugs in the country using any in- ‘‘(A) DISCRIMINATION.—It shall be an af- formation that is available to the public in tion, or that does not distribute, sell, or use firmative defense to a charge that a manu- any media. such a drug; facturer has discriminated under subpara- ‘‘(C) discriminate by denying, restricting, ‘‘(3) NOTICE.—The Secretary may notify, as graph (A), (B), (C), (D), or (M) of paragraph appropriate, registered exporters, registered or delaying supplies of a prescription drug to (1) that the higher price charged for a pre- importers, wholesalers, pharmacies, or the a registered exporter or other person in a scription drug sold to a person, the denial, public of a recall or withdrawal of a quali- permitted country that exports a qualifying restriction, or delay of supplies of a prescrip- fying drug in a permitted country. drug to the United States under this section tion drug to a person, the refusal to do busi- ‘‘(l) DRUG LABELING AND PACKAGING.— or to a registered importer or other person ness with a person, or other discriminatory ‘‘(1) IN GENERAL.—When a qualifying drug that distributes, sells, or uses a qualifying activity against a person, is not based, in that is imported into the United States by drug imported into the United States under whole or in part, on— an importer under subsection (a) is dispensed this section; ‘‘(i) the person exporting or importing a by a pharmacist to an individual, the phar- ‘‘(D) discriminate by publicly, privately, or qualifying drug into the United States under macist shall provide that the packaging and otherwise refusing to do business with a reg- this section; or labeling of the drug complies with all appli- istered exporter or other person in a per- ‘‘(ii) the person distributing, selling, or cable regulations promulgated under sec- mitted country that exports a qualifying using a qualifying drug imported into the tions 3 and 4 of the Poison Prevention Pack- drug to the United States under this section United States under this section. aging Act of 1970 (15 U.S.C. 1471 et seq.) and or with a registered importer or other person ‘‘(B) DRUG DIFFERENCES.—It shall be an af- shall include with any other labeling pro- that distributes, sells, or uses a qualifying firmative defense to a charge that a manu- vided to the individual the following: drug imported into the United States under facturer has caused there to be a difference ‘‘(A) The lot number assigned by the manu- this section; described in subparagraph (G) of paragraph facturer. ‘‘(E) knowingly fail to submit a notice (1) that— ‘‘(B) The name and registration number of under subsection (g)(2)(B)(i), knowingly fail ‘‘(i) the difference was required by the the importer. to submit such a notice on or before the date country in which the drug is distributed; ‘‘(C) If required under paragraph specified in subsection (g)(2)(B)(v) or as oth- ‘‘(ii) the Secretary has determined that the (2)(B)(vi)(III) of subsection (g), a prominent erwise required under subsection (e) (3), (4), difference was necessary to improve the safe- advisory that the drug is safe and effective and (5) of section 4 of the Pharmaceutical ty or effectiveness of the drug; but not bioequivalent to the U.S. label drug. Market Access and Drug Safety Act of 2007, ‘‘(iii) the person manufacturing the drug ‘‘(D) If the inactive ingredients of the drug knowingly submit such a notice that makes for distribution in the United States has are different from the inactive ingredients a materially false, fictitious, or fraudulent given notice to the Secretary under sub- for the U.S. label drug— statement, or knowingly fail to provide section (g)(2)(B)(i) that the drug for distribu- ‘‘(i) a prominent advisory that persons promptly any information requested by the tion in the United States is not different with allergies should check the ingredient Secretary to review such a notice; from a drug for distribution in permitted list of the drug because the ingredients of ‘‘(F) knowingly fail to submit an applica- countries whose combined population rep- the drug differ from the ingredients of the tion required under subsection (g)(2)(F), resents at least 50 percent of the total popu- U.S. label drug; and knowingly fail to submit such an application lation of all permitted countries; or ‘‘(iv) the difference was not caused, in ‘‘(ii) a list of the ingredients of the drug as on or before the date specified in subsection whole or in part, for the purpose of restrict- would be required under section 502(e). (g)(2)(F)(ii), knowingly submit such an appli- ing importation of the drug into the United ‘‘(2) PACKAGING.—A qualifying drug that is cation that makes a materially false, ficti- States under this section. packaged in a unit-of-use container (as those tious, or fraudulent statement, or knowingly ‘‘(4) EFFECT OF SUBSECTION.— terms are defined in the United States Phar- fail to provide promptly any information re- macopeia and National Formulary) shall not ‘‘(A) SALES IN OTHER COUNTRIES.—This sub- quested by the Secretary to review such an section applies only to the sale or distribu- be repackaged, provided that— application; ‘‘(A) the packaging complies with all appli- tion of a prescription drug in a country if the ‘‘(G) cause there to be a difference (includ- manufacturer of the drug chooses to sell or cable regulations under sections 3 and 4 of ing a difference in active ingredient, route of distribute the drug in the country. Nothing the Poison Prevention Packaging Act of 1970 administration, dosage form, strength, for- in this subsection shall be construed to com- (15 U.S.C. 1471 et seq.); or mulation, manufacturing establishment, pel the manufacturer of a drug to distribute ‘‘(B) the consumer consents to waive the manufacturing process, or person that manu- or sell the drug in a country. requirements of such Act, after being in- factures the drug) between a prescription ‘‘(B) DISCOUNTS TO INSURERS, HEALTH formed that the packaging does not comply drug for distribution in the United States PLANS, PHARMACY BENEFIT MANAGERS, AND with such Act and that the pharmacist will and the drug for distribution in a permitted COVERED ENTITIES.—Nothing in this sub- provide the drug in packaging that is compli- country; section shall be construed to— ant at no additional cost. ‘‘(H) refuse to allow an inspection author- ‘‘(i) prevent or restrict a manufacturer of a ‘‘(m) CHARITABLE CONTRIBUTIONS.—Not- ized under this section of an establishment withstanding any other provision of this sec- prescription drug from providing discounts that manufactures a qualifying drug that is, tion, this section does not authorize the im- to an insurer, health plan, pharmacy benefit or will be, introduced for commercial dis- portation into the United States of a quali- manager in the United States, or covered en- tribution in a permitted country; fying drug donated or otherwise supplied for tity in the drug discount program under sec- free or at nominal cost by the manufacturer ‘‘(I) fail to conform to the methods used in, tion 340B of the Public Health Service Act of the drug to a charitable or humanitarian or the facilities used for, the manufacturing, (42 U.S.C. 256b) in return for inclusion of the organization, including the United Nations processing, packing, or holding of a quali- drug on a formulary; and affiliates, or to a government of a for- fying drug that is, or will be, introduced for ‘‘(ii) require that such discounts be made eign country. commercial distribution in a permitted available to other purchasers of the prescrip- ‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND country to good manufacturing practice tion drug; or PRACTICES.— under this Act; ‘‘(iii) prevent or restrict any other meas- ‘‘(1) IN GENERAL.—It is unlawful for a man- ‘‘(J) become a party to a licensing agree- ures taken by an insurer, health plan, or ufacturer, directly or indirectly (including ment or other agreement related to a quali- pharmacy benefit manager to encourage con- by being a party to a licensing agreement or fying drug that fails to provide for compli- sumption of such prescription drug. other agreement), to— ance with all requirements of this section ‘‘(C) CHARITABLE CONTRIBUTIONS.—Nothing ‘‘(A) discriminate by charging a higher with respect to such drug; in this subsection shall be construed to— price for a prescription drug sold to a reg- ‘‘(K) enter into a contract that restricts, ‘‘(i) prevent a manufacturer from donating istered exporter or other person in a per- prohibits, or delays the importation of a a prescription drug, or supplying a prescrip- mitted country that exports a qualifying qualifying drug under this section; tion drug at nominal cost, to a charitable or

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TICE.—A violation of this subsection shall be during the pendency of that action, institute ‘‘(4) The importation of a drug in violation treated as a violation of a rule defining an an action under subparagraph (A) for the of a registration condition or other require- unfair or deceptive act or practice prescribed same violation against any defendant named ment under section 804, the falsification of under section 18(a)(1)(B) of the Federal Trade in the complaint in that action. any record required to be maintained, or pro- Commission Act (15 U.S.C. 57a(a)(1)(B)). ‘‘(E) VENUE.—Any action brought under vided to the Secretary, under such section, ‘‘(B) ACTIONS BY THE COMMISSION.—The subparagraph (A) may be brought in the dis- or the violation of any registration condition Federal Trade Commission— trict court of the United States that meets or other requirement under such section.’’; ‘‘(i) shall enforce this subsection in the applicable requirements relating to venue and same manner, by the same means, and with under section 1391 of title 28, United States (2) in section 303(a) (21 U.S.C. 333(a)), by the same jurisdiction, powers, and duties as Code. striking paragraph (6) and inserting the fol- though all applicable terms and provisions of ‘‘(F) SERVICE OF PROCESS.—In an action lowing: the Federal Trade Commission Act (15 U.S.C. brought under subparagraph (A), process ‘‘(6) Notwithstanding subsection (a), any 41 et seq.) were incorporated into and made may be served in any district in which the person that knowingly violates section 301(i) a part of this section; and defendant— (2) or (3) or section 301(aa)(4) shall be impris- ‘‘(ii) may seek monetary relief threefold ‘‘(i) is an inhabitant; or oned not more than 10 years, or fined in ac- the damages sustained, in addition to any ‘‘(ii) may be found. cordance with title 18, United States Code, other remedy available to the Federal Trade ‘‘(G) MEASUREMENT OF DAMAGES.—In any or both.’’. Commission under the Federal Trade Com- action under this paragraph to enforce a (c) AMENDMENT OF CERTAIN PROVISIONS.— mission Act (15 U.S.C. 41 et seq.). cause of action under this subsection in (1) IN GENERAL.—Section 801 of the Federal ‘‘(6) ACTIONS BY STATES.— which there has been a determination that a Food, Drug, and Cosmetic Act (21 U.S.C. 381) ‘‘(A) IN GENERAL.— defendant has violated a provision of this is amended by striking subsection (g) and in- ‘‘(i) CIVIL ACTIONS.—In any case in which subsection, damages may be proved and as- serting the following: ‘‘(g) With respect to a prescription drug the attorney general of a State has reason to sessed in the aggregate by statistical or sam- that is imported or offered for import into believe that an interest of the residents of pling methods, by the computation of illegal the United States by an individual who is that State have been adversely affected by overcharges or by such other reasonable sys- not in the business of such importation, that any manufacturer that violates paragraph tem of estimating aggregate damages as the is not shipped by a registered exporter under (1), the attorney general of a State may court in its discretion may permit without section 804, and that is refused admission bring a civil action on behalf of the residents the necessity of separately proving the indi- under subsection (a), the Secretary shall no- of the State, and persons doing business in vidual claim of, or amount of damage to, per- the State, in a district court of the United tify the individual that— sons on whose behalf the suit was brought. States of appropriate jurisdiction to— ‘‘(1) the drug has been refused admission ‘‘(H) EXCLUSION ON DUPLICATIVE RELIEF.— ‘‘(I) enjoin that practice; because the drug was not a lawful import The district court shall exclude from the ‘‘(II) enforce compliance with this sub- under section 804; amount of monetary relief awarded in an ac- section; ‘‘(2) the drug is not otherwise subject to a tion under this paragraph brought by the at- ‘‘(III) obtain damages, restitution, or other waiver of the requirements of subsection (a); torney general of a State any amount of compensation on behalf of residents of the ‘‘(3) the individual may under section 804 monetary relief which duplicates amounts State and persons doing business in the lawfully import certain prescription drugs which have been awarded for the same in- State, including threefold the damages; or from exporters registered with the Secretary jury. ‘‘(IV) obtain such other relief as the court under section 804; and ‘‘(7) EFFECT ON ANTITRUST LAWS.—Nothing may consider to be appropriate. ‘‘(4) the individual can find information in this subsection shall be construed to mod- ‘‘(ii) NOTICE.— about such importation, including a list of ify, impair, or supersede the operation of the ‘‘(I) IN GENERAL.—Before filing an action registered exporters, on the Internet website antitrust laws. For the purpose of this sub- under clause (i), the attorney general of the of the Food and Drug Administration or section, the term ‘antitrust laws’ has the State involved shall provide to the Federal through a toll-free telephone number re- meaning given it in the first section of the Trade Commission— quired under section 804.’’. Clayton Act, except that it includes section ‘‘(aa) written notice of that action; and (2) ESTABLISHMENT REGISTRATION.—Section 5 of the Federal Trade Commission Act to ‘‘(bb) a copy of the complaint for that ac- 510(i) of the Federal Food, Drug, and Cos- the extent that such section 5 applies to un- tion. metic Act (21 U.S.C. 360(i)) is amended in fair methods of competition. ‘‘(II) EXEMPTION.—Subclause (I) shall not paragraph (1) by inserting after ‘‘import into ‘‘(8) MANUFACTURER.—In this subsection, apply with respect to the filing of an action the United States’’ the following: ‘‘, includ- the term ‘manufacturer’ means any entity, by an attorney general of a State under this ing a drug that is, or may be, imported or of- including any affiliate or licensee of that en- paragraph, if the attorney general deter- fered for import into the United States under tity, that is engaged in— mines that it is not feasible to provide the section 804,’’. ‘‘(A) the production, preparation, propaga- notice described in that subclause before fil- (3) EFFECTIVE DATE.—The amendments tion, compounding, conversion, or processing ing of the action. In such case, the attorney made by this subsection shall take effect on of a prescription drug, either directly or in- general of a State shall provide notice and a the date that is 90 days after the date of en- directly by extraction from substances of copy of the complaint to the Federal Trade actment of this title. natural origin, or independently by means of Commission at the same time as the attor- (d) EXHAUSTION.— chemical synthesis, or by a combination of ney general files the action. (1) IN GENERAL.—Section 271 of title 35, extraction and chemical synthesis; or ‘‘(B) INTERVENTION.— United States Code, is amended— ‘‘(B) the packaging, repackaging, labeling, ‘‘(i) IN GENERAL.—On receiving notice (A) by redesignating subsections (h) and (i) relabeling, or distribution of a prescription under subparagraph (A)(ii), the Federal as (i) and (j), respectively; and drug.’’. Trade Commission shall have the right to in- (B) by inserting after subsection (g) the tervene in the action that is the subject of (b) PROHIBITED ACTS.—The Federal Food, following: the notice. Drug, and Cosmetic Act is amended— ‘‘(h) It shall not be an act of infringement ‘‘(ii) EFFECT OF INTERVENTION.—If the Fed- (1) in section 301 (21 U.S.C. 331), by striking to use, offer to sell, or sell within the United eral Trade Commission intervenes in an ac- paragraph (aa) and inserting the following: States or to import into the United States tion under subparagraph (A), it shall have ‘‘(aa)(1) The sale or trade by a pharmacist, any patented invention under section 804 of the right— or by a business organization of which the the Federal Food, Drug, and Cosmetic Act ‘‘(I) to be heard with respect to any matter pharmacist is a part, of a qualifying drug that was first sold abroad by or under au- that arises in that action; and that under section 804(a)(2)(A) was imported thority of the owner or licensee of such pat- ‘‘(II) to file a petition for appeal. by the pharmacist, other than— ent.’’. ‘‘(C) CONSTRUCTION.—For purposes of bring- ‘‘(A) a sale at retail made pursuant to dis- (2) RULE OF CONSTRUCTION.—Nothing in the ing any civil action under subparagraph (A), pensing the drug to a customer of the phar- amendment made by paragraph (1) shall be nothing in this subsection shall be construed macist or organization; or construed to affect the ability of a patent to prevent an attorney general of a State ‘‘(B) a sale or trade of the drug to a phar- owner or licensee to enforce their patent, from exercising the powers conferred on the macy or a wholesaler registered to import subject to such amendment. attorney general by the laws of that State drugs under section 804. (e) EFFECT OF SECTION 804.— to— ‘‘(2) The sale or trade by an individual of a (1) IN GENERAL.—Section 804 of the Federal ‘‘(i) conduct investigations; qualifying drug that under section Food, Drug, and Cosmetic Act, as added by ‘‘(ii) administer oaths or affirmations; or 804(a)(2)(B) was imported by the individual. subsection (a), shall permit the importation

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of qualifying drugs (as defined in such sec- date of enactment of this title, the Secretary (C) PRIORITY FOR DRUGS WITH HIGHER tion 804) into the United States without re- may limit the number of registered import- SALES.—The Secretary shall establish the gard to the status of the issuance of imple- ers under such section 804 to not less than dates described under subparagraph (A) so menting regulations— 200 (of which at least a significant number that the Secretary reviews the notices de- (A) from exporters registered under such shall be groups of pharmacies, to the extent scribed under such subparagraph with re- section 804 on the date that is 90 days after feasible given the applications submitted by spect to qualifying drugs with higher dollar the date of enactment of this title; and such groups), so long as the Secretary gives volume of sales in the United States before (B) from permitted countries, as defined in priority to those importers with dem- the notices with respect to drugs with lower such section 804, by importers registered onstrated ability to process a high volume of sales in the United States. under such section 804 on the date that is 1 shipments of drugs into the United States. (7) NOTICES FOR DRUGS APPROVED AFTER EF- year after the date of enactment of this title. (C) FURTHER LIMIT ON NUMBER OF IMPORT- FECTIVE DATE.—The notice required under (2) REVIEW OF REGISTRATION BY CERTAIN EX- ERS.—During any 1-year period beginning on subsection (g)(2)(B)(i) of such section 804 for PORTERS.— a date that is 3 or more years after the date a qualifying drug first introduced for com- (A) REVIEW PRIORITY.—In the review of reg- of enactment of this title, the Secretary may mercial distribution in a permitted country istrations submitted under subsection (b) of limit the number of registered importers (as defined in such section 804) after the date such section 804, registrations submitted by under such section 804 to not less than 50 of enactment of this title shall be submitted entities in Canada that are significant ex- more (of which at least a significant number to and reviewed by the Secretary as provided porters of prescription drugs to individuals shall be groups of pharmacies, to the extent under subsection (g)(2)(B) of such section 804, in the United States as of the date of enact- feasible given the applications submitted by without regard to paragraph (4), (5), or (6). ment of this title will have priority during such groups) than the number of such im- (8) REPORT.—Beginning with the first full the 90 day period that begins on such date of porters during the previous 1-year period, so fiscal year after the date of enactment of enactment. long as the Secretary gives priority to those this title, not later than 90 days after the (B) PERIOD FOR REVIEW.—During such 90- importers with demonstrated ability to proc- end of each fiscal year during which the Sec- day period, the reference in subsection ess a high volume of shipments of drugs to retary reviews a notice referred to in para- (b)(2)(A) of such section 804 to 90 days (relat- the United States. graph (4), (5), or (6), the Secretary shall sub- ing to approval or disapproval of registra- (4) NOTICES FOR DRUGS FOR IMPORT FROM mit a report to Congress concerning the tions) is, as applied to such entities, deemed CANADA.—The notice with respect to a quali- progress of the Food and Drug Administra- to be 30 days. fying drug introduced for commercial dis- tion in reviewing the notices referred to in (C) LIMITATION.—That an exporter in Can- tribution in Canada as of the date of enact- paragraphs (4), (5), and (6). ada exports, or has exported, prescription ment of this title that is required under sub- (9) USER FEES.— drugs to individuals in the United States on section (g)(2)(B)(i) of such section 804 shall (A) EXPORTERS.—When establishing an ag- or before the date that is 90 days after the be submitted to the Secretary not later than gregate total of fees to be collected from ex- date of enactment of this title shall not 30 days after the date of enactment of this porters under subsection (f)(2) of such sec- serve as a basis, in whole or in part, for dis- title if— tion 804, the Secretary shall, under sub- approving a registration under such section (A) the U.S. label drug (as defined in such section (f)(3)(C)(i) of such section 804, esti- 804 from the exporter. section 804) for the qualifying drug is 1 of the mate the total price of drugs imported under (D) FIRST YEAR LIMIT ON NUMBER OF EX- 100 prescription drugs with the highest dollar subsection (a) of such section 804 into the PORTERS.—During the 1-year period begin- volume of sales in the United States based United States by registered exporters during ning on the date of enactment of this title, on the 12 calendar month period most re- the first fiscal year in which this title takes the Secretary of Health and Human Services cently completed before the date of enact- effect to be an amount equal to the amount (referred to in this section as the ‘‘Sec- ment of this Act; or which bears the same ratio to $1,000,000,000 as retary’’) may limit the number of registered (B) the notice is a notice under subsection the number of days in such fiscal year during exporters under such section 804 to not less (g)(2)(B)(i)(II) of such section 804. which this title is effective bears to 365. than 50, so long as the Secretary gives pri- (5) NOTICE FOR DRUGS FOR IMPORT FROM (B) IMPORTERS.—When establishing an ag- ority to those exporters with demonstrated OTHER COUNTRIES.—The notice with respect gregate total of fees to be collected from im- ability to process a high volume of ship- to a qualifying drug introduced for commer- porters under subsection (e)(2) of such sec- ments of drugs to individuals in the United cial distribution in a permitted country tion 804, the Secretary shall, under sub- States. other than Canada as of the date of enact- section (e)(3)(C)(i) of such section 804, esti- (E) SECOND YEAR LIMIT ON NUMBER OF EX- ment of this title that is required under sub- mate the total price of drugs imported under PORTERS.—During the 1-year period begin- section (g)(2)(B)(i) of such section 804 shall subsection (a) of such section 804 into the ning on the date that is 1 year after the date be submitted to the Secretary not later than United States by registered importers dur- of enactment of this title, the Secretary may 180 days after the date of enactment of this ing— limit the number of registered exporters title if— (i) the first fiscal year in which this title under such section 804 to not less than 100, so (A) the U.S. label drug for the qualifying takes effect to be an amount equal to the long as the Secretary gives priority to those drug is 1 of the 100 prescription drugs with amount which bears the same ratio to exporters with demonstrated ability to proc- the highest dollar volume of sales in the $1,000,000,000 as the number of days in such ess a high volume of shipments of drugs to United States based on the 12 calendar fiscal year during which this title is effective individuals in the United States. month period that is first completed on the bears to 365; and (F) FURTHER LIMIT ON NUMBER OF EXPORT- date that is 120 days after the date of enact- (ii) the second fiscal year in which this ERS.—During any 1-year period beginning on ment of this title; or title is in effect to be $3,000,000,000. a date that is 2 or more years after the date (B) the notice is a notice under subsection (C) SECOND YEAR ADJUSTMENT.— of enactment of this title, the Secretary may (g)(2)(B)(i)(II) of such section 804. (i) REPORTS.—Not later than February 20 of limit the number of registered exporters (6) NOTICE FOR OTHER DRUGS FOR IMPORT.— the second fiscal year in which this title is in under such section 804 to not less than 25 (A) GUIDANCE ON SUBMISSION DATES.—The effect, registered importers shall report to more than the number of such exporters dur- Secretary shall by guidance establish a se- the Secretary the total price and the total ing the previous 1-year period, so long as the ries of submission dates for the notices under volume of drugs imported to the United Secretary gives priority to those exporters subsection (g)(2)(B)(i) of such section 804 States by the importer during the 4-month with demonstrated ability to process a high with respect to qualifying drugs introduced period from October 1 through January 31 of volume of shipments of drugs to individuals for commercial distribution as of the date of such fiscal year. in the United States. enactment of this title and that are not re- (ii) REESTIMATE.—Notwithstanding sub- (3) LIMITS ON NUMBER OF IMPORTERS.— quired to be submitted under paragraph (4) section (e)(3)(C)(ii) of such section 804 or sub- (A) FIRST YEAR LIMIT ON NUMBER OF IM- or (5). paragraph (B), the Secretary shall reesti- PORTERS.—During the 1-year period begin- (B) CONSISTENT AND EFFICIENT USE OF RE- mate the total price of qualifying drugs im- ning on the date that is 1 year after the date SOURCES.—The Secretary shall establish the ported under subsection (a) of such section of enactment of this title, the Secretary may dates described under subparagraph (A) so 804 into the United States by registered im- limit the number of registered importers that such notices described under subpara- porters during the second fiscal year in under such section 804 to not less than 100 (of graph (A) are submitted and reviewed at a which this title is in effect. Such reestimate which at least a significant number shall be rate that allows consistent and efficient use shall be equal to— groups of pharmacies, to the extent feasible of the resources and staff available to the (I) the total price of qualifying drugs im- given the applications submitted by such Secretary for such reviews. The Secretary ported by each importer as reported under groups), so long as the Secretary gives pri- may condition the requirement to submit clause (i); multiplied by ority to those importers with demonstrated such a notice, and the review of such a no- (II) 3. ability to process a high volume of ship- tice, on the submission by a registered ex- (iii) ADJUSTMENT.—The Secretary shall ad- ments of drugs imported into the United porter or a registered importer to the Sec- just the fee due on April 1 of the second fis- States. retary of a notice that such exporter or im- cal year in which this title is in effect, from (B) SECOND YEAR LIMIT ON NUMBER OF IM- porter intends to import such qualifying each importer so that the aggregate total of PORTERS.—During the 1-year period begin- drug to the United States under such section fees collected under subsection (e)(2) for such ning on the date that is 2 years after the 804. fiscal year does not exceed the total price of

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qualifying drugs imported under subsection an exporter registered with and approved by ‘‘(d) CERTAIN PROCEDURES.— (a) of such section 804 into the United States the Food and Drug Administration under ‘‘(1) IN GENERAL.—The delivery and de- by registered importers during such fiscal section 804 of the Federal Food, Drug, and struction of drugs under this section may be year as reestimated under clause (ii). Cosmetic Act, as added by this section, in- carried out without notice to the importer, (D) FAILURE TO PAY FEES.—Notwith- cluding information on how to verify wheth- owner, or consignee of the drugs except as standing any other provision of this section, er an exporter is registered and approved by required by section 801(g) or section 804(i)(2). the Secretary may prohibit a registered im- use of the Internet website of the Food and The issuance of receipts for the drugs, and porter or exporter that is required to pay Drug Administration and the toll-free tele- recordkeeping activities regarding the drugs, user fees under subsection (e) or (f) of such phone number required by this title; may be carried out on a summary basis. section 804 and that fails to pay such fees (2) that drugs that consumers attempt to ‘‘(2) OBJECTIVE OF PROCEDURES.—Proce- within 30 days after the date on which it is import from an exporter that is not reg- dures promulgated under paragraph (1) shall due, from importing or offering for importa- istered with and approved by the Food and be designed toward the objective of ensuring tion a qualifying drug under such section 804 Drug Administration can be seized by the that, with respect to efficiently utilizing until such fee is paid. United States Customs Service and de- Federal resources available for carrying out (E) ANNUAL REPORT.— stroyed, and that such drugs may be counter- this section, a substantial majority of ship- (i) FOOD AND DRUG ADMINISTRATION.—Not feit, unapproved, unsafe, or ineffective; ments of drugs subject to described in sub- later than 180 days after the end of each fis- (3) with regard to the suspension and ter- section (c) are identified and destroyed. cal year during which fees are collected mination of any registration of a registered ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not under subsection (e), (f), or (g)(2)(B)(iv) of importer or exporter under such section 804; be destroyed under subsection (c) to the ex- such section 804, the Secretary shall prepare and tent that the Attorney General of the United and submit to the House of Representatives (4) with regard to the availability at do- States determines that the drugs should be and the Senate a report on the implementa- mestic retail pharmacies of qualifying drugs preserved as evidence or potential evidence tion of the authority for such fees during imported under such section 804 by domestic with respect to an offense against the United such fiscal year and the use, by the Food and wholesalers and pharmacies registered with States. Drug Administration, of the fees collected and approved by the Food and Drug Adminis- ‘‘(f) RULE OF CONSTRUCTION.—This section for the fiscal year for which the report is tration. may not be construed as having any legal ef- made and credited to the Food and Drug Ad- (h) EFFECT ON ADMINISTRATION PRAC- fect on applicable law with respect to a ship- ministration. TICES.—Notwithstanding any provision of ment of drugs that is imported or offered for (ii) CUSTOMS AND BORDER CONTROL.—Not this title (and the amendments made by this import into the United States and has a de- later than 180 days after the end of each fis- title), the practices and policies of the Food clared value equal to or greater than cal year during which fees are collected and Drug Administration and Bureau of Cus- $10,000.’’. under subsection (e) or (f) of such section 804, toms and Border Protection, in effect on (b) PROCEDURES.—Procedures for carrying the Secretary of Homeland Security, in con- January 1, 2004, with respect to the importa- out section 805 of the Federal Food, Drug, sultation with the Secretary of the Treas- tion of prescription drugs into the United and Cosmetic Act, as added by subsection ury, shall prepare and submit to the House of States by an individual, on the person of (a), shall be established not later than 90 Representatives and the Senate a report on such individual, for personal use, shall re- days after the date of the enactment of this the use, by the Bureau of Customs and Bor- main in effect. title. der Protection, of the fees, if any, trans- (i) REPORT TO CONGRESS.—The Federal (c) EFFECTIVE DATE.—The amendments ferred by the Secretary to the Bureau of Cus- Trade Commission shall, on an annual basis, made by this section shall take effect on the toms and Border Protection for the fiscal submit to Congress a report that describes date that is 90 days after the date of enact- year for which the report is made. any action taken during the period for which ment of this title. (10) SPECIAL RULE REGARDING IMPORTATION the report is being prepared to enforce the SEC. l06. WHOLESALE DISTRIBUTION OF DRUGS; BY INDIVIDUALS.— provisions of section 804(n) of the Federal STATEMENTS REGARDING PRIOR (A) IN GENERAL.—Notwithstanding any pro- Food, Drug, and Cosmetic Act (as added by SALE, PURCHASE, OR TRADE. vision of this title (or an amendment made this title), including any pending investiga- (a) STRIKING OF EXEMPTIONS; APPLICABILITY by this title), the Secretary shall expedite tions or civil actions under such section. TO REGISTERED EXPORTERS.—Section 503(e) of the designation of any additional countries SEC. l05. DISPOSITION OF CERTAIN DRUGS DE- the Federal Food, Drug, and Cosmetic Act from which an individual may import a NIED ADMISSION INTO UNITED (21 U.S.C. 353(e)) is amended— qualifying drug into the United States under STATES. (1) in paragraph (1)— such section 804 if any action implemented (a) IN GENERAL.—Chapter VIII of the Fed- (A) by striking ‘‘and who is not the manu- by the Government of Canada has the effect eral Food, Drug, and Cosmetic Act (21 U.S.C. facturer or an authorized distributor of of limiting or prohibiting the importation of 381 et seq.), as amended by section l04, is record of such drug’’; qualifying drugs into the United States from further amended by adding at the end the (B) by striking ‘‘to an authorized dis- Canada. following section: tributor of record or’’; and (B) TIMING AND CRITERIA.—The Secretary ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DE- (C) by striking subparagraph (B) and in- shall designate such additional countries NIED ADMISSION. serting the following: under subparagraph (A)— ‘‘(a) IN GENERAL.—The Secretary of Home- ‘‘(B) The fact that a drug subject to sub- (i) not later than 6 months after the date of land Security shall deliver to the Secretary section (b) is exported from the United the action by the Government of Canada de- a shipment of drugs that is imported or of- States does not with respect to such drug ex- scribed under such subparagraph; and fered for import into the United States if— empt any person that is engaged in the busi- (ii) using the criteria described under sub- ‘‘(1) the shipment has a declared value of ness of the wholesale distribution of the drug section (a)(4)(D)(i)(II) of such section 804. less than $10,000; and from providing the statement described in (f) IMPLEMENTATION OF SECTION 804.— ‘‘(2)(A) the shipping container for such subparagraph (A) to the person that receives (1) INTERIM RULE.—The Secretary may pro- drugs does not bear the markings required the drug pursuant to the export of the drug. mulgate an interim rule for implementing under section 804(d)(2); or ‘‘(C)(i) The Secretary shall by regulation section 804 of the Federal Food, Drug, and ‘‘(B) the Secretary has requested delivery establish requirements that supersede sub- Cosmetic Act, as added by subsection (a) of of such shipment of drugs. paragraph (A) (referred to in this subpara- this section. ‘‘(b) NO BOND OR EXPORT.—Section 801(b) graph as ‘alternative requirements’) to iden- (2) NO NOTICE OF PROPOSED RULEMAKING.— does not authorize the delivery to the owner tify the chain of custody of a drug subject to The interim rule described under paragraph or consignee of drugs delivered to the Sec- subsection (b) from the manufacturer of the (1) may be developed and promulgated by the retary under subsection (a) pursuant to the drug throughout the wholesale distribution Secretary without providing general notice execution of a bond, and such drugs may not of the drug to a pharmacist who intends to of proposed rulemaking. be exported. sell the drug at retail if the Secretary deter- (3) FINAL RULE.—Not later than 1 year after ‘‘(c) DESTRUCTION OF VIOLATIVE SHIP- mines that the alternative requirements, the date on which the Secretary promulgates MENT.—The Secretary shall destroy a ship- which may include standardized anti-coun- an interim rule under paragraph (1), the Sec- ment of drugs delivered by the Secretary of terfeiting or track-and-trace technologies, retary shall, in accordance with procedures Homeland Security to the Secretary under will identify such chain of custody or the under section 553 of title 5, United States subsection (a) if— identity of the discrete package of the drug Code, promulgate a final rule for imple- ‘‘(1) in the case of drugs that are imported from which the drug is dispensed with equal menting such section 804, which may incor- or offered for import from a registered ex- or greater certainty to the requirements of porate by reference provisions of the interim porter under section 804, the drugs are in vio- subparagraph (A), and that the alternative rule provided for under paragraph (1), to the lation of any standard described in section requirements are economically and tech- extent that such provisions are not modified. 804(g)(5); or nically feasible. (g) CONSUMER EDUCATION.—The Secretary ‘‘(2) in the case of drugs that are not im- ‘‘(ii) When the Secretary promulgates a shall carry out activities that educate con- ported or offered for import from a reg- final rule to establish such alternative re- sumers— istered exporter under section 804, the drugs quirements, the final rule in addition shall, (1) with regard to the availability of quali- are in violation of a standard referred to in with respect to the registration condition es- fying drugs for import for personal use from section 801(a) or 801(d)(1). tablished in clause (i) of section 804(c)(3)(B),

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00104 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.071 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5419 establish a condition equivalent to the alter- (cc) are manufactured and distributed in a place and manner, and shall include in the native requirements, and such equivalent highly secure, tightly controlled environ- caption for the link the words ‘licensing and condition may be met in lieu of the registra- ment; and contact information’. tion condition established in such clause (dd) incorporate additional layers of non- ‘‘(b) INTERNET SALES WITHOUT APPRO- (i).’’; visible convert security features up to and PRIATE MEDICAL RELATIONSHIPS.— (2) in paragraph (2)(A), by adding at the including forensic capability, as described in ‘‘(1) IN GENERAL.—Except as provided in end the following: ‘‘The preceding sentence subparagraph (B); or paragraph (2), a person may not dispense a may not be construed as having any applica- (II) technologies that have a function of se- prescription drug, or sell such a drug, if— bility with respect to a registered exporter curity comparable to that described in sub- under section 804.’’; and clause (I), as determined by the Secretary. ‘‘(A) for purposes of such dispensing or (3) in paragraph (3), by striking ‘‘and sub- (B) STANDARDS FOR PACKAGING.—For the sale, the purchaser communicated with the section (d)—’’ in the matter preceding sub- purpose of making it more difficult to coun- person through the Internet; paragraph (A) and all that follows through terfeit the packaging of drugs subject to this ‘‘(B) the patient for whom the drug was ‘‘the term ‘wholesale distribution’ means’’ in paragraph, the manufacturers of such drugs dispensed or purchased did not, when such subparagraph (B) and inserting the fol- shall incorporate the technologies described communications began, have a prescription lowing: ‘‘and subsection (d), the term ‘whole- in subparagraph (A) into at least 1 additional for the drug that is valid in the United sale distribution’ means’’. element of the physical packaging of the States; drugs, including blister packs, shrink wrap, ‘‘(C) pursuant to such communications, the (b) CONFORMING AMENDMENT.—Section package labels, package seals, bottles, and person provided for the involvement of a 503(d) of the Federal Food, Drug, and Cos- boxes. practitioner, or an individual represented by metic Act (21 U.S.C. 353(d)) is amended by SEC. l07. INTERNET SALES OF PRESCRIPTION the person as a practitioner, and the practi- adding at the end the following: DRUGS. tioner or such individual issued a prescrip- ‘‘(4) Each manufacturer of a drug subject (a) IN GENERAL.—Chapter V of the Federal tion for the drug that was purchased; to subsection (b) shall maintain at its cor- Food, Drug, and Cosmetic Act (21 U.S.C. 351 ‘‘(D) the person knew, or had reason to porate offices a current list of the authorized et seq.) is amended by inserting after section know, that the practitioner or the individual distributors of record of such drug. 503A the following: referred to in subparagraph (C) did not, when ‘‘(5) For purposes of this subsection, the ‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION issuing the prescription, have a qualifying term ‘authorized distributors of record’ DRUGS. medical relationship with the patient; and means those distributors with whom a manu- ‘‘(a) REQUIREMENTS REGARDING INFORMA- ‘‘(E) the person received payment for the TION ON INTERNET SITE.— facturer has established an ongoing relation- dispensing or sale of the drug. ‘‘(1) IN GENERAL.—A person may not dis- ship to distribute such manufacturer’s prod- For purposes of subparagraph (E), payment pense a prescription drug pursuant to a sale ucts.’’. is received if money or other valuable con- of the drug by such person if— sideration is received. (c) EFFECTIVE DATE.— ‘‘(A) the purchaser of the drug submitted ‘‘(2) EXCEPTIONS.—Paragraph (1) does not (1) IN GENERAL.—The amendments made by the purchase order for the drug, or conducted apply to— paragraphs (1) and (3) of subsection (a) and any other part of the sales transaction for ‘‘(A) the dispensing or selling of a prescrip- by subsection (b) shall take effect on Janu- the drug, through an Internet site; tion drug pursuant to telemedicine practices ary 1, 2010. ‘‘(B) the person dispenses the drug to the sponsored by— (2) DRUGS IMPORTED BY REGISTERED IMPORT- purchaser by mailing or shipping the drug to ERS UNDER SECTION 804.—Notwithstanding the purchaser; and ‘‘(i) a hospital that has in effect a provider paragraph (1), the amendments made by ‘‘(C) such site, or any other Internet site agreement under title XVIII of the Social paragraphs (1) and (3) of subsection (a) and used by such person for purposes of sales of Security Act (relating to the Medicare pro- by subsection (b) shall take effect on the a prescription drug, fails to meet each of the gram); or date that is 90 days after the date of enact- requirements specified in paragraph (2), ‘‘(ii) a group practice that has not fewer ment of this title with respect to qualifying other than a site or pages on a site that— than 100 physicians who have in effect pro- drugs imported under section 804 of the Fed- ‘‘(i) are not intended to be accessed by pur- vider agreements under such title; or eral Food, Drug, and Cosmetic Act, as added chasers or prospective purchasers; or ‘‘(B) the dispensing or selling of a prescrip- by section l04. ‘‘(ii) provide an Internet information loca- tion drug pursuant to practices that promote (3) EFFECT WITH RESPECT TO REGISTERED EX- tion tool within the meaning of section the public health, as determined by the Sec- PORTERS.—The amendment made by sub- 231(e)(5) of the Communications Act of 1934 retary by regulation. section (a)(2) shall take effect on the date (47 U.S.C. 231(e)(5)). ‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.— that is 90 days after the date of enactment of ‘‘(2) REQUIREMENTS.—With respect to an ‘‘(A) IN GENERAL.—With respect to issuing this title. Internet site, the requirements referred to in a prescription for a drug for a patient, a (4) ALTERNATIVE REQUIREMENTS.—The Sec- subparagraph (C) of paragraph (1) for a per- practitioner has a qualifying medical rela- retary shall issue regulations to establish son to whom such paragraph applies are as tionship with the patient for purposes of this the alternative requirements, referred to in follows: section if— the amendment made by subsection (a)(1), ‘‘(A) Each page of the site shall include ei- ‘‘(i) at least one in-person medical evalua- that take effect not later than January 1, ther the following information or a link to a tion of the patient has been conducted by the 2010. page that provides the following informa- practitioner; or (5) INTERMEDIATE REQUIREMENTS.—The Sec- tion: ‘‘(ii) the practitioner conducts a medical retary shall by regulation require the use of ‘‘(i) The name of such person. evaluation of the patient as a covering prac- standardized anti-counterfeiting or track- ‘‘(ii) Each State in which the person is au- titioner. and-trace technologies on prescription drugs thorized by law to dispense prescription ‘‘(B) IN-PERSON MEDICAL EVALUATION.—A at the case and pallet level effective not drugs. medical evaluation by a practitioner is an later than 1 year after the date of enactment ‘‘(iii) The address and telephone number of in-person medical evaluation for purposes of of this title. each place of business of the person with re- this section if the practitioner is in the phys- (6) ADDITIONAL REQUIREMENTS.— spect to sales of prescription drugs through ical presence of the patient as part of con- (A) IN GENERAL.—Notwithstanding any the Internet, other than a place of business ducting the evaluation, without regard to other provision of this section, the Secretary that does not mail or ship prescription drugs whether portions of the evaluation are con- shall, not later than 18 months after the date to purchasers. ducted by other health professionals. of enactment of this title, require that the ‘‘(iv) The name of each individual who ‘‘(C) COVERING PRACTITIONER.—With respect packaging of any prescription drug incor- serves as a pharmacist for prescription drugs to a patient, a practitioner is a covering porates— that are mailed or shipped pursuant to the practitioner for purposes of this section if (i) a standardized numerical identifier site, and each State in which the individual the practitioner conducts a medical evalua- unique to each package of such drug, applied is authorized by law to dispense prescription tion of the patient at the request of a practi- at the point of manufacturing and repack- drugs. tioner who has conducted at least one in-per- aging (in which case the numerical identifier ‘‘(v) If the person provides for medical con- son medical evaluation of the patient and is shall be linked to the numerical identifier sultations through the site for purposes of temporarily unavailable to conduct the eval- applied at the point of manufacturing); and providing prescriptions, the name of each in- uation of the patient. A practitioner is a cov- (ii)(I) overt optically variable counterfeit- dividual who provides such consultations; ering practitioner without regard to whether resistant technologies that— each State in which the individual is li- the practitioner has conducted any in-person (aa) are visible to the naked eye, providing censed or otherwise authorized by law to medical evaluation of the patient involved. for visual identification of product authen- provide such consultations or practice medi- ‘‘(4) RULES OF CONSTRUCTION.— ticity without the need for readers, micro- cine; and the type or types of health profes- ‘‘(A) INDIVIDUALS REPRESENTED AS PRACTI- scopes, lighting devices, or scanners; sions for which the individual holds such li- TIONERS.—A person who is not a practitioner (bb) are similar to that used by the Bureau censes or other authorizations. (as defined in subsection (e)(1)) lacks legal of Engraving and Printing to secure United ‘‘(B) A link to which paragraph (1) applies capacity under this section to have a quali- States currency; shall be displayed in a clear and prominent fying medical relationship with any patient.

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00105 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.071 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5420 CONGRESSIONAL RECORD — SENATE May 1, 2007

‘‘(B) STANDARD PRACTICE OF PHARMACY.— ‘‘(3) The term ‘qualifying medical relation- (d) REPORTS REGARDING INTERNET-RELATED Paragraph (1) may not be construed as pro- ship’, with respect to a practitioner and a pa- VIOLATIONS OF FEDERAL AND STATE LAWS ON hibiting any conduct that is a standard prac- tient, has the meaning indicated for such DISPENSING OF DRUGS.— tice in the practice of pharmacy. term in subsection (b). (1) IN GENERAL.—The Secretary of Health ‘‘(C) APPLICABILITY OF REQUIREMENTS.— ‘‘(f) INTERNET-RELATED DEFINITIONS.— and Human Services (referred to in this sub- Paragraph (3) may not be construed as hav- ‘‘(1) IN GENERAL.—For purposes of this sec- section as the ‘‘Secretary’’) shall, pursuant ing any applicability beyond this section, tion: to the submission of an application meeting and does not affect any State law, or inter- ‘‘(A) The term ‘Internet’ means collec- the criteria of the Secretary, make an award pretation of State law, concerning the prac- tively the myriad of computer and tele- of a grant or contract to the National Clear- tice of medicine. communications facilities, including equip- inghouse on Internet Prescribing (operated ‘‘(c) ACTIONS BY STATES.— ment and operating software, which com- by the Federation of State Medical Boards) ‘‘(1) IN GENERAL.—Whenever an attorney prise the interconnected world-wide network for the purpose of— general of any State has reason to believe of networks that employ the transmission (A) identifying Internet sites that appear that the interests of the residents of that control protocol/internet protocol, or any to be in violation of Federal or State laws State have been or are being threatened or predecessor or successor protocols to such concerning the dispensing of drugs; adversely affected because any person has protocol, to communicate information of all (B) reporting such sites to State medical engaged or is engaging in a pattern or prac- kinds by wire or radio. licensing boards and State pharmacy licens- tice that violates section 301(l), the State ‘‘(B) The term ‘link’, with respect to the ing boards, and to the Attorney General and may bring a civil action on behalf of its resi- Internet, means one or more letters, words, the Secretary, for further investigation; and dents in an appropriate district court of the numbers, symbols, or graphic items that ap- (C) submitting, for each fiscal year for United States to enjoin such practice, to en- pear on a page of an Internet site for the pur- which the award under this subsection is force compliance with such section (includ- pose of serving, when activated, as a method made, a report to the Secretary describing ing a nationwide injunction), to obtain dam- for executing an electronic command— investigations undertaken with respect to ages, restitution, or other compensation on ‘‘(i) to move from viewing one portion of a violations described in subparagraph (A). behalf of residents of such State, to obtain page on such site to another portion of the (2) AUTHORIZATION OF APPROPRIATIONS.— reasonable attorneys fees and costs if the page; For the purpose of carrying out paragraph State prevails in the civil action, or to ob- ‘‘(ii) to move from viewing one page on (1), there is authorized to be appropriated tain such further and other relief as the such site to another page on such site; or $100,000 for each of the first 3 fiscal years in court may deem appropriate. ‘‘(iii) to move from viewing a page on one which this section is in effect. ‘‘(2) NOTICE.—The State shall serve prior Internet site to a page on another Internet (e) EFFECTIVE DATE.—The amendments written notice of any civil action under para- site. made by subsections (a) and (b) take effect 90 graph (1) or (5)(B) upon the Secretary and ‘‘(C) The term ‘page’, with respect to the days after the date of enactment of this provide the Secretary with a copy of its com- Internet, means a document or other file title, without regard to whether a final rule plaint, except that if it is not feasible for the accessed at an Internet site. to implement such amendments has been State to provide such prior notice, the State ‘‘(D)(i) The terms ‘site’ and ‘address’, with promulgated by the Secretary of Health and shall serve such notice immediately upon in- respect to the Internet, mean a specific loca- Human Services under section 701(a) of the stituting such action. Upon receiving a no- tion on the Internet that is determined by Federal Food, Drug, and Cosmetic Act. The tice respecting a civil action, the Secretary Internet Protocol numbers. Such term in- preceding sentence may not be construed as shall have the right— cludes the domain name, if any. affecting the authority of such Secretary to ‘‘(A) to intervene in such action; ‘‘(ii) The term ‘domain name’ means a promulgate such a final rule. ‘‘(B) upon so intervening, to be heard on all method of representing an Internet address SEC. l08. PROHIBITING PAYMENTS TO UNREGIS- matters arising therein; and without direct reference to the Internet Pro- TERED FOREIGN PHARMACIES. ‘‘(C) to file petitions for appeal. tocol numbers for the address, including (a) IN GENERAL.—Section 303 of the Federal ‘‘(3) CONSTRUCTION.—For purposes of bring- methods that use designations such as Food, Drug, and Cosmetic Act (21 U.S.C. 333) ing any civil action under paragraph (1), ‘.com’, ‘.edu’, ‘.gov’, ‘.net’, or ‘.org’. is amended by adding at the end the fol- nothing in this chapter shall prevent an at- ‘‘(iii) The term ‘Internet Protocol num- lowing: torney general of a State from exercising the bers’ includes any successor protocol for de- ‘‘(g) RESTRICTED TRANSACTIONS.— powers conferred on the attorney general by termining a specific location on the Inter- ‘‘(1) IN GENERAL.—The introduction of re- the laws of such State to conduct investiga- net. stricted transactions into a payment system tions or to administer oaths or affirmations ‘‘(2) AUTHORITY OF SECRETARY.—The Sec- or the completion of restricted transactions or to compel the attendance of witnesses or retary may by regulation modify any defini- using a payment system is prohibited. the production of documentary and other tion under paragraph (1) to take into ac- ‘‘(2) PAYMENT SYSTEM.— evidence. count changes in technology. ‘‘(A) IN GENERAL.—The term ‘payment sys- ‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil ‘‘(g) INTERACTIVE COMPUTER SERVICE; AD- tem’ means a system used by a person de- action brought under paragraph (1) in a dis- VERTISING.—No provider of an interactive scribed in subparagraph (B) to effect a credit trict court of the United States may be computer service, as defined in section transaction, electronic fund transfer, or brought in the district in which the defend- 230(f)(2) of the Communications Act of 1934 money transmitting service that may be ant is found, is an inhabitant, or transacts (47 U.S.C. 230(f)(2)), or of advertising services used in connection with, or to facilitate, a business or wherever venue is proper under shall be liable under this section for dis- restricted transaction, and includes— section 1391 of title 28, United States Code. pensing or selling prescription drugs in vio- ‘‘(i) a credit card system; Process in such an action may be served in lation of this section on account of another ‘‘(ii) an international, national, regional, any district in which the defendant is an in- person’s selling or dispensing such drugs, or local network used to effect a credit habitant or in which the defendant may be provided that the provider of the interactive transaction, an electronic fund transfer, or a found. computer service or of advertising services money transmitting service; and ‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.— does not own or exercise corporate control ‘‘(iii) any other system that is centrally ‘‘(A) Nothing contained in this section over such person.’’. managed and is primarily engaged in the shall prohibit an authorized State official (b) INCLUSION AS PROHIBITED ACT.—Section transmission and settlement of credit trans- from proceeding in State court on the basis 301 of the Federal Food, Drug, and Cosmetic actions, electronic fund transfers, or money of an alleged violation of any civil or crimi- Act (21 U.S.C. 331) is amended by inserting transmitting services. nal statute of such State. after paragraph (k) the following: ‘‘(B) PERSONS DESCRIBED.—A person re- ‘‘(B) In addition to actions brought by an ‘‘(l) The dispensing or selling of a prescrip- ferred to in subparagraph (A) is— attorney general of a State under paragraph tion drug in violation of section 503B.’’. ‘‘(i) a creditor; (1), such an action may be brought by offi- (c) INTERNET SALES OF PRESCRIPTION ‘‘(ii) a credit card issuer; cers of such State who are authorized by the DRUGS; CONSIDERATION BY SECRETARY OF ‘‘(iii) a financial institution; State to bring actions in such State on be- PRACTICES AND PROCEDURES FOR CERTIFI- ‘‘(iv) an operator of a terminal at which an half of its residents. CATION OF LEGITIMATE BUSINESSES.—In car- electronic fund transfer may be initiated; ‘‘(d) EFFECT OF SECTION.—This section rying out section 503B of the Federal Food, ‘‘(v) a money transmitting business; or shall not apply to a person that is a reg- Drug, and Cosmetic Act (as added by sub- ‘‘(vi) a participant in an international, na- istered exporter under section 804. section (a) of this section), the Secretary of tional, regional, or local network used to ef- ‘‘(e) GENERAL DEFINITIONS.—For purposes Health and Human Services shall take into fect a credit transaction, electronic fund of this section: consideration the practices and procedures of transfer, or money transmitting service. ‘‘(1) The term ‘practitioner’ means a prac- public or private entities that certify that ‘‘(3) RESTRICTED TRANSACTION.—The term titioner referred to in section 503(b)(1) with businesses selling prescription drugs through ‘restricted transaction’ means a transaction respect to issuing a written or oral prescrip- Internet sites are legitimate businesses, in- or transmittal, on behalf of an individual tion. cluding practices and procedures regarding who places an unlawful drug importation re- ‘‘(2) The term ‘prescription drug’ means a disclosure formats and verification pro- quest to any person engaged in the operation drug that is described in section 503(b)(1). grams. of an unregistered foreign pharmacy, of—

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00106 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.071 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5421 ‘‘(A) credit, or the proceeds of credit, ex- ‘‘(iv) any other person described in para- posed on a payment system, or a person de- tended to or on behalf of the individual for graph (2)(B) and specified by the Board in scribed in paragraph (2)(B) that is subject to the purpose of the unlawful drug importation such regulations, a regulation issued under this subsection, request (including credit extended through to establish policies and procedures that are under the laws of any state with respect to the use of a credit card); reasonably designed to prevent the introduc- any payment transaction by an individual ‘‘(B) an electronic fund transfer or funds tion of a restricted transaction into a pay- because the payment transaction involves a transmitted by or through a money trans- ment system or the completion of a re- payment to a foreign pharmacy. mitting business, or the proceeds of an elec- stricted transaction using a payment system ‘‘(10) TIMING OF REQUIREMENTS.—A payment tronic fund transfer or money transmitting ‘‘(B) REQUIREMENTS FOR POLICIES AND PRO- system, or a person described in paragraph service, from or on behalf of the individual CEDURES.—In promulgating regulations (2)(B) that is subject to a regulation issued for the purpose of the unlawful drug impor- under subparagraph (A), the Board shall— under this subsection, must adopt policies tation request; ‘‘(i) identify types of policies and proce- and procedures reasonably designed to com- ‘‘(C) a check, draft, or similar instrument dures, including nonexclusive examples, that ply with any regulations required under which is drawn by or on behalf of the indi- shall be considered to be reasonably designed paragraph (7) within 60 days after such regu- vidual for the purpose of the unlawful drug to prevent the introduction of restricted lations are issued in final form.’’. importation request and is drawn on or pay- transactions into a payment system or the (b) EFFECTIVE DATE.—The amendment able at or through any financial institution; completion of restricted transactions using a made by this section shall take effect on the or payment system; and day that is 90 days after the date of enact- ‘‘(D) the proceeds of any other form of fi- ‘‘(ii) to the extent practicable, permit any ment of this Act. nancial transaction (identified by the Board payment system, or person described in para- (c) IMPLEMENTATION.—The Board of Gov- by regulation) that involves a financial in- graph (2)(B), as applicable, to choose among ernors of the Federal Reserve System shall stitution as a payor or financial inter- alternative means of preventing the intro- promulgate regulations as required by sub- mediary on behalf of or for the benefit of the duction or completion of restricted trans- section (g)(7) of section 303 of the Federal individual for the purpose of the unlawful actions. Food, Drug, and Cosmetic Act (21 U.S.C. 333), drug importation request. ‘‘(C) NO LIABILITY FOR BLOCKING OR REFUS- as added by subsection (a), not later than 90 ‘‘(4) UNLAWFUL DRUG IMPORTATION RE- ING TO HONOR RESTRICTED TRANSACTION.— days after the date of enactment of this QUEST.—The term ‘unlawful drug importa- title. tion request’ means the request, or trans- ‘‘(i) IN GENERAL.—A payment system, or a mittal of a request, made to an unregistered person described in paragraph (2)(B) that is SEC. l09. IMPORTATION EXEMPTION UNDER foreign pharmacy for a prescription drug by subject to a regulation issued under this sub- CONTROLLED SUBSTANCES IMPORT AND EXPORT ACT. mail (including a private carrier), facsimile, section, and any participant in such pay- phone, or electronic mail, or by a means that ment system that prevents or otherwise re- Section 1006(a)(2) of the Controlled Sub- involves the use, in whole or in part, of the fuses to honor transactions in an effort to stances Import and Export Act (21 U.S.C. Internet. implement the policies and procedures re- 956(a)(2)) is amended by striking ‘‘not import ‘‘(5) UNREGISTERED FOREIGN PHARMACY.— quired under this subsection or to otherwise the controlled substance into the United The term ‘unregistered foreign pharmacy’ comply with this subsection shall not be lia- States in an amount that exceeds 50 dosage means a person in a country other than the ble to any party for such action. units of the controlled substance.’’ and in- United States that is not a registered ex- ‘‘(ii) COMPLIANCE.—A person described in serting ‘‘import into the United States not porter under section 804. paragraph (2)(B) meets the requirements of more than 10 dosage units combined of all ‘‘(6) OTHER DEFINITIONS.— this subsection if the person relies on and such controlled substances.’’. ‘‘(A) CREDIT; CREDITOR; CREDIT CARD.—The complies with the policies and procedures of SEC. l10. SEVERABILITY. terms ‘credit’, ‘creditor’, and ‘credit card’ a payment system of which the person is a If any provision of this title, an amend- have the meanings given the terms in sec- member or in which the person is a partici- ment by this title, or the application of such tion 103 of the Truth in Lending Act (15 pant, and such policies and procedures of the provision or amendment to any person or U.S.C. 1602). payment system comply with the require- circumstance is held to be unconstitutional, ‘‘(B) ACCESS DEVICE; ELECTRONIC FUND ments of the regulations promulgated under the remainder of this title, the amendments TRANSFER.—The terms ‘access device’ and subparagraph (A). made by this title, and the application of the ‘electronic fund transfer’— ‘‘(D) ENFORCEMENT.— provisions of such to any person or cir- ‘‘(i) have the meaning given the term in ‘‘(i) IN GENERAL.—This section shall be en- cumstance shall not affected thereby. section 903 of the Electronic Fund Transfer forced by the Federal functional regulators and the Federal Trade Commission under ap- Act (15 U.S.C. 1693a); and SA 991. Mr. KOHL (for himself, Mr. ‘‘(ii) the term ‘electronic fund transfer’ plicable law in the manner provided in sec- also includes any fund transfer covered tion 505(a) of the Gramm-Leach-Bliley Act GRASSLEY, Mr. LEAHY, and Mr. SCHU- under Article 4A of the Uniform Commercial (15 U.S.C. 6805(a)). MER) submitted an amendment in- Code, as in effect in any State. ‘‘(ii) FACTORS TO BE CONSIDERED.—In con- tended to be proposed by him to the ‘‘(C) FINANCIAL INSTITUTION.—The term ‘fi- sidering any enforcement action under this bill S. 1082, to amend the Federal Food, nancial institution’— subsection against a payment system or per- Drug, and Cosmetic Act to reauthorize ‘‘(i) has the meaning given the term in sec- son described in paragraph (2)(B), the Fed- and amend the prescription drug user tion 903 of the Electronic Transfer Fund Act eral functional regulators and the Federal fee provisions, and for other purposes; (15 U.S.C. 1693a); and Trade Commission shall consider the fol- ‘‘(ii) includes a financial institution (as de- lowing factors: which was ordered to lie on the table; fined in section 509 of the Gramm-Leach-Bli- ‘‘(I) The extent to which the payment sys- as follows: ley Act (15 U.S.C. 6809)). tem or person knowingly permits restricted At the end of the bill, insert the following: ‘‘(D) MONEY TRANSMITTING BUSINESS; MONEY transactions. TITLEllPRESERVE ACCESS TO TRANSMITTING SERVICE.—The terms ‘money ‘‘(II) The history of the payment system or AFFORDABLE GENERICS ACT transmitting business’ and ‘money transmit- person in connection with permitting re- ting service’ have the meaning given the stricted transactions. SEC. l01. SHORT TITLE. terms in section 5330(d) of title 31, United ‘‘(III) The extent to which the payment This title may be cited as the ‘‘Preserve States Code. system or person has established and is Access to Affordable Generics Act’’. ‘‘(E) BOARD.—The term ‘Board’ means the maintaining policies and procedures in com- SEC. l02. CONGRESSIONAL FINDINGS AND DEC- Board of Governors of the Federal Reserve pliance with regulations prescribed under LARATION OF PURPOSES. System. this subsection. (a) FINDINGS.—The Congress finds that— ‘‘(7) POLICIES AND PROCEDURES REQUIRED TO ‘‘(8) TRANSACTIONS PERMITTED.—A payment (1) prescription drugs make up 11 percent PREVENT RESTRICTED TRANSACTIONS.— system, or a person described in paragraph of the national health care spending but are ‘‘(A) REGULATIONS.—The Board shall pro- (2)(B) that is subject to a regulation issued 1 of the largest and fastest growing health mulgate regulations requiring— under this subsection, is authorized to en- care expenditures; ‘‘(i) an operator of a credit card system; gage in transactions with foreign pharmacies (2) 56 percent of all prescriptions dispensed ‘‘(ii) an operator of an international, na- in connection with investigating violations in the United States are generic drugs, yet tional, regional, or local network used to ef- or potential violations of any rule or require- they account for only 13percent of all ex- fect a credit transaction, an electronic fund ment adopted by the payment system or per- penditures; transfer, or a money transmitting service; son in connection with complying with para- (3) generic drugs, on average, cost 63 per- ‘‘(iii) an operator of any other payment graph (7). A payment system, or such a per- cent less than their brand-name counter- system that is centrally managed and is pri- son, and its agents and employees shall not parts; marily engaged in the transmission and set- be found to be in violation of, or liable (4) consumers and the health care system tlement of credit transactions, electronic under, any Federal, State or other law by would benefit from free and open competi- transfers or money transmitting services virtue of engaging in any such transaction. tion in the pharmaceutical market and the where at least one party to the transaction ‘‘(9) RELATION TO STATE LAWS.—No require- removal of obstacles to the introduction of or transfer is an individual; and ment, prohibition, or liability may be im- generic drugs;

VerDate Aug 31 2005 04:50 May 02, 2007 Jkt 059060 PO 00000 Frm 00107 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.071 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5422 CONGRESSIONAL RECORD — SENATE May 1, 2007

(5) full and free competition in the phar- any agreement that is contingent upon, pro- (b) CERTIFICATION OF AGREEMENTS.—Sec- maceutical industry, and the full enforce- vides a contingent condition for, or is other- tion 1112 of such Act is amended by adding at ment of antitrust law to prevent anti- wise related to the resolution or settlement the end the following: competitive practices in this industry, will of the claim. ‘‘(d) CERTIFICATION.—The Chief Executive lead to lower prices, greater innovation, and ‘‘(3) The term ‘ANDA’ means an abbre- Officer or the company official responsible inure to the general benefit of consumers. viated new drug application, as defined under for negotiating any agreement required to be (6) the Federal Trade Commission has de- section 505(j) of the Federal Food, Drug, and filed under subsection (a), (b), or (c) shall termined that some brand name pharma- Cosmetic Act (21 U.S.C. 355(j)). execute and file with the Assistant Attorney ceutical manufacturers collude with generic ‘‘(4) The term ‘ANDA filer’ means a party General and the Commission a certification drug manufacturers to delay the marketing who has filed an ANDA with the Federal as follows: ‘I declare under penalty of per- of competing, low-cost, generic drugs; Drug Administration. jury that the following is true and correct: (7) collusion by the brand name pharma- ‘‘(5) The term ‘ANDA product’ means the The materials filed with the Federal Trade ceutical manufacturers is contrary to free product to be manufactured under the ANDA Commission and the Department of Justice competition, to the interests of consumers, that is the subject of the patent infringe- under section 1112 of subtitle B of title XI of and to the principles underlying antitrust ment claim. the Medicare Prescription Drug, Improve- law; ‘‘(6) The term ‘drug product’ means a fin- ment, and Modernization Act of 2003, with (8) in 2005, 2 appellate court decisions re- ished dosage form (e.g., tablet, capsule, or respect to the agreement referenced in this versed the Federal Trade Commission’s long- solution) that contains a drug substance, certification: (1) represent the complete, standing position, and upheld settlements generally, but not necessarily, in association final, and exclusive agreement between the that include pay-offs by brand name pharma- with 1 or more other ingredients, as defined parties; (2) include any ancillary agreements ceutical manufacturers to generic manufac- in section 314.3(b) of title 21, Code of Federal that are contingent upon, provide a contin- turers designed to keep generic competition Regulations. gent condition for, or are otherwise related off the market; ‘‘(7) The term ‘NDA’ means a new drug ap- to, the referenced agreement; and (3) include (9) in the 6 months following the March plication, as defined under section 505(b) of written descriptions of any oral agreements, 2005 court decisions, the Federal Trade Com- the Federal Food, Drug, and Cosmetic Act representations, commitments, or promises mission found there were three settlement (21 U.S.C. 355(b)). between the parties that are responsive to agreements in which the generic received ‘‘(8) The term ‘NDA holder’ means— subsection (a) or (b) of such section 1112 and compensation and agreed to a restriction on ‘‘(A) the party that received FDA approval have not been reduced to writing.’.’’. its ability to market the product; to market a drug product pursuant to an SEC. l05. FORFEITURE OF 180-DAY EXCLUSIVITY (10) the FTC found that more than 2⁄3 of the NDA; PERIOD. approximately ten settlement agreements ‘‘(B) a party owning or controlling enforce- Section 505 of the Federal Food, Drug and made in 2006 include a pay-off from the brand ment of the patent listed in the Approved Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is in exchange for a promise by the generic Drug Products With Therapeutic Equiva- amended by inserting ‘‘section 28 of the company to delay entry into the market; and lence Evaluations (commonly known as the Clayton Act or’’ after ‘‘that the agreement (11) settlements which include a payment ‘FDA Orange Book’) in connection with the has violated’’. from a brand name manufacturer to a ge- NDA; or SEC. l06. STUDY BY THE FEDERAL TRADE COM- neric manufacturer to delay entry by generic ‘‘(C) the predecessors, subsidiaries, divi- MISSION. drugs are anti-competitive and contrary to sions, groups, and affiliates controlled by, (a) REQUIREMENT FOR A STUDY.—Not later the interests of consumers. controlling, or under common control with than 180 days after the date of enactment of (b) PURPOSES.—The purposes of this title any of the entities described in subclauses (i) this Act and pursuant to its authority under are— and (ii) (such control to be presumed by di- section 6(a) of the Federal Trade Commission (1) to enhance competition in the pharma- rect or indirect share ownership of 50 percent Act (15 U.S.C. 46(a)) and its jurisdiction to ceutical market by prohibiting anticompeti- or greater), as well as the licensees, prevent unfair methods of competition, the tive agreements and collusion between brand licensors, successors, and assigns of each of Federal Trade Commission shall conduct a name and generic drug manufacturers in- the entities. study regarding— tended to keep generic drugs off the market; ‘‘(9) The term ‘patent infringement’ means (1) the prevalence of agreements in patent (2) to support the purpose and intent of infringement of any patent or of any filed infringement suits of the type described in antitrust law by prohibiting anticompetitive patent application, extension, reissue, re- section 29 of the Clayton Act, as added by agreements and collusion in the pharma- newal, division, continuation, continuation this title, during the last 5 years; ceutical industry; and in part, reexamination, patent term restora- (2) the impact of such agreements on com- (3) to clarify the law to prohibit payments tion, patents of addition and extensions petition in the pharmaceutical market; and from brand name to generic drug manufac- thereof. (3) the prevalence in the pharmaceutical turers with the purpose to prevent or delay ‘‘(10) The term ‘patent infringement claim’ industry of other anticompetitive agree- the entry of competition from generic drugs. means any allegation made to an ANDA ments among competitors or other practices SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. filer, whether or not included in a complaint that are contrary to the antitrust laws, and (a) IN GENERAL.—The Clayton Act (15 filed with a court of law, that its ANDA or the impact of such agreements or practices U.S.C. 12 et seq.) is amended by inserting ANDA product may infringe any patent held on competition in the pharmaceutical mar- after section 28 the following: by, or exclusively licensed to, the NDA hold- ket during the last 5 years. ‘‘SEC. 29. UNLAWFUL INTERFERENCE WITH GE- er of the drug product.’’. (b) CONSULTATION.—In conducting the NERIC MARKETING. (b) REGULATIONS.—The Federal Trade Com- study required under this section, the Fed- ‘‘(a) It shall be unlawful under this Act for mission may, by rule promulgated under sec- eral Trade Commission shall consult with any person, in connection with the sale of a tion 553 of title 5, United States Code, ex- the Antitrust Division of the Department of drug product, to directly or indirectly be a empt certain agreements described in the Justice regarding the Justice Department’s party to any agreement resolving or settling section 29 of the Clayton Act, as added by findings and investigations regarding anti- a patent infringement claim which— subsection (a), if the Commission finds such competitive practices in the pharmaceutical ‘‘(1) an ANDA filer receives anything of agreements to be in furtherance of market market, including criminal antitrust inves- value; and competition and for the benefit of con- tigations completed by the Justice Depart- ‘‘(2) the ANDA filer agrees not to research, sumers. Consistent with the authority of ment with respect to practices or conduct in develop, manufacture, market, or sell the Commission, such rules may include inter- the pharmaceutical market. ANDA product for any period of time. pretive rules and general statements of pol- (c) REQUIREMENT FOR A REPORT.—Not later ‘‘(b) Nothing in this section shall prohibit icy with respect to the practices prohibited than 1 year after the date of enactment of a resolution or settlement of patent infringe- under section 29 of the Clayton Act. this Act, the Federal Trade Commission ment claim in which the value paid by the shall submit a report to the Judiciary Com- NDA holder to the ANDA filer as a part of SEC. l04. NOTICE AND CERTIFICATION OF mittees of Senate and House of Representa- the resolution or settlement of the patent in- AGREEMENTS. tives, and to the Department of Justice re- fringement claim includes no more than the (a) NOTICE OF ALL AGREEMENTS.—Section garding the findings of the study conducted right to market the ANDA product prior to 1112(c)(2) of the Medicare Prescription Drug, under subsection (a). This report shall con- the expiration of the patent that is the basis Improvement, and Modernization Act of 2003 tain the Federal Trade Commission’s rec- for the patent infringement claim. (21 U.S.C. 3155 note) is amended by— ommendation as to whether any amendment ‘‘(c) In this section: (1) striking ‘‘the Commission the’’ and in- to the antitrust laws should be enacted to ‘‘(1) The term ‘agreement’ means anything serting ‘‘the Commission (1) the’’; and correct any substantial lessening of competi- that would constitute an agreement under (2) inserting before the period at the end tion found during the study. section 1 of the Sherman Act (15 U.S.C. 1) or the following: ‘‘; and (2) a description of the (d) FEDERAL AGENCY CONSIDERATION.—Upon section 5 of the Federal Trade Commission subject matter of any other agreement the receipt of the report required by subsection Act (15 U.S.C. 45). parties enter into within 30 days of an enter- (c), the Attorney General or the Chairman of ‘‘(2) The term ‘agreement resolving or set- ing into an agreement covered by subsection the Federal Trade Commission, as appro- tling a patent infringement claim’ includes, (a) or (b)’’. priate, shall consider whether any additional

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00108 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.065 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5423 enforcement action is required to restore petition, the Secretary shall refer that peti- ‘‘SEC. 511. INTERNET PHARMACIES. competition or prevent a substantial less- tion to the Federal Trade Commission for ‘‘(a) DEFINITIONS.—In this section: ening of competition occurring as a result of further action as the Federal Trade Commis- ‘‘(1) ADVERTISING SERVICE PROVIDER.—The the conduct or practices that were the sub- sion finds appropriate. term ‘advertising service provider’ means an ject of the study conducted under subsection ‘‘(v) In determining whether to take an en- advertising company that contracts with a (b). forcement action described in subclause (I), provider of an interactive computer service SEC. l07. AUTHORIZATION OF APPROPRIATIONS. (II), (III), or (IV) of clause (iii) with respect (as defined in section 230(f) of the Commu- There are authorized to be appropriated to to a petition, and in determining the amount nications Act of 1934 (47 U.S.C. 230(f)) to pro- the Federal Trade Commission such sums as of any civil penalty or the length of any sus- vide advertising on the Internet. pension imposed under that clause, the Sec- may be necessary to carry out the provisions ‘‘(2) DESIGNATED PAYMENT SYSTEM.— retary shall consider the specific cir- of this title. ‘‘(A) IN GENERAL.—The term ‘designated cumstances of the situation, such as the payment system’ means a system used by a gravity and seriousness of the violation in- person described in subparagraph (B) to ef- SA 992. Mr. KOHL submitted an volved, the amount of resources expended in fect a credit transaction, electronic fund amendment intended to be proposed by reviewing the petition at issue, the effect on transfer, or money transmitting service that him to the bill S. 1082, to amend the marketing of competing drugs of the pend- the Board determines, by regulation or Federal Food, Drug, and Cosmetic Act ency of the improperly submitted petition, order, is regularly used in connection with, including whether the timing of the submis- to reauthorize and amend the prescrip- or to facilitate restricted transactions. sion of the petition appears to have been cal- tion drug user fee provisions, and for ‘‘(B) PERSONS DESCRIBED.—A person re- other purposes; which was ordered to culated to cause delay in the marketing of any drug awaiting approval, and whether the ferred to in subparagraph (A) is— lie on the table; as follows: petitioner has a history of submitting peti- ‘‘(i) a creditor; At the appropriate place, insert the fol- tions in violation of this subparagraph. ‘‘(ii) a credit card issuer; lowing: ‘‘(vi)(I) Any person aggrieved by a petition ‘‘(iii) a financial institution; SEC. ll. CITIZEN PETITIONS AND PETITIONS filed under such section 10.30 or section 10.35 ‘‘(iv) an operator of a terminal at which an FOR STAY OF AGENCY ACTION. (or any successor regulation), including a electronic fund transfer may be initiated; Section 505(j)(5) of the Federal Food, Drug, person filing an application under subsection ‘‘(v) a money transmitting business; or and Cosmetic Act (21 U.S.C. 355(j)(5)) is (b)(2) or (j) of this section to which such peti- ‘‘(vi) a participant in an international, na- amended by adding at the end the following: tion relates, may request that the Secretary tional, regional, or local network con- ‘‘(G)(i) Notwithstanding any other provi- initiate an investigation described under structed primarily to effect a credit trans- sion of law, any petition submitted under clause (ii) for an enforcement action de- action, electronic fund transfer, or money section 10.30 or section 10.35 of title 21, Code scribed under clause (iii). transmitting service. of Federal Regulations (or any successor reg- ‘‘(II) The aggrieved person shall specify the ‘‘(3) FEDERAL FUNCTIONAL REGULATOR.—The ulation), shall include a statement that to basis for its belief that the petition at issue term ‘Federal functional regulator’ has the the petitioner’s best knowledge and belief, is false, misleading, fraudulent, or submitted meaning given the term in section 509 of the the petition— for an improper purpose. The aggrieved per- Gramm-Leach-Bliley Act (15 U.S.C. 6809). ‘‘(I) includes all information and views on son shall certify that the request is sub- ‘‘(4) INTERNET PHARMACY.—The term ‘Inter- which the petitioner relies, including all rep- mitted in good faith, is well grounded in net pharmacy’ means a person that offers to resentative data and information known to fact, and not submitted for any improper dispense or dispenses in the United States a the petitioner that is favorable or unfavor- purpose. Any aggrieved person who know- prescription drug through an Internet able to the petition; ingly and intentionally violates the pre- website in interstate commerce, regardless ‘‘(II) is well grounded in fact and is war- ceding sentence shall be subject to the civil of whether the physical location of the prin- ranted by law; penalty described under clause (iii)(I). cipal place of business of the Internet phar- ‘‘(III) is not submitted for an improper pur- ‘‘(vii) The Secretary shall take final agen- macy is in the United States or in another pose, such as to harass or cause unnecessary cy action with respect to a petition filed country. delay (including unnecessary delay of com- under such section 10.30 or section 10.35 (or ‘‘(5) PRESCRIPTION DRUG.—The term ‘pre- petition or agency action); and any successor regulation) regarding an ab- scription drug’ means a drug described in ‘‘(IV) does not contain a materially false, breviated new drug application within 6 section 503(b) that is approved by the Sec- misleading, or fraudulent statement. months of receipt of such petition. The Sec- retary under section 505. ‘‘(ii) The Secretary shall investigate, on retary shall not extend such 6-month review ‘‘(6) RESTRICTED TRANSACTION.—The term receipt of a complaint, a request under period, even with consent of the petitioner, ‘restricted transaction’ means a transaction clause (vi), or on its own initiative, any peti- for any reason, including based upon the sub- or transmittal, on behalf of a individual who tion submitted under such section 10.30 or mission of comments relating to a petition places an unlawful Internet pharmacy re- section 10.35 (or any successor regulation), or supplemental information supplied by the quest to any person engaged in the operation that— petitioner. If the Secretary has not taken of an unlicensed Internet pharmacy, of— ‘‘(I) does not comply with the requirements final agency action on a petition regarding ‘‘(A) credit, or the proceeds of credit, ex- of clause (i); an abbreviated new drug application by the tended to or on behalf of the individual for ‘‘(II) may have been submitted for an im- date that is 6 months after the date of re- the purpose of the unlawful Internet request proper purpose as described in clause (i)(III); ceipt of the petition, such petition shall be (including credit extended through the use of or deemed to have been denied on such date. a credit card); ‘‘(III) may contain a materially false, mis- ‘‘(viii) The Secretary may promulgate reg- ‘‘(B) an electronic fund transfer or funds leading, or fraudulent statement as de- ulations to carry out this subparagraph, in- transmitted by or through a money trans- scribed in clause (i)(IV). cluding to determine whether petitions filed mitting business, or the proceeds of an elec- ‘‘(iii) If the Secretary finds that the peti- under such section 10.30 or section 10.35 (or tronic fund transfer or money transmitting tioner has knowingly and willingly sub- any successor regulation) merit enforcement service, from or on behalf of the individual mitted the petition for an improper purpose action by the Secretary under this subpara- for the purpose of the unlawful Internet re- as described in clause (i)(III), or which con- graph.’’. quest; tains a materially false, misleading, or ‘‘(C) a check, draft, or similar instrument fraudulent statement as described in clause SA 993. Mr. GREGG submitted an which is drawn by or on behalf of the indi- (i)(IV), the Secretary may— amendment intended to be proposed by vidual for the purpose of the unlawful Inter- ‘‘(I) impose a civil penalty of not more him to the bill S. 1082, to amend the net request and is drawn on or payable at or than $1,000,000, plus attorneys fees and costs Federal Food, Drug, and Cosmetic Act through any financial institution; or of reviewing the petition and any related to reauthorize and amend the prescrip- ‘‘(D) the proceeds of any other form of fi- proceedings; tion drug user fee provisions, and for nancial transaction (identified by the Board ‘‘(II) suspend the authority of the peti- other purposes; which was ordered to by regulation) that involves a financial in- tioner to submit a petition under such sec- lie on the table; as follows: stitution as a payor or financial inter- tion 10.30 or section 10.35 (or any successor mediary on behalf of or for the benefit of the regulation), for a period of not more than 10 At the appropriate place, insert the fol- individual for the purpose of the unlawful years; lowing: Internet request. ‘‘(III) revoke permanently the authority of TITLE l—INTERNET PHARMACIES ‘‘(7) TREATING PROVIDER.—The term ‘treat- the petitioner to submit a petition under SEC. l01. SHORT TITLE. ing provider’ means a health care provider li- such section 10.30 or section 10.35 (or any suc- This title may be cited as the ‘‘Safe Inter- censed in the United States who is author- cessor regulation); or net Pharmacy Act of 2007’’. ized to prescribe medications and who— ‘‘(IV) dismiss the petition at issue in its SEC. l02. INTERNET PHARMACIES. ‘‘(A)(i) performs a documented patient entirety. (a) INTERNET PHARMACIES.—Chapter V of evaluation (including a patient history and ‘‘(iv) If the Secretary takes an enforce- the Federal Food, Drug, and Cosmetic Act physical examination) of an individual, por- ment action described in subclause (I), (II), (21 U.S.C. 351 et seq.) is amended by inserting tions of which may be conducted by other (III), or (IV) of clause (iii) with respect to a after section 510 the following: health professionals;

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00109 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.065 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5424 CONGRESSIONAL RECORD — SENATE May 1, 2007 ‘‘(ii) discusses with the individual the ‘‘(aa) all employees and agents of the ‘‘(iv) A statement that the Internet phar- treatment options of the individual and the Internet pharmacy are in compliance with macy will dispense prescription drugs only risks and benefits of treatment; and applicable Federal and State laws regarding after receipt of a valid prescription from a ‘‘(iii) maintains contemporaneous medical the practice of pharmacy, including licens- treating provider. records concerning the individual; or ing laws and inspection requirements; ‘‘(v) A distinctive tamper resistant seal to ‘‘(B) provides care to an individual as part ‘‘(bb) the Internet pharmacy is in compli- identify that the Internet pharmacy is li- of an on-call or cross-coverage arrangement ance with applicable Federal and State laws censed. with a health care provider described in sub- regarding the practice of pharmacy, includ- ‘‘(C) PROFESSIONAL SERVICES REQUIRE- paragraph (A). ing licensing laws and inspection require- MENTS.—An Internet pharmacy shall carry ‘‘(8) UNLAWFUL INTERNET PHARMACY RE- ments; out the following: QUEST.—The term ‘unlawful Internet phar- ‘‘(cc) the Internet pharmacy expressly and ‘‘(i) Maintain patient medication profiles macy request’ means the request, or trans- affirmatively agrees to provide and maintain and other related data in a readily accessible mittal of a request, made to an unlicensed an agent for service of process in the United format organized to facilitate consultation Internet pharmacy for a prescription drug by States; with treating providers, caregivers, and pa- mail (including a private carrier), facsimile, ‘‘(dd) the Internet pharmacy expressly and tients. telephone, or electronic mail, or by a means affirmatively agrees to be subject to the ju- ‘‘(ii) Conduct prospective drug use reviews that involves the use, in whole or in part, of risdiction of the United States and any of its before dispensing medications or medical de- the Internet. States or territories where it engages in vices. ‘‘(9) UNLICENSED INTERNET PHARMACY.—The commerce; and ‘‘(iii) Ensure patient confidentiality and term ‘unlicensed Internet pharmacy’ means ‘‘(ee) the Internet pharmacy agrees to affix the protection of patient identity and pa- an Internet pharmacy that is not licensed to each shipping container of drugs to be tient-specific information, in accordance under this section. shipped in the United States such markings with the regulations promulgated under sec- ‘‘(10) OTHER DEFINITIONS.— as the Secretary determines to be necessary tion 264(c) of the Health Insurance Port- ‘‘(A) BOARD.—The term ‘Board’ means the to identify that the shipment is from a li- ability and Accountability Act of 1996. Board of Governors of the Federal Reserve censed Internet pharmacy, which may in- ‘‘(iv) Offer interactive and meaningful con- System. clude anticounterfeiting or track-and-trace sultation by a licensed pharmacist to the ‘‘(B) CREDIT; CREDITOR; CREDIT CARD.—The technologies; caregiver or patient before and after the terms ‘credit’, ‘creditor’, and ‘credit card’ ‘‘(ii) verification that the person that owns time at which the Internet pharmacy dis- have the meanings given the terms in sec- the Internet pharmacy has not had a license penses the drug. tion 103 of the Truth in Lending Act (15 for an Internet pharmacy terminated by the ‘‘(v)(I) Establish a mechanism for patients U.S.C. 1602). Secretary, and that no other Internet phar- to report errors and suspected adverse drug macy owned by the person has had a license reactions. ‘‘(C) ELECTRONIC FUND TRANSFER.—The term ‘electronic fund transfer’— under this subsection that has been termi- ‘‘(II) Document in the reporting mecha- ‘‘(i) has the meaning given the term in sec- nated by the Secretary; nism the response of the Internet pharmacy tion 903 of the Electronic Fund Transfer Act ‘‘(iii) verification from the person that to those reports. (15 U.S.C. 1693a); and owns the Internet pharmacy that the person ‘‘(III) Submit those reports within 3 days will permit inspection of the facilities and of receipt and the response of the Internet ‘‘(ii) includes any fund transfer covered business practices of the Internet pharmacy pharmacy to the Food and Drug Administra- under article 4A of the Uniform Commercial by the Secretary to the extent necessary to tion in a manner determined appropriate by Code, as in effect in any State. determine whether the Internet pharmacy is the Secretary. ‘‘(D) FINANCIAL INSTITUTION.—The term ‘fi- in compliance with this subsection; ‘‘(vi) Develop a system to inform care- nancial institution’— ‘‘(iv) in the case of an agreement between givers and patients about drug recalls. ‘‘(i) has the meaning given the term in sec- a patient and an Internet pharmacy that re- ‘‘(vii) Educate caregivers and patients tion 903 of the Electronic Transfer Fund Act leases the Internet pharmacy, and any em- about the appropriate means of disposing of (15 U.S.C. 1693a); and ployee or agent of the Internet pharmacy, expired, damaged, or unusable medications. ‘‘(ii) includes a financial institution (as de- from liability for damages arising out of the ‘‘(viii) Assure that the sale of a prescrip- fined in section 509 of the Gramm-Leach-Bli- negligence of the Internet pharmacy, an as- tion drug is in accordance with a valid pre- ley Act (15 U.S.C. 6809)). surance that such a limitation of liability scription from the treating provider of the ‘‘(E) MONEY TRANSMITTING BUSINESS; MONEY shall be null and void; individual. TRANSMITTING SERVICE.—The terms ‘money ‘‘(v) verification that the Internet phar- ‘‘(ix)(I) Verify the validity of the prescrip- transmitting business’ and ‘money transmit- macy expressly and affirmatively agrees to tion of an individual by using 1 of the fol- ting service’ have the meanings given the provide the Secretary with the identity of lowing methods: terms in section 5330(d) of title 31, United any providers of interactive computer serv- ‘‘(aa) If the prescription for any drug other States Code. ices that provide host services or advertising than a controlled substance (as defined in ‘‘(b) IN GENERAL.—An Internet pharmacy services for the Internet pharmacy; and section 102 of the Controlled Substances Act may only dispense or offer to dispense a pre- ‘‘(vi) assurance that the Internet pharmacy (21 U.S.C. 802)) is received from an individual scription drug to a person in the United will comply with the requirements under or the treating provider of the individual by States in accordance with this section. subparagraphs (B) and (C). mail (including a private carrier), or from ‘‘(c) LICENSING OF INTERNET PHARMACIES.— ‘‘(B) IDENTIFICATION REQUIREMENTS.—An the treating provider of the individual by ‘‘(1) IN GENERAL.—An Internet pharmacy Internet pharmacy shall post in a clear and electronic mail, the validity of the prescrip- shall be licensed by the Secretary in accord- visible manner, on each page of the website tion shall be confirmed in accordance with ance with this section prior to offering to of the Internet pharmacy or by a link to a all applicable Federal and State laws. dispense or dispensing a prescription drug to separate page, the following information: ‘‘(bb) If the prescription is for a controlled an individual. ‘‘(i) The street address, city, ZIP Code or substance (as defined in section 102 of the ‘‘(2) CONDITIONS FOR LICENSING.— comparable mail code, State (or comparable Controlled Substances Act), the validity of ‘‘(A) APPLICATION REQUIREMENTS.—An entity), country, and telephone number of— the prescription shall be confirmed with the Internet pharmacy shall submit to the Sec- ‘‘(I) each place of business of the Internet treating provider as described in subclause retary an application that includes— pharmacy; and (II). ‘‘(i)(I) in the case of an Internet pharmacy ‘‘(II) the name of the supervising phar- ‘‘(II) When seeking verification of a pre- located in the United States, verification macist of the Internet pharmacy and each scription of an individual under subclause that, in each State in which the Internet individual who serves as a pharmacist for (I)(bb), an Internet pharmacy shall provide pharmacy engages in dispensing or offering purposes of the Internet pharmacy website. to the treating provider the following infor- to dispense prescription drugs, the Internet ‘‘(ii) The names of all States in which the mation: pharmacy, and all employees and agents of Internet pharmacy and the pharmacists em- ‘‘(aa) The full name and address of the in- the Internet pharmacy, is in compliance ployed by the Internet pharmacy are li- dividual. with applicable Federal and State laws re- censed or otherwise authorized to dispense ‘‘(bb) Identification of the prescription garding— prescription drugs. drug. ‘‘(aa) the practice of pharmacy, including ‘‘(iii) If the Internet pharmacy makes re- ‘‘(cc) The quantity of the prescription drug licensing laws and inspection requirements; ferrals to, or solicits on behalf of, a health to be dispensed. and care practitioner or group of practitioners in ‘‘(dd) The date on which the individual pre- ‘‘(bb) the manufacturing and distribution the United States for prescription services— sented the prescription to the Internet phar- of controlled substances, including with re- ‘‘(I) the name, street address, city, ZIP macy. spect to mailing or shipping controlled sub- Code or comparable mail code, State, and ‘‘(ee) The date and time of the verification stances to consumers; or telephone number of the practitioner or request. ‘‘(II) in the case of an Internet pharmacy group; and ‘‘(ff) The name of a contact person at the whose principal place of business is located ‘‘(II) the name of each State in which each Internet pharmacy, including a voice tele- outside the United States, verification practitioner is licensed or otherwise author- phone number, electronic mail address, and that— ized to prescribe drugs. facsimile telephone number.

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‘‘(III) A prescription is verified under sub- ‘‘(iii) ONE FEE PER INTERNET PHARMACY.— ‘‘(B) has made an untrue statement of ma- clause (I)(bb) only if 1 of the following oc- The licensing application fee and yearly re- terial fact in its licensing application; or curs: newal fee shall be paid only once for each ‘‘(C) is in violation of any applicable Fed- ‘‘(aa) The treating provider confirms, by Internet pharmacy for a fiscal year in which eral or State law relating to the dispensing direct communication with the Internet the fee is payable. of a prescription drug. pharmacy, that the prescription is accurate. ‘‘(C) FEE AMOUNT.—The amount of the li- ‘‘(8) RENEWAL EVALUATION.— ‘‘(bb) The treating provider informs the censing application fee and the yearly re- ‘‘(A) IN GENERAL.—Before renewing a li- Internet pharmacy that the prescription is newal fee for an Internet pharmacy shall be cense of an Internet pharmacy under this inaccurate and provides the accurate pre- determined each year by the Secretary based subsection, the Secretary shall conduct an scription. on the anticipated costs to the Secretary of evaluation to determine whether the Inter- ‘‘(IV) An Internet pharmacy shall not fill a enforcing the requirements of this section in net pharmacy is in compliance with this sec- prescription if— the subsequent fiscal year. tion. ‘‘(aa) a treating provider informs the Inter- ‘‘(D) ANNUAL FEE DETERMINATION.— ‘‘(B) EVALUATION OF INTERNET PHAR- net pharmacy within 72 hours after receipt of ‘‘(i) IN GENERAL.—Not later than 60 days MACIES.—At the discretion of the Secretary a communication under subclause (I)(bb) before the beginning of each fiscal year be- and as applicable, an evaluation under sub- that the prescription is inaccurate or ex- ginning after September 30, 2007, the Sec- paragraph (A) may include testing of the pired; or retary shall determine the amount of the li- Internet pharmacy website or other systems ‘‘(bb) the treating provider does not re- censing application fee and the yearly re- through which the Internet pharmacy com- spond within that time. newal fee for that fiscal year. municates with consumers, and a physical ‘‘(x) Maintain, for such period of time as ‘‘(ii) PUBLICATION OF FEE AMOUNT.—Not inspection of the records and premises of the the Secretary shall prescribe by regulation, later than 60 days before each fiscal year, the pharmacy. a record of all direct communications with a Secretary shall publish the amount of the li- ‘‘(9) CONTRACT FOR OPERATION OF PRO- treating provider regarding the dispensing of censing application fee and the yearly re- GRAM.— a prescription drug, including verification of newal fee under this section for that fiscal ‘‘(A) IN GENERAL.—The Secretary may the prescription. year and provide for a period of 30 days for award a contract under this subsection for ‘‘(3) LICENSURE PROCEDURE.— the public to provide written comments on the operation of the licensing program. ‘‘(A) ACTION BY SECRETARY.—On receipt of the fees. ‘‘(B) TERM.—The duration of a contract a complete licensing application from an under subparagraph (A) shall not exceed 5 Internet pharmacy under paragraph (2), the ‘‘(E) USE OF FEES.—The fees collected under this section shall be used, without fur- years and may be renewable. Secretary shall— ‘‘(C) PERFORMANCE REVIEW.—The Secretary ‘‘(i) assign an identification number to the ther appropriation, to carry out this section. ‘‘(F) FAILURE TO PAY FEE.— shall annually review performance under a Internet pharmacy; contract under subparagraph (A). ‘‘(ii) notify the applicant of the receipt of ‘‘(i) DUE DATE.—A fee payable under this the licensing application; and section shall be paid by the date that is 30 ‘‘(d) PROVIDERS OF INTERACTIVE COMPUTER ‘‘(iii) if the Internet pharmacy is in com- days after the date on which the fee is due. SERVICES OR ADVERTISING SERVICES.—No pro- pliance with the conditions under paragraph ‘‘(ii) FAILURE TO PAY.—If an Internet phar- vider of interactive computer services (as de- (2), issue a license not later than 60 days macy subject to a fee under this section fails fined in section 230(f) of the Communications after receipt of a licensing application from to pay the fee by the date specified under Act of 1934 (47 U.S.C. 230(f)) or an advertising the Internet pharmacy. clause (i), the Secretary shall not permit the service provider shall be liable under this ‘‘(B) ELECTRONIC FILING.— Internet pharmacy to engage in the dis- section on account of another person’s sell- ‘‘(i) IN GENERAL.—For the purpose of reduc- pensing of drugs as described under this sec- ing or dispensing of a prescription drug, so ing paperwork and reporting burdens, the tion until all such fees owed by the Internet long as the provider of the interactive com- Secretary shall require the use of electronic pharmacy are paid. puter service or the advertising service pro- methods of submitting to the Secretary a li- ‘‘(G) REPORTS.—Beginning with fiscal year vider does not own or exercise corporate con- censing application required under this sec- 2008, not later than 60 days after the end of trol over such person. tion and provide for electronic methods of each fiscal year during which licensing appli- ‘‘(e) POLICIES AND PROCEDURES REQUIRED receiving the applications. cation fees are collected under this section, TO PREVENT PAYMENTS FOR UNLAWFUL INTER- ‘‘(ii) AUTHENTICATION.—In providing for the the Secretary shall submit to the Committee electronic submission of such licensing ap- on Health, Education, Labor, and Pensions of NET PHARMACY REQUESTS.— plications under this section, the Secretary the Senate and the Committee on Energy ‘‘(1) REGULATIONS.—Not later than 180 days shall ensure that adequate authentication and Commerce of the House of Representa- after designating a system under subsection protocols are used to allow identification of tives a report that describes— (a)(2), the Board shall promulgate regula- the Internet pharmacy and validation of the ‘‘(i) implementation of the licensing fee tions that require— data as appropriate. authority during the fiscal year; and ‘‘(A) an operator of a credit card system ‘‘(4) DATABASE.— ‘‘(ii) the use by the Secretary of the licens- that is a designated payment system, an op- ‘‘(A) IN GENERAL.—The Secretary shall ing fees collected during the fiscal year for erator of an international, national, or local compile, maintain, and periodically update a which the report is made. network used to effect a credit transaction, database of the Internet pharmacies licensed ‘‘(6) SUSPENSION.— electronic fund transfer, or money transmit- under this section. ‘‘(A) IN GENERAL.—If the Secretary deter- ting service that is a designated payment ‘‘(B) AVAILABILITY.—The Secretary shall mines that an Internet pharmacy is engaged system, and an operator of any other des- make the database described under subpara- in a pattern of violations of any of the re- ignated payment system specified by the graph (A) and information submitted by the quirements of this Act, the Secretary may Board that is centrally managed and is pri- licensee under paragraph (2)(B) available to immediately order the suspension of the li- marily engaged in the transmission and set- the public on an Internet website and cense of the Internet pharmacy. tlement of credit transactions, electronic through a toll-free telephone number. ‘‘(B) APPEAL OF SUSPENSION ORDER.—An transfers, or money transmitting services ‘‘(5) FEES.— Internet pharmacy subject to a suspension where at least 1 party to the transaction or ‘‘(A) IN GENERAL.— order under subparagraph (A) may appeal the transfer is an individual; and ‘‘(i) LICENSING APPLICATION FEE.—The Sec- suspension order to the Secretary. Not later ‘‘(B) in the case of a designated payment retary shall establish a licensing application than 30 days after an appeal is filed, the Sec- system, other than a designated payment fee to be paid by all applicants. retary, after providing opportunity for an in- system described in subparagraph (A), a per- ‘‘(ii) RENEWAL FEE.—The Secretary shall formal hearing, shall affirm or terminate the son described in subsection (a)(2)(B); establish a yearly renewal fee to be paid by order. to establish policies and procedures that are all Internet pharmacies licensed under this ‘‘(C) FAILURE TO ACT.—If, during the 30-day reasonably designed to prevent the introduc- section. period specified in subparagraph (B), the Sec- tion of restricted transactions into a des- ‘‘(B) COLLECTION.— retary fails to provide an opportunity for a ignated payment system or the completion ‘‘(i) COLLECTION OF LICENSING APPLICATION hearing or to affirm or terminate the order, of restricted transactions using a designated FEE.—A licensing application fee payable for the order shall be deemed to be terminated. payment system. the fiscal year in which the Internet phar- ‘‘(D) NO JUDICIAL REVIEW.—An order under ‘‘(2) REQUIREMENTS FOR POLICIES AND PRO- macy submits a licensing application, as es- this paragraph shall not be subject to judi- CEDURES.—In promulgating regulations tablished under subparagraph (C), shall be cial review. under paragraph (1), the Board shall— payable upon the submission to the Sec- ‘‘(7) TERMINATION OF LICENSE.—The Sec- ‘‘(A) identify types of policies and proce- retary of such licensing application. retary may terminate a license issued under dures, including nonexclusive examples, that ‘‘(ii) COLLECTION OF RENEWAL FEES.—After this subsection, after notice to the Internet shall be considered to be reasonably designed the licensing application fee is paid for the pharmacy and an opportunity for a hearing, to identify and reasonably designed to pre- first fiscal year of licensure, the yearly re- and if the Secretary determines that the vent the introduction of a restricted trans- newal fee, as established under subparagraph Internet pharmacy— action in a designated payment or the com- (C), shall be payable on or before October 1 of ‘‘(A) has demonstrated a pattern of non- pletion of restricted transactions using a each subsequent fiscal year. compliance with this section; designated payment system; and

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00111 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.067 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5426 CONGRESSIONAL RECORD — SENATE May 1, 2007 ‘‘(B) to the extent practicable, permit any ‘‘(3) submitting, for each fiscal year for ‘‘(C) shall specify the provider to which the designated payment system, or person de- which the award under this subsection is relief applies; and scribed in subsection (a)(2)(B), as applicable, made, a report to the Secretary describing ‘‘(D) shall specifically identify the location to choose among alternative means of pre- investigations undertaken with respect to of the website to be removed or to which ac- venting the introduction or completion of re- violations described in paragraph (1). cess is to be disabled.’’. stricted transactions. ‘‘(g) TRANSACTIONS PERMITTED.—A des- (d) REGULATIONS.— ‘‘(3) NO LIABILITY FOR BLOCKING OR REFUS- ignated payment system or person subject to (1) IN GENERAL.—Not later than 1 year after ING TO HONOR RESTRICTED TRANSACTION.— a regulation or an order issued under sub- the date of enactment of this title, the Sec- ‘‘(A) IN GENERAL.—A designated payment section (e) may engage in transactions with retary of Health and Human Services shall system, or a person described in subsection licensed and unlicensed Internet pharmacies promulgate interim final regulations to (a)(2)(B), that is subject to a regulation or an in connection with investigating violations carry out the amendments made by this sec- order issued under this subsection, and any or potential violations of any rule or require- tion. participant in such payment system, that— ment adopted by the payment system or per- (2) EFFECTIVE DATE.—The requirement of ‘‘(i) prevents or otherwise refuses to honor son in connection with complying with sub- licensure under section 511 of the Federal restricted transactions, in an effort to imple- section (e). A person subject to a regulation Food, Drug, and Cosmetic Act (as added by ment the policies and procedures required or an order issued under subsection (e) and this section) shall take effect on the date de- under this subsection or to otherwise comply the agents and employees of that person termined by the Secretary of Health and with this section, shall not be liable to any shall not be found to be in violation of, or Human Services but in no event later than 90 party for such action; and liable under, any Federal, State, or other law days after the effective date of the interim ‘‘(ii) prevents or otherwise refuses to honor for engaging in any such transaction. final regulations under paragraph (1). a nonrestricted transaction in an effort to ‘‘(h) RELATION TO STATE LAWS.—No re- (e) PENALTIES.—Section 303 of the Federal implement the policies and procedures under quirement, prohibition, or liability may be Food, Drug, and Cosmetic Act (21 U.S.C. 333) this subsection or to otherwise comply with imposed on a designated payment system or is amended by adding at the end the fol- this section, shall not be liable to any party person subject to a regulation or an order lowing: for such action. issued under subsection (e) under the laws of ‘‘(g) Notwithstanding subsection (a), any ‘‘(B) COMPLIANCE WITH THIS SUBSECTION.—A any State with respect to any payment person who knowingly violates paragraph (1), person described in subsection (a)(2)(B) transaction by an individual because the (2), (3), or (4) of section 301(hh) shall be im- meets the requirements of this subsection, if payment transaction involves a payment to prisoned for not more than 10 years or fined any, if the person relies on and complies an Internet pharmacy. in accordance with title 18, United States with the policies and procedures of a des- ‘‘(i) TIMING OF REQUIREMENTS.—A des- Code, or both.’’. ignated payment system or a person subject ignated payment system of which the person SA 994. Mr. GRASSLEY submitted an is a member or in which the person is a par- to a regulation under subsection (e) shall ticipant, and such policies and procedures of adopt policies and procedures reasonably de- amendment intended to be proposed by the designated payment system comply with signed to comply with any regulations re- him to the bill S. 1082, to amend the the requirements of the regulations under quired under subsection (e) not later than 180 Federal Food, Drug, and Cosmetic Act paragraph (1)(B). days after the date on which such final regu- to reauthorize and amend the prescrip- ‘‘(4) ENFORCEMENT.— lations are issued.’’. tion drug user fee provisions, and for ‘‘(A) IN GENERAL.—This subsection shall be (b) PROHIBITED ACTS.—Section 301 of the other purposes; which was ordered to Federal Food, Drug, and Cosmetic Act (21 enforced by the Federal functional regu- lie on the table; as follows: lators and the Federal Trade Commission U.S.C. 331) is amended by adding at the end At the appropriate place, insert the fol- under applicable law in the manner provided the following: lowing: in section 505(a) of the Gramm-Leach-Bliley ‘‘(hh)(1) The sale, under section 511, of a Act (21 U.S.C. 6805(a)). drug that is not a prescription drug, the sale SEC. ll. CENTER FOR POSTMARKET EVALUA- of such a prescription drug without a valid TION AND RESEARCH FOR DRUGS ‘‘(B) FACTORS TO BE CONSIDERED.—In con- AND BIOLOGICS. sidering any enforcement action under this prescription from a treating provider, or the ownership or operation of an Internet phar- (a) IN GENERAL.—Chapter V of the Federal subsection against a payment system or per- Food, Drug, and Cosmetic Act (21 U.S.C. 351 son described in subsection (a)(2)(B), the macy, in violation of section 511. ‘‘(2) The representation by advertisement, et seq.) is amended by inserting after section Federal functional regulators and the Fed- 506C the following: eral Trade Commission shall consider the sales presentation, direct communication (including telephone, facsimile, or electronic ‘‘SEC. 507. DRUG SAFETY. following factors: ‘‘(a) ESTABLISHMENT OF THE CENTER FOR ‘‘(i) The extent to which the payment sys- mail), or otherwise by an Internet pharmacy, that a prescription drug may be obtained POSTMARKET EVALUATION AND RESEARCH FOR tem or person knowingly permits restricted DRUGS AND BIOLOGICS.—There is established transactions. from the Internet pharmacy without a pre- scription, in violation of section 511. within the Food and Drug Administration a ‘‘(ii) The history of the payment system or Center for Postmarket Evaluation and Re- person in connection with permitting re- ‘‘(3) The advertisement related to a pre- scription drug through any media including search for Drugs and Biologics (referred to in stricted transactions. the section as the ‘Center’). The Director of ‘‘(iii) The extent to which the payment sales presentation, direct communication (including telephone, facsimile, or electronic the Center shall report directly to the Com- system or person has established and is missioner of Food and Drugs. maintaining policies and procedures in com- mail), by an unlicensed Internet pharmacy. ‘‘(4) The provision of an untrue statement ‘‘(b) DUTIES OF THE CENTER FOR pliance with regulations prescribed under of material fact in the licensing application POSTMARKET EVALUATION AND RESEARCH FOR this subsection. of an Internet pharmacy. DRUGS AND BIOLOGICS.— ‘‘(iv) The feasibility that any specific rem- ‘‘(5) For purposes of this subsection, any ‘‘(1) RESPONSIBILITIES OF DIRECTOR.—The edy prescribed can be implemented by the term used in this subsection that is also used Director of the Center, in consultation with payment system or person without substan- in section 511 shall have the meaning given the Director of the Center for Drug Evalua- tial deviation from normal business practice. that term in section 511.’’. tion and Research or the Director of the Cen- ‘‘(v) The costs and burdens the specific (c) LINKS TO UNLICENSED INTERNET PHAR- ter for Biologics Evaluation and Research, as remedy will have on the payment system or MACIES.—Section 302 of the Federal Food, appropriate, shall— person. Drug, and Cosmetic Act (21 U.S.C. 332) is ‘‘(A) conduct postmarket risk assessment ‘‘(f) REPORTS REGARDING INTERNET-RE- amended by adding at the end the following: of drugs approved under section 505 of this LATED VIOLATIONS OF FEDERAL AND STATE ‘‘(c)(1) In the case of a violation of section Act and of biological products licensed under LAWS ON DISPENSING OF DRUGS.—The Sec- 511 relating to an unlicensed Internet phar- section 351 of the Public Health Service Act; retary shall, pursuant to the submission of macy (as defined in such section 511), the dis- ‘‘(B) conduct and improve postmarket sur- an application meeting criteria prescribed by trict courts of the United States and the veillance of approved drugs and licensed bio- the Secretary, make an award of a grant or United States courts of the territories shall logical products using postmarket surveil- contract to an entity with experience in de- have jurisdiction to order a provider of an lance programs and activities (including veloping and maintaining systems for the interactive computer service to remove, or MedWatch), risk-benefit analyses, adverse purpose of— disable access to, links to a website violating event reports, the scientific literature, any ‘‘(1) identifying Internet pharmacy that section that resides on a computer serv- clinical or observational studies (including websites that are not licensed or that appear er that the provider controls or operates. studies required under subsection (d) or (e)), to be operating in violation of Federal or ‘‘(2) Relief under paragraph (1)— and any other resources that the Director of State laws concerning the dispensing of ‘‘(A) shall be available only after provision the Center determines appropriate; drugs; to the provider of notice and an opportunity ‘‘(C) determine whether a study is required ‘‘(2) reporting such Internet pharmacy to appear; under subsection (d) or (e) and consult with websites to State medical licensing boards ‘‘(B) shall not impose any obligation on the the sponsors of drugs and biological products and State pharmacy licensing boards, and to provider to monitor its service or to affirma- to ensure that such studies are completed by the Attorney General and the Secretary, for tively seek facts indicating activity vio- the date, and according to the terms, speci- further investigation; and lating section 511; fied by the Director of the Center;

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00112 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.067 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5427 ‘‘(D) contract, or require the sponsor of an postmarket studies to determine the safety ‘‘(B) order a corrective action under sub- application or the holder of an approved ap- or effectiveness of a drug or biological prod- section (k) be taken to protect patients and plication or license to contract, with the uct, including such safety or effectiveness as the public health. holders of domestic and international pa- compared to other drugs or biological prod- ‘‘(3) REQUIRED CONSULTATION AND CONSIDER- tient databases to conduct epidemiologic and ucts, to be completed by a date, and accord- ATIONS.—Before making a determination other observational studies; ing to the terms, specified by the Director of under paragraph (2), ordering a study under ‘‘(E) determine, based on postmarket sur- the Center; or subsection (d) or (e), or taking a corrective veillance programs and activities (including ‘‘(B) contract, or require the sponsor of the action under subsection (k), the Director of MedWatch), risk-benefit analyses, adverse application to contract, with a holder of a the Center shall— event reports, the scientific literature, and domestic or an international patient data- ‘‘(A) consult with the Director of the Cen- any clinical or observational studies (includ- base to conduct 1 or more epidemiologic or ter for Drug Evaluation and Research or the ing studies required under subsection (d) or other observational studies. Director of the Center for Biologics Evalua- (e)), and any other resources that the Direc- ‘‘(e) POSTMARKETING STUDIES OF DRUG tion and Research, as appropriate; and tor of the Center determines appropriate, SAFETY.— ‘‘(B) consider— whether a drug or biological product may ‘‘(1) IN GENERAL.—At any time after a drug ‘‘(i) the benefit-to-risk profile of the drug present an unreasonable risk to the health of is approved under section 505 of this Act or a or biological product; patients or the general public, and take cor- biological product is licensed under section ‘‘(ii) the effect that a corrective action, or rective action if such an unreasonable risk 351 of the Public Health Service Act, the Di- failure to take corrective action, will have may exist; rector of the Center, may— on the patient population that relies on the ‘‘(F) make information about the safety ‘‘(A) require that the holder of an approved drug or biological product; and and effectiveness of approved drugs and li- application or license conduct 1 or more ‘‘(iii) the extent to which the drug or bio- censed biological products available to the studies to determine the safety or effective- logical product presents a meaningful thera- public and healthcare providers in a timely ness of such drug or biological product, in- peutic benefit as compared to other available manner; and cluding such safety and effectiveness as com- treatments. ‘‘(G) conduct other activities as the Direc- pared to other drugs or biological products, tor of the Center determines appropriate to to be completed by a date, and according to ‘‘(h) PUBLIC INFORMATION.—Periodically, ensure the safety and effectiveness of all the terms, specified by such Director; or but not less often than every 90 days, the drugs approved under section 505 and all bio- ‘‘(B) contract, or require the holder of the Secretary shall make available to the public, logical products licensed under section 351 of approved application or license to contract, by publication in the Federal Register and the Public Health Service Act. with a holder of a domestic or an inter- posting on an Internet website, the following ‘‘(2) DETERMINATION OF UNREASONABLE national patient database to conduct 1 or information: RISK.—In determining whether a drug or bio- more epidemiologic or other observational ‘‘(1) Studies required under subsection (d) logical product may present an unreasonable studies. or (e) including— risk to the health of patients or the general ‘‘(2) REVIEW OF OUTSTANDING STUDIES.—Not ‘‘(A) the type of study; public, the Director of the Center, in con- later than 90 days after the date of enact- ‘‘(B) the nature of the study; sultation with the Director of the Center for ment of the Food and Drug Administration ‘‘(C) the primary and secondary outcomes Drug Evaluation and Research or the Direc- Safety Act of 2007, the Director of the Center of the study; tor of the Center for Biologics Evaluation shall— ‘‘(D) the date the study was required under and Research, as appropriate, shall consider ‘‘(A) review and publish a list in the Fed- subsection (d) or (e) or was agreed to by the the risk in relation to the known benefits of eral Register of any postmarketing studies sponsor; such drug or biological product. outstanding on the date of enactment of the ‘‘(E) the deadline for completion of the ‘‘(c) SECRETARIAL AUTHORITY.— Food and Drug Administration Safety Act of study; and ‘‘(1) IN GENERAL.—Approval of a drug under 2007; and ‘‘(F) if the study has not been completed section 505 of this Act or issuance of a li- ‘‘(B) as the Director determines appro- by the deadline under subparagraph (E), a cense for a biological product under section priate, require the sponsor of a study de- statement that explains why. 351 of the Public Health Service Act may be scribed in subparagraph (A) to conduct such ‘‘(2) The periodic progress reports and re- subject to the requirement that the sponsor study under this subsection. sults of completed studies described under conduct 1 or more postmarket studies as de- ‘‘(f) PUBLICATION OF PROGRESS REPORTS subsection (f). scribed in subsection (d) or (e) of this sec- AND COMPLETED STUDIES.— ‘‘(3) Any determinations made by the Di- tion, or other postmarket studies as required ‘‘(1) IN GENERAL.—The Director of the Cen- rector of the Center under subsection (g), in- by the Secretary, to validate the safety and ter shall require that the sponsor of a study cluding— effectiveness of the drug or biological prod- under subsection (d) or (e) submit to the Sec- ‘‘(A) reasons for the determination, includ- uct. retary— ing factual basis for such determination; ‘‘(2) DEFINITION.—For purposes of this sec- ‘‘(A) not less frequently than every 90 days, ‘‘(B) reference to supporting empirical tion, the term ‘postmarket’ means— an up-to-date report describing the progress data; and ‘‘(A) with respect to a drug, after approval of such study; and ‘‘(C) an explanation that describes why of an application under section 505; and ‘‘(B) upon the completion date of such contrary data is insufficient. ‘‘(B) with respect to a biological product, study, the results of such study. ‘‘(i) DRUG ADVISORY COMMITTEE.—The Drug after licensure under section 351 of the Pub- ‘‘(2) COMPLETION DATE.—For purposes of Safety and Risk Management Advisory Com- lic Health Service Act. this section, the completion date of such mittee within the Center of the Food and ‘‘(d) PREAPPROVAL REVIEW.— study shall be determined by the Director of Drug Administration shall— ‘‘(1) REVIEW OF APPLICATION.— the Center. ‘‘(1) meet not less frequently than every ‘‘(A) IN GENERAL.— ‘‘(g) DETERMINATIONS BY DIRECTOR.— 180 days; and ‘‘(i) REVIEW.—At any time before a drug is ‘‘(1) RESULTS OF STUDY.—The Director of approved under section 505 of this Act or a the Center shall determine, upon receipt of ‘‘(2) make recommendations to the Direc- biological product is licensed under section the results of a study required under sub- tor of the Center with respect to— 351 of the Public Health Service Act, the Di- section (d) or (e)— ‘‘(A) which drugs and biological products rector of the Center shall review the applica- ‘‘(A) whether the drug or biological prod- should be the subject of a study under sub- tion (or supplement to the application), and uct studied may present an unreasonable section (d) or (e); any analyses associated with the applica- risk to the health of patients or the general ‘‘(B) the design and duration for studies tion, of such drug or biological product. public; and under subsection (d) or (e); ‘‘(C) which drugs and biological products ‘‘(ii) EFFECT OF APPROVAL OR LICENSURE.— ‘‘(B) what, if any, corrective action under The approval of a drug under section 505 or subsection (k) shall be taken to protect pa- may present an unreasonable risk to the the licensure of a biological product under tients and the public health. health of patients or the general public; and ‘‘(D) appropriate corrective actions under such section 351 shall not affect the continu- ‘‘(2) RESULTS OF EVIDENCE.—The Director ation and completion of a review under of the Center may, at any time, based on the subsection (k). clause (i). empirical evidence from postmarket surveil- ‘‘(j) PENALTIES.— ‘‘(B) LIMITATION.—In no case shall the re- lance programs and activities (including ‘‘(1) IN GENERAL.—If the Secretary deter- view under subparagraph (A) delay a decision MedWatch), risk-benefit analyses, adverse mines, after notice and opportunity for an with respect to an application for a drug event reports, the scientific literature, any informal hearing, that a sponsor of a drug or under section 505 of this Act or for a biologi- clinical or observational studies (including biological product or other entity has failed cal product under section 351 of the Public studies required under subsection (d) or (e)), to complete a study required under sub- Health Service Act. or any other resources that the Director of section (d) or (e) by the date or to the terms ‘‘(2) RESULT OF REVIEW.—The Director of the Center determines appropriate— specified by the Secretary under such sub- the Center may, based on the review under ‘‘(A) make a determination that a drug or section, the Secretary may order such spon- paragraph (1)— biological product may present an unreason- sor or other entity to— ‘‘(A) require that the sponsor of the appli- able risk to the health of patients or the gen- ‘‘(A) complete the study in a specified cation agree to conduct 1 or more eral public; and time;

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00113 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.073 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5428 CONGRESSIONAL RECORD — SENATE May 1, 2007 ‘‘(B) revise the study to comply with the nications of the Food and Drug Administra- uct prior to the dissemination of such mate- terms specified by the Secretary under sub- tion, shall— rial. section (d) or (e); or ‘‘(A) notwithstanding section 502(n), re- ‘‘(m) WITHDRAWAL OR SUSPENSION OF AP- ‘‘(C) pay a civil penalty. quire that the sponsor of such drug or bio- PROVAL OR LICENSURE.— ‘‘(2) AMOUNT OF PENALTIES.— logical product submit to the Director of the ‘‘(1) IN GENERAL.—The Director of the Cen- ‘‘(A) IN GENERAL.—The civil penalty or- Center copies of all promotional material ter, may withdraw or suspend approval of a dered under paragraph (1) shall be $250,000 for with respect to the drug or biological prod- drug or licensure of a biological product the first 30-day period after the date speci- uct not less than 30 days prior to the dis- using expedited procedures (as prescribed by fied by the Secretary that the study is not semination of such material; and the Secretary in regulations promulgated completed, and shall double in amount for ‘‘(B) require that all promotional material not later than 1 year after the date of enact- every 30-day period thereafter that the study with respect to the drug or biological prod- ment of the Food and Drug Administration is not completed. uct include certain disclosures, which shall Safety Act of 2007, which shall include an op- ‘‘(B) LIMITATION.—In no case shall a pen- be displayed prominently and in a manner portunity for an informal hearing) after con- alty under subparagraph (A) exceed $2,000,000 easily understood by the general public, in- sultation with the Director of the Center for for any 30-day period. cluding— Drug Evaluation and Research or the Direc- ‘‘(3) NOTIFICATION OF PENALTY.—The Sec- ‘‘(i) a statement that describes the unrea- tor of the Center for Biologics Evaluation retary shall publish in the Federal Register sonable risk to the health of patients or the and Research, as appropriate, and any other any civil penalty ordered under this sub- general public as determined by the Director person as determined appropriate by the Di- section. of the Center; rector of the Center, if— ‘‘(k) RESULT OF DETERMINATION.— ‘‘(ii) a statement that encourages patients ‘‘(A) the Director of the Center makes a de- ‘‘(1) IN GENERAL.—If the Director of the termination that the drug or biological prod- Center makes a determination that a drug or to discuss potential risks and benefits with their healthcare provider; uct may present an unreasonable risk to the biological product may present an unreason- health of patients or the general public, and able risk to the health of patients or the gen- ‘‘(iii) a description of the corrective ac- tions required under subsection (k); that risk cannot be satisfactorily alleviated eral public under subsection (g), such Direc- by a corrective action under subsection (k); tor shall order a corrective action, as de- ‘‘(iv) where appropriate, a statement ex- plaining that there may be products avail- or scribed under paragraph (2). ‘‘(B) the sponsor fails to comply with an ‘‘(2) CORRECTIVE ACTIONS.—The corrective able to treat the same disease or condition that present a more favorable benefit-to-risk order or requirement under this section. action described under subsection (g)— ‘‘(2) PUBLIC INFORMATION.—The Secretary ‘‘(A) may include— profile, and that patients should talk to their healthcare provider about the risks and shall make available to the public, by publi- ‘‘(i) requiring a change to the drug or bio- cation in the Federal Register and posting logical product label by a date specified by benefits of alternative treatments; ‘‘(v) a description of any requirements of on an Internet website, the details of the the Director of the Center; consultation described in paragraph (1), in- ‘‘(ii) modifying the approved indication of outstanding clinical and observational stud- ies, including the purpose of each study; and cluding— the drug or biological product to restrict use ‘‘(A) the reason for the determination to to certain patients; ‘‘(vi) contact information to report a sus- pected adverse reaction. withdraw, suspend, or failure to withdraw or ‘‘(iii) placing restriction on the distribu- suspend, approval for the drug or licensure tion of the drug or biological product to en- ‘‘(2) NEW PRODUCTS; OUTSTANDING STUD- for the biological product; sure safe use; IES.—For the first 2-year period after a drug ‘‘(B) the factual basis for such determina- ‘‘(iv) requiring the sponsor of the drug or is approved under section 505 of this Act or a tion; biological product or license to establish a biological product is licensed under section ‘‘(C) reference to supporting empirical patient registry; 351 of the Public Health Service Act, and data; ‘‘(v) requiring patients to sign a consent with respect to drugs and biological products ‘‘(D) an explanation that describes why form prior to receiving a prescription of the for which there are outstanding study re- contrary data is insufficient; and drug or biological product; quirements under subsection (d) or (e), the ‘‘(E) the position taken by each individual ‘‘(vi) requiring the sponsor to monitor Director of the Center, in consultation with consulted. sales and usage of the drug or biological the Division of Drug Marketing, Advertising, ‘‘(n) EFFECT OF SECTION.—The authorities and Communications of the Food and Drug product to detect unsafe use; conferred by this section shall be separate Administration, shall— ‘‘(vii) requiring patient or physician edu- from and in addition to the authorities con- ‘‘(A) notwithstanding section 502(n), re- cation; and ferred by section 505B. quire that the sponsor of such drug or bio- ‘‘(viii) requiring the establishment of a ‘‘(o) ADMINISTRATION OF SECTION.—The pro- risk management plan by the sponsor; and logical product submit to the Director of the visions of this section shall be carried out by ‘‘(B) shall include the requirements with Center copies of all promotional material the Secretary, acting through the Director respect to promotional material under sub- with respect to the drug or biological prod- of the Center.’’. section (l)(1). uct not less than 30 days prior to the dis- (b) MISBRANDING.—Section 502 of the Fed- ‘‘(3) PENALTIES.— semination of such material; and eral Food, Drug, and Cosmetic Act (21 U.S.C. ‘‘(A) IN GENERAL.—If the Secretary deter- ‘‘(B) require that all promotional material 352) is amended by inserting after subsection mines, after notice and opportunity for an with respect to the drug or biological prod- (j) the following: informal hearing, that a sponsor of a drug or uct include certain disclosures, which shall ‘‘(k) If it is a drug or biological product for biological product has failed to take the cor- be displayed prominently and in a manner which the sponsor of an application or holder rective action ordered by the Director of the easily understood by the general public, in- of an approved application or license has not Center under this subsection or has failed to cluding— complied with an order or requirement under comply with subsection (l)(2), the Secretary ‘‘(i) a statement explaining that the drug section 507.’’. may order such sponsor to pay a civil pen- or biological product is newly approved or li- (c) REPORT ON DEVICES.—Not later than 6 alty. censed or the subject of outstanding clinical months after the date of enactment of this ‘‘(B) AMOUNT OF PENALTIES.— or observational studies, as the case may be, Act, the Secretary of Health and Human ‘‘(i) IN GENERAL.—The civil penalty ordered and, as a result, not all side effects or drug Services, in consultation with the Commis- under subparagraph (A) shall be $250,000 for interactions may be known; sioner of Food and Drugs, the Director of the the first 30-day period that the sponsor does ‘‘(ii) the number of people in which the Center for Postmarket Evaluation and Re- not comply with the order under paragraph drug or biological product has been studied search for Drugs and Biologics, and the Di- (1), and shall double in amount for every 30- and the duration of time during which the rector of the Center for Devices and Radio- day period thereafter that the order is not drug or biological product has been studied; logical Health, shall submit to Congress a re- complied with. ‘‘(iii) a statement that encourages patients port that— ‘‘(ii) LIMITATION.—In no case shall a pen- to discuss the potential risks and benefits of (1) identifies gaps in the current process of alty under clause (i) exceed $2,000,000 for any treatment with their healthcare provider; postmarket surveillance of devices approved 30-day period. ‘‘(iv) a description of any requirements of under the Federal Food, Drug, and Cosmetic ‘‘(C) NOTIFICATION OF PENALTY.—The Sec- outstanding clinical and observational stud- Act (21 U.S.C. 321 et seq.); retary shall publish in the Federal Register ies, including the purpose of each study; and (2) includes recommendations on ways to any civil penalty ordered under this para- ‘‘(v) contact information to report a sus- improve gaps in postmarket surveillance of graph. pected adverse reaction. devices; and ‘‘(l) PROMOTION MATERIAL.— ‘‘(3) EFFECT OF VOLUNTARY SUBMISSION.— (3) identifies the changes in authority ‘‘(1) SAFETY ISSUE.—If the Director of the Paragraphs (1)(A) and (2)(A) shall not apply needed to make those improvements, recog- Center makes a determination that a drug or to the sponsor of a drug or biological product nizing the legitimate differences between de- biological product may present an unreason- if such sponsor has voluntarily submitted to vices and other medical products regulated able risk to the health of patients or the gen- the Division of Drug Marketing, Advertising, by the Food and Drug Administration. eral public under subsection (g), such Direc- and Communications of the Food and Drug (d) TRANSFER OF FUNCTIONS.—The func- tor, in consultation with the Division of Administration all promotional material tions and duties of the Office of Surveillance Drug Marketing, Advertising, and Commu- with respect to the drug or biological prod- and Epidemiology, including the Drug Safety

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and Risk Management Advisory Committee, ‘‘(r) CERTIFICATION OF INFORMATION.—When ‘‘(bb) used in advertising or labeling to of the Food and Drug Administration on the submitting information in support of a new make a claim about the drug or device in- day before the date of enactment of this Act drug application or a supplemental new drug volved. shall be transferred to the Center for application, the sponsor shall certify, in Postmarket Evaluation and Research for writing, that all clinical trials, federally or SA 998. Mr. GRASSLEY submitted an Drugs and Biologics established under sec- privately funded, whether conducted within amendment intended to be proposed by tion 507 of the Federal Food, Drug, and Cos- or outside the United States, related to the him to the bill S. 1082, to amend the metic Act (as added by this section). The safety or efficacy of the drug under review, Federal Food, Drug, and Cosmetic Act Center for Postmarket Evaluation and Re- have been submitted to the Food and Drug to reauthorize and amend the prescrip- search for Drugs and Biologics shall be a sep- Administration.’’. arate entity within the Food and Drug Ad- tion drug user fee provisions, and for ministration and shall not be an administra- SA 997. Mr. GRASSLEY submitted an other purposes; which was ordered to tive office of the Center for Drug Evaluation amendment intended to be proposed by lie on the table; as follows: and Research or the Center for Biologics him to the bill S. 1082, to amend the At the appropriate place in section 505(o) Evaluation and Research. of the Federal, Food, Drug, and Cosmetic, as (e) AUTHORIZATION OF APPROPRIATIONS.— Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescrip- added by section 202, insert the following: There are authorized to be appropriated to ‘‘(9) CIVIL MONETARY PENALTY.—Notwith- carry out this section (and the amendments tion drug user fee provisions, and for standing any other provision of this Act, an made by this section)— other purposes; which was ordered to applicant (as such term is defined for pur- (1) $50,000,000 for fiscal year 2008; lie on the table; as follows: poses of this section) that knowingly fails to (2) $75,000,000 for fiscal year 2009; Strike clause (i) of section 402(j)(3)(A) of comply with a requirement of an approved (3) $100,000,000 for fiscal year 2010; the Public Health Service Act, as added by risk evaluation and mitigation strategy (4) $125,000,000 for fiscal year 2011; and this bill, and insert the following: under this subsection shall be subject to a (5) $150,000,000 for fiscal year 2012. ‘‘(i) IN GENERAL.— civil money penalty of $250,000 for the first Mr. GRASSLEY submitted an ‘‘(I) REQUIREMENT.—Not later than 90 days 30-day period that the applicant is in non- SA 995. compliance, and such amount shall double amendment intended to be proposed by after the date of enactment of the Food and Drug Administration Revitalization Act, for for every 30-day period thereafter that the him to the bill S. 1082, to amend the all clinical trials (except as provided in sub- requirement is not complied with, not to ex- Federal Food, Drug, and Cosmetic Act clause (II)), whether federally or privately ceed $2,000,000.’’. to reauthorize and amend the prescrip- funded, conducted to test the safety or effi- tion drug user fee provisions, and for cacy (including comparative efficacy), of any SA 999. Mr. GRASSLEY submitted an other purposes; which was ordered to drug or device (including those drugs or de- amendment intended to be proposed by lie on the table; as follows: vices approved or cleared by the Secretary), him to the bill S. 1082, to amend the At the end of subtitle E of title II, insert the Secretary shall ensure that the registry Federal Food, Drug, and Cosmetic Act the following: data bank includes links to results informa- to reauthorize and amend the prescrip- tion for such clinical trial— SEC. 2l. AUTHORITY OF THE OFFICE OF SUR- tion drug user fee provisions, and for VEILLANCE AND EPIDEMIOLOGY; ‘‘(aa) not earlier than 30 days after the date of the approval of the drug involved or other purposes; which was ordered to CHIEF SAFETY OFFICER. lie on the table; as follows: (a) AUTHORITY.—With respect to all actions clearance or approval of the device involved; of the Food and Drug Administration related or At the end of section 505 of the Federal to postmarketing drug safety, including la- ‘‘(bb) not later than 30 days after such in- Food, Drug, and Cosmetic Act, as amended beling changes, postapproval studies, and re- formation becomes publicly available, as ap- by section 251 of the bill, add the following: strictions on distribution or use of drugs plicable. ‘‘(r) CERTIFICATION OF INFORMATION.— with serious risks, the Office of Surveillance ‘‘(II) EXCEPTION.—The requirement of sub- ‘‘(1) CERTIFICATION.— and Epidemiology (or successor office) of clause (I) shall not apply to phase I clinical ‘‘(A) REQUIREMENT.—When submitting in- such Administration and the Office of New investigations conducted to test solely the formation in support of a new drug applica- Drugs (or successor office) of such Adminis- safety of an unapproved drug or unlicensed tion or a supplemental new drug application, tration shall make decisions jointly. In the biological product, or pilot or feasibility the sponsor shall certify, in writing, that the event of a disagreement with respect to an studies conducted to confirm the design and information submitted to the Food and Drug action related to postmarketing drug safety, operating specifications of an unapproved or Administration complies with the require- including labeling changes, postapproval not yet cleared medical device. ments of this Act and that such information studies, and restrictions on distribution or ‘‘(III) VOLUNTARY SUBMISSION.—A respon- is not false or misleading. use of drugs with serious risks, between such sible party for a clinical trial that is not an ‘‘(B) FAILURE TO SUBMIT.—If the sponsor 2 offices, the Commissioner of Food and applicable drug clinical trial or an applicable fails to provide a certification as required Drugs shall make the decision with respect device clinical trial may submit to the Sec- under subparagraph (A), the Secretary shall to such action. retary results information for a clinical trial transmit to such sponsor a notice stating (b) CHIEF SAFETY OFFICER.—Notwith- described in subclause (II). that such sponsor shall submit the certifi- standing any other provision of law, the Di- At the end section 402(j)(4) of the Public cation by a date determined by the Sec- rector of the Office of Surveillance and Epi- Health Service Act, as added by this bill, in- retary. If, by the date specified by the Sec- demiology (or successor office) of the Food sert the following: retary in the notice under this subparagraph, and Drug Administration shall serve as the ‘‘(F) TRIALS CONDUCTED OUTSIDE OF THE the Secretary has not received the certifi- Chief Postmarket Drug Safety Officer within UNITED STATES.— cation, the Secretary, after providing the op- the Food and Drug Administration. In such ‘‘(i) IN GENERAL.—With respect to clinical portunity for a hearing, shall order such capacity, the Director shall serve as a liaison trials described in clause (ii), the responsible sponsor to pay a civil monetary penalty of between the Office of the Commissioner of party shall submit to the Secretary the in- $10,000 for each day after such date that such Food and Drugs and employees of the Food formation required under this subsection. certification is not submitted. and Drug Administration. To ensure drug The Secretary shall ensure that such infor- ‘‘(C) ADDITIONAL CIVIL MONETARY PEN- safety concerns are identified and promptly mation and the results of such clinical trials ALTY.—If the Secretary determines, after no- evaluated and resolved, any employee of the are made available to the public in a timely tice and opportunity for a hearing, that a Center for Drug Evaluation and Research manner and as soon as practicable after re- sponsor knew or should have known that the within the Food and Drug Administration ceiving such information. Failure to comply information submitted in support of a new who has drug safety concerns may report with this paragraph shall be deemed to be a drug application or a supplemental new drug such concerns to the Chief Postmarket Drug failure to submit information as required application was false or inaccurate, the Sec- Safety Officer. under this subsection, and the appropriate retary shall order such sponsor to pay a civil remedies and sanctions under this section monetary penalty of not less than $100,000, SA 996. Mr. GRASSLEY submitted an shall apply. but not to exceed $2,000,000. amendment intended to be proposed by ‘‘(ii) CLINICAL TRIAL DESCRIBED.—A clinical ‘‘(2) REQUIRED STATEMENT.—The certifi- him to the bill S. 1082, to amend the trial is described in this clause if— cation under paragraph (1) shall include a Federal Food, Drug, and Cosmetic Act ‘‘(I) such trial is conducted outside of the statement that all clinical trials, federally to reauthorize and amend the prescrip- United States; and or privately funded, whether conducted with- ‘‘(II) the data from such trial is— in or outside the United States, related to tion drug user fee provisions, and for ‘‘(aa) submitted to the Secretary as part of the safety or efficacy of the drug under re- other purposes; which was ordered to an application, including a supplemental ap- view, have been submitted to the Food and lie on the table; as follows: plication, for a drug or device under section Drug Administration. At the end of section 505 of the Federal 505, 510, 515, or 520 of the Federal Food, Drug, ‘‘(3) CLINICAL COMPARISON STUDIES.— Food, Drug, and Cosmetic Act, as amended and Cosmetic Act or for the biological prod- ‘‘(A) IN GENERAL.—The Secretary shall de- by section 251 of the bill, add the following: uct under section 351 of this Act; or posit funds collected under paragraph (1)

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00115 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.073 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5430 CONGRESSIONAL RECORD — SENATE May 1, 2007 into an account and use such funds shall be ‘‘(2) any hearing, investigation, or other SEC. 211A. REQUIREMENT TO SUBMIT INFORMA- used, after consultation with the Director of proceeding to determine if a person is in TION ELECTRONICALLY. the Agency for Healthcare Research and compliance with a standard or other require- Subchapter E of chapter V of the Federal Quality, to fund studies that compare the ment under this Act, or Food, Drug, and Cosmetic Act (21 U.S.C. clinical effectiveness of 2 or more treatments ‘‘(3) any hearing, investigation, or other 360bbb et seq.), as amended by this Act, is for similar diseases or conditions. proceeding to establish a standard or other further amended by adding at the end the ‘‘(B) PRIORITY LIST.—The Secretary shall requirement under this Act, following: award funding under subparagraph (A) based the Commissioner may issue subpoenas re- ‘‘SEC. 567. REQUIREMENT TO SUBMIT INFORMA- on a priority list established, not later than quiring the attendance and testimony of wit- TION ELECTRONICALLY. 6 months after the date of enactment of this nesses and the production of documentary ‘‘Not later than 5 years after the date of Act, by the Director of the Agency for evidence. Such attendance of witnesses and enactment of the Food and Drug Administra- Healthcare Research and Quality and peri- production of evidence at the designated tion Revitalization Act, the Secretary shall odically updated as determined appropriate place of such hearing, investigation, or other ensure that any information required to be by the Director. proceeding may be required from any place submitted to the Food and Drug Administra- ‘‘(4) DRUG CONSULTATIONS.—Not later than in the United States or in any territory or tion under section 505, 505A, 505B, 506A, 506B, 90 days after the date of the completion of a possession of the United States. Subpoenas 510, 512, 513, 515, 519, 520, or 526 is submitted written consultation on a drug concerning of the Commissioner shall be served by a per- in electronic form that is interoperable with the drug’s safety, as conducted by the Office son authorized by the Commissioner by de- the Food and Drug Administration’s infor- of Surveillance and Epidemiology, regardless livering a copy thereof to the person named mation technology systems.’’. of whether such consultation was initiated therein or by certified mail addressed to by such Office or by an entity outside of the such person at such person’s last known Office, the Commissioner of Food and Drugs dwelling place or principal place of business. SA 1004. Ms. LANDRIEU proposed an shall make available to the public a full copy A verified return by the person so serving amendment to the bill S. 1082, to of such consultation. the subpoena setting forth the manner of amend the Federal Food, Drug, and ‘‘(5) RULE OF CONSTRUCTION.—Nothing in service, or, in the case of service by certified Cosmetic Act to reauthorize and amend this subsection shall be construed to alter or mail, the return post office receipt therefor the prescription drug user fee provi- amend section 301(j) of this Act or section signed by the person so served, shall be proof sions, and for other purposes; as fol- 1905 of title 18, United States Code.’’. of service. Witnesses so subpoenaed shall be paid the same fees and mileage as are paid lows: SA 1000. Mr. GRASSLEY submitted witnesses in the district courts of the United At the end of the bill, add the following: States. an amendment intended to be proposed TITLEllDOMESTIC PET TURTLE ‘‘(d) In case of a refusal to obey a subpoena by him to the bill S. 1082, to amend the MARKET ACCESS Federal Food, Drug, and Cosmetic Act duly served upon any person under sub- section (c), any district court of the United SEC. ll. SHORT TITLE. to reauthorize and amend the prescrip- States for the judicial district in which such tion drug user fee provisions, and for This title may be cited as the ‘‘Domestic person charged with refusal to obey is found, Pet Turtle Market Access Act of 2007’’. other purposes; which was ordered to resides, or transacts business, upon applica- SEC. ll. FINDINGS. lie on the table; as follows: tion by the Commissioner, shall have juris- At the appropriate place, insert the fol- diction to issue an order requiring such per- Congress makes the following findings: lowing: son to appear and give testimony or to ap- (1) Pet turtles less than 10.2 centimeters in pear and produce evidence, or both. The fail- diameter have been banned for sale in the TITLEllFDA EMPLOYEE PROTECTIONS ure to obey such order of the court may be United States by the Food and Drug Admin- SEC. ll01. SHORT TITLE. punished by the court as contempt thereof.’’. istration since 1975 due to health concerns. This title may be cited as the ‘‘FDA Em- (b) ENFORCEMENT.—Section 301 (21 U.S.C. (2) The Food and Drug Administration does ployee Rights Protection Act’’. 331) is amended by adding at the end the fol- not ban the sale of iguanas or other lizards, SEC. ll02. EMPLOYEES’ RIGHT TO PETITION lowing: snakes, frogs, or other amphibians or rep- CONGRESS. ‘‘(jj) The failure or refusal to obey a sub- tiles that are sold as pets in the United The right of all employees of the Food and poena issued by the Commissioner under sec- States that also carry salmonella bacteria. Drug Administration, individually or collec- tion 310(c).’’. The Food and Drug Administration also does tively, to petition Congress or a Member of not require that these animals be treated for Congress, or to furnish information to either SA 1002. Mr. GRASSLEY submitted salmonella bacteria before being sold as pets. House of Congress, or to a committee or an amendment intended to be proposed (3) The technology to treat turtles for sal- Member thereof, shall not be interfered with by him to the bill S. 1082, to amend the monella, and make them safe for sale, has greatly advanced since 1975. Treatments or denied by any employee of the Food and Federal Food, Drug, and Cosmetic Act Drug Administration, the Department of exist that can nearly eradicate salmonella Health and Human Services, the Department to reauthorize and amend the prescrip- from turtles, and individuals are more aware of Justice, or any other employee of the Ex- tion drug user fee provisions, and for of the causes of salmonella, how to treat sal- ecutive Branch of the Federal Government. other purposes; which was ordered to monella poisoning, and the seriousness asso- SEC. l03. PENALTIES. lie on the table; as follows: ciated with salmonella poisoning. Any individual who intentionally or will- At the appropriate place, insert the fol- (4) University research has shown that fully obstructs, impedes, or otherwise inter- lowing: these turtles can be treated in such a way that they can be raised, shipped, and distrib- feres with an employee’s right to furnish in- SEC. ll. REQUIREMENT TO DOCUMENT CON- formation as described in section ll02 shall TACT WITH DRUG SPONSORS. uted without having a recolonization of sal- be subject to a fine of not less than $10,000 Section 505 of the Federal Food, Drug, and monella. per violation, or imprisoned for not more Cosmetic Act (21 U.S.C. 355), as amended by (5) University research has also shown that than 1 year, or both. section 251, is further amended by adding at pet owners can be equipped with a treatment the end the following: regiment that allows the turtle to be main- tained safe from salmonella. SA 1001. Mr. GRASSLEY submitted ‘‘(r) REQUIREMENT TO DOCUMENT CONTACT (6) The Food and Drug Administration an amendment intended to be proposed WITH DRUG SPONSOR.—Each employee of the should allow the sale of turtles less than 10.2 by him to the bill S. 1082, to amend the Food and Drug Administration shall docu- ment, in writing, each communication or centimeters in diameter as pets as long as Federal Food, Drug, and Cosmetic Act the sellers are required to use proven meth- to reauthorize and amend the prescrip- contact, and the purpose of such communica- tion or contact, that such official has with a ods to treat these turtles for salmonella. tion drug user fee provisions, and for sponsor of a drug for which an application is SEC. ll. SALE OF BABY TURTLES. other purposes; which was ordered to filled pursuant to subsection (b) or (j).’’. (a) Notwithstanding any other provision of lie on the table; as follows: law, the Food and Drug Administration shall At the appropriate place, insert the fol- SA 1003. Mr. GRASSLEY submitted not restrict the sale by a turtle farmer, lowing: an amendment intended to be proposed wholesaler or commercial retail seller of a SEC. ll. SUBPOENA AUTHORITY OF THE COM- by him to the bill S. 1082, to amend the turtle that is less than 10.2 centimeters in di- MISSIONER OF FOOD AND DRUGS. Federal Food, Drug, and Cosmetic Act ameter as a pet if— (a) IN GENERAL.—Section 310 of the Federal to reauthorize and amend the prescrip- (1) the State or territory in which such Food, Drug, and Cosmetic Act (21 U.S.C. 337) tion drug user fee provisions, and for farmer is located has developed a regulatory is amended by adding at the end the fol- process by which pet turtle farmers are re- lowing: other purposes; which was ordered to quired to have a State license to breed, ‘‘(c) For the purpose of— lie on the table; as follows: hatch, propagate, raise, grow, receive, ship, ‘‘(1) any hearing, investigation, or other After section 211 of the bill, insert the fol- transport, export, or sell pet turtles or pet proceeding respecting a violation of this Act, lowing: turtle eggs;

VerDate Aug 31 2005 04:38 May 02, 2007 Jkt 059060 PO 00000 Frm 00116 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.075 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5431 (2) such State or territory requires certifi- other purposes; which was ordered to mittee on Homeland Security and Gov- cation of sanitization that is signed by a vet- lie on the table; as follows: ernmental Affairs be authorized to erinarian who is licensed in the State or ter- At the end of section 505(o)(6) of the Fed- meet on Tuesday, May 1, 2007, at 9:30 ritory, and approved by the State or terri- eral Food, Drug, and Cosmetic Act, as added a.m. to consider the nomination of tory agency in charge of regulating the sale by section 202 of the bill, insert the fol- of pet turtles; Howard C. Weizmann to be Deputy Di- lowing: (3) the certification of sanitization re- rector of the Office of Personnel Man- ‘‘(H) In a case where a drug may be pre- quires each turtle to be sanitized or treated agement. scribed only by a physician with particular for diseases, including salmonella, and is de- The PRESIDING OFFICER. Without training or experience, or who is specially pendant upon using the Siebeling method, or objection, it is so ordered. certified, a health care provider who is not other such proven method, which uses an an- so certified or trained to prescribe the drug COMMITTEE ON THE JUDICIARY tibiotic to make the turtle salmonella-free; may enter into a cooperation plan with a Mr. SCHUMER. Mr. President, I ask and physician who has particular training or ex- unanimous consent that the Senate (4) the turtle farmer or commercial retail perience, or is specially certified, in order to Committee on the Judiciary be author- seller includes, with the sale of such a turtle, prescribe such drug with the informed con- a disclosure to the buyer that includes— ized to meet to conduct a hearing on sent of the patient. The Commissioner of (A) information regarding— Process Patents for Tuesday, May 1, Food and Drugs shall determine the require- (i) the possibility that salmonella can re- 2007, at 2:30 p.m. in Dirksen Senate Of- ments for such cooperation plan. colonize in turtles; fice Building Room 226. (ii) the dangers, including possible severe Witness list: Wayne Herrington, As- SA 1007. Mr. REID (for Mr. BUNNING) illness or death, especially for at-risk people sistant General Counsel, United States proposed an amendment to the resolu- who may be susceptible to salmonella poi- International Trade Commission, tion S. Res. 162, commemorating and soning, such as children, pregnant women, Washington, DC; John R. Thomas, Pro- acknowledging the dedication and sac- and others who may have weak immune sys- fessor of Law, Georgetown University rifice made by the men and women who tems, that could result if the turtle is not Law Center, Washington, DC; Mike properly handled and safely maintained; have lost their lives while serving as Kirk, Executive Director, American In- (iii) the proper handling of the turtle, in- law enforcement officers; as follows: cluding an explanation of proper hygiene tellectual Property Law Association, On page 2, strike the first whereas clause Arlington, VA; and Christopher A. such as handwashing after handling a turtle; and insert: and Whereas peace officers are on the front Cotropia, Professor of Law, Richmond (iv) the proven methods of treatment that, lines in protecting the schools and school- School of Law, Richmond, VA. if properly applied, keep the turtle safe from children of the United States; The PRESIDING OFFICER. Without salmonella; objection, it is so ordered. f (B) a detailed explanation of how to prop- SEAPOWER SUBCOMMITTEE erly treat the turtle to keep it safe from sal- AUTHORTIY FOR COMMITTEES TO Mr. SCHUMER. Mr: President, I ask monella, using the proven methods of treat- MEET ment referred to under subparagraph (A), unanimous consent that the Seapower and how the buyer can continue to purchase COMMITTEE ON AGRICULTURE, NUTRITION, AND Subcommittee of the Committee on the tools, treatments, or any other required FORESTRY Armed Services be authorized to meet item to continually treat the turtle; and Mr. SCHUMER. Mr. President, I ask during the session of the Senate on (C) a statement that buyers of pet turtles unanimous consent that the Com- Tuesday, May 1, 2007, at 2:30 p.m., in should not abandon the turtle or abandon it mittee on Agriculture, Nutrition and open session to receive testimony on outside, as the turtle may become an Forestry be authorized to conduct a Department of Defense Transportation invasive species to the local community, but hearing during the session of the Sen- programs in review of the defense au- should instead return them to a commercial thorization request for fiscal year 2008 retail pet seller or other organization that ate on Tuesday, May 1, 2007 at 2 p.m. in would accept turtles no longer wanted as 328A, Senate Russell Office Building. and the future years defense program. pets. The purpose of this Committee hearing The PRESIDING OFFICER. Without (b) FDA REVIEW OF STATE PROTECTIONS.— will be to consider conservation policy objection, it is so ordered. The Food and Drug Administration may, recommendations for the farm bill. SELECT COMMITTEE ON INTELLIGENCE after providing an opportunity for the af- The PRESIDING OFFICER. Without Mr. SCHUMER. Mr. President, I ask fected State to respond, restrict the sale of a objection, it is so ordered. unanimous consent that the Select turtle only if the Secretary of Health and Committee on Intelligence be author- Human Services determines that the actual COMMITTEE ON COMMERCE, SCIENCE, AND implementation of State health protections TRANSPORTATION ized to meet during the session of the described in subsection (a) are insufficient to Mr. SCHUMER. Mr. President, I ask Senate on May 1, 2007 at 2:30 p.m. to protect consumers against infectious dis- unanimous consent that the Com- hold a hearing. eases acquired from such turtles at the time mittee on Commerce, Science, and The PRESIDING OFFICER. Without of sale. Transportation be authorized to hold a object it is so ordered. f SA 1005. Mr. LEVIN submitted an hearing during the session of the Sen- amendment intended to be proposed by ate on Tuesday, May 1, 2007, at 2:30 PRIVILEGES OF THE FLOOR him to the bill S. 1082, to amend the p.m., in room 253 of the Russell Senate Mr. REED. Mr. President, I ask unan- Federal Food, Drug, and Cosmetic Act Office Building. The purpose of the imous consent that Jessica Gerrity, a to reauthorize and amend the prescrip- hearing is to examine Electronic On- fellow in my office, be accorded the tion drug user fee provisions, and for Board Recorders (EOBRs) and Truck privilege of the floor. other purposes; which was ordered to Driver Fatigue, and related regulations The PRESIDING OFFICER. Without lie on the table; as follows: to be issued by the Federal Motor Car- objection, it is so ordered. At the appropriate place, insert the fol- rier Safety Administration. Mr. KENNEDY. Mr. President, I ask lowing: The PRESIDING OFFICER. Without unanimous consent that Adam Solan- SEC. ll. SAFETY OF FOOD ADDITIVES. objection, it is so ordered. der, an intern on my staff, be granted Not later than 90 days after the date of en- Mr. SCHUMER. Mr. President, I ask floor privileges during the debate on actment of this Act, the Food and Drug Ad- unanimous consent that the Com- the Food and Drug Administration Re- ministration shall issue a report on the ques- mittee on Finance be authorized to vitalization Act. tion of whether substances used in fresh meet during the Session of the Senate The PRESIDING OFFICER. Without meat that are capable of artificially keeping on Tuesday, May 1, 2007, at 10 a.m., in objection, it is so ordered. such meat red beyond the point of spoilage of 215 Dirksen Senate Office Building, to such meat, create a health risk or are mis- Mr. HATCH. Mr. President, I ask leading to consumers. hear testimony on ‘‘Advanced Tech- unanimous consent that Remy Yucel, a nology Vehicles: The Road Ahead.’’ fellow in my staff, be granted the privi- SA 1006. Ms. MURKOWSKI submitted The PRESIDING OFFICER. Without lege of the floor for the pendency of the an amendment intended to be proposed objection, it is so ordered. consideration of S. 1082, including any by her to the bill S. 1082, to amend the COMMITTEE ON HOMELAND SECURITY AND conference report. Federal Food, Drug, and Cosmetic Act GOVERNMENTAL AFFAIRS The ACTING PRESIDENT pro tem- to reauthorize and amend the prescrip- Mr. SCHUMER. Mr. President, I ask pore. Without objection, it is so or- tion drug user fee provisions, and for unanimous consent that the Com- dered.

VerDate Aug 31 2005 04:38 May 02, 2007 Jkt 059060 PO 00000 Frm 00117 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.076 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5432 CONGRESSIONAL RECORD — SENATE May 1, 2007 NOTICE: PUBLIC FINANCIAL the table, and that any statements re- the clandestine groups, the purging of the DISCLOSURE REPORTS lating thereto be printed in the RECORD police and judicial institutions, and the im- plementation of key justice and police re- The filing date for 2006 Public Finan- as if read. The ACTING PRESIDENT pro tem- forms. cial Disclosure reports is Tuesday, May pore. Without objection, it is so or- f 15, 2007. Senators, political fund des- dered. ignees and staff members whose sala- RECOGNIZING THE ACHIEVEMENTS The resolution (S. Res. 155) was ries exceed 120% of the GS–15 pay scale OF THE U.S. AIR FORCE ACAD- agreed to. EMY FOOTBALL PROGRAM must file reports. The preamble was agreed to. Public Financial Disclosure reports The resolution, with its preamble, Mr. REID. Mr. President, I ask unan- should be submitted to the Senate Of- reads as follows: imous consent that the Senate proceed fice of Public Records, 232 Hart Build- S. RES. 155 to the consideration of S. Res. 181. ing, Washington, D.C. 20510–7116. The ACTING PRESIDENT pro tem- Whereas warring parties in Guatemala The Public Records office will be ended a 36-year internal armed conflict with pore. The clerk will report the resolu- open from 9:00 a.m. to 6:00 p.m. on the a peace agreement in 1996, but the country tion by title. filing date to accept these filings. For has since faced alarming levels of violence, The legislative clerk read as follows: further information, please contact the organized crime, and corruption; A resolution (S. Res. 181) honoring and rec- Public Records office at (202) 224–0322. Whereas the alleged involvement of senior ognizing the achievements of the United officials of the National Civilian Police in States Air Force Academy football program f the murder of three Salvadoran parliamen- over the last 27 years. APPOINTMENTS tarians and their driver, and the subsequent There being no objection, the Senate killing of four of the police officers while in proceeded to consider the resolution. The ACTING PRESIDENT pro tem- custody underscored the need to purge and pore. The Chair, pursuant to Executive Mr. REID. Mr. President, I ask unan- strengthen law enforcement and judicial in- imous consent that the resolution be Order 12131, as amended and extended, stitutions in Guatemala; reappoints and appoints the following Whereas high-level officials of the Govern- agreed to, the preamble be agreed to, Members to the President’s Export ment of Guatemala have acknowledged the and the motion to reconsider be laid Council: Reappointment: the Senator infiltration of organized criminal networks upon the table. into the state apparatus and the difficulty of The ACTING PRESIDENT pro tem- from North Dakota (Mr. DORGAN); Ap- combating these networks when they are pore. Without objection, it is so or- pointment: the Senator from Ohio (Mr. deeply entrenched in public institutions; dered. BROWN) and the Senator from Michigan Whereas, in its 2006 Country Report on The resolution (S. Res. 181) was (Ms. STABENOW). Human Rights Practices in Guatemala, the agreed to. f Department of State noted that police cor- The preamble was agreed to. ruption was a serious problem in Guatemala MEASURE PLACED ON The resolution, with its preamble, and that there were credible allegations of reads as follows: CALENDAR—H.R. 1332 involvement by individual police officers in S. RES. 181 Mr. REID. Mr. President, I under- criminal activity, including rapes, killings, and kidnappings; Whereas, Fisher DeBerry, originally of stand that H.R. 1332 is at the desk and Whereas, in its most recent report on Gua- Cheraw, South Carolina, coached football at due for a second reading. temala, the United Nations High Commis- the United States Air Force Academy for 27 The ACTING PRESIDENT pro tem- sioner for Human Rights notes that impu- years, 23 of which as head coach; pore. The majority leader is correct. nity continues to undermine the credibility Whereas, Fisher DeBerry is the winningest The clerk will report. of the justice system in Guatemala and that head coach of any United States service The legislative clerk read as follows: the justice system is still too weak to con- academy with a record of 169–109–1; front organized crime and its powerful struc- Whereas, Fisher DeBerry has amassed a 35– A bill (H.R. 1332) to improve the access to tures; and 11 record against the United States Military capital programs of the Small Business Ad- Whereas, the Government of Guatemala Academy and the United States Naval Acad- ministration, and for other purposes. and the United Nations signed an agreement emy, and led the U.S. Air Force Academy to Mr. REID. Mr. President, I object to on December 12, 2006, to establish the Inter- 14 of its 16 Commander-in-Chief Trophy ti- any further proceedings at this time. national Commission against Impunity in tles; The ACTING PRESIDENT pro tem- Guatemala (Comisio´ n Internacional Contra Whereas, Fisher DeBerry led his Air Force pore. Objection is heard. la Impunidad en Guatemala—CICIG), to as- teams to 3 conference championships and 12 The bill will be placed on the cal- sist local authorities in investigating and bowl games; Whereas, Fisher DeBerry has been recog- endar. dismantling the illegal security groups and clandestine organizations that continue to nized numerous times for his coaching suc- f operate in Guatemala: Now, therefore, be it cess, including selection as National Coach Resolved, That— of the Year for 1985; selection 3 times as EXPRESSING THE SENSE OF THE (1) it is the sense of the Senate that the Western Athletic Conference Coach of the SENATE ON EFFORTS TO CON- International Commission against Impunity Year; induction into the South Carolina TROL GUN VIOLENCE IN GUATE- in Guatemala is an innovative mechanism to Sports Hall of Fame; induction into the Col- MALA support local efforts to confront the en- orado Springs Sports Hall of Fame; induc- Mr. REID. Mr. President, I ask unan- trenched and dangerous problem posed by il- tion into the Independence Bowl Hall of legal armed groups and clandestine security Fame; the 2001 State Farm Coach of Distinc- imous consent that the Foreign Rela- organizations in Guatemala and their infil- tion honor; an honorary doctorate of human- tions Committee be discharged from tration into state institutions; ities from Wofford College; service as presi- consideration of S. Res. 155 and that (2) the Senate commends the Government dent of the American Football Coaches Asso- the Senate proceed to its consider- of Guatemala, local civil society organiza- ciation (AFCA); and service as Chairman of ation. tions, and the United Nations for such a cre- the AFCA ethics committee; The ACTING PRESIDENT pro tem- ative effort; Whereas, Fisher DeBerry has acted as a pore. Without objection, it is so or- (3) the Senate encourages the Guatemalan pillar of the Colorado Springs, Colorado, dered. The clerk will report the resolu- Congress to enact necessary legislation re- community during the past 27 years through quired to implement the International Com- his active involvement and volunteerism tion by title. mission against Impunity in Guatemala and with local church, charity, and community The legislative clerk read as follows: other pending legislation needed to fulfill organizations; A resolution (S. Res. 155) expressing the the 1996 peace agreement; Whereas, in 2004 Fisher DeBerry founded sense of the Senate on efforts to control vio- (4) the Senate calls on the Government of the Fisher DeBerry Foundation, which is lence and strengthen the rule of law in Gua- Guatemala and all sectors of society in Gua- dedicated to the support and education of temala. temala to unreservedly support the inves- single mothers and their children, as well as There being no objection, the Senate tigation and prosecution of illegal armed other charitable causes; proceeded to consider the resolution. groups and clandestine security organiza- Whereas, Fisher DeBerry has served as a tions; and positive influence and role model to numer- Mr. REID. Mr. President, I ask unan- (5) the Senate reiterates its commitment ous future Air Force officers, including imous consent that the resolution be to support the Government of Guatemala in coaching 3,375 players; having a graduation agreed to, the preamble be agreed to, its efforts to strengthen the rule of law in success rate of 91.6 percent among his play- the motion to reconsider be laid upon that country, including the dismantling of ers; and producing 19 All-American players,

VerDate Aug 31 2005 04:38 May 02, 2007 Jkt 059060 PO 00000 Frm 00118 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.022 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5433 124 All-Conference players, 11 Academic All- Association of America, MPAA. He The resolution (S. Res. 182) was Americans, and 9 Postgraduate Scholarship held this, his most famous position, for agreed to. winners; 38 years before retiring in 2004. The preamble was agreed to. Whereas, Fisher DeBerry imparted to his As president of MPAA, Jack arbi- players the core values of the United States trated one of the most famous develop- The resolution, with its preamble, Air Force: Integrity First, Service Before reads as follows: Self, and Excellence In All We Do; and ments the film industry has ever come Whereas, the United States Air Force out with—the voluntary rating system. S. RES. 182 Academy football program under the leader- The ratings ‘‘G,’’ ‘‘PG,’’ ‘‘PG–13’’ and Whereas Jack Valenti was born September ship of Fisher DeBerry has served as an ex- ‘‘R’’ have become staples, not only in 5, 1921, in Houston, Texas, the grandson of ample of these values for its community and the movie-going practices of every Sicilian immigrants, Joe and Josephine Va- the entire Nation: Now, therefore, be it American but also in our Nation’s cul- lenti, and was the youngest high school grad- Resolved, That the United States Senate tural consciousness. However, more im- uate in the city at age 15; honors and recognizes the numerous con- portant than the societal notions and Whereas Jack Valenti married his beloved tributions made by the United States Air Mary Margaret in 1962, with whom he had 3 Force Academy football program over the the cliche´d images associated with these ratings is the real assistance that children, John, Alexandra, and Courtenay; last 27 years to Colorado Springs and the sur- Whereas Jack Valenti joined the United rounding communities, the United States this system has provided to parents States Army Air Forces in 1942 and flew 51 Air Force Academy, and the United States and families in evaluating the appro- combat missions as a pilot of a B-25 attack Air Force. priateness of various movies. Indeed, bomber with the 12th Air Force in Italy dur- f the MPAA rating system pioneered by ing World War II, obtained the rank of lieu- Jack Valenti has become a prime ex- tenant, and received 4 decorations, including HONORING THE LIFE OF JACK the Distinguished Flying Cross, the Air VALENTI ample of the effectiveness of industry self-regulation without government Medal with 4 clusters, the Distinguished Mr. REID. Mr. President, I ask unan- intervention, and I am very grateful Unit Citation with one cluster, and the Euro- imous consent that the Senate proceed pean Theater Ribbon with 4 battle stars; for Jack’s work in this area even when Whereas Jack Valenti received a B.A. de- to the consideration of S. Res. 182. many in his industry fought him along The ACTING PRESIDENT pro tem- gree from the University of Houston in 1946 the way. after doing all of his undergraduate work at pore. The clerk will report the resolu- In addition to pioneering the rating night and working during the day, and be- tion by title. system, Jack Valenti also worked to came the first University of Houston grad- The legislative clerk read as follows: advance the film industry into the 21st uate to be admitted to Harvard Business A resolution (S. Res. 182) honoring the life century. Indeed, during his tenure at School, receiving an M.B.A. degree in 1948; of Jack Valenti. the MPAA, he presided over unprece- Whereas, in 1952, Jack Valenti cofounded There being no objection, the Senate Weekley and Valenti, an advertising and po- dented changes in the worldwide film litical consulting agency that worked on proceeded to consider the resolution. industry, including the advancement of Dwight D. Eisenhower’s presidential cam- f the digital era. I remember having sev- paign in Texas, Representative Albert Thom- eral conversations with Jack as the THE PASSING OF MR. JACK as’s run for Congress, and John Connally’s film industry struggled to deal with campaign for Governor of Texas; VALENTI the new challenges presented by digital Whereas Jack Valenti met then-Senate Mr. HATCH. Mr. President, I wish to distribution of their content. Together, Majority Leader Lyndon B. Johnson in 1957, honor my good friend Jack Valenti, Jack and I worked tirelessly to balance the two became close friends, and Valenti worked on Lyndon Johnson’s presidential who, passed away last week on April 26. the competing demands of consumer’s Throughout his life, Jack Valenti campaign during the primaries of 1960; rights and the protection of one of Whereas Weekley and Valenti handled wore several hats, including that of a America’s largest exports—entertain- press during President John F. Kennedy’s soldier, a devoted public servant, and a ment. and Vice President Lyndon Johnson’s fateful pioneer in the film industry. With Jack’s help, we were able to trip to Dallas, Texas, in November 1963; Jack was born on September 5, 1921, refocus the Federal Government’s re- Whereas Jack Valenti became the first spe- in Houston, TX and was the grandson sources to more effectively protect the cial assistant hired when Lyndon Johnson of Sicilian immigrants. At age 15, he creative genius of a great American in- ascended to the Presidency; became the youngest high school grad- dustry—the film industry. We all know Whereas Jack Valenti resigned his White House post in 1966 and went on to serve as uate in the history of the city of Hous- how blatantly some bad actors around ton and began a career as an office boy the president of the Motion Picture Associa- the world pirate America’s movies and tion of America (MPAA) for the next 38 with Exxon Oil. rob the United States of jobs. Thanks years; Jack served honorably in the Army to Jack’s efforts, we have made great Whereas Jack Valenti, as president of the Air Corps during World War II, flying strides in this area and laid the MPAA, created the voluntary film rating in 51 separate combat missions as pilot groundwork to allow us to stamp out system that is still in place today, which of the B–25 attack bomber with the this criminal activity in the years provides parents with advance information 12th Air Force in Italy. He obtained the ahead. Combating the theft and piracy they can use to determine which movies are appropriate for their children; rank of lieutenant and received mul- of intellectual property was a real pas- tiple decorations, including the Distin- Whereas Jack Valenti’s persona and skill sion for Jack, and I was privileged to combined to give the motion picture indus- guished Flying Cross, the Air Medal work with him in this endeavor. try a strong and enduring presence in the with four clusters, the Distinguished Mr. President, those of us who knew Nation’s capital, which grew year by year Unit Citation with one cluster, and the Jack Valenti personally will always re- during his nearly 4 decade tenure at the European Theater Ribbon with four member him as a charitable man who MPAA; battle stars. was devoted to his family. While his in- Whereas Jack Valenti presided over a After serving in the war, Jack at- fluence on the film industry has been worldwide change in the motion picture in- tended college at the University of famous and unmistakable, many of us dustry, ushered movies into the digital era, Houston, doing all his undergraduate championed artists’ rights, and condemned will remember him more for the per- intellectual property theft; work at night as he worked during the sonal friendship we shared with him. I Whereas Jack Valenti authored 5 books, day. He earned a bachelor of arts de- will miss him greatly. including ‘‘A Very Human President’’, ‘‘Pro- gree in 1946 and later became the Uni- Mr. REID. Mr. President, I ask unan- tect and Defend’’, ‘‘The Bitter Taste Of versity of Houston’s first graduate ever imous consent that the resolution be Glory’’, ‘‘Speak Up With Confidence’’, and, to be admitted to Harvard Business agreed to, the preamble be agreed to, his most recent, ‘‘This Time, This Place: My School. He received an MBA from Har- the motion to reconsider be laid upon Life in War, the White House, and Holly- vard in 1948. the table, and that any statements re- wood’’, and wrote numerous essays for the In the intervening years, Jack held New York Times, the Washington Post, the lating to the resolution be printed in Los Angeles Times, Reader’s Digest, Atlantic many positions in this town, but in 1966 the RECORD. Monthly, Newsweek, Cox newspapers, and Jack resigned from a top position in The ACTING PRESIDENT pro tem- other publications; the White House to become only the pore. Without objection, it is so or- Whereas Jack Valenti was awarded with third president of the Motion Picture dered. France’s highly-prized Legion d’Honneur, the

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00119 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.024 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5434 CONGRESSIONAL RECORD — SENATE May 1, 2007 French Legion of Honor, and has been hon- The new Educational Network Model tional public schools, and often set higher ored with his own star on the Hollywood will organize schools, the majority of and additional individual goals to ensure Walk of Fame; and them charters, into small groups to that charter schools are of high quality and Whereas Jack Valenti will be remembered provide support, foster collaboration truly accountable to the public; as a dedicated family man, a philanthropist, Whereas charter schools give parents new a voice for copyright owners, a true vision- and ensure accountability. This will freedom to choose public schools, routinely ary whose devotion, intelligence, creativity, shift the majority of money and deci- measure parental satisfaction levels, and and wisdom transformed the film industry, sionmaking to the school level, where must prove their ongoing success to parents, and as Hollywood’s ultimate leading man: it can be managed based on the needs policymakers, and communities; Now, therefore, be it of the students in each school. It will Whereas nearly 56 percent of charter Resolved That the Senate honors the life also create a lean district office fo- schools report having a waiting list, and the of Jack Valenti, a pioneer in the fields of cused on academic standards and per- total number of students on all such waiting motion pictures and public service, a dedi- formance monitoring, allowing more lists is enough to fill over 1,100 average-sized cated family man, and a legendary figure in dollars to go to schools. Finally, it will charter schools; the history of the United States. Whereas charter schools nationwide serve migrate toward a single, aligned and f a higher percentage of low-income and mi- highly-effective governing board that nority students than the traditional public NATIONAL CHARTER SCHOOLS provides a stable leadership team with school system; WEEK skills to oversee successful implemen- Whereas charter schools have enjoyed Mr. REID. Mr. President, I ask unan- tation of the plan. broad bipartisan support from the President, imous consent that the Senate proceed Today, over 50 percent of our schools Congress, State governors and legislatures, in New Orleans have reopened as char- educators, and parents across the United to the consideration of S. Res. 183. States; and The ACTING PRESIDENT pro tem- ter schools. They have provided us with an expedient means to restart public Whereas the eighth annual National Char- pore. The clerk will report the resolu- ter Schools Week, to be held April 30 through tion by title. education in New Orleans. It is my May 4, 2007, is an event sponsored by charter The legislative clerk read as follows: hope that we can continue this trend schools and grassroots charter school organi- A resolution (S. Res. 183) supporting the by utilizing the Educational Network zations across the United States to recognize goals and ideals of National Charter Schools Model for these schools and others na- the significant impacts, achievements, and Week, April 30, 2007, through May 4, 2007. tionwide by engaging community in- innovations of charter schools: Now, there- There being no objection, the Senate volvement and support through a fore, be it proceeded to consider the resolution. shared services model. Resolved, That the Senate— Ms. LANDRIEU. Mr. President, today Mr. REID. Mr. President, I ask unan- (1) acknowledges and commends charter imous consent that the resolution be schools and students, parents, teachers, and I wish to honor National Charter administrators of charter schools across the School Week. The role of charter agreed, the preamble be agreed to, the United States for their ongoing contribu- schools has become increasingly impor- motion to reconsider be laid upon the tions to education and improving and tant as these institutions have become table, and that any statements relating strengthening the public school system; one of the fastest growing innovative to the resolution be printed in the (2) supports the goals and ideals of the forces in education policy. The District RECORD, with no intervening action or eighth annual National Charter Schools of Columbia and 40 States have laws debate. Week; and that allow charter schools. There are The ACTING PRESIDENT pro tem- (3) encourages the people of the United States to conduct appropriate programs, over 4,000 public charter schools serv- pore. Without objection, it is so or- dered. ceremonies, and activities to demonstrate ing more than 1.1 million students and support for charter schools during this week- there are many more students on wait- The resolution (S. Res. 183) was long celebration in communities throughout ing lists who want to attend. agreed to. the United States. The preamble was agreed to. As many of you know, I have been a f part of that charter school growth, The resolution, with its preamble, both here in Washington, DC, and in reads as follows: NATIONAL CHILDHOOD STROKE my home, Louisiana. Today, more than S. RES. 183 AWARENESS DAY 30 percent of all DC public school stu- Whereas charter schools deliver high-qual- Mr. REID. Mr. President, I ask unan- dents attend charter schools and are ity education and challenge students to imous consent that the Senate proceed largely successful. These charter reach their potential; Whereas charter schools provide thousands to the consideration of S. Res. 184. school projects are largely successful. of families with diverse and innovative edu- The ACTING PRESIDENT pro tem- These charter schools not only help to cational options for their children; pore. The clerk will report the resolu- better educate students, but are also Whereas charter schools are public schools tion by title. helping to build a better, stronger, authorized by designated public entities to The legislative clerk read as follows: more prosperous city. respond to the needs of communities, fami- A resolution (S. Res. 184) expressing the In addition to having an impact in lies, and students, and to promote the prin- sense of the Senate with respect to childhood Washington, DC, charter schools are ciples of quality, choice, and innovation; stroke and designating May 5, 2007 as ‘‘Na- also helping to rebuild the school sys- Whereas, in exchange for the flexibility tional Childhood Stroke Awareness Day.’’ and autonomy given to charter schools, tem in New Orleans. Hurricanes charter schools are held accountable by their There being no objection, the Senate Katrina and Rita did not just wash sponsors for improving student achievement proceeded to consider the resolution. away our levees—they also washed and for their finances and other operations; Mr. REID. Mr. President, I ask unan- away our homes and schools. We must Whereas 40 States and the District of Co- imous consent that the resolution be seize upon this opportunity and build a lumbia have passed laws authorizing charter agreed to, the preamble be agreed to, better, stronger school system for New schools; and the motion to reconsider be laid Orleans and throughout Louisiana. Whereas more than 4,000 charter schools upon the table. operating across the United States serve Charter schools are key players in The ACTING PRESIDENT pro tem- this process by not only rebuilding our more than 1,140,000 students; Whereas, over the last 13 years, Congress pore. Without objection, it is so or- school system, but reinventing it. has provided more than $2,026,225,000 in sup- dered. Every step in this process is based on port to the charter school movement by pro- The resolution (S. Res. 184) was what is best for our students, with the viding facilities, financing assistance, and agreed to. goal of delivering learning and achieve- grants for planning, startup, implementa- The preamble was agreed to. ment for all students. The new school tion, and dissemination of information; The resolution, with its preamble, system effectively eliminates the pre- Whereas many charter schools improve the reads as follows: achievement of students and stimulate im- vious system of have and have-nots, al- S RES. 184 lowing parents to choose from any provement in traditional public schools; Whereas charter schools must meet the Whereas a stroke, also known as a ‘‘cere- school in the network, making quality student achievement accountability require- brovascular accident’’, is an acute neurologic school options available to all students ments under section 1111 of the Elementary injury that occurs when the blood supply to and raising the bar for educators and Secondary Education Act of 1965 (20 a part of the brain is interrupted by a clot in throughout the system. U.S.C. 6311) in the same manner as tradi- the artery or a burst of the artery;

VerDate Aug 31 2005 04:38 May 02, 2007 Jkt 059060 PO 00000 Frm 00120 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.025 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5435 Whereas a stroke is a medical emergency preamble be agreed to, the motion to stances of survivors and heirs of Holocaust that can cause permanent neurologic damage reconsider be laid on the table, and any victims being refused their moral and legal or even death if not promptly diagnosed and statements be printed in the RECORD. right to information, for restitution pur- treated; The ACTING PRESIDENT pro tem- poses, slave labor compensation, and per- Whereas 26 out of every 100,000 newborns pore. Without objection, it is so or- sonal closure; and almost 3 out of every 100,000 children Whereas opening the historic records is a have a stroke each year; dered. vital contribution to the world’s collective Whereas an individual can have a stroke The resolution (S. Res. 141) was memory and understanding of the Holocaust before birth; agreed to. and efforts to ensure that the anti-Semitism Whereas stroke is among the top 10 causes The preamble was agreed to. that made such horrors possible is never of death for children in the United States; The resolution, with its preamble, again permitted to take hold; Whereas 12 percent of all children who ex- reads as follows: Whereas anti-Semitism has seen a resur- perience a stroke die as a result; S. RES. 141 gence in recent years, and as recently as De- Whereas the death rate for children who Whereas the International Tracing Service cember 2006, the President of Iran, Mahmoud experience a stroke before the age of 1 year (ITS) archives located in Bad Arolsen, Ger- Ahmadinejad, held the second Holocaust de- is the highest out of all age groups; many, which are administered by the Inter- nial conference in Tehran in one year; and Whereas many children who experience a national Committee of the Red Cross, con- Whereas in light of this conference, the stroke will suffer serious, long-term neuro- tain an estimated 50,000,000 records on the anti-Semitic rhetoric of President logical disabilities, including— fates of some 17,500,000 individual victims of Ahmadinejad, and a resurgence of anti-Semi- (1) hemiplegia, which is paralysis of 1 side Nazi war crimes; tism in part of the world, the opening of the of the body; Whereas the ITS archives at Bad Arolsen archives at Bad Arolsen could not be more (2) seizures; remain the largest closed Holocaust-era ar- urgent: Now, therefore, be it Resolved, That the Senate— (3) speech and vision problems; and chives in the world; (1) commends in the strongest terms all (4) learning difficulties; Whereas, although access to individual countries that have to date ratified the Whereas those disabilities may require on- records can be requested by Holocaust sur- amendments to the Agreement Constituting going physical therapy and surgeries; vivors and their descendants, many who have an International Commission for the Inter- Whereas the permanent health concerns requested information from the ITS archives national Tracing Service, signed at Bonn and treatments resulting from strokes that have reported facing significant delays and June 6, 1955 (6 UST 6186) (commonly known occur during childhood and young adulthood even unresponsiveness; as the ‘‘Bonn Accords’’) to allow for open ac- have a considerable impact on children, fam- Whereas the ITS archives remain inacces- cess to the Holocaust archives of the Inter- ilies, and society; sible to researchers and research institu- national Tracing Service (ITS) located at Whereas very little is known about the tions; Bad Arolsen, Germany; cause, treatment, and prevention of child- Whereas the Agreement Constituting an (2) commends the countries that have com- hood stroke; International Commission for the Inter- mitted to expedite the process of releasing Whereas medical research is the only national Tracing Service, signed at Bonn the archives and expects those countries to means by which the citizens of the United June 6, 1955 (6 UST 6186) (commonly known abide by their commitments; States can identify and develop effective as the ‘‘Bonn Accords’’) established an inter- (3) strongly urges all countries that have treatment and prevention strategies for national commission of 11 member countries to yet to ratify the amendments to abide by childhood stroke; (Belgium, France, Germany, Greece, Israel, the treaty obligations made in May 2006 and Whereas early diagnosis and treatment of Italy, Luxembourg, the Netherlands, Poland, to expedite the ratification of the amend- childhood stroke greatly improves the the United Kingdom, and the United States) ments; chances that the affected child will recover charged with overseeing the administration (4) strongly urges all member countries of and not experience a recurrence; and of the ITS Holocaust archives; the International Commission of the ITS to Whereas the Children’s Hospital of Phila- Whereas, following years of delay, in May consider the short time left to Holocaust delphia should be commended for its initia- 2006 in Luxembourg, the International Com- survivors and unanimously consent to open tive in creating the Nation’s first program mission of the ITS agreed upon amendments the ITS archives should all countries not dedicated to pediatric stroke patients: Now, to the Bonn Accords that would allow re- ratify the amendments by May 2007; therefore, be it searchers to use the archives and would (5) expresses the hope that bureaucratic Resolved, That the Senate— allow each member country of the Inter- and diplomatic processes will not further (1) designates May 5, 2007 as ‘‘National national Commission to receive digitized delay this process; and Childhood Stroke Awareness Day’’; and copies of archive materials and make the (6) refuses to forget the murder of 6,000,000 (2) urges the people of the United States to records available to researchers under the re- Jews and more than 5,000,000 other victims support the efforts, programs, services, and spective national laws relating to archives during the Holocaust by Nazi perpetrators advocacy of organizations that work to en- and privacy; and their collaborators. hance public awareness of childhood stroke. Whereas the May 2006 amendments to the f Bonn Accords require each of the 11 member f countries of the International Commission DESIGNATING APRIL 30, 2007, AS URGING ALL MEMBER COUNTRIES to ratify the amendments before open access ‘‘DIA DE LOS NIN˜ OS: CELE- OF THE INTERNATIONAL COM- to the Holocaust archives is permitted; BRATING YOUNG AMERICANS’’ MISSION OF THE INTER- Whereas, although the final signature was NATIONAL TRACING SERVICE TO affixed to the amendments in October 2006, Mr. REID. Mr. President, I ask unan- EXPEDITE THE RATIFICATION only 5 out of the 11 member countries of the imous consent that the Judiciary Com- PROCESS International Commission, the United mittee be discharged from consider- States, Israel, Poland, the Netherlands, and ation of S. Res. 177. Mr. REID. Mr. President, I ask unan- the United Kingdom, have ratified the The ACTING PRESIDENT pro tem- imous consent that the Foreign Rela- amendments; pore. Without objection, it is so or- tions Committee be discharged from Whereas the United States Holocaust Me- dered. The clerk will report the resolu- morial Museum has for years been working further consideration of S. Res. 141. tion by title. The ACTING PRESIDENT pro tem- tirelessly to provide public access to the ma- terials in the Bad Arolsen archives; The legislative clerk read as follows: pore. Without objection, it is so or- Whereas, on March 8, 2007, representatives A resolution (S. Res. 177) designating April dered. The clerk will report the resolu- from the 11 member countries of the Inter- 30, 2007, as ‘‘Dia de los Nin˜ os: Celebrating tion by title. national Commission of the ITS met in the Young Americans,’’ and for other purposes. The legislative clerk read as follows: Netherlands and reviewed the current ratifi- There being no objection, the Senate A resolution (S. Res. 141) urging all mem- cation status of each country and the ratifi- proceeded to consider the resolution. ber countries of the International Commis- cation process in its entirety; Mr. REID. I ask unanimous consent sion of the International Tracing Service Whereas it is a moral and humanitarian that the resolution be agreed to, the who have yet to ratify the May 2006 amend- imperative to permit public access to the preamble be agreed to, the motion to ments to the 1955 Bonn Accords to expedite millions of Holocaust records housed at Bad reconsider be laid on the table, and any the ratification process to allow for open ac- Arolsen; Whereas it is essential that researchers ob- statements be printed in the RECORD cess to the Holocaust archives located at Bad with no intervening action or debate. Arolsen, Germany. tain access while Holocaust survivors are liv- ing, so that the researchers can benefit in The ACTING PRESIDENT pro tem- There being no objection, the Senate their scholarly work from the insights of pore. Without objection, it is so or- proceeded to consider the resolution. eyewitnesses; dered. Mr. REID. I ask unanimous consent Whereas, in the aftermath of the Holo- The resolution (S. Res. 177) was that the resolution be agreed to, the caust, there have been far too many in- agreed to.

VerDate Aug 31 2005 04:38 May 02, 2007 Jkt 059060 PO 00000 Frm 00121 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.030 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5436 CONGRESSIONAL RECORD — SENATE May 1, 2007 The preamble was agreed to. (C) provide opportunities for children of all States, 75 percent of the people affected are The resolution, with its preamble, backgrounds to learn about one another’s women, and the prevalence of autoimmune reads as follows: cultures and to share ideas; diseases is rising; (D) include all members of the family, es- Whereas NIH estimates the annual direct S. RES. 177 pecially extended and elderly family mem- health care costs associated with auto- Whereas many nations throughout the bers, so as to promote greater communica- immune diseases at more than $100,000,000,000 world, and especially within the Western tion among the generations within a family, and there are over 250,000 new diagnoses each ´ ˜ hemisphere, celebrate ‘‘Dıa de los Ninos’’, or enabling children to appreciate and benefit year; ‘‘Day of the Children’’ on the 30th of April, in from the experiences and wisdom of their el- Whereas autoimmune diseases are among recognition and celebration of their coun- derly family members; the top 10 leading causes of death in female try’s future—their children; (E) provide opportunities for families with- children and adult women; Whereas children represent the hopes and in a community to get acquainted; and Whereas autoimmune diseases most often dreams of the people of the United States; (F) provide children with the support they affect children and young adults, leading to Whereas children are the center of Amer- need to develop skills and confidence, and to a lifetime of disability; ican families; find the inner strength—the will and fire of Whereas diagnostic tests for most auto- Whereas children should be nurtured and the human spirit—to make their dreams immune diseases are not standardized, mak- invested in to preserve and enhance eco- come true. ing autoimmune diseases very difficult to di- nomic prosperity, democracy, and the Amer- agnose; ican spirit; f Whereas, because autoimmune diseases are Whereas Hispanics in the United States, THE CALENDAR difficult to diagnose, treatment is often de- the youngest and fastest growing ethnic community in the Nation, continue the tra- Mr. REID. Mr. President, I ask unan- layed, resulting in irreparable organ damage and unnecessary suffering; dition of honoring their children on this day, imous consent that the Senate now and wish to share this custom with the rest Whereas the Institute of Medicine of the proceed en bloc to the consideration of National Academies reported that the United of the Nation; the following calendar items: Calendar Whereas it is projected that by the year States is behind other countries in research 2050, 1 in 4 Americans will be of Hispanic de- No. 121, S. Res. 116; Calendar No. 122, S. into immune system self-recognition, the scent, and currently approximately 12,300,000 Res. 125; Calendar No. 123, S. Res. 146; cause of autoimmune diseases; Hispanic children live in the United States; and Calendar No. 124, S. Res. 162. Whereas a study by the American Auto- Whereas traditional Hispanic family life There being no objection, the Senate immune Related Diseases Association re- centers largely on children; proceeded to consider the resolutions vealed that it takes the average patient with an autoimmune disease more than 4 years, Whereas the primary teachers of family en bloc. values, morality, and culture are parents and and costs more than $50,000, to get a correct Mr. REID. I ask unanimous consent diagnosis; family members, and we rely on children to that the resolutions be agreed to en pass on these family values, morals, and cul- Whereas there is a significant need for ture to future generations; bloc; the amendment to the preamble, more collaboration and cross-fertilization of Whereas more than 500,000 children drop where applicable, be agreed to; the pre- basic autoimmune research; out of school each year, 138,000 of whom are ambles, as amended if amended, be Whereas there is a significant need for re- Hispanic, and these dropout rates are unac- agreed to en bloc; the motions to re- search focusing on the etiology of all auto- ceptably high; consider be laid upon the table en bloc; immune-related diseases, to increase under- standing of the root causes of these diseases Whereas the importance of literacy and that the consideration of these items education are most often communicated to rather treating the symptoms after the dis- appear separately in the RECORD and ease has had its destructive effect; children through family members; any statements be printed in the Whereas families should be encouraged to Whereas the National Coalition of Auto- engage in family and community activities RECORD. immune Patient Groups is a coalition of na- that include extended and elderly family The ACTING PRESIDENT pro tem- tional organizations focused on autoimmune members and encourage children to explore, pore. Without objection, it is so or- diseases working to consolidate the voices of develop confidence, and pursue their dreams; dered. patients with autoimmune diseases and to promote increased education, awareness, and Whereas the designation of a day to honor f the children of the United States will help research into all aspects of autoimmune dis- affirm for the people of the United States the DESIGNATING MAY 2007 AS ‘‘NA- eases through a collaborative approach; and significance of family, education, and com- TIONAL AUTOIMMUNE DISEASES Whereas designating May 2007 as ‘‘National munity; AWARENESS MONTH’’ Autoimmune Diseases Awareness Month’’ Whereas the designation of a day of special would help educate the public about auto- recognition for the children of the United The resolution (S. Res. 116) desig- immune diseases and the need for research States will provide an opportunity for chil- nating May 2007 as ‘‘National Auto- funding, accurate diagnosis, and effective dren to reflect on their future, to articulate immune Diseases Awareness Month’’ treatments: Now, therefore, be it their dreams and aspirations, and to find and supporting efforts to increase Resolved, That the Senate— comfort and security in the support of their awareness of autoimmune diseases and (1) designates May 2007 as ‘‘National Auto- family members and communities; increase funding for autoimmune dis- immune Diseases Awareness Month’’; Whereas the National Latino Children’s In- ease research was agreed to; as follows: (2) supports the efforts of health care pro- stitute, serving as a voice for children, has viders and autoimmune patient advocacy worked with cities throughout the country S. RES. 116 and education organizations to increase to declare April 30 as ‘‘Dı´a de los Nin˜ os: Cele- Whereas autoimmune diseases are chronic, awareness of the causes of, and treatments brating Young Americans’’—a day to bring disabling diseases in which underlying de- for, autoimmune diseases; and together Hispanics and other communities fects in the immune system lead the body to (3) supports the goal of increasing Federal nationwide to celebrate and uplift children; attack its own organs and tissues; funding for aggressive research to learn the and Whereas autoimmune diseases can affect root causes of autoimmune diseases, as well Whereas the children of a nation are the any part of the body, including the blood, as the best diagnostic methods and treat- responsibility of all its people, and people blood vessels, muscles, nervous system, gas- ments for people with autoimmune diseases. should be encouraged to celebrate the gifts trointestinal tract, endocrine glands, and of children to society—their curiosity, multiple-organ systems, and can be life- f laughter, faith, energy, spirit, hopes, and threatening; dreams: Now, therefore, be it Whereas researchers have identified over 80 Resolved, That the Senate— different autoimmune diseases, and suspect ENDANGERED SPECIES DAY (1) designates April 30, 2007, as ‘‘Dı´a de los at least 40 additional diseases of qualifying Nin˜ os: Celebrating Young Americans’’; and as autoimmune diseases; The resolution (S. Res. 125) desig- (2) calls on the people of the United States Whereas researchers have identified a close nating May 18, 2007, as ‘‘Endangered to join with all children, families, organiza- genetic relationship and a common pathway Species Day,’’ and encouraging the peo- tions, communities, churches, cities, and of disease that exists among autoimmune ple of the United States to become edu- States across the United States to observe diseases, explaining the clustering of auto- cated about, and aware of, threats to the day with appropriate ceremonies, includ- immune diseases in individuals and families; species, success stories in species re- ing activities that— Whereas the family of autoimmune dis- covery, and the opportunity to pro- (A) center around children, and are free or eases is under-recognized, and poses a major minimal in cost so as to encourage and fa- health care challenge to the United States; mote species conservation worldwide, cilitate the participation of all our people; Whereas the National Institutes of Health was agreed to. The preamble was (B) are positive and uplifting and that help (NIH) estimates that autoimmune diseases agreed to. The resolution (S. Res. 125), children express their hopes and dreams; afflict up to 23,500,000 people in the United with its preamble, reads as follows:

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00122 Fmt 0624 Sfmt 0634 E:\CR\FM\G01MY6.088 S01MYPT1 hmoore on PRODPC68 with HMSENATE May 1, 2007 CONGRESSIONAL RECORD — SENATE S5437 S. RES. 125 (11) the Department of Health and Human agreed to S. Res. 146, a bipartisan reso- Whereas in the United States and around Services; lution establishing a national Amer- the world, more than 1,000 species are offi- (12) the Department of Energy; ican Eagle Day, on June 20, 2007, the (13) the Department of Housing and Urban cially designated as at risk of extinction and day the bald eagle was selected as our thousands more also face a heightened risk Development; (14) the Central Intelligence Agency; and national emblem during the Second of extinction; Continental Congress in 1782. I am de- Whereas the actual and potential benefits (15) the United States Postal Service; derived from many species have not yet been Whereas, the bald eagle is an inspiring lighted that the bald eagle is scheduled fully discovered and would be permanently symbol of the American spirit of freedom to be ‘‘delisted’’ from the Endangered lost if not for conservation efforts; and democracy; Species Act on June 20 of this year. I Whereas, the image, meaning, and sym- Whereas recovery efforts for species such commend Senators ALEXANDER and as the whooping crane, Kirtland’s warbler, bolism of the bald eagle have played a sig- nificant role in American art, music, his- BYRD for their work on this resolution. the peregrine falcon, the gray wolf, the gray The bald eagle has been protected whale, the grizzly bear, and others have re- tory, literature, architecture, and culture since the founding of our Nation; under Federal law since Congress sulted in great improvements in the viabil- passed the Bald and Golden Eagle Pro- ity of such species; Whereas, the bald eagle is featured promi- Whereas saving a species requires a com- nently on United States stamps, currency, tection Act in 1940. This law prohibits bination of sound research, careful coordina- and coinage; the taking, possessing, or commerce of tion, and intensive management of conserva- Whereas, the habitat of bald eagles exists both bald and golden eagles. The En- tion efforts, along with increased public only in North America; dangered Species Act of 1973 reinforced awareness and education; Whereas, by 1963, the number of nesting pairs of bald eagles in the lower 48 States protection of the bald eagle. I am a Whereas two-thirds of endangered or longtime supporter of the Endangered threatened species reside on private lands; had dropped to about 417; Whereas, the bald eagle was first listed as Species Act, a landmark environ- Whereas voluntary cooperative conserva- mental law that provides crucial pro- tion programs have proven to be critical for an endangered species in 1967 under the En- habitat restoration and species recovery; and dangered Species Preservation Act, the Fed- tection to fish and wildlife on the verge Whereas education and increasing public eral law that preceded the Endangered Spe- of extinction. awareness are the first steps in effectively cies Act of 1973; Vermont is actually one of the only informing the public about endangered spe- Whereas, caring and concerned citizens of States in the continental United States cies and species restoration efforts: Now, the United States in the private and public sectors banded together to save, and help en- without nesting bald eagles. Senator therefore, be it JEFFORDS funded a program about Resolved, That the Senate— sure the protection of, bald eagles; Whereas, in 1995, as a result of the efforts three years ago where orphaned or (1) designates May 18, 2007, as ‘‘Endangered threatened nestlings were relocated Species Day’’; and of those caring and concerned citizens, bald (2) encourages— eagles were removed from the ‘‘endangered’’ from sites between Maryland and (A) educational entities to spend at least 30 species list and upgraded to the less imper- Maine to nests in the Dead Creek State minutes on Endangered Species Day teach- iled ‘‘threatened’’ status under the Endan- wildlife management area in Addison ing and informing students about threats to, gered Species Act of 1973; County, VT, along Lake Champlain. and the restoration of, endangered species Whereas, by 2006, the number of bald eagles in the lower 48 States had increased to ap- About 25 individual birds were suc- around the world, including the essential cessfully raised and released from nests role of private landowners and private stew- proximately 7,000 to 8,000 nesting pairs; Whereas, the administration is likely to of- there. While eagles usually return to ardship to the protection and recovery of nest in the general area where they species; ficially delist the bald eagle from both the (B) organizations, businesses, private land- ‘‘endangered’’ and ‘‘threatened’’ species lists were nestlings, it can take up to 4 owners, and agencies with a shared interest under the Endangered Species Act of 1973, years. Vermont fish and wildlife staff in conserving endangered species to collabo- with a final decision expected no later than are closely monitoring the effort to see rate on educational information for use in June 29, 2007; if Vermont will be successful in joining Whereas, if delisted under the Endangered schools; and other states as a home to the bald (C) the people of the United States to ob- Species Act of 1973, bald eagles should be provided strong protection under the Bald eagle. serve the day with appropriate ceremonies I support the passage of this resolu- and activities. and Golden Eagle Protection Act and the Mi- gratory Bird Treaty Act; tion, which would allow all of us to cel- f Whereas, bald eagles would have been per- ebrate the successful recovery of the manently extinct if not for vigilant con- bald eagle, and to remember the free- DESIGNATING JUNE 20, 2007, AS servation efforts of concerned citizens and ‘‘AMERICAN EAGLE DAY’’ doms and ideals that the eagle rep- strict protection laws; resents as a symbol of our country. The resolution (S. Res. 146) Desig- Whereas, the dramatic recovery of the bald nating June 20, 2007, as ‘‘American eagle population is an endangered species f Eagle Day,’’ and celebrating the recov- success story and an inspirational example for other wildlife and natural resource con- ery and restoration of the American SACRIFICE MADE BY THE MEN servation efforts around the world; AND WOMEN WHO HAVE LOST bald eagle, the national symbol of the Whereas, the initial recovery of the bald United States, was agreed to; as fol- THEIR LIVES WHILE SERVING AS eagle population was accomplished by the LAW ENFORCEMENT OFFICERS lows: concerted efforts of numerous government S. RES. 146 agencies, corporations, organizations, and The Senate proceeded to consider the Whereas, the bald eagle was designated as individuals; and resolution (S. Res. 162) commemorating the national emblem of the United States on Whereas, the sustained recovery of the and acknowledging the dedication and June 20, 1782, by our country’s Founding Fa- bald eagle population will require the con- sacrifice made by the men and women thers at the Second Continental Congress; tinuation of recovery, management, edu- who have lost their lives while serving cation, and public awareness programs, to Whereas, the bald eagle is the central as law enforcement officers. image used in the Great Seal of the United ensure that the population and habitat of bald eagles will remain healthy and secure Mr. LEAHY. Mr. President, I am States and the seals of the President and pleased the Senate is considering today Vice President; for future generations: Now, therefore, be it Resolved, That the Senate— a bipartisan resolution to designate Whereas, the image of the bald eagle is dis- (1) designates June 20, 2007, as ‘‘American played in the official seal of many branches May 15, 2007, as National Peace Officers Eagle Day’’; and and departments of the Federal Government, Memorial Day that Senator SPECTER (2) encourages— including— and I introduced along with the major- (A) educational entities, organizations, (1) Congress; ity leader, and Senators BIDEN, GRASS- businesses, conservation groups, and govern- (2) the Supreme Court; ment agencies with a shared interest in con- LEY, CORNYN, STABENOW, MENENDEZ, (3) the Department of Defense; serving endangered species to collaborate on DURBIN, KOHL, KENNEDY and (4) the Department of the Treasury; education information for use in schools; and BROWNBACK. Last week, the Judiciary (5) the Department of Justice; (B) the people of the United States to ob- Committee favorably reported this res- (6) the Department of State; serve American Eagle Day with appropriate (7) the Department of Commerce; olution unanimously. I thank all mem- ceremonies and other activities. (8) the Department of Homeland Security; bers of the Judiciary Committee and (9) the Department of Veterans Affairs; Mr. LEAHY. Mr. President, I am the cosponsors on this bipartisan reso- (10) the Department of Labor; pleased that today the Senate has lution for their support in recognizing

VerDate Aug 31 2005 03:34 May 02, 2007 Jkt 059060 PO 00000 Frm 00123 Fmt 0624 Sfmt 0634 E:\CR\FM\A01MY6.038 S01MYPT1 hmoore on PRODPC68 with HMSENATE S5438 CONGRESSIONAL RECORD — SENATE May 1, 2007 the sacrifices that law enforcement of- Act of 2005. It is now authorized at $50 S. RES. 162 ficers make each day for the American million per year through fiscal year Whereas the well-being of all citizens of people. 2009 to help State, tribal and local ju- the United States is preserved and enhanced This is now the eleventh year run- risdictions purchase armor vests for as a direct result of the vigilance and dedica- ning that I have been involved in this use by law enforcement officers. I have tion of law enforcement personnel; resolution to honor the sacrifice and already begun to work with my col- Whereas more than 900,000 men and commitment of those law enforcement women, at great risk to their personal safe- leagues to make sure that the bullet- ty, presently serve their fellow citizens as officers who give their lives serving proof vest partnership grant program is guardians of the peace; their communities. For many years I fully funded this year. Bulletproof Whereas peace officers are on the front introduced this resolution with my vests have saved the lives of thousands lines in protecting the schools and school- friend Senator CAMPBELL, a former of officers and are a fundamental line children of the United States; deputy sheriff. Both SENATOR CAMP- of defense that no officer should be Whereas 147 peace officers across the BELL, and I, as a former prosecutor, without. I know I am not alone in call- United States were killed in the line of duty witnessed firsthand the risks faced by ing for the Senate to fully fund the bul- during 2006, which is below the decade-long law enforcement officers every day letproof vest partnership program and I annual average of 167 deaths; Whereas a number of factors contributed while they serve and protect our com- hope the Congress agrees that it is cru- to this reduction in deaths, including— munities. I am pleased that Senator cially important that we provide the (1) better equipment and increased use of SPECTER, himself a former prosecutor, funding authorized for this program. bullet-resistant vests; former chair of the Judiciary Com- Hundreds of thousands of police offi- (2) improved training; mittee, and now our ranking member, cers are counting on us. (3) longer prison terms for violent offend- has become the lead Republican spon- I am also pleased to join with Sen- ers; and sor of this bipartisan measure. ator REED and others to introduce the (4) advanced emergency medical care; Currently, more than 870,000 men and Equity in Law Enforcement Act, which Whereas every other day, 1 out of every 16 women who guard our communities do will provide parity in Federal benefits peace officers is assaulted, 1 out of every 56 for law enforcement officers working in peace officers is injured, and 1 out of every so at great risk. After the hijacked 5,500 peace officers is killed in the line of planes hit the World Trade Center in private educational institutions and duty somewhere in the United States; and New York City on September 11, 2001, for our Nation’s rail carriers. Among Whereas on May 15, 2007, more than 20,000 72 peace officers died while trying to these benefits are access to grants peace officers are expected to gather in ensure that their fellow citizens in under the bulletproof vest partnership, Washington, D.C., to join with the families those buildings got to safety. That act and survivor benefits. All of the men of their recently fallen comrades to honor of terrorism resulted in the highest and women who serve our society as those comrades and all others who went be- number of peace officers ever killed in law enforcement officers should be fore them: Now, therefore, be it Resolved, That the Senate— a single incident in the history of our equally entitled to all of the benefits the Federal Government provides, no (1) recognizes May 15, 2007, as ‘‘Peace Offi- country, and is a tragic reminder of cers Memorial Day’’, in honor of the Federal, how important it is for the Congress to matter where they serve. State, and local officers that have been provide all of the resources necessary I think we can all agree that the men killed or disabled in the line of duty; and to protect officers in the line of duty. and women in law enforcement who (2) calls on the people of the United States Since the first recorded police death have sacrificed for our safety deserve to observe that day with appropriate cere- in 1792, there have been more than our deep gratitude and respect. Na- monies and respect. 17,900 law enforcement officers who tional Peace Officers Memorial Day have made the ultimate sacrifice. We will offer the people of the United f are fortunate in Vermont that we rank States, in their communities, in their ORDERS FOR WEDNESDAY, MAY 2, as the State with the fewest officer State capitals, and in the Nation’s Cap- 2007 deaths in history. With 19 deaths, how- ital, the opportunity to honor and re- ever, that is 19 deaths too many. In flect on the extraordinary service and Mr. REID. Mr. President, I ask unan- 2006, 147 law enforcement officers died sacrifice given year after year by our imous consent that when the Senate while serving in the line of duty, well police forces. completes its business today, it stand below the decade-long average of 165 Our Nation’s law enforcement offi- adjourned until 9:30 a.m., Wednesday, deaths annually, and a drop from 2005 cers deserve our commitment to pro- May 2; that on Wednesday, following when 156 officers were killed. That is tect those who help keep us all safe. the prayer and pledge, the Journal of 147 officers too many. We need to con- They are the real-life heroes; too many proceedings be approved to date, the of whom too often make the ultimate tinue our support for better equipment morning hour be deemed expired, and sacrifice. It is important to support and the increased use of bullet-resist- the time for the two leaders be re- and respect our State and local police ant vests, improved training, and ad- served for their use later in the day; officers and all of our first responders, vanced emergency medical care. I hope that there then be a period of morning and to recognize their role in upholding as the 110th Congress moves forward business for 60 minutes, with the first the rule of law and keeping our Na- that all Senators can work together to half controlled by the majority and the tion’s citizens safe and secure. During ensure that all of our law enforcement final portion under the control of the the week of May 13, more than 20,000 officers and their families have the full Republicans; that at the close of morn- peace officers are expected to gather in support and the resources they need ing business the Senate then resume Washington to join with the families of from the Federal Government. consideration of S. 1082, and the man- I am proud of the work I have been their fallen comrades. I thank the Sen- datory quorum call under rule XXII be involved in to help make it safer on the ate for joining in honoring their serv- waived. beat for our officers. Back in 1998, Sen- ice and passing this bipartisan resolu- The PRESIDING OFFICER. Without ator Campbell and I authored the Bul- tion. objection, it is so ordered. The amendment (No. 1007) was agreed letproof Vest Grant Partnership Act in to, as follows: response to the tragic Carl Drega f shootout on the Vermont-New Hamp- AMENDMENT NO. 1007 shire border, in which two State troop- On page 2, strike the first whereas clause ADJOURNMENT UNTIL 9:30 A.M. and insert: TOMORROW ers who lacked bulletproof vests were Whereas peace officers are on the front killed. Since then, we have successfully lines in protecting the schools and school- Mr. REID. Mr. President, if there is reauthorized this program three more children of the United States; no further business to come before the times: In the Bulletproof Vest Partner- The resolution (S. Res. 162), as Senate this evening, I now ask unani- ship Grant Act of 2000, in the State amended, was agreed to. mous consent the Senate stand ad- Justice Institute Reauthorization Act The preamble, as amended, was journed under the previous order. of 2004, and most recently as part of agreed to. There being no objection, the Senate, the Violence Against Women and De- The resolution, with its preamble, as at 7:49 p.m., adjourned until Wednes- partment of Justice Reauthorization amended, reads as follows: day, May 2, 2007, at 9:30 a.m.

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