December 7, 1995 CONGRESSIONAL RECORD — SENATE S18183 Reid Rockefeller Simon Mr. KENNEDY. Mr. President I yield were a lawyer advising a physician who Robb Sarbanes Wellstone myself 4 minutes and 15 second and ask performed abortions, I would tell him NOT VOTING—1 to be notified at that time. to stop, because there is just no way to Moynihan Mr. President, I oppose the pending tell whether the procedure will [violate So the conference report was agreed bill and strongly support the Boxer this law].’’ Dr. Robinson, who has practiced med- to. amendment to protect the lives and icine for over 40 years, expressed the Mr. GREGG. Mr. President, I move to health of women. I came away from the fear that if doctors are unwilling to reconsider the vote. November 17 Judiciary Committee hearing more convinced than ever that perform needed abortions, women will Mr. HOLLINGS. I move to lay that resort to the back-alley methods that motion on the table. this bill is an unwise, unconstitu- tional—— were used before safe, legal abortions The motion to lay on the table was became available. He testified: agreed to. Mrs. BOXER. Mr. President, if I could ask the Senator to yield, the In the 1950’s in New York, I watched f Senate is not in order. women die from abortions that were improp- PARTIAL-BIRTH ABORTION BAN The PRESIDING OFFICER. Will the erly done. By banning this technique, you would, in practice, ban most later abortions ACT Senators to the left of me take their altogether by making them virtually un- The PRESIDING OFFICER. Under conversations off the floor? available. And that means that women will the previous order, the Senate will now The Senator from Massachusetts. probably die. I know. I’ve seen it happen. resume the consideration of H.R. 1833, Mr. KENNEDY. Mr. President, I op- Despite the bill’s apparently delib- which the clerk will now report. pose the pending bill to outlaw medi- erate vagueness, the one activity it The legislative clerk read as follows: cally necessary abortions, and I strong- clearly bans is a procedure known as ly support the Boxer amendment to A bill (H.R. 1833) to amend title 18, United ‘‘intact dilation and extraction’’ or States Code, to ban partial-birth abortions. protect the lives and health of women. ‘‘D&E’’ surgery. There are perhaps 450 The Senate began to debate H.R. 1833 such operations performed in the The Senate resumed the consider- last month, a mere 6 days after the bill ation of the bill. United States each year, and they in- had passed the House. At first, the volve ‘‘wanted pregnancies gone trag- Pending: bill’s Senate sponsors even refused the ically awry,’’ according to Dr. Mary Smith amendment No. 3080, to provide a reasonable request that hearings be life-of-the-mother exception. Campbell of Planned Parenthood, who Dole amendment No. 3081 (to amendment held. But a strong bipartisan majority testified at the hearing. Dr. Campbell No. 3080), of a perfecting nature. of the Senate rejected that unaccept- explained that when emergency condi- Pryor amendment No. 3082, to clarify cer- able approach. The bill was committed tions threaten the life or health of the tain provisions of law with respect to the ap- to the Judiciary Committee for a hear- pregnant woman, this procedure is proval and marketing of certain prescription ing. But there was no committee mark- safer than any other abortion method, drugs. up and the Senate does not have the such as induced labor or caesarean sec- Boxer amendment No. 3083 (to amendment benefit of a committee report. tion. No. 3082), to clarify the application of certain The haste with which this bill is Depending upon the position of the provisions with respect to abortions where being pushed through the Senate is un- fetus in the womb, a woman is 14 times necessary to preserve the life or health of as likely to die from a C-section as the woman. seemly. Obviously, its proponents don’t Brown amendment No. 3085, to limit the want their proposal examined too from a D&E, and twice as likely to die ability of dead beat fathers and those who closely. They’d rather have the Senate from induced labor as from a D&E, ac- consent to the mother receiving a partial- vote on emotion, not on the facts. cording to Dr. Campbell. C-sections birth abortion to collect relief. I attended the November 17 hearing, create an increased risk of rupture of AMENDMENT NO. 3083 TO AMENDMENT NO. 3082, and I came away from it more con- the uterus in future pregnancies. AND AMENDMENT NO. 3081 TO AMENDMENT NO. vinced than ever that this bill is an un- The bill’s supporters ignore this com- 3080 wise, unconstitutional, and dangerous pelling medical testimony and the The PRESIDING OFFICER. Under proposal. scholarly articles that support it. They the previous order, there will now be 60 The hallmark of good legislation is rely instead on a single quotation from minutes equally divided for debate on clarity. But the November 17 hearing a single doctor to the effect that 80 per- amendments by Senators DOLE and revealed that this bill is unacceptable cent of these abortions he performs are ‘‘elective.’’ But proponents of the bill BOXER. vague. In criminal legislation like this, are grossly distorting what that doctor The Senate will be in order. that’s unconstitutional, and it’s quite said. They never complete the Who seeks recognition? likely that the courts will throw out quotation—the doctor stated that he is Mr. KENNEDY addressed the Chair. this bill under the void for vagueness referring to abortions before the sixth The PRESIDING OFFICER. The Sen- doctrine. ator from Massachusetts. month of pregnancy. The problem is obvious. The Judici- The Supreme Court has made plain Mr. KENNEDY. Mr. President, I ask ary Committee heard from a panel of that in the case of such pre-viability the Senator from California for 5 min- medical experts who could not even abortions, a woman may elect to ter- utes, when the Senate is in order. agree among themselves on the med- minate her pregnancy without the Mrs. BOXER. Mr. President, if you ical meaning of the legislative lan- undue interference from the Govern- will bring the Senate to order? guage, or on which procedures might be ment. After viability, of course, there The PRESIDING OFFICER. The Sen- banned. Dr. Courtland Robinson of are no elective abortions. As Dr. Camp- ator from Massachusetts has asked for Johns Hopkins University called the bell noted emphatically, ‘‘third tri- 5 minutes from the Senator from Cali- language ‘‘vague, not medically sub- mester abortion for healthy babies is fornia. stantiated, and just not medically cor- not available in this country.* * * Oc- Mrs. BOXER. Yes, as soon as the Sen- rect . . . the name [partial-birth abor- casionally, someone comes to see me ate is in order. I do not believe we tion] did not exist until someone who who thinks she is 10 weeks pregnant; it should start the clock running until wanted to ban an abortion procedure turns out she is 32 weeks pregnant. I the Senate is in order. Mr. President, made up this erroneous, inflammatory don’t say, ‘where can we get you a this is a very serious difficult debate. term.’’ third-trimester abortion.’ I say, ‘You Members on both sides feel very The bill’s very vagueness itself will be having a baby.’’’ strongly. I will be happy to yield 5 min- threatens the lives and health of Amer- The Judiciary Committee heard the utes to the Senator from Massachu- ican women. In the absence of a clear facts about the D&E procedure from setts when the Chair believes the Sen- definition of what is outlawed, doctors doctors. We also heard moving testi- ate is in order. will decline to perform any abortion mony from two women who needed and The PRESIDING OFFICER. The Sen- that a prosecutor or jury might later obtained this surgery to avoid serious ator will begin debate when there is find objectionable. health consequences. order. Prof. Louis Michael Seidman of Coreen Costello is a pro-life Repub- The Senator from Massachusetts. Georgetown Law Center testified: ‘‘If I lican. She learned that the fetus she

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00067 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18184 CONGRESSIONAL RECORD — SENATE December 7, 1995 was carrying had ‘‘a lethal neuro- sage will advance their goal of discred- Senator SMITH and Senator DOLE logical disorder.***Due to swelling, iting Roe versus Wade and eventually know how to write a genuine life-of- her head was already larger than that outlawing all abortions. The bill’s sup- the-mother exception. The model is ob- of a full-term baby. Natural birth or an porters in the House boasted of such a vious—the long-standing Hyde amend- induced labor were impossible.’’ The strategy. At least one witness at the ment in Medicaid, which allows Med- D&E procedure, she said, ‘‘greatly low- committee hearing spoke frankly of icaid to pay for abortions in cases ered the risk of my death.***There this broader agenda. Helen Alvare of where it is necessary to save the life of was no reason to risk leaving my chil- the Catholic Conference testified in the mother. dren motherless if there was no hope of support of the bill. She responded to But Senator SMITH and Senator DOLE saving [my baby].’’ questioning by Senator FEINGOLD that don’t want a real exception for the life Vicki Wilson testified about an she absolutely favored criminal pen- of the mother. In fact, their language equally tragic pregnancy. As she told alties for all abortion procedures. As does not even protect a woman’s life. It the committee, ‘‘approximately 2/3 of she said, ‘‘If abortion proponents are contains two gaping loopholes, and my daughter’s brain had formed on the afraid that somehow this [bill] opens these loopholes make it meaningless. outside of her skull.***Because of the public mind to considering abor- First, the Smith/Dole amendment the size of her anomaly, the doctors tion further, they are certainly right.’’ limits the types of life-threatening sit- feared that my uterus would rupture in That is why supporters of this bill do uations in which the exception applies. the birthing process, most likely ren- not mind its vagueness. They do not Only threats to a woman’s life that dering me sterile.’’ She pleaded with really want to imprison the doctors arise from ‘‘a physical disorder, illness the committee: ‘‘There will be families who perform this procedure. They want or injury’’ are covered. It does not in the future faced with this tragedy to intimidate all doctors into refusing cover the threat to a woman’s life that because prenatal testing is not infal- to perform any abortions at all. may arise from the pregnancy itself, lible. I urge you, please don’t take Before we head down that dangerous since pregnancy is not a ‘‘physical dis- away the safest procedure available. road, we should remember that Roe order, illness or injury.’’ Coreen This issue isn’t about choice, it’s about versus Wade and the subsequent Su- Costello, for example, did not have an medical necessity.’’ preme Court decisions affirming a illness like cancer or diabetes that The bill’s supporters obviously can- woman’s right to choose are based threatened her life. The threat to her not deal with the force of this first- squarely on the Constitution. The con- life arose from her pregnancy itself, hand testimony. So what do they do? stitutional basis of the decision has and would not be covered by the Smith/ They now suggest that the surgical been reaffirmed by the Supreme Court Dole exception. procedures that saved Coreen Costello in case after case since 1973. In its deci- Second, the Smith/Dole exception is and Viki Wilson were not ‘‘partial- sion in Planned Parenthood versus conditioned on whether ‘‘any other birth abortions.’’ Danforth, the Supreme Court specifi- medical procedure would suffice’’ to That devious retreat speaks volumes cally invalidated a Missouri law that save the woman’s life. This proviso is about the vagueness of this bill, and banned a particular abortion proce- an outrageous example of second-guess- the uncertainty it is designed to cre- dure. The Court held that the Missouri ing a doctor’s judgment. Doctors who ate. Even its sponsors don’t know what law might force ‘‘a woman and her phy- had literally saved a patient’s life it means. But let there be absolutely sician to terminate her pregnancy by could find themselves in a Federal pris- no mistake. The procedure that these methods more dangerous to her health on because a prosecutor and a jury con- two witnesses underwent was an intact than the method outlawed.’’ cluded after the fact that the patient’s D&E. It was the procedure depicted on This bill is a frontal assault on set- life could also have been saved using a Senator SMITH’s charts. It is the proce- tled Supreme Court law. Basically, it different medical procedure that of- dure that the bill’s proponents say they asks the Supreme Court to overrule fended Congress’ sensibilities less. object to. It is the procedure that saved Roe versus Wade. What doctor would take that chance? the lives and health of Coreen Costello At the hearing, Professor Seidman of None. The Smith/Dole exception is a and Vicki Wilson. And now the bill’s Georgetown Law Center identified a sham. It provides no significant addi- supporters pretend the bill wouldn’t half dozen independent reasons why the tional protection to doctors who want apply to those cases. If it doesn’t apply bill is unconstitutional. The most dis- to save the life of the woman. to those cases, it will not apply to any turbing of all the reasons is the bill’s Few aspects of the lives of citizens cases. failure to permit abortions that are are as sensitive and as deserving of pri- These two brave women do not stand necessarily to preserve the life of the vacy as the relationship between pa- alone. Five other women submitted woman or to protect her from serious tients and their physicians. Several testimony for the record describing adverse health consequences. years ago, we debated a proposal to gag similar cases. Thousands of women owe The Boxer amendment would at least physicians and prevent them from their lives or their health to the avail- remedy this most glaring defect. It counseling women about abortion. But ability of a surgical procedure that the states clearly that the criminal prohi- this bill makes the gag rule debate pale U.S. Senate is on the verge of out- bition in the bill will not apply in the by comparison. It puts the Federal lawing and sending any doctor to pris- case of pre-viability abortions, or in Government—indeed, Federal law en- on who performs it. the case of abortions that in the med- forcement officers—directly into the On its face, this bill is an unprece- ical judgment of the attending physi- doctor’s office in the most intrusive dented intrusion by Congress into the cian are necessary to preserve the life way. practice of medicine. Its passage would of the mother or avoid serious, adverse The procedure involved in this case is represent the first time in American health consequences. extremely rare. It involves tragic cir- history that Congress has outlawed a Every Member of the Senate who cumstances late in pregnancy where specific medical procedure and imposed supports Roe versus Wade should sup- the mother’s life or health is in danger. criminal penalties on doctors for treat- port the Boxer amendment. So should The Federal Government has no busi- ing their patients. As Dr. Robinson told every Member of the Senate who wants ness intruding into these family deci- the Judiciary Committee: ‘‘With all to protect the lives and health of sions at all, and certainly not in so due respect, the Congress of the United American women. misguided a fashion. States is not qualified to stand over In contrast, the Smith/Dole version The laws in 41 States already regu- my shoulder in the operating room and of the exception is grossly inadequate. late post-viability abortions. The ap- tell me how to treat my patients.’’ It fails to address the situation where propriations of medical practices is This political excursion into the an abortion is necessary to avoid seri- overseen by state and local health de- practice of medicine is plainly inappro- ous adverse health consequences. The partments, medical societies, hospital priate. So why is it before the Senate Boxer amendment protects both the ethical boards, and other organiza- today? The answer is simple. The right- life and the health of the woman. The tions. The Federal criminal law is a to-life movement has brought this bill Smith/Dole amendment protects only preposterous means of regulating the to Congress in the hope that its pas- the woman’s life. highly personal, individual decisions

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00068 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18185 facing families with tragic preg- and grabbed the baby’s legs and pulled them MOLINARI, and JOHN DINGELL? One pro- nancies. down into the birth canal. Then he delivered choice Member of the House com- Coreen Costello told the Judiciary the baby’s body and the arms—everything mented, ‘‘It undermines the credibility Committee: ‘‘We are the families that but the head. The doctor kept the head right of the pro-choice movement to be de- inside the uterus.... ache to hold our babies, to raise them, The baby’s little fingers were clasping and fending such an indefensible proce- to love and nurture them. We are the unclasping, and his little feet were kicking. dure.’’ families who will forever have a hole in Then the doctor stuck the scissors in the When we strip away all these argu- our hearts. We are the families that back of his head, and the baby’s arms jerked ments, we are left an uncomfortable had to choose how our babies would out, like a startled reaction, like a flinch, truth: This procedure is not the prac- die. Each one of you should be grateful like a baby does when he thinks he is going tice of medicine, it is an act of vio- that you and your families have not to fall. lence. had to face such a choice. I pray that The Doctor opened up the scissors, stuck a It is hard to clearly confront reality high-powered suction tube into the opening, no one you love ever does. Please put a and sucked the baby’s brains out. Now the in this matter, because clarity causes stop to this terrible bill. baby went completely limp. such anguish. But that reality is sim- I join Coreen Costello in urging the I was really completely unprepared for ple and terrible: The death of a child Senate to defeat this bill. The test for what I was seeing. I almost threw up as I with the most perfect angelic face I every male Senator in this Chamber is watched Dr. Haskell doing these things. think I have ever seen in my life. That very simple—would you deny this pro- Next, Dr. Haskell delivered the baby’s face should haunt us and shame us as a cedure to your wife or daughter if it’s head. He cut the umbilical cord and deliv- society. It should cause us to grieve— needed to save her life or health? ered the placenta. He threw the baby into a but more than that, it should cause us Would you send her doctor who per- pan, along with the placenta and the instru- ments he had just used. I saw the baby move to turn back from this path to barba- formed it to jail? in the pan. I asked another nurse, and she rism. This bill is medical malpractice. The said it was just ‘‘reflexes.’’ Mr. President, I ask unanimous con- Senate should stop practicing medicine I had been a nurse for a long time, and I sent to have printed in the RECORD an without a license. This bill should be have seen a lot of death—people maimed in article written by George Will called, defeated. accidents, gunshot wounds, you name it. I ‘‘Fanatics For ‘Choice.’ Partial-birth The PRESIDING OFFICER. Who have seen surgical procedures of every sort. abortions, sonogram photos and ‘the seeks recognition? But in all my professional years, I had never idea that the fetus means nothing.’’’ Mr. GRAMM addressed the Chair. witnessed anything like this. The woman wanted to see her baby, so they There being no objection, the article The PRESIDING OFFICER. The Sen- was ordered to be printed in the ator from Texas. cleaned up the baby and put it in a blanked RECORD, as follows: Mr. GRAMM. Mr. President, I yield and handed it to her. She cried the whole time. She kept saying, ‘‘I am so sorry, please as much time as he might require to FANATICS FOR ‘‘CHOICE’’ forgive me.’’ I was crying, too. I couldn’t (By George F. Will) the distinguished Senator from Indi- take it. That baby boy had the most perfect Americans are beginning to recoil against ana, Senator COATS. angelic face I think I have ever seen in my the fanaticism that has helped to produce The PRESIDING OFFICER. The Sen- life. this fact: more than a quarter of all Amer- ator from Indiana is recognized. The only possible way to defend this Mr. COATS. Mr. President, Ameri- ican pregnancies are ended by abortions. procedure is with evasion and mis- Abundant media attention has been given to cans have honest disagreements over representation. the extremism that has tainted the right-to- the subject of abortion. Strong convic- It is said that this procedure is rare. life movement. Now events are exposing the tions often lead to strident rhetoric, at But we are safely talking about hun- extraordinary moral evasions and callous- times straining the bounds of civil dis- dreds of these abortions annually. And ness characteristic of fanaticism, prevalent in the abortion-rights lobby. course. Labels and name calling too as a matter of unalienable human easily substitute for persuasion as a Begin with ‘‘partial-birth abortions.’’ Pro- rights, it should not only be rare, it abortion extremists object to that name, means of winning the hearts and minds should be nonexistent. of fellow citizens. Extremism and fa- preferring ‘‘intact dilation and evacuation,’’ I suggest, if we are talking about 1 for the same reason the pro-abortion move- naticism are served up as daily fare, abortion with this procedure rather ment prefers to be called ‘‘pro-choice.’’ What often being dismissively attached to than 600, the issue is exactly the same. is ‘‘intact’’ is a baby. During the debate that those with strong pro-life views. It is said that the child feels nothing. led to House passage of a ban on partial- And yet there are times when strong But we know that a mother’s anes- birth abortions, the right-to-life movement words are necessary, when truth, raw was criticized for the sensationalism of its thesia does not eliminate her child’s and exposed, merits an apt label. There print advertisements featuring a Dayton pain. And we know that a child killed is only one issue at stake here: It is an nurse’s description of such an abortion: in this procedure feels exactly what a affront to humanity and justice to kill ‘‘The mother was six months pregnant. The preemie would feel if its doctors de- baby’s heartbeat was clearly visible on the a kicking infant with scissors as it cided to kill it in its nursery. ultrasound screen. The doctor went in with emerges from its mother. It is said that this procedure is done forceps and grabbed the baby’s legs and This legislation is not the expression pulled them down into the birth canal. Then of extremism. Only the procedure itself to save the life of the mother. But we know that this procedure is not with- he delivered the baby’s body and the arms— is extreme—extreme in its violence, ex- everthing but the head. The doctor kept the treme in its disregard for human life out substantial risk for the mother. baby’s head just inside the uterus. The and dignity. And, in fact, its primary purpose is the baby’s little fingers were clasping and un- We have listened to the words of an convenience of the abortionist. clasping and his feet were kicking. Then the eyewitness to this procedure. So we It is said that partial birth abortions doctor stuck the scissors through the back of know what the procedure is. A pro- are part of the mainstream of medi- his head, and the baby’s arms jerked out in cine. But we know that the AMA Coun- a flinch, a startle reaction, like a baby does choice nurse who assisted an abor- when he thinks that he might fall. The doc- tionist in this procedure described the cil on Legislation stated that this prac- tice is not a ‘‘recognized medical tech- tor opened up the scissors, stuck a high-pow- procedure. I do not like to describe the ered suction tube into the opening and procedure on this floor. I do not like to nique’’ and that the ‘‘procedure is basi- sucked the baby’s brains out.’’ read the procedure. But I know one cally repulsive.’’ To object to this as sensationalism is to thing. I cannot condone or support this I am quoting. The AMA Council on say that discomforting truths should be sup- procedure. And, if we are going to vote Legislation said that this procedure is pressed. But increasingly the language of pro-abortion people betrays a flinching from with a clear understanding of what it is ‘‘basically repulsive.’’ I think anyone who understands the procedure and facts. In a woman’s story about her chemical we are dealing with, we need to under- abortion, published last year in Mother stand the procedure. knows the description of the procedure can come to no other conclusion. Jones magazine, she quotes her doctor as I quote from this pro-choice nurse saying, ‘‘By Sunday you won’t see on the who assisted an abortionist in this pro- It is said that only prolife fanatics monitor what we call the heartbeat.’’ ‘‘What cedure. support this legislation. But how could we call’’? In partial-birth abortions the birth What I saw is branded on my mind this possibly apply to Members of the is kept (just barely) partial to preserve the forever...Dr. Haskell went in with forceps House like PATRICK KENNEDY, SUSAN legal fiction that a baby (what some pro-

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00069 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18186 CONGRESSIONAL RECORD — SENATE December 7, 1995 abortion people call ‘‘fetal material’’) is not Wolf argued for keeping abortion legal but preferable one because it articulates being killed. An abortionist has told The treating it as a matter of moral gravity be- the basic constitutional standard New York Times that some mothers find cause ‘‘grief and respect are the proper tones which was setforth in Row v. Wade and such abortions comforting because after the for all discussions about choosing to endan- upheld in Casey v. Planned Parenthood killing, the small body can be ‘‘dressed and ger or destroy a manifestation of life.’’ This held’’ so the (if pro-abortionists will pardon temperate judgment drew from Jane John- in 1992, an opinion written by three the expression) mother can ‘‘say goodbye.’’ son, interim president of Planned Parent- Justices appointed by Presidents The New York Times reports, ‘‘Most of the hood, a denunciation of the ‘‘view that there Reagan and Bush. doctors interviewed said they saw no moral are good and bad reasons for abortion.’’ So, When you talk about the life of the difference between dismembering the fetus who now are the fanatics? mother and the health of the mother, within the uterus and partially delivering it, Mr. COATS. With that, Mr. Presi- conditioning the health on ‘‘serious ad- intact, before killing it.’’ Yes. dent, I yield the floor. verse health consequences,’’ that is the Opponents of a ban on partial-birth abor- constitutionally protected doctrine. tions say almost all such abortions are medi- The PRESIDING OFFICER. Who cally necessary. However, an abortionist at yields time? When you talk about the language of the Dayton clinic is quoted as saying 80 per- Mrs. BOXER. Mr. President, I yield the Dole amendment, which I intend to cent are elective. Opponents of a ban on such myself 2 minutes, and then I will yield support, it is not in the blanket terms abortions assert that the baby is killed be- directly to Senator SPECTER. of life of the mother as in the Hyde fore the procedure, by the anesthesia given I wish to put a face to the women in amendment or the traditional amend- to the mother. (The baby ‘‘undergoes de- this debate, so night after night as ments which are offered on appropria- mise,’’ in the mincing words of Kate Senator SMITH and I have debated this tions bills which make an exception for Michelman of the National Abortion and Re- issue, I have shown the faces of dif- life of the mother but instead talks productive Rights Action League. Does ferent families who have had to face about ‘‘saving the life of the mother Michelman say herbicides cause the crab grass in her lawn to ‘‘undergo demise’’? Such this tragedy who are never shown on whose life is endangered by a physical Orwellian language is a sure sign of squeam- the posters that the other side has used disorder, illness or injury, provided ishness.) However, the president of the during this debate. Those are the faces that no other medical procedure would American Society of Anesthesiologists says that I think are very, very crucial and suffice for that purpose.’’ this ‘‘misinformation’’ has ‘‘absolutely no very, very important. That language is hard to interpret at basis in scientific fact’’ and might endanger This is Coreen Costello about whom best, and I do believe would place sub- pregnant women’s health by deterring them Senator KENNEDY commented. This is a stantial doubt in the minds of many from receiving treatment that is safe. woman who describes herself as a pro- doctors who would be called upon to Opponents of a ban say there are only about 600 such procedures a year. Let us sup- life Republican who underwent this try to figure out what it means. pose, as not everyone does, the number 600 is procedure so she could live to see her This is a medical procedure which is accurate concerning the more than 13,000 other children grow. chilling beyond any question, and we abortions performed after 21 weeks of gesta- Why on Earth would we in the Sen- do at the present time have a line tion. Still, 600 is a lot. Think of two crashes ate, knowing nothing about medicine, drawn as to when there is someone of jumbo airliners. Opponents of the ban ban a procedure that some doctors tes- alive protected by the laws against darkly warn that it would be the first step tified before us at the Judiciary Com- homicide and infanticide and the con- toward repeal of all abortion rights. Col- mittee saves lives like this and gives stitutional protections which apply on umnist John Leo of U.S. News & World Re- these children a mother. the medical procedure of abortions. port says that is akin to the gun lobby’s ar- We had only 1 day of hearings on this gument that a ban on assault weapons must I would say that as Senator COATS lead to repeal of the Second Amendment. read the quote from the nurse, what he matter. The day we had was certainly In a prophecy born of hope, many pundits failed to say is she had worked for 3 preferable to having no hearings at all, have been predicting that the right-to-life days in this clinic in a temporary ca- but we were unable to get on relatively ‘‘extremists’’ would drastically divide the pacity. The fact is that her supervisor short notice, because we had a very Republican Party. But 73 House Democrats wrote the following, and I would place limited time span, the doctors who voted to ban partial-birth abortions; only 15 it in the RECORD: were really familiar with these proce- Republicans opposed the ban. If the ban sur- dures. The fact is that those who are vives the Senate, President Clinton will Miss Pratt— probably veto it. The convention that nomi- This nurse— familiar were reluctant to step forward nated him refused to allow the Democratic Absolutely could not have witnessed and offer medical judgments. But we governor of Pennsylvania, Bob Casey, who is fetal movement as she describes. We do heard very profound testimony from pro-life, to speak. Pro-choice speakers ad- not train temporary nurses in second physicians who expressed the concern dressed the 1992 Republican Convention. The trimester dilation and extractions about having legislation in this field two presidential candidates who hoped that a since it is highly technical and would where it is very difficult to start to pro-choice stance would resonate among Re- not be performed by someone in a tem- draw lines about what medical prac- publicans—Gov. Pete Wilson, Sen. Arlen porary capacity. tices and what medical procedures Specter—have become the first two can- He also failed to mention that the ought to be. didates to fold their tents. In October in The New Republic, Naomi American Nurses Association, which There is so much to be said for the Wolf, a feminist and pro-choice writer, ar- represents 2.2 million nurses, who learn proposition that it is between the doc- gued that by resorting to abortion rhetoric to save lives, strongly opposes this leg- tor and the patient as to what is nec- that recognizes neither life nor death, pro- islation. They do not believe it is hu- essary for the life of a mother, which is choice people ‘‘risk becoming precisely what mane to deprive women such as Coreen at least the most restrictive standard our critics charge us with being: callous, Costello and their beautiful families of which ought to be adopted in clearcut selfish and casually destructive men and a chance to live. So we will be talking terms and really is not by the amend- women who share a cheapened view of about that. ment offered by the distinguished ma- human life.’’ Other consequences of a ‘‘lexi- And now I would yield 4 minutes to jority leader but really ought to be ex- con of dehumanization’’ about the unborn are ‘‘hardness of heart, lying and political the Senator from Pennsylvania, Mr. tended life of the mother or health of failure.’’ Wolf said that the ‘‘fetus means SPECTER. the mother which has been established nothing’’ stance of the pro-choice movement The PRESIDING OFFICER. The Sen- by the constitutional parameters by is refuted by common current practices of ator from Pennsylvania. the Supreme Court of the United parents-to-be who have framed sonogram Mr. SPECTER. Mr. President, I States. photos and fetal heartbeat stethoscopes in thank the distinguished Senator from We have legislation which is very their homes. Young upscale adults of child- California. profound in its import, which had one bearing age are a solidly pro-choice demo- Mr. President, I support both of the limited hearing in the House, one lim- graphic group. But they enjoy watching pending amendments, the amendment ited hearing in the Senate, and which their unborn babies on sonograms, respond- offered by the distinguished majority we will be legislating upon which will ing to outside stimuli, and they read ‘‘The Well Baby Book,’’ which says: ‘‘Increasing leader, Senator DOLE, and the amend- leave many, many open questions and knowledge is increasing the awe and respect ment offered by the distinguished Sen- many doubts on a very, very serious we have for the unborn baby and is causing ator from California, Mrs. BOXER. medical procedure. us to regard the unborn baby as a real person I believe that the broader amend- So, at a minimum, Mr. President, I long before birth...’’ ment, the Boxer amendment, is the hope that the Boxer amendment would

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00070 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18187 be adopted as well as the Dole amend- only the head of the child remains in of us advocated that this legislation go ment. the womb, its life is terminated—just 3 to committee so that we would have a The PRESIDING OFFICER. The 4 inches away from the full protection of chance to hear first hand from those minutes yielded to the Senator from the Constitution. women who would be affected by this Pennsylvania have expired. This amendment bans no other type kind of legislation, that without a The Senator from New Hampshire. of abortion. It simply bans this proce- doubt this amendment becomes even Mr. SMITH. Mr. President, how much dure, which I believe is offensive, and more important, more crucial, more time is available on our side. which I believe is unacceptable in a vital to women’s health. The PRESIDING OFFICER. There civilized society. Twenty-two years ago the Supreme are 22 minutes, 14 seconds. I hope our colleagues will vote for Court handed down the Roe versus Mr. SMITH. And the other side? the Dole amendment because it formal- Wade decision. It said that the wom- The PRESIDING OFFICER. There izes what those of us who were for the an’s interest and decisions in reproduc- are 19 minutes exactly. Smith proposal to begin with under- tive matters should remain paramount. Mr. SMITH. I will yield 5 minutes to stood, and that is, the life of the moth- It also said the States could ban abor- the Senator from Texas, Mr. GRAMM. er exception was included to begin tion in the last trimester. But they The PRESIDING OFFICER. The Sen- with. This further clarifies it for some- also had to include exceptions for when ator from Texas. one who is concerned about that. And I the life and health of the mother is in Mr. GRAMM. Mr. President, I wish to think it is a legitimate concern, danger—let me repeat—as long as they begin by congratulating our dear col- though I was satisfied with the original allowed exceptions for cases in which a league from New Hampshire. First of language. But with the Dole amend- woman’s life and health is endangered. all, I wish to congratulate him for his ment adopted, I think we have a clear- The Supreme Court has reaffirmed leadership on this issue. I wish to con- cut choice. I hope our colleagues will that decision time and time again. gratulate him for the way that he has vote for the Dole amendment, against Forty-one States ban abortion in the handled the issue. I hope that we are the Boxer amendment, and then vote last trimester, but they provide excep- successful today in ending this proce- for the Smith proposal. tions for the life and health of the dure which I believe no civilized soci- I think it is the right thing to do. I mother, as is constitutionally required ety can condone. am very proud to associate myself with by the Roe versus Wade decision. That This is not an issue that I had heard the distinguished Senator from New is what the Boxer amendment does. It discussed before on the Senate floor Hampshire on this issue. I reserve the upholds that decision providing for the until one day I came over to the floor remainder of our time. life and health of the mother. The Su- to speak on another subject, and the Mrs. BOXER addressed the Chair. preme Court recognized, in its wisdom, distinguished Senator from New Hamp- The PRESIDING OFFICER. The Sen- that there would be certain limiting, shire was describing this procedure. ator from California. exceptional, tragic circumstances that Questions were raised as to whether Mrs. BOXER. I plan to yield to the may require an abortion in the final someone might be offended by the de- Senator from Maine, Senator SNOWE, in trimester. That is a decision that has scription. I rose simply to make the a moment. to be made between the doctor and his point that if we are offended by the de- I wanted to answer a couple points patient. scription of the procedure, surely we made by my friend from Texas. First, have to be offended by the fact that the he did describe the usual life-of-the- Without such an exception, without procedure is occurring in America mother exception, which we voted on providing for life and health excep- today. many times in the Senate, which is tions, innocent women are harmed. I I joined the distinguished Senator usually the Hyde language. That is not have been somewhat amazed by some from New Hampshire as his original co- the language in the Dole amendment. of the discussion that has taken place sponsor when he introduced the bill. The language in the Dole amendment, here on the floor. These are not casual There were only two of us to begin although described as life-of-the-moth- decisions. These are not decisions that with on the bill. That number has er, relates to a woman with a pre- are made lightly. This procedure is not grown. existing condition, not to situations performed for sex selection. I do not know that I can add much to that we are talking about where the These are tragic and compelling cir- this debate. But let me try to sum up woman’s life is in danger due to the cumstances under which a woman has my feelings on the issue. The Dole pregnancy itself. to make this decision. That was amendment, which is now pending, re- So the only real life-of-the-mother verified and reinforced by the testi- moves any doubt about the fact that exception is the Boxer amendment. But mony presented by so many women be- the life of the mother and any threat we will support both Dole and Boxer fore the Judiciary Committee recently. to the life of the mother is a defense because under the Dole amendment It was compelling testimony. These are for using this procedure. If the moth- two or three women may be saved a heart-wrenching decisions and very dif- er’s life is in danger, this procedure can year. Under the Boxer amendment you ficult ones. These are procedures that be used. will save more women like Coreen and are rarely performed, seldom per- So the question really boils down to others. So we would advise Senators to formed. But there are times in which whether a civilized society can condone vote for both. they have to be performed to save the this procedure when the life of the I want to say that I am very proud life of the mother or to prevent drastic mother is not at risk. And I submit that we reached across the aisle here consequences to her health. Those are this: We have heard the description. We and the Boxer amendment is supported the facts. have heard testimony of a nurse who by Senator BROWN, Senator SPECTER, There have been 450 such procedures witnessed this procedure first-hand. It Senator SNOWE, and also on our side, performed annually. They are so rare really boils down to this. This proce- Senators MURRAY, MOSELEY-BRAUN, that they amount to 0.04 percent in the dure is almost always used with a late- and LAUTENBERG. last trimester. Now we are talking term baby, which is generally viable At this time I yield 4 minutes to the about criminalizing a procedure that outside the womb. And when the baby Senator from Maine, Senator SNOWE. can save the life and the health of the is 3 inches away from the full protec- Ms. SNOWE. I thank the Senator for mother. Now we are saying that polit- tion of the Constitution, the baby’s life yielding. ical judgment will override medical is terminated in a violent manner that Mr. President, Members of the Sen- judgment. I think is objectionable in a civilized ate, I rise in support of the amendment I cannot imagine that any doctor, society. that has been offered by my colleague under the language in this legislation, The question is, Are we going to stop from California, Senator BOXER. I if this amendment is not accepted, it? I remind my colleagues, this is a think there is no question in light of would be willing to take an action that vote about banning a procedure when the testimony that was presented to is the safest and the most appropriate the mother’s life is not in danger. The the Judiciary Committee during a course, given the criminal prosecution child is delivered feet first, and when hearing on this legislation, when many involved in this legislation, unless we

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00071 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18188 CONGRESSIONAL RECORD — SENATE December 7, 1995 accept the Boxer amendment that pro- of either body on the issue of abortion. way delivered through the birth canal. vides for the exception in cases of life I never felt in my heart comfortable It is not terminated, it is killed. and health. coming to the floor and talking about Whether you are for abortions or One doctor was quoted in the New legislating the issue of abortion. against abortions, you cannot be for York Times recently. He said, ‘‘I don’t I thought, as do many folks who vote doing this. It shocks the conscience of want to make medical decisions based pro-life here, that the issue is one that a society and should not—should not— on congressional language. I don’t we have to educate and we have to be a procedure that is sanctioned by want to be that vulnerable. It’s not change hearts and we have to go out to this body. what I want for my patients.’’ the public and sensitize the public to I yield back the remainder of my The PRESIDING OFFICER. The Sen- the horrors of abortion in this country. time. ator’s time has expired. I say that as someone who is pro-life, Mrs. BOXER addressed the Chair. Mrs. BOXER. I yield the Senator an but I think there are people who are The PRESIDING OFFICER. The Sen- additional 60 seconds. pro-choice who believe also that abor- ator from California. The PRESIDING OFFICER. The Sen- tion is wrong, it should be minimized Mrs. BOXER. Mr. President, I yield ator is recognized for an additional 60 in this country. So I always felt un- myself 4 minutes, and I am glad the seconds. comfortable talking about legislating Senator from Pennsylvania is staying Ms. SNOWE. Another doctor, Dr. abortion. here because his remarks about this Robinson, an OB-GYN at Johns Hop- I have to say, I felt compelled to family are the most outrageous thing I kins, testified before the Judiciary come up and talk about this. This is have ever heard. Committee: not about pro-life or pro-choice. This is The reason this family is smiling is Telling a doctor that it is illegal for him or about a horrific procedure that should because Coreen Costello was pregnant her to perform a procedure that is safest for shock the conscience of anyone who with her daughter, Katherine Grace, a patient is tantamount to legislating mal- has heard how this procedure is done. and the dad’s hand is on her stomach, practice. The Senator from Maine just said, and they are so excited about having So what we are doing under this leg- ‘‘Well, you are going to take folks and this baby, their third child. islation if we do not accept the Boxer force them from one risky procedure to This is a woman who is pro-life who amendment is saying to doctors, we another risky procedure. That may be found out that Katherine Grace had a want you to perform more dangerous, true, but this risky procedure shocks lethal neurological disorder and had more traumatic procedures for the the conscience of anyone who has been unable to move for 2 weeks. woman, even if it is against their best heard it described. This is so horrific. Do you want facts? I will give you medical advice; for example, caesarean There is some sort of moral code in facts, sir. sections, that would require four times this country. To see a baby three-quar- The movements that Coreen had been the risk of death as vaginal delivery. In ters born have scissors stuck in the feeling were not the healthy kicking of fact, a woman is 14 times more likely back of their brain—where have we her baby. They were nothing more than to die from a caesarean section than come as a country when we say, ‘‘Well, bubbles in amniotic fluid which had from the procedure that this legisla- we need a statute to prohibit that,’’— puddled in her uterus rather than flow- tion seeks to outlaw. this is wrong. ing through the baby. The baby had not Induced labor carries a potentially I do not even think we should be hav- been able to move for months—not her life-threatening risk and threatens the ing debate about it. One of the prob- eyelids, not her tongue, nothing. The future fertility of women by poten- lems I think many of us have who are baby’s chest cavity was unable to rise tially causing cervical lacerations and pro-life, who are conservative is that and fall to stretch her lungs to prepare hysterectomies which leave women we tend to argue facts and figures. I them for air. Her lungs and her chest often unable to have children for the was ready to read you that of the two were left severely undeveloped, almost remainder of their lives. doctors who performed the majority of to the point of nonexistence. Her vital As one professor said during the these abortions, half of the babies who organs were atrophying. hearing, the only thing that this proce- were born were perfectly healthy. One The doctors told Coreen and her hus- dure does is to channel women from doctor testified to that effect and nine band the baby was not going to survive, one less risky abortion procedure to of the flawed babies had cleft palate. and they recommended terminating another more risky abortion procedure. Flawed babies. the pregnancy. She did not have an op- That is what we are doing here. He said We had Dr. Haskell, the other abor- tion. Her doctor told her if she did not that the Government does not have a tionist who does this, saying 80 percent use this procedure, which you will vote legitimate interest in trying to dis- of the abortions were purely elective to outlaw today, she would probably courage that. abortions. So do not try to sell a bill of not live. I hope that we will not throw wom- goods. Those are facts and figures. So when you stand up here and you en’s lives and women’s health into I think what we have trouble with talk about happy faces and you try to limbo by rejecting this legislation. I sometimes, as Republicans, is we put demean the other side, you ought to hope that they support the Boxer up charts, graphs, and numbers, and know your facts and, sir—— amendment. people just sort of glaze over. On the Mr. SANTORUM. If the Senator from The PRESIDING OFFICER. The Sen- other side, they are much smarter. California will yield. ator from California. There is Senator BOXER with pictures Mrs. BOXER. I have no time to yield Mrs. BOXER. Mr. President, I do not of happy faces. There are no facts and on my time. I will be glad to yield on need time at this point. figures. your time. The PRESIDING OFFICER. The Sen- There is no medical evidence to sup- Mr. SANTORUM. Thirty seconds. ator from New Hampshire. port that partial birth abortion is the You cannot have it both ways, Senator. Mr. SMITH. I yield 5 minutes to the right thing to do, this is the moral You cannot have it both ways. You Senator from Pennsylvania. thing to do, that this is what our soci- cannot have a life-of-the-mother excep- The PRESIDING OFFICER. The Sen- ety should stand for. No, you put up tion, claim her life is in jeopardy and ator from Pennsylvania. pictures of happy, smiling faces. You say our bill does not take care of that. Mr. SANTORUM. Mr. President, I pull at the heartstrings on the other If you are going to claim life-of-the- thank the Senator from New Hamp- side and hope that all the truth just mother in her case, our bill covers shire for yielding. I want to congratu- gets pushed in the background. that. late him on the work he has done. He There is an obvious truth here. There If you are going to claim that she has been here many, many days and is an obvious truth here. You have a had alternative procedures, like a ce- many, many hours debating a very dif- baby, not what they like to refer to as, sarean or other kinds of procedures ficult, emotional issue. ‘‘an intact dilation and extraction.’’ where she could have had an alter- I have been in the U.S. Senate and That is the way they describe this. An native, you cannot argue both sides of the House of Representatives now for 5 intact procedure. This intact thing is a the story, Senator. You have to argue years. I have never spoken on the floor baby, and it is three-quarters of the the facts, just one side at a time.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00072 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18189 Mrs. BOXER. Mr. President, if I may Second, it is poorly drafted. The But I believe it is absolutely essen- reclaim my time. bill’s vague language will have a tial that we pass the amendment of- The PRESIDING OFFICER. The Sen- chilling effect on physicians who pro- fered by Senator BOXER. Her amend- ator from California has the floor. vide abortions. ment provides clear, direct language. It Mrs. BOXER. Mr. President, I have Third, it provides no exceptions for will enable physicians to use their ex- read you the facts of the case. The doc- cases involving threats to the life and pert medical judgment to act to pre- tor said her life might be in danger. health of the woman. serve the life of the woman or to avert The doctor said for sure she could suf- Fourth, most significantly, it is a di- serious, adverse consequences to her fer infertility. That is not excepted in rect assault on Roe versus Wade. In my health. your bill. As a matter of fact, sir, when view, the bill is part of a concerted ef- Senator BOXER’S amendment makes your bill was written, there was no ex- fort to ban all abortions. it clear that when a woman must ception at all, and the exception that is I oppose this bill because it is a dan- choose abortion late in pregnancy, she now in your bill would not cover her gerous and unwarranted intrusion on must have access to the safest possible particular case in any event because the doctor/patient relationship. It has procedure. And, physicians, not Sen- your exception only covers a pre- an impact far beyond the issue of abor- ators, should make that decision. existing condition. Therefore, the tion. For the first time, Congress The Boxer amendment lets doctors be Boxer-Brown language is absolutely es- would be deciding what medical proce- doctors. It trusts them to do what is sential to cover this particular case. dures a doctor can and cannot provide. right for their patients. It ensures that I will give you more facts, I say to This bill substitutes political reasoning women’s lives and health are not put at my friend from Pennsylvania. The for medical judgment. Congress, not risk. I strongly urge my colleagues to American College of Obstetricians and medical experts, would pass judgment vote for this essential amendment. Gynecologists represents 35,000 physi- on a medical procedure. I oppose this bill because it is poorly cians. They opposes this bill. They H.R. 1833 makes criminals of doctors, drafted. It is filled with vague, non- think it is dangerous. doing their best to serve the patient’s medical terminology. Much of the Ju- The American Nurses Association, needs, who perform the procedure diciary Committee hearing was spent representing 2.2 million nurses, oppose banned by the bill. It makes criminals debating what the bill meant. Wit- this bill. So those are just some of the of doctors even when in their expert nesses and committee members alike facts. opinion, the procedure is medically could not agree on such basic questions Mr. President, I ask unanimous con- necessary to save a woman’s life or pre- as: How is the procedure in question sent to add Senator MIKULSKI as a co- vent serious, adverse consequences to actually performed? What procedure is sponsor of the Boxer-Brown amend- her health. the bill describing at all? What does ment. At the November 17 hearing, medical partial birth mean? The PRESIDING OFFICER. Without experts had very different views on If Congress passes H.R. 1833, and it is objection, it is so ordered. what the procedure involves, on what signed into law, I guarantee you will Mrs. BOXER. I yield the floor and re- the medical alternatives would be, and open the door to endless litigation in serve the remainder of my time. on what is best to safeguard a woman’s an effort to sort out what the bill does The PRESIDING OFFICER. Who life and health. If they cannot agree on and does not do. yields time? this medical issue, how can we expect The bill’s vagueness creates a further Ms. MIKULSKI. Mr. President, I rise to legislate in this area? This is reason problem, whether intentionally or not in opposition to H.R. 1833. I oppose it enough why Congress should not inter- is unclear. This lack of clarity would because it is a direct assault upon vene in decisions on medical procedure. have a chilling effect on abortion pro- women’s reproductive rights. I oppose this bill because it provides viders, who are trying to make the best But let me first thank Senator SMITH no true exception for the life and decision for their patients. Physicians for agreeing to support the motion health needs of the woman. At the who are trying to do their duty to pro- which the Senate adopted on November hearing, very compelling testimony tect life or health, now will have to 8. This motion called on the Judiciary was offered by women who have faced guess whether their decision might vio- Committee to hold a hearing on H.R. the difficult decision to have a late late Federal law. 1833, the so-called partial-birth abor- term abortion to save their lives or How many doctors will continue to tion ban. their health. These were women who perform this type of late term abor- As my colleagues know, the com- eagerly awaited the birth of their tion, or any abortions at all, if faced mittee held that hearing on November child. with possible criminal or civil liability. 17. I believe the hearing process was Then a medical emergency oc- There is already a tremendous shortage very important. The issues raised by curred—one that threatened their lives of abortion providers. The bill will this bill are complex and sensitive. It is or posed serious consequences to their make this shortage even greater. And, vital they be thoroughly explored be- health. Congress should not tell these of course, that is part of the plan—to fore the Senate votes on this legisla- women, and others who face this most scare doctors from the field. tion. tragic and personal of decisions, that Doctors who provide abortion serv- I believe both proponents and oppo- they cannot have the medical proce- ices already face death threats, nents of H.R. 1833 found the hearing dure their physician recommends to firebombings, and harassment at work most helpful. I think all would agree save their life, or their health, or their and home. Now they will have to look Senator HATCH conducted a fair and in- ability to have a child in the future. over their shoulder in fear of arrest. formative hearing. We heard from med- Congress should not tell them that it Who will be willing to provide abortion ical professionals, legal and constitu- knows better than their doctor what services in that climate? And who will tional experts, and from the women medical care they should be provided. pay the price? Women will pay the themselves who courageously shared Senator SMITH has offered an amend- price, women trying to exercise their their compelling and heartrending sto- ment to provide an exception for cases right to a legal medical procedure. ries. where the woman’s life is at risk. I Finally, Mr. President, I oppose this After reviewing all of the testimony, have some concerns about this amend- bill because it is a direct assault on I am more convinced than ever that ment. I fear it may not cover all situa- Roe versus Wade. In Roe and all its Congress should not pass the bill before tions where the life of the woman is subsequent rulings, the Supreme Court us. I heard nothing to change my mind, threatened by continuing her preg- has consistently upheld the right of and much to reinforce my deep con- nancy. And I am concerned that, under doctors to perform late term abortions cerns. his amendment, the burden of proof to protect life or health. The Court has Let me tell you why I oppose this will still be placed upon the physician. allowed States to ban post-viability bill. However, I will support his amend- abortions, but only when an exception First, it intrudes on the doctor/pa- ment. If it will save even a few women for life or health is provided. tient relationship, by criminalizing a who need a late term abortion to save The Court has maintained that a doc- specific medical procedure. their lives, I cannot oppose it. tor’s first duty is to the woman. Her

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00073 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18190 CONGRESSIONAL RECORD — SENATE December 7, 1995 life and health must be the doctor’s But, unfortunately, it looks like Mr. LEVIN. Mr. President, the Su- paramount concern. The doctor cannot there are Senators who are intent on preme Court has held in Roe versus trade off her life for the life of the pressing on with this bill, and so we, at Wade and reaffirmed in Planned Par- fetus. least, have to try and do what our col- enthood versus Casey, that States can So, this bill, by ignoring the Court’s leagues in the House failed to do—to ban late-term abortions except when requirement of a life and health excep- include an exception for cases to save necessary to preserve a woman’s life or tion is a direct challenge to Roe. And the life and health of the mother. Mr. health. Forty-one States have estab- not the last challenge. Proponents of President. The Senator from New lished postviability bans on abortion this bill have made clear they want to Hampshire has offered an amendment with exceptions to preserve a woman’s ban all abortions, one procedure at a which he claims provides a life of the life or health. Only one State has time, one woman at a time. mother exception. Well, I will vote for banned the intact D&E abortion proce- If they succeed in passing this bill, his amendment, because it is at least a dure which is the apparent subject of what procedure will they target next? step in the right direction. the bill before the Senate and that ban Which women will next be denied their But let’s be honest. The amendment is being challenged in the courts. right to choose? If we allow this bill to makes no room for instances where, in Forty-nine States have not banned pass, even with the amendments which the medical judgment of the attending this procedure. If the bill before the I hope will be adopted, Congress will physician, the procedure would be nec- Senate becomes law, the Federal Gov- have struck a major blow against re- essary to avert serious health con- ernment would dictate the regulation productive rights. sequences to the woman—consequences of abortion by banning a specific abor- Mr. President, the basic question is such as severe hemorrhaging or paral- tion procedure. This Federal ban in not what is decided, but who decides. ysis. this bill would even apply to abortions And the answer is, women and their Only the Boxer amendment can be performed previability, that is, in the doctors should decide, not politicians. considered a true life exception. Only second trimester and the bill does not Women must have the right to make the Boxer amendment takes the health contain the exception required by Roe, their own decisions on reproductive of women into account. Only the Boxer to preserve a woman’s health. matters, in consultation with their amendment sends the right message to Some physicians believe the intact physicians. That is what it means to be the families of this Nation, to the D&E abortion procedure represents the pro-choice, and that is why I will op- women who are faced with an unimagi- safest late-term abortion option. Oth- pose this bill. nable tragedy. We hear, over and over ers disagree. Politicians are not again, graphic depictions of this proce- Mrs. MURRAY. Mr. President, let me equipped to make decisions banning dure, but what of the vivid descriptions just say at the outset that I think it is specific medical procedures when the of the pain and torment these mothers incredible that we are here today de- medical community itself cannot even have gone through? Of the horror of bating this bill. There are unfinished reach agreement on these decisions. We losing a much wanted child? Of the fear appropriations bills, and an unresolved should not be voting to criminalize a that she will never again have a chance Federal budget situation that demand specific medical procedure when doc- our full attention. I believe the Amer- to have a baby? Is there anyone here who honestly tors themselves are divided on the mat- ican people would prefer us to address ter. the real issues of the day—issues that believes these women are choosing to have a late-term abortion? This insinu- If a physician is engaged in any inap- affect our hard-working families—and propriate medical practice, the medical not this kind of divisive, inflammatory ation is an affront to the women of this Nation. The small number of women establishment has systems of peer and legislation. who have late-term abortions do so be- professional review in every State to Of course, the reality is that we are deal with it. These systems of review here and we are considering this so- cause their doctors have determined it to be medically necessary to save their include State medical boards and peer called partial-birth abortion ban, and review on hospital review boards that there are a few things that I want to lives and their health. End of story. The Boxer amendment says: We re- police their membership. They should say regarding the bill, and also to talk spect you and will leave this difficult be the ones to ban a procedure if they briefly about the amendment offered decision where it belongs—between determine it to be inappropriate. by my friend, Senator BOXER. you, your doctor, and your God. We But physicians and their review proc- Mr. President, I have listened care- think it is important to allow families esses have not banned this procedure. fully to this debate and I am increas- to choose the procedure that is best for In fact, the American College of Obste- ingly convinced that it is far from them, to best protect the health of the tricians and Gynecologists, an organi- being a clear and narrowly defined woman and to best safeguard her zation representing more than 35,000 piece of legislation, as the proponents chances of being able to conceive physicians that specialize in this area of the bill keep claiming it to be. I find again. of medicine, oppose the bill before us. it to be a vaguely written and dan- Without this amendment we send the It wrote, in a letter to majority leader gerous attempt to ban not just a single women of this country the message: DOLE, that: procedure. Rather, I see it as a way to ‘‘We don’t care about you, we don’t re- The College finds very disturbing that Con- instill fear and confusion in the doctors spect your or your doctors. The U.S. gress would take any action that would su- who perform abortions, and to deter Congress and the Federal Government persede the medical judgment of trained them from performing a procedure that know best. physicians and criminalize medical proce- may help save a woman whose life is in Well, I don’t believe Congress know dures that may be necessary to save the life danger. best. We should leave this difficult de- of a woman. It seems clear to me this bill is about cision to the experts and to the fami- The American Medical Women’s As- families who are faced with a terrible lies who are faced with this tragedy. sociation, Inc., representing 13,000 tragedy, and it is about the doctors Congress has no place telling doctors woman physicians, has also said of the who must make an expert decision what procedures they can and cannot bill: based on what they believe to be in the perform—we have never even consid- This legislation represents a serious im- best interest of the mother. Frankly, ered getting involved in the lives of pingement on the rights of physicians to de- this bill is about Congress muscling its physicians, and we shouldn’t start now. termine appropriate medical management way into the doctor’s office. It is not Not this way. for individual patients. only presumptuous, it is unprecedented There is too much at stake, and I ap- In addition, the American Nurses As- and it is dangerous. We are proposing peal to the common sense and human- sociation, the only full-service profes- to criminalize doctors, and I want to ity of each Member of this Chamber: If sional organization representing the caution each and every one of my col- you must pass this reprehensible bill, Nation’s 2.2 million registered nurses leagues to stop this legislation. Like at least vote to include this critical through its 53 constituent associations, Senator BOXER has said, this is a slip- modification, and allow for exceptions oppose the bill. Their letter states: pery slope we do not want to start in cases where women’s health and It is the view of the American Nurses Asso- down. lives are at stake. ciation that this proposal would involve an

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00074 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18191 inappropriate intrusion of the federal gov- left legal when some have argued they AMERICAN MEDICAL ernment into a therapeutic decision that are less safe for the mother, while this WOMEN’S ASSOCIATION, INC., should be left in the hands of a pregnant one procedure, which some physicians Alexandria, VA, November 5, 1995. woman and her health care provider. believe is the safest for the mother, is Hon. ——— ———, I also received letters from physi- U.S. Senate, made criminal? Washington, DC. cians in Michigan familiar with this These other procedures that are left field of medicine opposing the proposed DEAR SENATOR ———: On behalf of the legal under this bill include inducing 13,000 women physician members of The ban of the intact D&E abortion proce- labor and delivery with drugs despite American Medical Women’s Association, I dure. I ask unanimous consent to in- evidence of risk to the woman. A cae- write to express AMWA’s concern regarding sert those letters in the RECORD. sarean operation called a hysterotomy, Senate bill S. 939, ‘‘The Partial-Birth Abor- The PRESIDING OFFICER. Without which could result in severe bleeding, tion Ban’’. objection, it is so ordered. infection and even death for the It is the position of the American Medical [See exhibit 1.] Women’s Association that this legislation woman, is also left legal, even in the Mr. LEVIN. This bill would crim- represents a serious impingement on the third trimester to preserve the wom- inalize a so-called partial birth abor- rights of physicians to determine appro- an’s life. Another procedure that would tion which is defined by the bill as, ‘‘an priate medical management for individual be left legal under this bill is called abortion in which the person per- patients. AMWA recently passed resolution standard D&E which is performed in 15, which opposes federal legislation banning forming the abortion partially the second trimester and does not de- this or any other medical procedure deter- vaginally delivers a living fetus before liver the fetus intact, but removes the mined to be of benefit to patients, at its an- killing the fetus and completing the fetus from the uterus piece by piece. nual House of Delegates Meeting. delivery.’’ Senator HATCH referred to a AMWA urges the Senate to carefully con- statement by Dr. Haskell, a physician In conclusion, the Supreme Court has sider the implications that its support of who has performed many intact D&E held that States can ban late-term this legislation will have on the practice of abortion procedures, that only about abortions except when necessary to medicine. We encourage the Senate to ac- one-third of the fetuses he extracted protect a woman’s life or health. tively oppose S. 939 as legislation which un- using the procedure were dead. Forty-one States have done that. But duly interferes with the physician-patient only one State has banned the intact relationship. My question is, in the one-third of Sincerely, the intact D&E abortion procedures he D&E abortion procedure, and that ban is being challenged in the courts. JEAN L. FOURCROY, MD, Ph.D., performed where the fetuses were dead, President. did Dr. Haskell know before beginning Forty-nine States have not acted to the procedure if those fetuses were ban intact D&E. The medical profes- AMERICAN NURSES ASSOCIATION, dead? If he, and any other physicians in sion’s own self-regulating system has Washington, DC, November 8, 1995. this situation, did not, they were tak- also not acted to ban intact D&E. The Hon. CARL M. LEVIN, ing a risk by beginning a procedure U.S. Senate is not equipped to make U.S. Senate, that could be a criminal act under the this technical medical decision. Washington, DC. terms of this bill. The bill under consideration today DEAR SENATOR LEVIN: I am writing to ex- The Senator from New Hampshire press the opposition of the American Nurses would ban abortions using this proce- Association to H.R. 1833, the ‘‘Partial-Birth and others have said that Coreen dure even in the second trimester and Abortion Ban Act of 1995’’, which is sched- Costello’s abortion was not a partial it does not allow for an exception re- uled to be considered by the Senate this birth abortion, presumably because she quired by Roe, to preserve a woman’s week. This legislation would impose Federal said the ‘‘fetus passed away peacefully health. criminal penalties and provide for civil ac- in the womb.’’ Finally, this bill establishes Federal tions against health care providers who per- Did the physician know when he criminal penalties for a specific abor- form certain late-term abortions. began the procedure whether the fetus tion procedure which may be the safest It is the view of the American Nurses Asso- ciation that this proposal would involve an was alive or dead? If a physician alternative for the mother while per- doesn’t know for sure before beginning inappropriate intrusion of the federal gov- mitting other abortion procedures that ernment into a therapeutic decision that an abortion procedure whether the could be less safe for the mother. We should be left in the hands of a pregnant fetus is alive or dead, wouldn’t the phy- should leave this issue to the medical woman and her health care provider. ANA sician who starts down the path of per- profession and the State legislatures, has long supported freedom of choice and eq- forming the procedure be facing the where it is now and where it belongs. uitable access of all women to basic health possibility of criminal prosecution services, including services related to repro- under the terms of this bill? EXHIBIT 1 ductive health. This legislation would im- In addition, the physician who per- THE AMERICAN COLLEGE OF pose a significant barrier to those principles. formed the intact D&E procedure on OBSTETRICIANS AND GYNECOLOGISTS, Furthermore, very few of those late-term Washington, DC, November 6, 1995. Mrs. Costello might not be sure when abortions are performed each year and they Hon. ROBERT DOLE, are usually necessary either to protect the he began the procedure if the fetus Majority Leader, life of the mother or because of severe fetal would be alive or dead when extracted Washington, DC. abnormalities. It is inappropriate for Con- since there is a range of fetal response DEAR MAJORITY LEADER DOLE: The Amer- gress to mandate a course of action for a to the anesthesia administered in an ican College of Obstetricians and Gyne- woman who is already faced with an in- intact D&E abortion, the procedure cologists (ACOG), an organization rep- tensely personal and difficult decision. This that Mrs. Costello underwent. resenting more than 35,000 physicians dedi- procedure can mean the difference between The performance of that procedure cated to improving women’s health care, life and death for a woman. might then be considered an attempt does not support HR 1833, the Partial-Birth The American Nurses Association is the at committing a crime even if the fetus Abortion Ban Act of 1995. The College finds only full-service professional organization very disturbing that Congress would take turned out to be dead upon delivery. representing the nation’s 2.2 million Reg- any action that would supersede the medical istered Nurses through its 53 constituent as- The procedure Mrs. Costello underwent judgment of trained physicians and crim- sociations. ANA advances the nursing profes- thus could be covered by this bill and inalize medical procedures that may be nec- sion by fostering high standards of nursing the physician that performed it subject essary to save the life of a woman. Moreover, practice, promoting the economic and gen- to Federal criminal prosecution even if in defining what medical procedures doctors eral welfare of nurses in the workplace, pro- the fetus turned out to be dead when may or may not perform, HR 1833 employs jecting a positive and realistic view of nurs- delivered. terminology that is not even recognized in ing, and by lobbying the Congress and regu- While banning one abortion proce- the medical community—demonstrating why latory agencies on health care issues affect- Congressional opinion should never be sub- ing nurses and the public. dure, this bill leaves legal other abor- stituted for professional medical judgment. tion procedures which can be used in The American Nurses Association respect- Thank you for considering our views on fully urges you to vote against H.R. 1833 later-term pregnancies. Are those this important matter. when it is brought before the Senate. other procedures as safe for the moth- Sincerely, Sincerely, er? Are they any less destructive to the RALPH W. HALE, M.D., GERI MARULLO, MSN, RN, fetus? Why are the other procedures Executive Director. Executive Director.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00075 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18192 CONGRESSIONAL RECORD — SENATE December 7, 1995 ROSEVILLE, MI, December 7, 1995. their families. Several women who not undertake a surgery at all if they Hon. CARL LEVIN, were forced to have such an abortion were legally prohibited from com- Washington, DC. testified at the Senate Judiciary Com- pleting it in the safest, most effective DEAR SENATOR LEVIN: I am writing you with concerns about the S.B. 939, the D&X mittee hearing about the pain and an- way, according to their professional Abortion Procedure Ban. I am absolutely op- guish they and their families had expe- judgment. posed to political intervention in the prac- rienced. Mr. President, I want to reiterate tice of medicine. This bill would place the Federal that the measure under consideration As a practicing OB–Gyn, I cannot begin to Government into the role of deciding would insert the Federal Government cite the ramifications of such a bill. If what procedures a physician can or into one of the most intensely private passed, it will prevent me from providing the cannot use in performing a late-term and personal areas. This bill would best possible care for my patients in emer- abortion. It would substitute the judg- have Congress override the decisions gency situations. The D&X procedure is the ment of Congress for the judgment of safest option for many women faced with made by a woman and her physician in medical emergencies during pregnancy. It is the individual physician performing an an area that literally involves life or done only in extreme situations, such as abortion. death. when a woman’s life is in danger or when a I believe that such legislation is bad It is ironic that many of the same in- fetus has severe abnormalities that are in- policy. The American people have re- dividuals who strongly challenged the compatible with life. This bill endangers the peatedly said that they want less gov- ability of the Federal Government to lives of women, who are already making ernment interference in their lives. handle comprehensive health care re- heartwrenching decisions. This bill moves in exactly the wrong I find it very disturbing that the Senate form are among the foremost pro- direction. ponents of this effort to insert the Fed- would take any action that would overrule Since the beginning of the 104th Con- the judgment of trained physicians. As a eral Government into a physician’s de- physician, I and others like myself, would gress, there has been a great deal of cisions in the operating room. find it frightening that my government rhetoric about how we need to restrain For example, during last year’s would prevent me from providing the best the Federal Government, about how health care debate, the distinguished possible care for my patients. Please do not the Federal Government has usurped Senator from North Carolina (Mr. lot this happen. the powers of State and local govern- HELMS) asked: Sincerely, ment entities, and about how the Fed- Do you want the Federal Government, the SAMUEL EDWIN, M.D. eral Government has intervened in Government that operates your postal sys- areas beyond its primary realm of re- tem to decide whether you should have an DEPARTMENT OF DERMATOLOGY, operation or not? With this kind of govern- HENRY FORD HOSPITAL, sponsibility. We have heard repeatedly Detroit, MI, November 6, 1995. that we need fewer Federal mandates ment intervention, what is left for the doc- Re Bills to limit physician abortion proce- and fewer Federal regulations. tor and the patient to decide? dures. Mr. President, let me say that I agree Yet, that is precisely the kind of Senator CARL LEVIN, with a good deal of those sentiments. I intervention that is being proposed by U.S. Senate, believe that the Federal Government this legislation. This measure says Washington, DC. has gone too far in many areas. That is that a physician who determines that a DEAR SENATOR LEVIN: I am very upset to one reason why I voted against last specific procedure is necessary to pro- hear proposed legislation to make criminal year’s Federal crime bill and this tect the life or health of his or her pa- various surgical procedures performed by tient may face a Federal criminal pros- physicians. I realize the legislation is being year’s terrorism bill. In each instance, introduced as a method to limit abortion. I saw examples of the Federal Govern- ecution for exercising his professional However I am incensed that non-physicians ment overzealously reaching into areas judgment. are trying to limit the scope of medical prac- of law which have traditionally been Mr. President, it is also important to tice, and make it criminal as well! within the jurisdiction of State and note that the language of this bill is so Personally I feel it is the woman’s right to local law enforcement agencies. vague that a number of physicians choose, and as men, we should not interfere. I voted for the unfunded mandate leg- have indicated that they would simply But as a physician it is a slippery slope for islation because I agree that the Fed- stop performing late-term abortions non-physicians to limit our practices espe- rather than run the risk of criminal cially for political means. eral Government needs to exercise re- Please block this legislation! straint in forcing the States to comply prosecution or endangering the life or Sincerely, with Federal mandates. I support many health of their patient. Dr. Robinson TOR SHWAYDER, M.D., aspects of the regulatory reform drive told the committee: Director, Pediatric Dermatology; Fellow, because we do need greater flexibility For many physicians, this law would American Academies of Pediatrics & Der- and less Federal micromanagement in amount to a ban on a D&E [procedure] en- matology. many areas. tirely the law is so vague and based on erro- But now, Mr. President, we are pre- neous assumptions, it would leave doctors Mr. FEINGOLD. Mr. President, I rise wondering if they were open to prosecution in opposition to H.R. 1833. sented with legislation that places the Federal Government in the role of de- or not each time they performed a late abor- I do so because this legislation raises tion. That means that by banning this tech- serious policy, legal and medical ciding what specific procedures a phy- nique, you would in practice ban most later issues. sician should use or not use when faced abortions altogether by making them vir- H.R. 1833 seeks to impose criminal with a problem pregnancy and a wom- tually unavailable. And that means that sanctions upon physicians who perform an’s desire to terminate that preg- women will probably die. certain types of late term abortions. nancy. Dr. Robinson, incidently, is a former It is important, Mr. President, to un- Mr. President, there are many rea- Presbyterian missionary who has prac- derstand that very few late term abor- sons why this is a dangerous area for ticed medicine for more than 40 years. tions take place in this country, under Federal Government intervention. One He described for the committee his ex- any circumstances. It is estimated that of the physicians said it well during posure to the consequences of illegal there are approximately 600 abortions the Judiciary Committee hearing on abortions prior to the Roe decision. He annually performed in the third tri- November 17. Dr. J. Courtland Robin- testified that over a period of five mester of pregnancy, with about 450 son testified: years on the staff of a hospital in New done by what is called an intact D&E Sometimes, as any doctor will tell you, York, he watched women die from procedure. The procedure which would you begin a surgical procedure expecting it abortions that were improperly per- be banned under this legislation is a to go one way, only to discover that the formed. His concerns about the con- unique demands of the case require that you form of an intact D&E procedure. Late- do something different. Telling a physician sequences of legislation that would term abortions take place under the that it is illegal for him or her to adapt his make certain types of abortions illegal most tragic of circumstances, where or her surgical methods for the safety of the and deny women access to the safest something has gone wrong with the patient . . . flies in the face of standards for abortion procedure for their individual pregnancy. Late-term abortions are quality medical care. circumstances were clearly an out- physically difficult and emotionally Dr. Robinson also pointed out in his growth of his familiarity with what devastating to the women involved and testimony that many physicians would happens when Government treads too

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00076 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18193 far into what should be a decision made at the Judiciary Committee hearing likely to die’’ with an induction proce- by a woman and her physician. will be quoted as to their view regard- dure, an alternative abortion procedure Mr. President, that brings me to a ing whether the procedure under dis- in a late-term pregnancy. She further second policy concern regarding this cussion is more or less safe for a testified that a cesarean section was legislation. On its face, H.R. 1833 seeks woman than other procedures, whether another option, but that a woman was to criminalize the performance of a the procedure may be necessary in a 14 times as likely to die with a Cesar- particular type of abortion. Yet, Mr. particular situation to protect a wom- ean hysterotomy as with a D&E proce- President, there is little doubt that the an’s future ability to bear children, and dure. purpose behind this legislation is to precisely what the procedure is that Dr. Campbell outlined her views as to begin the process of curtailing and ulti- would be banned under this legislation. why the intact D&E procedure was mately denying all access to legal What occurred at the hearing, Mr. preferable in certain cases. According abortion. President, was a professional disagree- to Dr. Campbell, the procedure requires When pressed, many of the pro- ment among members of the medical less dilation of the cervix and thus ponents of H.R. 1833 will admit the community on the efficacy and risks markedly decreases the chances of cer- truth of this assertion. associated with various abortion proce- vical lacerations and cervical incom- One of the major House proponents, dures. That members of the medical petence which can adversely affect fu- Congressman CHRIS SMITH (R. N.J.) community have different opinions on ture pregnancies. She also testified stated in a November 9, 1995, USA these issues is both understandable and that the uterine scar, especially from Today article, ‘‘ We will begin to focus expected. the kind of vertical incision most often on the methods [of abortion] and de- It is also precisely the reason why used in cesarean sections involving ab- clare them to be illegal.’’ trained physicians and their patients, normal preterm fetuses, creates an in- At the Judiciary Committee hearing not members of the Congress, should creased risk of uterine rupture in fu- on this measure, I asked one of the pro- make the decisions about what course ture pregnancies. ponents, Helen Alvare, Director of of treatment is appropriate in indi- Dr. Robinson testified with the same Planning and Information, Secretariat vidual situations. concerns about the risks posed by al- for Pro-Life Activities of the National The ability to choose between alter- ternative procedures. In response to Conference of Catholic Bishops, wheth- native courses of medical treatment my question, Dr. Robinson testified er all methods of abortion should be and the ability to choose between phy- that a vertical scar in the uterus re- criminalized. The response I received sicians who favor one procedure over sulting from such a cesarean was defi- was very clear. Ms. Alvare stated her another is something that we often nitely an increased hazard when a view that ‘‘every single kind of proce- take for granted. woman has a subsequent pregnancy. dure that takes an unborn life’’ should Physicians who themselves do not Included in the hearing record are be outlawed. choose to perform the type of proce- letters from Dr. Elaine Carlson of Ce- Mr. President, I specifically asked dure at issue have also made it clear dars-Sinai Medical Center in Los Ange- whether that included nonsurgical that they do not believe Congress les indicating that alternative proce- forms of abortion, such as the use of a should be legislating in this area. In dures can cause a traumatic stretching drug like RU–486 which leads to the particular, Dr. Warren M. Hern of Boul- of the cervix that then increases a termination of a pregnancy in the very der, Colorado, a physician who per- woman’s changes for infertility in the early stages, the first few weeks. The forms late-term abortions has been answer was yes, and Ms. Alvare was future and from Dr. George Henry of quoted by proponents of H.R. 1833 as Denver, CO, indicating similar con- very clear that she found the use of an having reservations about this par- abortifacient drug at the earliest cerns. Dr. Henry, in a subsequent letter ticular procedure. However, in his tes- to me elaborated on the risks to both a stages of a pregnancy to be as objec- timony submitted to the Senate Judi- tionable as the procedure under discus- woman’s life and her future ability to ciary Committee on November 17, 1995, bear children from a cesarean section sion. he outlined the possible advantages of Mr. President, I think the record type of surgical approach. ‘‘Such a sur- using the intact D&E procedure, in- gery,’’ Dr. Henry wrote, ‘‘exposes the should also note that in the past there cluding a reduction of the risk of per- have been efforts to ban other methods patient herself to much greater med- foration of the uterus and reducing the ical risk immediately and also in- of abortion which the proponents of risk of embolism of cerebral tissue into this legislation now point to as remain- creases the need for repeat C- sections the woman’s blood stream. He con- in future pregnancies as well as the ing available should this ban be en- cluded by stating: acted into law. For example, in 1976, in risk of uterine rupture in future preg- While I may choose a different method of Planned Parenthood versus Danforth, nancies because of the uterine scar— performing a late abortion, I support the and even the potential loss of the uter- the Supreme Court struck down a Mis- right of my medical colleagues to use what- souri statute which would have prohib- ever methods they deem appropriate to pro- us if emergency hysterectomy is re- ited saline abortion procedures after tect the woman’s safety during this difficult quired.’’ the first 12 weeks of pregnancy. procedure. It is simply not possible for oth- Other witnesses, proponents of this It is clear that this legislation is part ers to second guess the surgeon’s judgment legislation, disagreed and stated their of a calculated plan to make abortion in the operating room. That would be dan- view that the intact D&E procedure more difficult for women and their gerous and unacceptable. was more risky than the other proce- physicians. It is part of a calculated Mr. President, I am not sure that it dures, and that there were no cir- plan to limit and erode a woman’s abil- is appropriate for Members of Congress cumstances where they would consider ity to exercise her constitutionally to even try to resolve a matter that is this procedure necessary to protect the protected rights. We cannot lose sight the subject of debate between physi- life or health of the woman. of the fact that Dr. Robinson’s memo- cians as to whether there are situa- Mr. President, what this debate told ries of a time when abortion was illegal tions where this procedure is preferable me is that there is room for disagree- and women died from illegal abortions to another procedure. It is clear from ment between physicians about specific might become a reality again if these the testimony at the Judiciary hearing medical procedures; it is not for Con- efforts are successful. that there are respectable differences gress to determine which side of this Mr. President, I want to focus now of opinion in this area. debate is right or wrong. These are upon an important aspect of the Judi- For example, Dr. Mary Campbell, medical questions which ought to be ciary Committee hearings dealing with medical director of Planned Parent- decided by medical professionals, not why this particular procedure might, hood of Washington, DC, testified there Members of Congress. Congress ought in the judgment of a woman’s attend- were a number of situations where al- not to tie the hands of a physician try- ing physician, be the most appropriate ternative abortion procedures such as ing to make the best decision for his or in light of her individual cir- induction or cesarean section are con- her patient. As Dr. Robinson testified, cumstances. sidered less safe than an intact D&E ‘‘The physician needs to be able to de- Mr. President, throughout this de- procedure. For example, Dr. Campbell cide, in consultation with the patient bate, different physicians who testified testified that ‘‘a woman is twice as and based upon her specific physical

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00077 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18194 CONGRESSIONAL RECORD — SENATE December 7, 1995 and emotional needs, what is the ap- the woman’s health. The proponents of decisions that women and families propriate method. The practice of med- this legislation seem to take the view must face. I do believe it should be a icine by committee or legislature is that even if an alternative procedure rarely used procedure and in that re- not good for patients or for medicine in would result in a woman being unable gard have been informed that there is general.’’ to bear a child in the future, that is an no recollection of it being used in my Mr. President, the reasons why Con- adequate alternative. State of Rhode Island. Indeed, there gress ought to stay out of this deci- Mr. President, I find this to be a par- are only a handful of practices sionmaking process was also elo- ticularly harsh judgement to be im- throughout the country that utilize it quently made by several women who posed upon families who have experi- and the total number of cases amount had made the difficult choice of choos- enced the tragic end to a much-sought to less than one-tenth of 1 percent of ing this procedure when a much wanted pregnancy. To tell a woman and her total abortions. I also believe that the pregnancy has turned into a tragedy. family that Congress will not allow her heightened scrutiny that this proce- Coreen Costello testified: doctor to use a procedure which will dure has received will reduce those oc- It deeply saddens me that you are making allow her a greater chance to be able to casions when it is used inappropriately. a decision having never walked in our shoes. have another pregnancy and bear a In the end, however, I believe that it When families like ours are given this kind child in the future is cruel and uncon- should remain an option available to of tragic news, the last people we want to scionable. doctors when they deem it medically seek advise from are politicians. We talk to Mr. President, let me conclude by re- necessary in order to terminate a preg- our doctors, lots of doctors. We talk to our iterating again that this legislation nancy. families and other loved ones, and we ponder would insert the Federal Government long and hard into the night with God. By way of conclusion, I ask unani- into one of the most private, personal mous consent to have printed in the Mr. President, we ought to heed decisions a woman and her family and RECORD an article from the New York those words. These decisions are pri- her physician must face. The American Times written by a woman who went vate, personal decisions to be made by people have said time and again they through this procedure. I believe it elo- the families involved, guided by their want less Government intrusion into quently makes the case that it would physicians. The Federal Government their lives, not more. This bill is in be wrong to enact the outright ban ought to leave these decisions with the every way an inappropriate extension contained in this bill for this procedure people involved. of power by the Federal Government and, accordingly, that this option Finally, Mr. President, let me briefly into the lives of individual Americans should remain available to women and address the Constitutional issues at a very traumatic and emotion point. families of this country. raised by this legislation. It ought to be rejected. There being no objection, the article H.R. 1833, in my view, is fatally Mr. PELL. Mr. President. A month was ordered to be printed in the flawed because it fails to adequately ago, the Senate chose to refer to the Record, as follows: provide protections for procedures nec- Senate Judiciary Committee a bill [From the New York Times, November 29, essary to preserve or protect a wom- which would ban from use a medical 1995] an’s life or health. Roe vs. Wade, and procedure currently used to terminate GIVING UP MY BABY the cases that have followed including late-term pregnancies. I supported that (By Coreen Costello) Casey, have made it clear that States referral because it was unclear what all Those who want Congress to ban a con- have the authority to restrict and even of the ramifications of such a ban were troversial late-term abortion technique ban abortions after fetal viability ex- and the Senate deserved the oppor- might think I would be an ally. I was raised cept where necessary to protect a wom- tunity to have a complete record upon in a conservative, religious family. My par- an’s life or health. H.R. 1833 as origi- which to make an informed decision re- ents are Rush Limbaugh fans. I’m a Repub- nally proposed included an utterly in- garding this complex and controversial lican who always believed that abortion was adequate provision allowing only an af- wrong. issue. Then I had one. firmative defense to be asserted by the Today, we have that record before us. It wasn’t supposed to be that way. My lit- physician that the procedure was nec- I thank the members of the committee tle girl, Katherine Grace, was supposed to essary to protect a woman’s life. In for their thorough and detailed work in have been born in the summer. The births of other words, a physician who performs exploring this difficult matter and my two other children had been easy, and this procedure in order to save a wom- based on that record, I have come to my husband and I planned a home delivery. an’s life could be hauled into a Federal the conclusion that I will oppose this But disaster struck in my seventh month. court and prosecuted for violating this Ultrasound testing showed that something legislation. was terribly wrong with my baby. Because of statute. The physician would only be I do so because I believe that the bill a lethal neuromuscular disease, her body had able to raise as a defense that the pro- goes too far in its virtual ban of the stiffened up inside my uterus. She hadn’t cedure was performed to save a wom- use of this procedure, despite the fact been able to move any part of her tiny self an’s life. It is only after extensive de- that in many cases medical profes- for at least two months. Her lungs had been bate that the proponents of H.R. 1833 sionals believe that it is the safest unable to stretch to prepare them for air. proposed to change their language to means to terminate troubled and tragic Our doctors told us that Katherine Grace provide an explicit exception from the late-term pregnancies. I believe that could not survive, and that her condition statute’s coverage for a procedure nec- made giving birth dangerous for me—pos- medical doctors, following the con- sibly even life-threatening. Because she essary to preserve a woman’s life. How- stitutional guidelines under which could not absorb amniotic fluid, it had gath- ever, the amendment they have offered abortion is legal and following con- ered in my uterus to such dangerous levels contains limitations upon the life of sultation with a woman and her fam- that I weighed as much as if I were at full the mother exception which also raise ily, should be able to choose the med- term. questions as to whether it comports ical procedure he or she deems most I carried my daughter for two more agoniz- with the standard set forth in Roe v. appropriate to terminate a pregnancy ing weeks. If I couldn’t save her life, how Wade. without facing criminal or civil pen- could I spare her pain? How could I make her passing peaceful and dignified? At first I Moreover, the proponents have failed alties. Indeed, criminalizing a medical wanted the doctors to induce labor, but they to even acknowledge the requirement procedure in the manner proposed in told me that Katherine was wedged so tight- that an exception be provided where the bill would be the first such time we ly in my pelvis that there was a good chance the procedure is necessary to protect a have done so in our country’s history. my uterus would rupture. We talked about a woman’s health, including her future I do not come to this position lightly. Caesarean section. But they said that this, ability to bear children. The pro- I, and I believe virtually all Americans, too, would have been too dangerous for me. ponents argue that such an exception am disturbed with the harsh realities Finally we confronted the painful reality: is unnecessary because alternative pro- that this issue forces our human con- our only real option was to terminate the pregnancy. Geneticists at Cedars-Sinai Med- cedures are available. Those arguments science to acknowledge. In the end, ical Center in Los Angeles referred us to a fail to acknowledge the medical dis- however, I believe that it is not the doctor who specialized in cases like ours. He agreement over whether such alter- place of Congress to interject itself in knew how much pain we were going through, native procedures pose greater risks to this manner into the tragic personal and said he would help us end Katherine’s

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00078 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18195 pain in the way that would be safest for me was the most comfortable place for her to be. ator from California has up there is and allow me to have more children. When I awoke a few hours later, she was also not factual, is that true? That’s just what happened. For two days, brought to us. She was beautiful. She was Mr. SMITH. It is a fact that that is my cervix was dilated until the doctor could not missing any part of her brain. She had the family, but it is not a fact that bring Katherine out without injuring me. not been stabbed in the head with scissors. Her heart was barely beating. As I was She looked peaceful. they had a partial-birth abortion. Mr. SANTORUM. So we are going to placed under anesthesia, it stopped. She sim- Mr. President, that is my point. continue to throw pictures up, and that ply went to sleep and did not wake up. The Mr. SANTORUM. If the Senator will doctor then used a needle to remove fluid is how we are going to deal with facts. yield, that picture is not factual, right? from the baby’s head so she could fit through Mr. SMITH. Yes. This bill is very That picture is not factual, is it? the cervix. clear and specific, and it outlines this When it was over, they brought Katherine Mr. SMITH. The Senator is correct. Mrs. BOXER. Will the Senator yield procedure in the birth canal. That is in to us. She was wrapped in a blanket. My all this allows. I say that in sincerity husband and I held her and sobbed. She was to me on my own time? absolutely beautiful. Giving her back was Mr. SMITH. Yes. to the Senator because I know he feels the hardest thing I’ve ever done. Mrs. BOXER. I will place in the very strongly. I must say to him, that After Katherine, I didn’t think I would RECORD a letter from these women, and is the fact. have more children. I couldn’t imaging liv- I will read it later, which completely Why Senators would come down here ing with the worry for nine months, imag- makes the statement that this par- and testify to things that are not accu- ining all the things that could go wrong. But rate, you will have to ask them. Lis- my doctor changed that. ‘‘You’re a great ticular procedure that they underwent is, in fact, the procedure that would be ten, here is the exact language of my mother,’’ he told me. ‘‘If you want more bill: kids, you should have them.’’ I’m pregnant outlawed. And, in fact, the doctor that again, due in June. was vilified in this debate—by name, The term partial-birth abortion means an I still have mixed feelings about abortion. Dr. McMahon—and was summoned be- abortion in which the person performing the But I have no mixed feelings about the bill, fore the House committee is the doctor abortion partially, vaginally delivers a liv- already passed by the House and being con- ing fetus before killing the fetus and com- that performed the intact dilation and pleting the delivery. sidered in the Senate, that would ban the evacuation procedure. These women surgical procedure I had, called intact dila- When I read the testimony of the two are completely upset, and here is a tion and evacuation. As I watched the Sen- women, both of them said their child quote from the first sentence: ate debate on C-Span this month, I was sick died in their womb peacefully. Now, We are shocked and outraged— at heart. Senator after senator talked about dying in womb peacefully—does that the procedure I underwent as if they had This is to Senator SMITH. say ‘‘an abortion in which the person seen one, and senator after senator got it —at attempts by you and other Members of wrong. Katherine was not cavalierly pulled performing the abortion partially, the Senate to dismiss our significance as vaginally delivers a living fetus before halfway out and stabbed with scissors, as witnesses against the partial-birth abortion some senators described the process. ban. killing the fetus and completing the I had one of the safest, gentlest, most com- delivery’’? That is what this bill stops. I have to tell you Senators, you can passionate ways of ending a pregnancy that That is all it stops. That is all it says. fight this and you may well have the had no hope. I will probably never have to go That is exactly what it says. through such an ordeal again. But other votes. But do not demean these women. I say to my colleagues, no matter women, other families, will receive dev- I have to say, Viki Wilson, who you how you feel on the issue, please, at astating news and have to make decisions said yesterday did not have this proce- least accept facts as being facts. This is like mine. Congress has no place in our trag- dure, had Dr. McMahon as a doctor. the floor of the U.S. Senate. We have edies. She is a registered nurse. Her husband an obligation to tell the truth. That is Mr. SMITH. Mr. President, how much is a physician in an emergency room. not the truth, what Senator BOXER is time do I have remaining? They both know this bill. They say saying. Whether it is meant to be or The PRESIDING OFFICER (Mr. what Viki underwent is exactly what is thought to be is another issue. But it is ABRAHAM). The Senator from New described in the bill. not fact. I know what my bill says. Hampshire has 12 minutes and 15 sec- So if we are going to have an argu- That is what it says. I just read it to onds remaining. ment every time I bring out another you. Mr. SMITH. Mr. President, I hope my family, and you are going to say they How much time is remaining? colleagues are listening carefully at are excepted, are we going to write leg- The PRESIDING OFFICER. Six min- this stage of the debate, because we are islation like that? down now to where we are about to I reserve the remainder of my time. utes thirty seconds. vote on two very important amend- Mr. SMITH. Reclaiming my time, Mr. Mr. SMITH. I yield 2 minutes to my- ments related to this bill. President, when you look out the win- self and ask to be notified when the 2 Senator BOXER has taken the time to dow and it is raining, and the person minutes are up. go through two very compelling cases, sitting next to you says it is not rain- Let me just say that this Dole-Smith very tragic cases. Both of those women ing—I mean, you can argue this, but amendment provides a life-of-the- testified before the Judiciary Com- facts are facts. I am not demeaning the mother exception. We had an affirma- mittee, and that was heart-rending tes- testimony of Viki Wilson or Coreen tive defense in the bill. Members came timony. Costello. They were very, very moving to me and said, ‘‘We want it a little I viewed the testimony. I have read stories. This Senator was very moved more clarified.’’ I said, ‘‘Fine,’’ and we it. There is only one problem, and I by those stories. But they are not par- clarified it because I think Senators have said it, Senator DEWINE has said tial-birth abortions. sincerely had a concern about that— it and others have said it: These This Senator’s bill, and all the even though there have been no wit- women did not have partial-birth abor- amendments we are talking about on nesses to testify that the mother’s life tions. I will repeat, these women did the bill, does not stop the procedure was ever a problem. Let me just say not have partial-birth abortions. that Viki Wilson and Coreen Costello that this applies to any situation in Coreen Costello and Viki Wilson did had. which a pregnant woman’s life is phys- not have partial-birth abortions. Sen- I will now repeat and read verbatim ically threatened by any pregnancy, ator BOXER knows that, and both of the from the testimony of Viki Wilson. complication, or other disorder, and a young women know that. A partial- Please listen carefully and make your partial-birth abortion is the only birth abortion specifically is killing a own judgment. means by which her life can be saved. child who is 90 percent born through Viki Wilson said: That is the life-of-the-mother excep- the birth canal by the use of the cath- My daughter died with dignity inside my tion. It is very clear. There is no ques- eter and the scissors. womb. She was not stabbed in the back of tion about it. Now, let me read from the testimony the head with scissors. No one dragged her If we go to the Boxer partial-birth of Coreen Costello: out half alive and killed her. We would never abortion on demand amendment, it al- When I was put under anesthesia, have allowed that. lows partial-birth abortions on demand Katherine’s heart stopped. She was able to Mr. SANTORUM. If the Senator will throughout the full 9 months of the pass away peacefully inside my womb, which yield. So the second picture the Sen- pregnancy. If a woman has any health

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00079 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18196 CONGRESSIONAL RECORD — SENATE December 7, 1995 problem that she so indicates, then any Now, this is Viki Wilson. She testi- tion’’ controversy. In no way are these done child could be aborted for any reason. fied to the Judiciary Committee as fol- only on abnormal infants. This is just an- That is a fact. lows. These are facts, facts from her other brutal way to destroy life. This proce- We voted on this before on the floor mouth. dure is not necessary to protect the life or health of women in this country. of the Senate, and we voted it down. I I am a practicing Catholic and I couldn’t hope that we will vote it down now and help but believe that God had some reason Another one from Dr. Lauri Scott, have a true life-of-the-mother excep- for giving us such a burden, and then I found M.D., assistant professor of maternal- tion, as we have tried to do. out about this legislation. I knew then and fetal medicine in Dallas, TX. I remember in the debate when the there that Abigail’s life had special meaning. I am a specialist in maternal-fetal medi- I think God knew I would be strong enough cine and on faculty in the Department of Ob- Senator from California, and others, to come here and tell you my story, to try to made a big case here on the floor to stetrics and Gynecology at the University of stop this legislation from passing and caus- Texas, Southwestern Medical Center. It is please have the life-of-the-mother ex- ing incredible devastation for other families the nature of my specialty that I deal with ception, have it clarified. We have done like ours, because there will be other fami- high-risk pregnancies and would be the con- that. In fact, I voted to send the bill lies in our situation, because prenatal test- sultant called to deal with issues regarding back to committee to have time to do ing is not infallible and I urge you please do the ‘‘life-of-the-mother.’’ that and to hear the testimony of the not take away the safest method known. I can tell you unequivocally there is no witnesses. The PRESIDING OFFICER. There maternal medical reason for ‘‘late-term I will conclude on this point, Mr. are 4 minutes 30 seconds remaining. abortions.’’ In situations where the life of President. We had no doctors who per- Mrs. BOXER. I will take an addi- the mother is at stake, we simply deliver the tional 30 seconds, and I will retain the infants and the baby takes its chances in the formed partial-birth abortions testi- nursery. fying and no women who had them tes- time for my colleague from New Jer- tifying. So I am not sure what the com- sey. ‘‘DEAR SENATOR SMITH,’’ Mary Dav- mittee hearing produced. Coreen Costello says, ‘‘I hope you can enport, Oakland, CA: Thank you, Mr. President. put aside your political differences, I am writing to you in support of the par- Mrs. BOXER. Mr. President, how your positions on abortion, your party tial-birth abortion bill. There is no medical much time remains on my side? affiliation’’—this is a picture of indication for this procedure, and the per- formance of this operation is totally in oppo- The PRESIDING OFFICER. Seven Coreen—‘‘and just try to remember us. We are the ones who know. We are the sition to 2,000 years of Hippocratic medical minutes, 30 seconds. ethics. Please do your best to eliminate this Mrs. BOXER. I ask that I be notified families that ache to hold our babies, procedure. It is not done in any other nation when I have used 3 minutes. to love them, to nurture them. We are of the world. Mr. President, I will tell you, this de- the families who will forever have a Margaret Nordell, M.D., caring for bate is one of the most fascinating I hole in our hearts.’’ women of all ages, Minot, ND: have ever been in. I will hold up picture I say to any Senator that tries to de- mean these families and tell them they I am a member of the DakotaCare Physi- after picture of people who know that cians Association. I believe that this proce- this bill applies to the procedure they do not know what went on in these dure is unnecessary to protect either the life had, and my colleague, who thinks he families should think again. We were or health of women in this country. elected to be Senators, not doctors, and might perhaps be a doctor, and his Dr. Karin Shinn, Coney Island Hos- not God. friends think that, in fact, they do not pital: know what they are doing because they I retain the remainder of my time. Mr. SMITH. Mr. President, how much DEAR SENATOR SMITH: I am a practicing ob- are U.S. Senators. After all, they know gyn on the staff of Coney Island Hospital. It more than the families that went time remains? The PRESIDING OFFICER. Four is my professional opinion that the partial- through this what happened. Again, birth abortion procedure is very dangerous minutes twenty-two seconds. and absolutely unnecessary to protect either here is the letter I read part of, dated Mr. SMITH. I yield myself 3 minutes December 7—and that is today. This the life or the health of the women in Amer- 22 seconds. ica. was raised yesterday as a red herring, Mr. President, it is very frustrating. that these people that I held up did not Again, I will just repeat for emphasis Letter after letter after letter, Mr. know what they were talking about. for those, I hope, who are listening to President, all over the country. To say These women and families wrote us. the debate: Viki Wilson in her testi- that somehow the U.S. Senator who Seven of them said this, and I will mony not only indicated that she did stands here on the floor, quoting from quote—this is to Senator SMITH: not have a partial-birth abortion, she doctors about a medical procedure, to We are shocked and outraged by attempts said she would not have one. So these taking the ‘‘slam’’ that somehow we by you to dismiss our significance as wit- are not partial-birth abortions. But cannot vote for something or talk nesses against the partial-birth abortion bill. again I will not continue to debate it. about something because we are not Then they say: Any reasonable person, hopefully, doctors—we send troops into Bosnia, Your rhetoric vilifies our physician, Dr. who is watching the debate would un- that will happen. And I assure you that McMahon, who is the Nation’s leading devel- derstand the definition is very clear. A every Senator who votes to send them oper and practitioner of this technique for partial-birth abortion is when a child is there has never served in combat and third-trimester abortions, and you claim si- probably never been there. That is for multaneously that we did not undergo the killed in the birth canal. These two women in the horrible circumstances sure. We vote on Medicare and we vote procedure in question. But we definitely had on Medicaid and not everybody here is intact dilation and evacuation procedures, they went through lost their children and it is definite that no doctor who wants in the womb. This amendment would a senior citizen. to stay out of prison will perform that proce- not prevent what happened to them. The argument is absolutely ludicrous dure, or any surgery that remotely resem- Since I have been accused of not and frankly insulting. I hope my col- bles it, if your bill is passed. being a doctor, which is a fair accusa- leagues will defeat the Boxer amend- They write this: tion, let me offer into the RECORD a ment and support the Smith-Dole If your bill passes, families with tragedies sample of the 200 unsolicited letters amendment. like ours will have added misery and pain be- from ob-gyn’s from all over America. I EXHIBIT 1 cause the surgical procedure that helped us ask unanimous consent that all of PHILADELPHIA, PA, will be unavailable. Please stop pushing this these be printed in the RECORD after November 28, 1995. awful bill and please stop pretending that we this debate. Hon. ROBERT SMITH, are irrelevant. The PRESIDING OFFICER. Without U.S. Senate, Of course, Senators will continue to objection, it is so ordered. Washington, DC. DEAR SENATOR SMITH: I appreciate your ef- say that these people, religious fami- (See exhibit No. 1.) lies, loving families, simply do not forts on behalf of the ‘‘partial birth abor- Mr. SMITH. I will quote from a letter tion’’ controversy. In no way are these done know what they are talking about and from a Dr. Dorothy Czarnecki, an ob- only on abnormal infants. This is just an- do not know what was done to the body gyn from Philadelphia. She says: other brutal way to destroy life. This proce- of their incredibly important family DEAR SENATOR SMITH: I appreciate your ef- dure is not necessary to protect the life or member. forts on behalf of the ‘‘partial-birth abor- health of women in this country.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00080 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18197 Thank you again and keep up the fight to ciation. I believe that this procedure is un- that choice simply to rid themselves of protect our children. necessary to protect either the life or the that pregnancy. Sincerely, health of women in this country. This is a sad day, I think, Mr. Presi- DOROTHY CZARNECKI, M.D. Sincerely, dent. MARGARET NORDELL, M.D. Mr. President, the bill before us is ex- DALLAS, TX, November 7, 1995. CONEY ISLAND HOSPITAL, tremely dangerous and I strongly op- Re late term abortions. DEPARTMENT OF OBGYN, pose it. Hon. ROBERT SMITH, Brooklyn, NY, November 26, 1995. This bill is poorly titled for many U.S. Senator, Washington, DC. Hon. ROBERT SMITH, reasons. It would more appropriately DEAR SENATOR SMITH: I am a specialist in U.S. Senate, be called The Big Government Intru- Maternal-Fetal Medicine and on faculty in Washington, DC. sion into the Doctor-Patient Relation- the Department of Obstetrics and Gyne- DEAR SENATOR SMITH: I am a practicing ship Act. cology at the University of Texas South- OBGYN on the staff of Coney Island Hospital western Medical Center. It is the nature of in Brooklyn, New York. It is my professional Under this bill, we will literally have my specialty that I deal with high risk preg- opinion that the partial birth abortion pro- FBI agents snooping around examining nancies, and thus would be the consultant cedure is very dangerous and absolutely un- rooms. Let me repeat this. This legisla- called to deal with issues regarding ‘‘the life necessary to protect either the life or the tion authorizes the FBI to go wan- of the mother’’. Prenatal diagnosis is also health of women in America. Therefore, I dering around doctors’ offices looking part of my specialty, and I am the one who whole heartedly support the partial birth at patients and what doctors are doing breaks the news of fetal abnormalities and abortion ban bill to be passed and become of- to them. helps to plan how best to manage the rest of ficially law. Thank you. Furthermore, this bill does not in- the pregnancy. Sincerely, clude a life and health of the mother I can tell you unequivocally that there is KARIN E. SHINN, D.O., no maternal medical indication for ‘‘late Assistant attending. exemption. term abortions.’’ In situations where the life The PRESIDING OFFICER. The Sen- This bill will send a chilling signal to of the mother is at stake, we simply deliver ator from California has 3 minutes 52 doctors in this country. And they will the infant and the baby takes its chances in seconds. leave the practice of reproductive the nursery. In our nursery, 50% of the in- health care in droves. fants born at 24 weeks gestation will survive, Mrs. BOXER. I yield 2 minutes to the Senator from New Jersey. And women could die in waiting most without significant problems. Prior to rooms while doctors are on the phone, 24 weeks we recognize that the baby will gen- Mr. LAUTENBERG. Mr. President, erally die due to extreme prematurity, but first, let me commend my colleague consulting with defense and constitu- we perform no procedures to ensure its from California for speaking so forth- tional lawyers, about what they can or death; there is no medical reason for this rightly about an issue that does not be- cannot do to treat their patients. when the concern is with the life of the long in the kind of debate that we have Mr. President, one reason I am oppos- mother. ‘‘Late term abortions’’ are no safer, heard from the other side from the pro- ing this bill is because I believe doctors and may be more dangerous for the mother, ponents of this amendment. and patients can make proper decisions than simple induction of labor. about which health care treatment is The only reason for a ‘‘late term abortion’’ Strangely enough, and I speak now as is to ensure that the late second trimester a father and a grandfather, as a father most appropriate. and third trimester fetus is born dead. The of four. We lost a couple because of Mr. President, one of the most ex- only possible medical indication would be a health problems with my wife, and treme elements of this bill is its failure situation in which the fetus has abnormali- every one of those pregnancies that to include an exception to deal with ties incompatible life. However, in most of was lost was a terrible experience for situations in which the life or health of these situations, the infant would die shortly us. the mother is at risk. The pending after birth anyway and terminating the When my youngest daughter lost a Boxer amendment seeks to make this pregnancy in the late 2nd or 3rd trimester fetus, lost a pregnancy that was in its bill a little less extreme. The Boxer carries the same complications as allowing amendment would create a real health the pregnancy to go to term and end natu- 7th month because the baby was entan- rally. gled in the cord, it was very painful, and life-of-the-mother exception. This procedure has no place in modern ob- very painful. We did not know whether Under the bill, as originally pre- stetrics and only serves to destroy lives that we had a healthy baby or not, but we sented, if a doctor thought it likely might otherwise survive. I suspect that the were torn by this experience, to have that a woman would become perma- women who made such tragic decisions for her go to the hospital, spend 8 hours in nently disabled if she carried a fetus to medical reasons chose this procedure with- labor to deliver the fetus. term, the doctor would still be prohib- out truly informed consent or full knowledge ited from performing this procedure. of their options. It should never be per- The interesting thing to me, Mr. formed as an elective procedure. Please sup- President, is I have not heard one Can you imagine that? A doctor would port legislation banning this procedure. woman speak for that side. It is the have to feel certain that carrying a Sincerely, men who speak on what women ought fetus to term would endanger the life L. LAURIE SCOTT, M.D., to do, tell them how to conduct their of the mother in order to do what is Assistant Professor, lives, tell them what to do with their medically required for treatment. Maternal-Fetal Medicine. bodies, describe the pain that they will Otherwise, the doctor could not per- never feel. It is quite interesting. They form this procedure even though the OAKLAND, CA, woman could suffer severe, permanent December 1, 1995. want to tell everybody what the moral DEAR SENATOR SMITH: I am writing to you right is. health damage without the procedure. in support of the partial birth abortion bill. I just heard one of our Senators say Mr. President, this bill will affect There is NO medical indication for this pro- something that to me is so prepos- real people. Real women and families cedure, and the performance of this oper- terous. He says those who will vote to who have had to go through this proce- ation is totally in opposition to 2000 years of send troops to Bosnia will never serve dure. Hippocratic medical ethics. Please do your in combat. Who is he that knows all One such woman is Viki Wilson, a best to eliminate this procedure. It is not this information? What a silly thing to nurse, who 18 months ago was expect- done in any other nation of the world. ing her first child. Early tests showed Sincerely yours, say. It is the same thing we are talking MARY L. DAVENPORT, M.D. about here. the child to be normal but an 8-month What this is is license for the Gov- ultrasound revealed that the fetus had MINOT, ND, ernment to participate in the operating a fatal condition—two thirds of the November 28, 1995. room when a doctor does a procedure, brain had formed outside the skull. Senator ROBERT SMITH, when a doctor decides to perform a pro- Carrying the pregnancy to term U.S. Senate, cedure that the woman carrying the would have imperiled Viki’s life and Washington, DC. fetus wants to have done because she health. In consultation with her doc- DEAR MR. SMITH: I, Margaret Nordell, a medical doctor of obstetrics and gynecology feels that it is essential or the doctor tor, Viki and her husband Bill made am supporting Senator Robert Smith in the feels it is essential for her health. the heartbreaking decision to undergo ban against ‘‘partial birth abortion’’. I am a These abortions, these procedures are this procedure. This bill would make member of the DakotaCare Physicians Asso- rarely done when someone was making this practice illegal.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00081 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18198 CONGRESSIONAL RECORD — SENATE December 7, 1995 Mr. President, I would like to quote [Rollcall Vote No. 592 Leg.] Coats Grams McCain Cochran Grassley McConnell Viki at this point. She stated ‘‘I YEAS—98 Conrad Gregg Murkowski strongly believe that this decision Abraham Feingold Lott Coverdell Hatch Nickles should be left within the intimacy of Akaka Feinstein Lugar Craig Hatfield Pressler the family unit.’’ Ashcroft Ford Mack D’Amato Heflin Reid Baucus Frist McCain DeWine Helms Roth So do I Mr. President. Bennett Glenn McConnell Dole Hutchison Santorum While this bill is really extreme, the Biden Gorton Mikulski Domenici Inhofe Shelby Bingaman Graham Moseley-Braun Exon Johnston Smith Boxer amendment would make it a lit- Bond Gramm Faircloth Kempthorne Stevens tle less extreme. At a minimum, we Murkowski Boxer Grams Murray Ford Kyl Thomas ought to adopt the amendment, which Bradley Grassley Nickles Frist Lott Thompson would establish a meaningful exception Breaux Gregg Nunn Gorton Lugar Thurmond Gramm Mack Warner Brown Harkin Pell in cases where the life and health of Bryan Hatch Pressler the mother is at stake. Bumpers Hatfield NOT VOTING—1 Pryor Burns Heflin Moynihan I urge my colleagues to adopt the Reid Byrd Helms Robb Boxer amendment and I yield the floor. Campbell Hollings So the amendment (No. 3083) was re- Rockefeller The PRESIDING OFFICER. The time Chafee Hutchison jected. Roth of the Senator has expired. Coats Inhofe Mr. SMITH. Mr. President, I move to Cochran Inouye Santorum reconsider the vote. Mr. LAUTENBERG. I yield the floor Sarbanes Cohen Jeffords Mr. DOLE. I move to lay that motion and hope that my colleagues will sup- Conrad Johnston Shelby Simon on the table. port the amendment that is proposed Coverdell Kassebaum Craig Kempthorne Simpson The motion to lay on the table was by Senator BOXER. D’Amato Kennedy Smith agreed to. Mrs. BOXER. Mr. President, I retain Daschle Kerrey Snowe The PRESIDING OFFICER. Under the remainder of my time. DeWine Kerry Specter Dodd Kohl Stevens the previous order, the Senator from The PRESIDING OFFICER. The Sen- Dole Kyl Thomas New Hampshire is recognized. ator has no other time. Domenici Lautenberg Thompson AMENDMENT NO. 3088 TO AMENDMENT NO. 3082 Dorgan Leahy Thurmond (Purpose: To express the sense of the Senate Mrs. BOXER. I thought I saved some Exon Levin Warner time. Faircloth Lieberman Wellstone that the Senate should, through the Com- The PRESIDING OFFICER. They mittee on the Judiciary, conduct hearings NOT VOTING—1 to investigate the effect of the new patent have no time. Moynihan provisions of title 35, United States Code, Mrs. BOXER. How much time do I (as amended by the Uruguay Round Agree- have remaining? So the amendment (No. 3081) was ments Act) on the approval of generic The PRESIDING OFFICER. The Sen- agreed to. drugs) ator has 1 minute. Mr. COHEN. Mr. President, I move to Mr. SMITH. Mr. President, I send a reconsider the vote. Mrs. BOXER. Mr. President, this has second-degree amendment to the desk Mr. GRAMM. I move to lay that mo- been a tough debate so far. We have and ask for its immediate consider- tion on the table. gone through it for 3 days. Maybe this ation. The motion to lay on the table was The PRESIDING OFFICER. The is the 4th day, Senator SMITH. agreed to. clerk will report. I have to say, it is emotional. Why is The PRESIDING OFFICER. Under The assistant legislative clerk read it emotional? Because what we are the previous order, the underlying as follows: doing impacts real people. We have amendment, No. 3080, as amended, is The Senator from New Hampshire [Mr. seen these families night after night. agreed to. SMITH], for Mr. DEWINE and Mr. DODD, pro- We have seen charts of part of a wom- poses an amendment numbered 3088 to an’s body, as if she had no face. I have VOTE ON AMENDMENT NO. 3080 amendment No. 3082. to say to my colleagues, if they really The PRESIDING OFFICER. The Mr. SMITH. Mr. President, I ask think about it, if their daughter came question now is on agreeing to amend- unanimous consent that reading of the to them and said, ‘‘Dad, I have been ment No. 3083 offered by the Senator amendment be dispensed with. told the most horrible news. If I do not from California. The yeas and nays The PRESIDING OFFICER. Without terminate this pregnancy, even though have been ordered. The clerk will call objection, it is so ordered. it is so late term, I could die. I could be the roll. The amendment is as follows: infertile. And the only procedure is The legislative clerk called the roll. Beginning on page 1, line 3, strike ‘‘AP- this procedure,’’ I really do believe, if Mr. FORD. I announce that the Sen- PROVAL’’ and all that follows through line Senators are honest, male or female, ator from New York [Mr. MOYNIHAN] is 22 on page 3 and insert the following: necessarily absent. ‘‘SENSE OF THE SENATE. they would fall to their knees and pray ‘‘It is the sense of the Senate that the Sen- to God and go ahead and have that pro- The PRESIDING OFFICER (Mr. BEN- ate should, through the Committee on the cedure. NETT). Are there any other Senators in Judiciary, conduct hearings to investigate Why would we want to risk that the Chamber who desire to vote? the effect of the new patent provisions of woman’s life? Please vote ‘‘yes’’ for The result was announced—yeas 47, title 35, United States Code (as amended by nays 51, as follows: subtitle C of title V of the Uruguay Round Dole and ‘‘yes’’ for Boxer-Brown. Agreements Act (Public Law 103-465; 108 [Rollcall Vote No. 593 Leg.] VOTE ON AMENDMENT NO. 3081 Stat. 4982)), on the approval of generic drugs The PRESIDING OFFICER. The YEAS—47 under section 505 of the Federal Food, Drug, question now occurs on amendment No. Akaka Feingold Lieberman and Cosmetic Act (21 U.S.C. 355).’’. Baucus Feinstein Mikulski Mr. SMITH. Mr. President, I will try 3081, offered by the majority leader, Biden Glenn Moseley-Braun Mr. DOLE. Bingaman Graham to explain the amendment. Murray First, I yield to the majority leader. The yeas and nays have been ordered. Boxer Harkin Nunn Bradley Hollings The clerk will call the roll. Pell SCHEDULE Brown Inouye Pryor Mr. DOLE. Mr. President, I have been The assistant legislative clerk called Bryan Jeffords Robb Bumpers Kassebaum asked to indicate what may be in store the roll. Rockefeller Byrd Kennedy for the rest of the evening. It is not Sarbanes Mr. FORD. I announce that the Sen- Campbell Kerrey Simon certain that these are all the amend- OYNIHAN Chafee Kerry ator from New York [Mr. M ] is Simpson ments, but we have an amendment by necessarily absent. Cohen Kohl Daschle Lautenberg Snowe Senator BINGAMAN on shutting down The PRESIDING OFFICER. Are there Dodd Leahy Specter the Government; an amendment by Wellstone any other Senators in the Chamber Dorgan Levin Senator FEINSTEIN which, as I under- who desire to vote? NAYS—51 stand it, is similar to the Boxer amend- The result was announced—yeas 98, Abraham Bennett Breaux ment just disposed of; a Brown amend- nays 0, as follows: Ashcroft Bond Burns ment on deadbeat dads; then we have

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00082 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18199 the pending amendment of Senator it will not delay a vote on the bill, as When people do go to the polls they PRYOR, which Senator SMITH will sec- other Senators have expressed interest will have to decide where they stand. ond-degree. There may be additional to me—or have asked me whether or Could they stand with a Government amendments. I think it is safe to say not there would be a vote tonight on that wants to get right into the hos- there will be votes well into the final passage of the partial-birth bill. I pital room with your family, right into evening. am prepared to do that at any time. I your bedroom with your family, or do I yield the floor. do not know specifically of other they believe that the families in our Mr. CHAFEE. I wonder if the major- amendments, but you never know. country with their God and with their ity leader has any indication, if this is If this second-degree amendment conscience can make those kind of de- disposed of this evening, what would fails or if any other Senators are going cisions? happen tomorrow? to try to load the bill up, we will have I am very moved by the vote that we Mr. DOLE. We have a cloture vote to be offering second-degree amend- had. I will certainly vote against the scheduled on the constitutional amend- ments on all kinds of things from sex final passage of this bill. Senator FEIN- ment on the desecration of the flag. selection to Down’s syndrome, and STEIN will be offering us an excellent That could be resolved if we get an Lord knows what. Let’s hope we do not substitute which basically restates the agreement on State Department reor- get into all that. law of the land that says in the late ganization. If we do that, then we can Hopefully, Mr. President, why don’t term of a pregnancy the States control vitiate the vote on cloture and prob- we just vote and move on and see what happens in these late-term abor- ably have debate only tomorrow on the where the votes fall on this bill. tions. flag amendment, but no final disposi- If we want to talk about patent pro- I think everyone was very surprised tion. tections, come to the hearing and tes- by this vote. I was moved by the vote. Mr. JOHNSTON. Does the majority tify about patent protections. Then I hope colleagues will vote ‘‘no’’ on leader expect we will have a small win- when the Senate is ready to vote on final passage, since there is no excep- dow where we might get home to get a that, when we can come down and de- tion for the life of the mother. The bite to eat? bate it. Senate voted for a partial exception, It is a very complicated issue, pat- Mr. DOLE. How close are you? and therefore it makes it a very, I ents and trade. I don’t think it ought Mr. JOHNSTON. About 20, 25 min- think, weak bill, and the President has to go through the Senate in a hurry utes. said he would veto it. I applaud that. without having an opportunity to hear Mr. DOLE. You are not going to New I yield the floor. from both sides. The Senator from Ar- Orleans, are you? I think we may have Mr. PRYOR. Mr. President, I thank kansas voted a couple weeks ago to a vote in the next few minutes, and the Chair for recognizing me. Mr. have a hearing on partial-birth abor- then we can probably arrange at least President, the day before yesterday I tion, and we did. I was not originally in an hour. introduced an amendment on behalf of favor of it, I admit, but we did have the Mr. JOHNSTON. I thank the major- myself and my very good friend from hearing. ity leader. Rhode Island, Senator CHAFEE, and our The PRESIDING OFFICER. The Sen- I did reconsider my views and al- lowed it to be sent to the committee. I good friend from Colorado, Senator ator from New Hampshire is recog- hope the Senator from Arkansas will BROWN. nized. Mr. President, I ask unanimous con- Mr. SMITH. Mr. President, let me do the same. I urge my colleagues if there is a vote sent that Senator Robert BYRD of West just say, for the benefit of my col- to vote for the Smith amendment so we Virginia be added as an original co- leagues, I am not going to prolong the can have a full hearing under this issue sponsor of this amendment. debate on this second-degree amend- of patent protection. I yield the floor. The PRESIDING OFFICER. Without ment. I know Senator PRYOR has some Mrs. BOXER. Before my colleague objection, it is so ordered. comments and Senator DEWINE wants from Arkansas speaks on this par- Mr. PRYOR. Mr. President, what we to speak. I do not know of any others. ticular subject which he has been such are seeing here tonight on the second- But if others are going to speak, hope- a leader on, I wanted to make a com- degree amendment, and I say this in all fully, they will come to the floor and ment that President Clinton has long due respect to my colleagues who have we can expedite this matter as quickly believed that it is important to protect offered this second-degree amendment as possible. the life and the health of a mother, of to this principal amendment, this is This amendment requires hearings on a woman. merely an attempt to kill the Pryor- the relationship between GATT patent We know he will, in fact, veto this Chafee-Brown-Byrd amendment. That laws and the FDA Hatch-Waxman law bill because the Senate now voted this is it, pure and simple. relating to prescription drugs. At the down. A very close vote. I want to First, it is a sense-of-the-Senate reso- outset, let me say I would have pre- thank my colleagues who stood with lution which all of us know in this ferred not to have this bill, become a Senator BROWN, with me, and with body has no force of law. It has no real Christmas tree for nongermane amend- those who feel so strongly about this, meaning. It has no traction, as we say ments. It was hopeful that we would that we must put a woman’s face on around here. Beyond that, it does not not have nongermane amendments. this debate. require any Committee to hold any But the underlying Pryor amendment I am very moved by the vote that we hearing at any specific time. dealing with pharmaceutical products, had. It sends a very strong signal to It merely says that the Judiciary GATT, and patent protections has the President of the United States: Committee would conduct hearings to nothing to do with partial-birth abor- That 47 Senators, notwithstanding in- investigate the effect of the new patent tion. However, I recognize the right my credible organized phone banks, et provisions of title 35 U.S. code as colleague has to offer such an amend- cetera, stood up for the life and the amending subtitle C. of title 5 of the ment, and I respect that. I hope that health of the women in this country. I Uruguay Round agreements. we will not spend a lot of time on this am proud that you stood with me. I am Mr. President, this amendment would and delay this bill. We saw the same proud that you stood with women. probably end up in the wastebasket. tactic a few weeks ago, and it seems to I want to particularly thank in that There is no date certain for a hearing. me that maybe there is some reluc- context every one of my colleagues Additionally, the amendment sends in- tance to face the issue at hand. that spoke on this. Senator MOSELEY- structions for a hearing, under this Mr. President, this second-degree BRAUN spoke so eloquently yesterday sense-of-the-Senate amendment, to the amendment calls for hearings in the and she made the point that the women Judiciary Committee. It would not be Judiciary Committee to look into this of America will have to wake up to sent to the Labor Committee that has issue. I say to my colleague from Ar- what is happening to their rights. She jurisdiction over food and drug issues. kansas that it is an important issue did that in the most beautiful fashion. It is being sent to the Judiciary Com- and deserves a hearing, and I recognize I urge everyone to read the RECORD, be- mittee of the U.S. Senate. that. I recognize that the Senator has a cause this assault on a woman’s right Once again, there is no date certain legitimate interest in this. I hope that to choose has begun in earnest. for when a hearing might be held on

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00083 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18200 CONGRESSIONAL RECORD — SENATE December 7, 1995 the effect of the proposal that we are ever made, but it was a costly one. We This is what we might call a ‘‘good discussing this evening in the U.S. Sen- failed to consider a conforming amend- Government’’ amendment. It seeks to ate. ment to the patent provisions of the close a loophole which was uninten- Make no mistake, what this amend- Food, Drug and Cosmetic Act, which tionally created. We made a mistake, ment is all about is an attempt to kill Senator PRYOR previously alluded to. and now we are trying to correct it. the Pryor-Chafee-Brown-Byrd amend- The consequence of this oversight is Does it have any support outside of ment. It is a tactic to delay. It is a mo- that one group of generic manufactur- those of us here? Certainly a broad coa- tion to protect one of the greatest ers—in other words, those coming on lition of senior citizens and consumer windfalls that we have ever created in with a substitute product—had been groups support it. Furthermore, it is the history of our entire Government. denied the benefits of this transition the right thing to do. Occasionally we Now, Mr. President, I have several provision. These were the generic phar- do the right thing around here. things I want to say during the course maceutical manufacturers. So, while I certainly hope that this amendment of this debate. I see my very good col- the manufacturers, that is the manu- of the Senator from Utah, to send this league, Senator CHAFEE, my colleague facturers who had the patent of these back, and the Senator from New Hamp- on the Finance Committee, who has branded pharmaceutical products, got shire, would not prevail. I hope it will been so loyal as a friend and as a sup- an extra 3 years, the generic drug man- not prevail because, if it does prevail, porter in trying to close this loophole ufacturers were cut out altogether that does in the Pryor effort here. that we created when we did not con- from transition remedies—from doing Could I ask the Senator from Arkan- form the food, drug and cosmetic law anything. sas, does this amendment provide for a to the GATT treaty and its provisions. This oversight, if left uncorrected, I date that the hearing must be com- Mr. President, I also see my friend must say, is a wonderful windfall for pleted? from Colorado, Senator BROWN, an the pharmaceutical manufacturers who Mr. PRYOR. Mr. President, I respond original cosponsor of our amendment. are protected by it, who got this wind- to my colleague from Rhode Island, Mr. President, expecting that my col- fall which was never planned for. This there is absolutely no date set forth in leagues might have something to say windfall is in the area of billions of dol- the sense-of-the-Senate resolution to on this issue, for the moment I yield lars—not millions, but billions. So, require the Judiciary Committee, or the floor and I reserve the opportunity quite understandably, they are very en- any other committee of the Senate, to to address this issue further. thusiastic to prevent anything from hold a hearing. It is totally open ended. Mr. CHAFEE. Mr. President, I want happening around here, to prevent the Again, there is no date specified in the to take a moment to discuss the pend- Pryor amendment from going into ef- sense-of-the-Senate resolution. Mr. CHAFEE. I have a question for ing amendment. This is really a very fect. Obviously, others can give illus- the distinguished Senator from New simple issue. trations of this. Under the Uruguay Round the na- What will be the effect of the passage Hampshire. He mentioned the sending tions agreed to boost protection of pat- of the Chafee-Brown-Pryor-Byrd of his bill back to committee for a ents significantly. This was an historic amendment? First, it will level the study. I guess the Senator from New step. Indeed, this was the first time playing field by making the GATT Hampshire supported that in the end, reluctantly. that in these multilateral trade agree- transition provision available to ge- My question is this: Did that amend- ments such as this, the GATT, we be- neric drug manufacturers like it is to ment, that sent the Senator’s bill back came involved with so-called intellec- generic blue jeans manufacturers, or to committee, have a date at which the tual property. whoever it might be. This is what we committee must report back? As I re- In order to implement the provisions intended. Second, it will stop the unin- call, it did. I may be mistaken. of the commitment to increase the pro- tended, and therefore unfair, windfall. Mr. SMITH. I believe it was 17 days, tection for patents, the Congress And, third, it will save consumers, in- I say to my colleague, Senator CHAFEE. changed the U.S. patent law from 17 surers, and, I might say, the Govern- But I need to check that. years from approval to 20 years from ment—because the Government will Mr. CHAFEE. I certainly would abide filing date. This was a change to con- benefit greatly from getting their Med- by whatever the Senator says, and if he form with GATT. icaid prescription drugs at a far lower wishes to correct it later, that is fine. To be fair to existing patent holders, price than otherwise would be true. But, as I recall, when that was sent, Congress gave those existing patent There are two counterpoints that op- Senator SMITH’s bill which came up holders the option of taking the longer ponents of this will make. Some have here, say, a month ago, when that was term. As a result, those holding pat- warned that this amendment would ne- sent back to committee, that was sent ents as of June 1985 received an exten- gate or otherwise affect the hard-won back with a time limit to it, a definite sion of up to 3 years. gains that came about through GATT period. Whether it was 17 days or 3 However, granting this extension af- and the intellectual property protec- weeks or whatever it was, I am not fected generic drug manufacturers who tions. That is a red herring. The STR, sure. But I remember, to the best of my had been preparing to go to market the Special Trade Representative, has recollection, there was a time certain. after the original patents expired. To assured us that our amendment will Yet, in this case, the Senator from New be fair to them, too, Congress made a not in any way interfere with the Hampshire, in his amendment, has not compromise: manufacturers who had GATT intellectual property protection provided for a date certain. What does already made a substantial investment rights. In fact, the USTR supports this the Senator from Arkansas suggest on preparing to go into the market, would amendment, for they say the con- that? Would this be more palatable if be allowed to proceed—but they would forming amendment—namely, the there was a time limit? be required to pay a royalty to the Pryor effort—should have been in- Mr. PRYOR. Let me respond, Mr. holder of the patents. This was a care- cluded in the GATT bill but was over- President, to my friend from Rhode Is- fully worked out compromise. looked inadvertently. land once again. It would certainly be This transition was made available Now, as to the argument that our more palatable if we had an imminent to all manufacturers, not just generic amendment would upset the delicate date for the Judiciary Committee to manufacturers of drugs. There are ge- balance of the Hatch-Waxman Act, hold such a hearing. But, to be honest, neric manufacturers of blue jeans and that also is a red herring. This is not I do not think a Judiciary Committee every other patent. Wherever there is a about Hatch-Waxman; this is about hearing is going to give us any more patent involved someone is waiting for GATT. Officials of the Food and Drug facts than we know today. We pretty the patent to expire and then come for- Administration have assured us that well have the facts. Those facts are ward with their own product. our amendment absolutely would not that the Congress made an mistake. We The product is called a generic prod- disturb the so-called Hatch-Waxman created an error in the GATT legisla- uct—not just a generic drug, but ge- Act. Let me say, if this were inter- tion. We opened a loophole, and now we neric blue jeans, or whatever it might fering with GATT in some way, the in- have an opportunity to fix it. be. However, Congress made an error. tellectual property provisions, I would As the Senator from Rhode Island It is not the first error Congress has not be for this amendment. just stated, this is really a very, very

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00084 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18201 simple matter. It becomes dramatic be- I will make my points afterwards. Mr. CHAFEE. I would certainly like cause of all the dollars involved: All But the reason it is sent to the Judici- to hear the Senator make that expla- the dollars that appeared unexpectedly ary Committee is because it involves nation, if he might. in a windfall that goes to a small hand- the most important aspects of the pat- Mr. PRYOR. I would like to just say, ful of drug companies that had no idea ent law and intellectual property law. if we allow this situation to persist and a year ago that this windfall would That is what is involved here. refuse to close this loophole, let us for occur and that these billions of dollars Mr. CHAFEE. Mr. President, first of a moment look at what is going to hap- would basically be falling out of the all, if it involves treaties, then, of pen to one pharmaceutical company trees into their bank accounts. course, it goes to the Finance Com- that has inherited this windfall. Let us So I say, even if there were a day cer- mittee. The last place in the world it look at Glaxo. They make Zantac. Here tain, we are about to leave for Christ- should go is the Judiciary Committee. is some Zantac. It cost $170 a bottle. mas. If we even set a day certain of 10 Mr. HATCH. Not if it involves pat- You can go over to Canada, by the way, days from now, perhaps the Senate and ents. and buy this for about $70 a bottle. Or, the House will not even be in session. Mr. CHAFEE. If you want time, you if in our country we had the competi- We do not know when we are coming can have time after I finish. tion for Zantac on the shelves today, as back in session next year. So I say once We have a letter from Mickey we should have occurred earlier this again, this is an attempt to kill the Kantor, U.S. Trade Representative, week, it would cost about half of what original Pryor-Chafee-Brown-Byrd September 25, 1995: this $170 bottle of Zantac cost. amendment. The extension of the section 1534(c)—that But, if we go forward, let us say even Mr. CHAFEE. I would ask the Sen- is what we are doing here to pharmaceutical for an additional 30 days and allow this ator from Arkansas another question. property products—would not undermine on- windfall to continue, or let us say just It seems to me that this is an odd pro- going U.S. efforts to seek high levels of intel- to Christmas day—and Christmas day vision, in that it is referred to the Ju- lectual property protection around the is just a few days away, Mr. Presi- diciary Committee, yet the jurisdiction world. dent—Glaxo is going to make another of the Food and Drug Administration is So there is no problem here with pat- $115 million. If we hold a hearing in the in the Labor Committee. ents. That does not have anything to Judiciary Committee, say next Novem- Mr. PRYOR. The Senator is abso- do with it. The fact of the matter is ber, and then keep this thing in effect, lutely correct. that this reference, if indeed it should maybe until 1996, a year from Christ- Mr. CHAFEE. So, why is this being be made—I do not think it should—but mas and do not correct it until a year sent to the Judiciary Committee? if it should, it should go to one of two from this Christmas, this one com- Mr. PRYOR. I believe the distin- places: The Finance Committee, which pany—because of our mistake and be- guished Senator from New Hampshire deals with trade, or the Labor Com- cause of our refusal to correct that is the author of this amendment. Per- mittee, which deals with FDA. I would mistake—will have made an extra haps he could advise us as to why the be far happier to see it go there than to $2.328 billion. amendment is being sent to the Judici- the place suggested. Do we want our patent law in this ary Committee. Mr. PRYOR. Mr. President, if the country to be based upon an error, to Mr. SMITH. The Senator from New Senator from Rhode Island will yield— be based on a mistake that we made, Hampshire is not the sponsor of the then I want to hear, and I know we all and refuse to correct? I do not think amendment. The Senator from New do, our friend from Colorado, Senator so, Mr. President. Hampshire offered the amendment. I look forward to hearing some of the Mr. HATCH. If the Senator will yield, BROWN—I’d like to ask if in the history of the Judiciary Committee has that comments from other colleagues who I will be happy to answer that. I will be feel, I believe, as strongly about this happy to answer that. It is because it committee held hearings on the Food, Drug and Cosmetic Act? That com- issue as I do. involves a hallowed and important ele- Mr. CHAFEE. Mr. President, I would mittee does not have jurisdiction over ment in the history of this country and like to ask the Senator from Arkansas this act, yet that is where we are about in the world, and that is patents. We one more question. I understand that to dump this issue. happen to handle patents. It involves these substantial amounts will be made The second point I would like to raise intellectual property. It also involves by the companies that they would not is my friend from Utah, Senator an international intellectual property otherwise make, if we corrected this. HATCH, has talked about, ‘‘Oh, this is agreement which we better be careful My question is: But, if we correct it relating to patents. We have to protect of here, because there are a lot coun- sometime in the future, then is there a tries out there that do not honor intel- these patent rights.’’ That seems iron- refund in some type that occurs? Does lectual property. ic, since on June 7, 1995 the United it undo itself, or everything is just pro- There are a lot of countries out there States Patent Office ruled—the Patent spective? that do not believe in patents. Or, if Office ruled, Mr. President—that they Mr. PRYOR. The way that I under- they do not believe in patent terms—if, determined the expiration dates of the stand the law, I say to my friend, if a after a multiyear negotiated agree- patents in question. They are in force generic company has been out there ment in international relations, intri- on June 8, 1995 and, therefore, are en- and has made what we call a substan- cate, negotiated every line of that tered into the greater of the term of 20 tial investment where they are ready agreement—it is bunk to say that this years from their relevant filing days, to come into the market at the end of was a mistake. We then retrench on or 17 years from grant. In other words, the 17-year patent protection period, patent terms the first time out of the they held in our favor. The Patent Of- then the generic would be allowed to go blocks when we have gone all over the fice held in our favor that the generics on the shelves, to go on the market, to world talking about intellectual prop- could in fact come in and compete with be advertised, to be marketed, selling erty, respect for intellectual property, the brand-name companies. Of course, for one-half of what the brand name and for other countries to treat Amer- the brand-name companies with all of sells these drugs for today. At that ican products fairly. And right out of their high-powered lawyers, money, et time a royalty for this time that was the blocks we say we have to do away cetera, moved on to the courts. And be- unexpired—like for 600 additional days with that, you send a message that we cause the courts interpreted literally for Glaxo and Zantac—a royalty would are going to wreck the world window our mistake as being the intent of Con- be paid even to the Glaxo company by on the rest of our lives. We have taken gress, and I must say that I think they the competing generic drug company. years to get to this point. made a mistake, Glaxo and other major The amount of that royalty would be I am going to have a lot to say on pharmaceutical companies won out. established in a court of law, and there why there are two sides to this thing, I would like to make one more point, is a system whereby that amount and that it is more important to up- and then I am going to sit down for a would be established. hold the international treaty, uphold spell. I think that is the question the Sen- the international patent protection, The PRESIDING OFFICER. The Sen- ator from Rhode Island is asking. than it is to demagogue on this par- ator from Rhode Island controls the Mr. CHAFEE. I understand that. But ticular issue. floor. now my question is: But, let us assume

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00085 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18202 CONGRESSIONAL RECORD — SENATE December 7, 1995 that this is referred back to this com- that the amendment offered by the dis- Judiciary Committee would be a great mittee—the wrong committee, as it tinguished Senator from Arkansas is a committee. It has some of the bright- turns out, but nonetheless it is referred friend of the taxpayers of this country. est, most able Members, and the most back—nothing happens, and finally let It has a significant impact in a positive modest, too, in the Senate. But the us say in March we straighten out the way on reducing the deficit. point is this should not go to com- law, then retroactively is there some Second, this amendment is very mittee at all. The point is if you send compensation that takes place? much a friend of the consumers in this it to the committee, what you do is Mr. PRYOR. Mr. President, I apolo- country. It saves the consumers of this you cost consumers hundreds of mil- gize to my friend from Rhode Island. I country literally billions of dollars. Is lions of dollars just by the delay, and did not understand his original ques- it the $6 billion the Newark paper you cost the taxpayers some money, tion. I do now. talked about? My guess is it is less too. In other words, if we were to correct than that. But it is a huge amount. If I think the last point that deserves this, even in March or April, whenever, you are concerned about the consumers addressing is this one. Are we doing and admit we made a mistake, which of this country, you ought to be in something, with the Pryor amendment we did and we all agree that we did, favor of it. are we doing something that violates then the company gets to keep all of Two other points have been raised, the GATT treaty? We do have—and I that money. There is no refund. The and I think they merit addressing. One acknowledge it—a vested interest in Medicaid programs have continued to is, is this fair? Is it fair to adjust the making sure that treaty is honored. pay the highest price for these drugs. rules? Well, let us take a look at it. For that point I wish to draw Mem- The Veterans Administration has con- When the patent for this medicine was bers’ attention to some information. It tinued to pay the highest price for granted, it extended 17 years from the is the treaty itself. I know a lot of these drugs. The consumers get no re- time of filing. Is that diminished in Members did not get a chance to read bate. The consumers get no relief. The any way if this amendment passes? The it, and having tried to read it myself I only benefit accrues to a very few drug answer is no. The answer is absolutely understand why. But there are some in- companies that we failed to include in no. The drug company gets exactly teresting things you find out. I wish to the coverage of the new law in the what they thought they were getting read you the precise words of the GATT treaty. They get to keep all of when they filed for the patent. They do agreement itself because it relates spe- these excess profits. And that is what not lose in any way. They get exactly cifically to this point. And I am talk- this fight is all about. Every time, what they were offered at the time ing about part VII. This is under arti- every day that these drug companies they developed the product, at the time cle 70. The title is: ‘‘Protection of Ex- get to keep this amount of money, they marketed the product, at the time isting Subject Matter.’’ In paragraph 4, these exorbitant profits, this windfall, they put the factory together to there are the following words: it comes out of the pocketbooks of the produce the product. Nothing has consumer, the veterans, the Medicaid . . . or in respect of which a significant in- changed. vestment was made, before the date of ac- programs, and every citizen of this What do they lose? They lose the ceptance of the WTO Agreement by that land. windfall that came from the treaty. Member, any Member may provide— Mr. CHAFEE. I thank the Senator. I If you are on the subject of what is By ‘‘Member’’ they are referring to a thank the Chair. fair, let us ask ourselves, what if you Mr. BROWN addressed the Chair. country— The PRESIDING OFFICER. The Sen- were a different firm? What if you were for a limitation of the remedies available to ator from Colorado. a firm that was aware of the drug and the right holder as to the continued perform- Mr. BROWN. Mr. President, I appre- aware of the law and got geared up to ance of such acts after the date of applica- ciate the thought. I wish to assure my produce a competitive product in reli- tion of this Agreement for that Member. In such cases the Member shall, however, at good friend from Ohio that I will not be ance on the laws of this Nation, and the laws of this Nation said the exclu- least provide for the payment of equitable long. remuneration. I hope Members, as they vote on this, sivity ends after 17 years. will consider a couple of points. I don’t For this particular drug, there are Mr. President, the treaty itself an- think these are in dispute. If they are, competing companies. There are com- ticipates exactly this kind of legisla- I know my good friends will correct panies that relied on the law. There are tion. Let me repeat it. This amend- me. But I think every Member ought to companies that made investments. ment in no way is at odds with the be aware that this amendment is very They put together a plant to produce treaty. It in no way violates the treaty. important and would have a significant this, and they geared up to produce it As a matter of fact, the exact words of impact on the Treasury of the United and sell it on the market. If you are the treaty anticipate this very action. States. The estimates are that this will concerned about fairness, you should Now, to suggest that we somehow are save the taxpayers in the neighborhood not be concerned about Glaxo. They jeopardizing our intellectual property of $150 million. It may be more than got exactly what they invested for. rights by taking this action, I do not that, but CBO has come forward with You ought to be concerned about the believe conforms with either the spirit that figure. So one of the things Mem- companies, honest people who invested of the treaty or the precise words of bers ought to think about is the dra- in facilities and plants and processes in the treaty. The reality is if someone matic, significant increase in revenue reliance on our law and had the prod- has made a substantial investment re- and reduction of the deficit that this uct taken away from them after they lying on our current law, we have a amendment can have if it is passed. made that big investment. Now, if you right under the treaty, in specific Second, many Members may have are concerned about fairness, you terms, to do this. read the Newark Star Ledger’s edi- ought to be in favor of the amendment, Mr. President, there are two edi- torial of October 26. Let me quote it: not against it. torials at this point I would like to Thanks to a gigantic loophole resulting in Last, Mr. President, let me simply enter into the RECORD because they the GATT, consumers may wind up paying as add one other thing that I think is im- make the point very well. One is by the much as $6 billion more for higher priced portant. It has been suggested on this Des Moines Register and the other is brand name drugs. floor by a number of people that doing by the Washington Post. I ask unani- Mr. President, I do not know if the $6 this somehow will be inconsistent with mous consent that they be printed in billion figure is correct or not. That is our treaties under GATT, and the very the RECORD. an estimate by the paper. I must say distinguished chairman of the Judici- There being no objection, the edi- my own estimate is less than that. But ary Committee has just pointed out torials were ordered to be printed in there is no question this is big, big, big what a great investment we have in in- the RECORD, as follows: money, and it comes right out of the tellectual property. He is absolutely [From the Des Moines Register, Nov. 27, 1995] pockets of the consumers of this coun- right. A COSTLY OVERSIGHT—FINE PRINT IN GATT try. I might say, Mr. President, from my LAW COULD COST ZANTAC USERS MILLIONS So the two things that I think are point of view, if you were going to send The nation’s prescription drug makers are really without question here are first this to a committee, I would think the at war again, with a $1 billion-plus purse

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00086 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18203 going to the winner. If the brand-name drug It’s a cast study in legislation and high- the GATT treaty loophole that creates manufacturers win, the losers will include powered lobbying. When Congress enacted a windfall profit for certain prescrip- the millions of Americans who suffer from the big Uruguay Round trade bill a year ago, tion drug companies. ulcers or heartburn, and take the drug it changed the terms of American patents to The GATT treaty, voted on by Con- Zantac regularly to combat the problem. It’s a new worldwide standard. The effect was to going to cost each of them about $1,600. lengthen existing patents, usually by a year gress, included two important provi- Zantac is made by Glaxo Wellcome, the or two. But Congress had heard from compa- sions that affected every product, com- biggest in the business. nies that were counting on the expiration of pany, and industry in the country. One, Here’s what started the current war: competitors’ patents. It responded by writ- provided that all patents would be ex- When a new prescription drug hits the ing into the trade bill a transitional provi- tended from 17 to 20 years; an addi- market, generic drug manufacturers await sion. Any company that had already invested tional 3 years of protection. Two, pro- the patent expiration so they can enter the in facilities to manufacture a knock-off, it market with the same drug. They offer it for vided that a generic company, in any said, could pay a royalty to the patent-hold- industry, would be permitted to go to sale without the brand name, usually at a er and go into production on the patent’s fraction of the brand-name price. original expiration date. the marketplace and compete on the The new international GATT treaty signed But Congress neglected to add a clause 17-year expiration date, if the generic by the United States and 122 other countries amending a crucial paragraph in the drug company had made a substantial in- sets the life of a patent at 20 years from the laws. The result is that the transitional vestment, and was willing to pay a roy- date of application. Former U.S. law pro- clause now applies to every industry but alty. vided patent protection for pharmaceuticals drugs. That set off a huge lobbying and pub- An unintended loophole was created, for 17 years from the date of approval. Be- lic relations war with the generic manufac- however, when the prescription drug cause the difference could have a significant turers enlisting the support of consumers’ impact on the number of years a firm could industry was accidently excluded from organizations and Glaxo Wellcome invoking the generic competition provision. The market its patented drug without competi- the sacred inviolability of an American pat- tion. Congress made special provisions for ent. loophole means that prescription drug drugs under patent at the time GATT was Mickey Kantor, the president’s trade rep- companies have a 3 year longer patent approved last summer. resentative, who managed the trade bill for period, without any competition during But when the legal beagles got done read- the administration, says that the omission that time extension from generic com- ing all the fine print, it turned out that was an error, pure and simple. But it has cre- Zantac was granted a 19-month extension of panies. This loophole has created a ated a rich benefit for one company in par- its patent life—and it is such a hugely pop- multimillion dollar windfall for certain ticular. A small band of senators led by ular drug that that translates into a multi- drug companies that must be cor- David Pryor (D–Ark.) has been trying to million-dollar windfall. rected. right this by enacting the missing clause, Generic drug makers call the windfall a but so far it hasn’t got far. Glaxo Wellcome Seniors use prescription drugs more congressional oversight, and estimate the and the other defenders of drug patents are than any other age group. For them, difference is worth $2.2 billion to Glaxo, be- winning. Other drugs are also involved, inci- this loophole means they will pay high- cause the generics can’t enter the market for dentally, although Zantac is by far the most er drug prices for 3 years because of a 19 more months. Glaxo counters that Con- important in financial terms. gress made no mistake, that the extension mistake. Without the ability of generic Drug prices are a particularly sensitive was part of the compromise with generics. It drug companies to compete, drug prices area of health economics because Medicare won’t wash. Nothing in the GATT treaty was will remain artificially high during does not, in most cases, cover drugs. The intended to further enrich the happy handful that 3-year period. There is no reason money spent on Zantac is only a small frac- of brand-name drug makers who hold lucra- tion of the $80 billion a year that Americans why seniors should suffer because of an tive patents—or to penalize the users of the spend on all prescription drugs. Especially unintended mistake that can be cor- drugs. for the elderly, the cost of drugs can be a ter- rected today. A month’s supply of Zantac ordinarily sells What drugs are involved here? More for around $115; the generic price—meaning rifying burden. That makes it doubly dif- the same drug without the Zantac label— ficult to understand why the Senate refuses than 100 drugs would be protected from would be around $35, the generic makers con- to do anything about a windfall that, as far generic drug competition. The world’s tend. Unless Congress changes the wording of as the administration is concerned, is based best-selling ulcer drug, Zantac, would the law regarding transition to GATT provi- on nothing more than an error of omission. cost twice as much as it should because sions, Zantac users will pay the difference Mr. BROWN. Mr. President, let me of the loophole. The hypertension drug, for 19 months longer. simply conclude this way. If you are Capoten, will cost 40 percent more than Some generic drug manufacturers had al- concerned about the taxpayers, you it should because of the loophole. Addi- ready spent a bundle preparing to enter the ought to like the Pryor amendment be- market before the GATT treaty took effect. tionally such drugs as Mevacor for low- They lose. So do taxpayers, who pay for Med- cause the CBO says it brings us in $150 ering cholesterol, Prilosec for ulcers, icaid prescriptions. The Generic Drug Equity million, or saves it. If you are con- and Diflucan, an antifungal agent are Coalition estimates that the higher cost of cerned about the consumers of this affected. Zantac and some other drugs affected by the country, you ought to be in favor of the This loophole will also affect the mistake (such as Capoten, for high blood Pryor amendment because it is going drug prices paid by the Medicaid Pro- pressure) will cost Iowa Medicaid $3.5 mil- to save them $6 billion, if you believe gram. Medicaid already faces deep cuts lion. Further, say the generic drug makers, some estimates, or a little less if you in its funding. If this loophole is not it will tack another $1.2 million onto the believe my estimate. corrected, Medicaid will be forced to cost of health-insurance premiums for Iowa state employees. If you are concerned about fairness, pay higher drug prices during the 3- Glaxo’s political-action committee has you ought to be in favor of the Pryor year period, further straining its abil- doubled its contributions to Congress in re- amendment because people have in- ity to provide medical care for the cent months. Glaxo wants the mistake to vested money in plant and process and most vulnerable in our country. stay in the law. Generic drug manufacturers production capability to comply with Veterans will also suffer as the Vet- want it out. our laws and they are simply out by erans Affairs Administration will be So should ulcer sufferers. So should tax- this windfall. forced to pay higher drug prices. Peo- payers. So should Congress. Last, Mr. President, if you are con- ple using public health services will [From the Washington Post, Dec. 4, 1995] cerned about the integrity of our pro- also be affected. The bottomline is that THE ZANTAC WINDFALL tection of intellectual property, you taxpayers will pay more for the drugs All for lack of a technical conforming ought to be for the Pryor amendment used by these programs than they clause in a trade bill, full patent protection because this is precisely and exactly should, because competitive generic al- for a drug called Zantac will run 19 months what the treaty anticipated. ternatives will not be available. beyond its original expiration date. Zantac, I yield the floor. There is no reason to allow some pre- used to treat ulcers, is the world’s most Mr. BRYAN. Mr. President, I have scription drug companies an unin- widely prescribed drug, and its sales in this come to the Senate floor a number of tended windfall profit to the detriment country run to more than $2 billion a year. times to talk about prescription drug of all Americans who depend on drugs The patent extension postpones the date at which generic products can begin to compete pricing, and to support Senator for their continued health. Seniors, with it and pull the price down. That pro- PRYOR’s efforts to control the costs of veterans, and the most vulnerable in vides a great windfall to Zantac’s maker, drugs. Today I am pleased to cosponsor our country particularly deserve our Glaxo Wellcome Inc. Senator PRYOR’s amendment to correct protection from unnecessarily high

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00087 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18204 CONGRESSIONAL RECORD — SENATE December 7, 1995 drug prices. I hope my colleagues will maceutical companies was created. I do of an intra-industry dispute, invites re- see this loophole for the mistake it is, not believe this assertion is fair or ac- taliation from other countries eager to and support this amendment to correct curate. undo our gains. it. The GATT law was very clear. The One of my main concerns is that if Ms. MOSELEY-BRAUN. Mr. Presi- implementing legislation provided the United States is seen as hesitant dent, I would like to take this oppor- that, in certain circumstances, individ- about implementing this part of the tunity to express my support for the uals or organizations that had relied on new GATT, a number of countries that Dodd-DeWine amendment. This amend- the shorter expiration term could use have been reluctant to prevent their ment would require the Judiciary Com- the patented technology during the ex- firms from pirating United States prod- mittee to hold hearings on the GATT tension period, although they must pay ucts would have the excuse they need patent extension provisions. The GATT a royalty to the patent holder to do so. to go slow in implementing the agree- issue is a complex one and requires full Section 102 of the GATT, however, ment, or to avoid implementing it at disclosure. The Pryor amendment has states that ‘‘Nothing in this Act shall all. That would result in the desta- no place on the partial birth abortion be construed...to amend or modify bilization of the U.S. market, a loss of bill. Hearings are appropriate and, in any law of the United U.S. exports and U.S. jobs, have a let- my opinion, critical to ensure that the States...unless specifically provided ter here, that I would like to place in members of this body fully understand for in this Act.’’ GATT changed many the RECORD from Sir Leon Brittan, the issue and the implications of any areas of patent law, but it did not Vice President of the European Com- action to modify the GATT agreement. change current Federal law that pro- mission, that comments on a proposed The Pryor amendment would modify hibits the FDA from granting approval changes to the patent extension provi- the current General Agreement on Tar- for the manufacture of generic drugs sions in GATT. Brittan states that iffs and Trade [GATT] as it applies to until the patent term on the original ‘‘this threat causes serious concern to patent protections for pharmaceutical product has expired. On May 25, the the European research-based pharma- products. This amendment, which was FDA ruled that nothing in the GATT ceutical industry and to the Commis- voted down in the Finance Committee, explicitly overrules this provision and sion, and it seems to be in contradic- has been portrayed as a technical cor- on November 1, the court of appeals for tion with the long-standing U.S. policy rection to the General Agreement on the Federal circuit also upheld the pat- of providing strong protection for re- Tariffs and Trade [GATT] agreement. ent extension provisions in GATT. search-based, intellectual property It is not. This amendment opens up an The actions by the FDA and the Fed- right both home and abroad.’’ Brittan international agreement on trade to re- eral circuit court of appeals underscore also notes that changes to the GATT solve a domestic intra-industry dis- the purpose of the GATT treaty which law in the area of patent extension will pute. It is shortsighted, counter- is to make trade laws more uniform set back hard-won improvements in productive and will impede the avail- and consistent. Uniformity is needed to universally agreed upon patent protec- ability of life saving drugs and thera- prevent countries from passing laws tions. pies for all of us. that are favorable to their own domes- Finally, I would like to return to my Before, I discuss substantively the tic companies; 110 countries worked for first concern—consumer interest. On issue at hand, I would like to state un- over 7 years to complete negotiations average it takes 12 years and $360 mil- equivocally that I firmly believe that on GATT. The intellectual property lion to bring a new drug to market. Re- all persons who are sick should have issues were among the most conten- search-based, pharmaceutical firms access to affordable, comprehensive tious. The essential goal of patent pro- spend nearly $18 billion annually on re- health care services. In 1992, I cam- tections are to allow companies and in- search and development. This emphasis paigned on the issue of health care re- dividuals to invest freely and securely on R&D has produced treatments not form and I remain firmly committed to in the development of important and only for common conditions and ail- that goal. My views on the GATT pat- needed products. If companies are pro- ments, but also for life-threatening dis- ent extension issue are in no way in- vided exclusive protection over an in- eases. The United States invests more consistent with my support for reform. novation, they are more likely to in- than any other nation on research. I In fact, I believe present attempts to vest the necessary resources into devel- have received numerous letters from undo and reopen GATT could have an oping a safe and effective product. This patient groups that are very concerned adverse impact on the development of kind of market stability and security that modifications to GATT will ad- state of the art medicines and treat- are vital with respect to pharma- versely impact research and develop- ments, which in turn deny all of us the ceutical products, which require enor- ment, particularly on orphan diseases benefit of advances in medical science. mous R & D resources. Achieving bet- for which there is little or no ability to At question, is a provision, in the ter protection of intellectual property recoup the up-front, financial invest- newly adopted agreement, that pro- was a major victory for the United ment. At the close of my statement I vides additional patent protection to States as U.S. manufactured products, will insert several of these letters for pharmaceutical products. GATT pro- trademarks, and services are increas- the RECORD. We must continue to in- vides 20 year patent protection to all ingly counterfeited abroad. The agree- crease our investment if we are to dis- products and industries covered by the ment is final and cannot be renegoti- cover cures and effective treatments agreement—there are over 1 million ated without putting these hard for diseases that continue to plague patent holders in the United States fought, and hard won, protections at millions of Americans like AIDS, Alz- who will receive extended patent pro- risk. heimers, Parkinson’s disease, and can- tection. This change, which extends The patent language in GATT gives cer. U.S. patent protection from the cur- the United States greater assurance Some have maintained that repealing rent 17 years from the date the patent that innovations that originate here the patent-extension provisions, as is granted to 20 years from the date of will not be pirated by foreign firms. they apply to pharmaceutical products, filing, conforms U.S. patent law to the The benefits of the provisions cannot is appropriate, because it would make international standards agreed to be overstated. First, it will provide available cheaper versions of a limited under GATT. The agreement, including American companies the economic and number of name-brand drugs a few the patent provisions, was overwhelm- intellectual security needed to develop months earlier than they would other- ingly approved by Congress last No- safe and effective new products; second, wise be available. I believe there is a vember. The Pryor amendment would it will ensure stability in the U.S. more compelling issue regarding the repeal the patent extension provisions pharmaceutical market. This will not balance of trade and the larger con- as they apply to pharmaceutical prod- only stabilize the U.S. market, but also sumer interest. Increased patent pro- ucts. Some of my colleagues believe protect U.S. jobs. Third, it will ensure tection ensures that research and de- this amendment is needed because they research and investment by U.S. com- velopment will continue in, not only, believe the patent extension provisions panies on products that are needed to the medical field, but also in all areas were a mistake and that an inad- treat fatal disease. To change this of innovation. This country leads the vertent windfall to a handful of phar- international agreement now, because world in research and innovation; it

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00088 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18205 contributes to the public good both nificantly extend the life, greatly improve NATIONAL KIDNEY ASSOCIATION, here and abroad, and every American the quality of life, and help avoid complex, Evanston, IL, November 22, 1995. benefits from our leadership. Changes risky surgery for people suffering from PPH. Hon. CAROL MOSELEY-BRAUN, to the GATT agreement that seek to I know of no generic drug company that Senate Hart Office Building, would commit the millions of dollars or Washington, DC. repeal patent extensions for only one many, many years of research to discover or DEAR SENATOR MOSELEY-BRAUN: I am writ- class of innovations are, in my opinion, develop such a medicine, and it is unlikely ing you as both a constituent, and as the shortsighted. Such changes will de- that they will ever produce a generic version President of the National Kidney Cancer As- crease private sector revenues for re- for a patient population so small. There are sociation. Thank you for your recent vote in search and development, compromise many other similar patient populations who support of the enforcement of the General U.S. leadership on intellectual prop- depend on the research-based companies to Agreement on Tariffs and Trade (GATT) pro- erty protection, and adversely impact bring these new medicines to market. vision regarding drug patents. The purpose of the General Agreement on Your action will allow significant pharma- the competitiveness of U.S. companies ceutical research to continue on numerous in relation to their foreign counter- Tariffs and Trade (GATT) was to strengthen intellectual property law around the world diseases, including kidney cancer. As you parts. and bring U.S. intellectual property law into may be aware, kidney cancer afflicts thou- The competitiveness of U.S. indus- compliance with other industrialized coun- sands of individuals each year and at the tries is of great concern to me since I tries. If the GATT resulted in longer patent present time, no cure exists for this disease. became a Member of this body 3 years protection for a few medicines—all of which Our greatest hope for a cure is innovative ago. This is because of the inextricable already face competition from other thera- pharmaceutical and biotechnology products, derived from private sector efforts. To find linkage between competitive industries pies—that in my view is a benefit for our so- ciety. this cure, millions of dollars will have to be and the growth and maintenance of spent. It is imperative that Congress provide U.S. jobs. This is why I supported legis- Our patients have experienced the direct steadfast support for scientific discovery and lation such as NAFTA, GATT, product benefits of the tremendous investments that strong patent protection for new drugs and liability reform. I have given careful the pharmaceutical industry has made in re- therapies. My view is that this new GATT search and development. Research-based consideration to all of the these issues. law will encourage further investment in re- companies need and deserve the incentives search and development, and make new I am convinced that these measures provided by strong intellectual property pro- will increase the ability of U.S. indus- medicines possible. This new law gives hope tection. Please do nothing to weaken them. to millions around the world, including kid- tries to compete and lead to a more Sincerely, ney cancer patients, who currently have no UDITH SIMPSON, viable job market. The patent-exten- J options. sion issue is a complex one, and I be- R.N., Ed. S., President, UPAPH. I applaud your courage in opposing efforts lieve, any action by Congress to modify to weaken the GATT patent provisions. Keep the GATT agreement should only be FIBROSIS FOUNDATION, up the important battle to support research undertaken after a thoughtful and Bethesda, MD, November 8, 1995. and development of new drugs. Thank you Hon. CAROL MOSELEY-BRAUN, thorough review of the long-term im- for your determination and insightful leader- U.S. Senate, Hart Senate Office Building, ship. plications of such action. It is for these Washington, DC. Sincerely, reasons that I must oppose the Pryor DEAR SENATOR MOSELEY-BRAUN: I under- EUGENE P. SCHONFELD, amendment. stand Senators Pryor and Chafee are at- President and Chief Executive Officer. I ask unanimous consent that the tempting to amend the Hatch-Waxman Act letters referred to earlier be printed in to eliminate extensions for existing pharma- THE NATIONAL ORGANIZATION ON the RECORD. ceutical patents granted by GATT. I urge FETAL ALCOHOL SYNDROME, There being no objection, the letters you not to vote for that amendment, but in- Washington, DC, November 8, 1995. were ordered to be printed in the stead to protect existing legislation that pre- Hon. CAROL MOSELEY-BRAUN, serves incentives for research and develop- Hart Senate Office Building, RECORD, as follows: ment. Washington, DC. UNITED PATIENTS’ ASSOCIATION As President and Chief Executive Officer of DEAR SENATOR MOSELEY-BRAUN: It has FOR PULMONARY HYPERTENSION, INC., the Cystic Fibrosis Foundation, I have per- come to my attention that, through an effort Speedway, IN. sonally witnessed the great suffering en- by Senator Pryor, Congress is considering Hon. CAROL MOSELEY-BRAUN, dured by patients and their families in their changes to existing law that would chip Hart Senate Office Building, fight against cystic fibrosis (CF). There are away at patent protections in the United U.S. Senate, 30,000 young individuals in this country with States, and possibly around the world. I ask Washington, DC. CF, a fatal genetic disease; more than 900 you to reject that effort. DEAR SENATOR MOSELEY-BRAUN: I’m writ- live in Illinois. I have also witnessed how, for This nation has sought to protect and fos- ing to you on behalf of 400–500 Americans many patients, modern medicines have ter innovation since its very beginnings, pri- who suffer from a very rare and very deadly brought hope, relief from suffering, and even marily through our system of patent protec- disease known as Primary Pulmonary Hyper- a return to health—a miracle made possible tions. Most recently, as a result of the Gen- tension (PPH). Until recently, the best hope by biomedical research. eral Agreements on Tariffs and Trade, the for long-term survival from PPH was U.S. changed its patent terms to bring them By rewarding ingenuity and encouraging through a lung or heart/lung transplant. in line with international standards. Yet innovation, patent protection makes pos- However, today, thanks to research which Congress is now considering weakening that sible the investment of hundreds of millions dates back to the 1970’s, a new drug was re- agreement. of dollars and years of time and effort in cently approved to treat PPH which not only As a member of the National Organization medical research, all the while with no guar- is extending these patients’ lives but is al- on Fetal Alcohol Syndrome, I find that pos- antee of success. Because of the discoveries lowing them to live full, active and produc- sibility very disturbing. Patients afflicted born of these investments, the patients we tive lives. with disease book to biomedical research, es- come in contact with every day benefit I have learned that some generic compa- pecially research taking place in America’s through saved lives and improved quality of nies are now trying to change the law so that pharmaceutical industry, for new and better life. Our health care system benefits from a they can gain financially by bringing their treatments to restore them to health. But reduction in the overall cost of care. products to market before the patents on the this country’s huge investments in research pioneering companies’ products expire. I can While we certainly support patient access and development cannot be maintained with- attest to the value that research-based com- to lower cost treatments for disease, that out the assurance of strong patent protec- panies bring to patients as a result of strong short-term benefit pales if it comes at the tion, not only in the U.S., but also in other patent protection, and I urge you to oppose long-term expense of finding cures to life- markets around the world. these efforts. threatening illnesses. The current law gov- If Congress begins chipping away at patent While I appreciate the cost savings that ge- erning pharmaceutical patents is fair and in protection in the U.S., it begins chipping neric drugs can offer in the short term, I also the long-term best interest of patients. away at the foundations of a system that has know that innovative new therapies for com- On behalf of those patients who still await made this country Number One in the world plex, life-threatening diseases will come only a cure or effective treatment to alleviate in the discovery of new medicines. It also be- from research-based pharmaceutical compa- their suffering, I again urge you not to un- gins to undermine patent protection stand- nies. When it comes to serving patients suf- dercut the patent protection that underlies ards around the world. And it begins the fering from deadly orphan diseases like PPH, America’s best hope for new and better an- process of deflating the hopes of millions of it is the research-based companies that give swers to disease. patients in this country who depend on med- us hope. Sincerely, ical research to find a cure. Glaxo Wellcome recently received approval ROBERT J. BEALL, Please, cast your vote in favor of innova- to market the first medicine that will sig- President and Chief Executive Officer. tion, and against any effort to undermine

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00089 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18206 CONGRESSIONAL RECORD — SENATE December 7, 1995 patent protection in this or any other coun- expense of seniors, the poor and all amendment offered by my colleague, try around the world. consumers. This bill would allow ge- for though it is well intentioned, it Sincerely, neric drug companies to sell some of does have important potential adverse PATTI MUNTER, the world’s most frequently prescribed effects on our international trade President. drugs at half the cost that they are agreements. ALLIANCE FOR AGING RESEARCH available at today. This legislation would deny inno- Washington, DC, November 9, 1995. Here is an opportunity for the Con- vator pharmaceutical products the full Hon. CAROL MOSELEY-BRAUN, gress to lower out-of-pocket health statutory term of patent protection U.S. Senate, Washington, DC. care costs. It is an opportunity that that was provided under GATT and the DEAR SENATOR MOSELEY-BRAUN: It has comes at a time when Congress is dis- Uruguay Round Agreements Act come to my attention that, in connection cussing multibillion dollar cuts in [URAA]. There is a requirement in the with a proposal sponsored by Senator David Medicare and Medicaid that will in- Pryor, Congress is considering changes to ex- GATT Intellectual Property Agree- isting patent law that would erode patent crease health care costs for seniors and ment [TRIPS], found in article 70:2, protection in the United States. I am pleased low-income Americans. that WTO members provide TRIPS to see that you are opposed to that effort. Today, seniors who rely on Medicare level patent protection for existing America has always sought to protect and for their health insurance do not re- subject matter on the date of applica- foster innovation primarily through our sys- ceive assistance for the cost of pre- tion of the agreement for the country tem of patent protection and patent-term scription drugs. Even if a senior also in question. This requirement will restoration. Recently in accordance with its has private health insurance, there is multilateral obligations under the Agree- greatly benefit U.S. industries across a no guarantee that it will cover pre- broad range of intellectual property ment on Trade-Related Aspects of Intellec- scription drug bills. Seniors on fixed tual Property Rights negotiated during the elements; not just those industries con- Uruguay Round of GATT, Congress amended incomes depend on money saving ge- cerned about pharmaceutical patents. the Patent Code to harmonize its provisions neric drugs. It is in the U.S. interest that countries with international standards. As a result, Seniors need the savings on prescrip- with weak patent protection provide patent terms for certain eligible products— tion drugs now more than ever. So do the shortest possible transition peri- in all industries—were extended. Under the the over 40 million Americans with no ods. This is the clear objective of the Pryor proposal, however, Congress would health insurance whatsoever. TRIPS agreement and, in particular, weaken our implementation of GATT patent Prescription drugs and the research article 70:2. provisions. devoted to developing new drugs are To meet this key objective of the As the Executive Director of the Alliance vital to meet the health care needs of for Aging Research, I am concerned by any TRIPS agreement, I believe the FDA many Americans. While the manufac- proposal that would have such as effect. Pat- interpretation of the Hatch/Waxman turers that take risks and invest in the ent rights are the cornerstone of America’s Act must prevail. Article 70:2 was spe- development of new drugs have a right biomedical research enterprise. Patents pro- cifically inserted in the TRIPS agree- to a return on their research invest- vide a critical incentive for all companies, ment to prevent WTO members from particularly pioneer pharmaceutical manu- ment, we must not allow prohibitive delaying the application of the strong- facturers, to conduct ground breaking bio- costs to jeopardize consumer access to er protection found in the TRIPS medical research. Patients and their physi- these drugs. There must be a balance. cians depend upon access to the fruits of bio- If the GATT loophole is closed, Med- agreement to existing patents, most of medical research—access which can only icaid will save $150 million over 5 years which we can safely say will be held by occur if there are adequate incentives for the and consumers will save up to $2 bil- U.S. rightholders. research to be conducted in the first place. lion. In my home State of Vermont I strongly believe that U.S. commer- Congress cannot expect the private sector to cial interests in WTO countries that continue making high-risk investments in alone, the savings in Medicaid are esti- mated to be almost $1 million. And, currently provide weak protection will research and development if there is no as- be dealt a severe blow should this surance of strong patient protection (and if Vermont consumers are expected to there is no assurance that the United States save as much as $6.8 million in pre- amendment pass. We need look no fur- will meet its multilateral obligations to pro- scription drug costs. ther than Argentina, whose patent pro- vide such protection). Opponents of the Pryor legislation tection laws are bad and getting worse, This is a particularly critical issue for the argue that it will prevent drug compa- as an example of what might happen if aging Americans represented by the Alli- nies from conducting research and de- the United States pursues a policy that ance. Clearly, the curtailment of biomedical velopment on new drugs. Under the minimizes GATT mandated improve- R&D will lead to a downturn in the rate at ments in patent rights. And there are which biomedical innovations will become Pryor legislation, however, these com- available to the public. New incentives for panies still would have had more than other countries whose patent regimes research and innovation such as those pro- the full 17 year protection they ex- offer no protection to the makers of vided by GATT must be maintained. Other- pected to have when they introduced patented pharmaceutical products, wise, Congress will erode the foundations of their products, to gain a return on costing billions of dollars that would a system that has made America the leader their research investment. In addition, otherwise go into research for new in the discovery of new medicines. drug companies will continue to re- breakthrough drugs. I thank you for supporting innovation and ceive royalties from the generic com- I should also point out that the research for new treatments that will benefit courts have had a chance to render America’s elderly. panies who market competing prescrip- Best regards, tion drug products. judgment on this issue, and they have DANIEL PERRY, Drug firms pocket almost $6 million upheld the current interpretation of Executive Director. each day that the GATT loophole is in the Hatch-Waxman Act that this effect. These companies will go to no amendment would overturn. So I urge GATT AND PRESCRIPTION DRUGS end to protect their windfall. They my colleagues to vote against this Mr. LEAHY. Mr. President, I have have launched a multimillion dollar ef- amendment and for the motion to send worked for many years with Senator fort to lobby Congress. They even went this to the Judiciary Committee. PRYOR on trying to keep prescription as far as misrepresenting a statement Mr. BYRD. Mr. President, the Pryor drugs affordable for Americans. High by former Surgeon General, C. Everett amendment would correct an unin- prices for prescription drugs force some Koop, by portraying him as a strong tended loophole created in the legisla- elderly and low-income Vermonters to supporter of their billion dollar wind- tion implementing the General Agree- choose between buying food or fuel for fall. ment on Tariffs and Trade [GATT]. heat and paying for their medication. We in Congress have a responsibility This loophole will cost consumers bil- In this continuing effort, I am very to protect consumers against these lions and give a windfall profit to cer- pleased to join Senator PRYOR as a co- drug company giants. I urge my col- tain drug companies. Congress must sponsor of S. 1277, the Prescription leagues to support the Prescription take the responsible course of action Drug Equity Act of 1995. This bill cor- Drug Equity Act of 1995 and pass this and correct its mistake by passing the rects a loophole in the GATT Treaty legislation as soon as possible. Pryor amendment. Omissions and er- that gives a handful of drug companies Mr. GRASSLEY. Mr. President, I rors are more likely to happen when as much as a $6 billion windfall at the would like to say a few words about the large, complex bills are taken up under

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00090 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18207 limited time constraints. Such is the Mr. PELL. Mr. President, today the ket as planned once they pay the pat- case with GATT, which was considered Senate considered an amendment au- ent-holder the required royalty. This under fast track procedure and was thored by my friends and colleagues, correction is needed because certain rushed through Congress. I believe this Senators PRYOR and CHAFEE meant to provisions in the Hatch/Waxman Act, is an ill-advised way to conduct Senate clarify confusion that has resulted dealing with drug development, have business. It is the responsibility of the from the implementing legislation had the unintended consequence of pro- Congress to correct its unintended Congress wrote following approval of hibiting generic companies from using oversights and omissions. the GATT Treaty last year. Specifi- the GATT transition rules. Pharma- How did this loophole come about? cally, the issue involves when the pat- ceuticals are the only industry unable When Congress enacted the Uruguay ent terms on domestic pharmaceutical to use these rules. Round Agreements Act [URAA], the products expire and when generic com- Under GATT, new pharmaceuticals legislation implementing the General panies can begin to market copies of are given patent protection for the Agreement on Tariffs and Trade those products to the general public. longer of 20 years from the filing date [GATT], which I opposed, it extended Since this issue has been brought to or 17 years from the patent issuance. all patent terms from 17 years from public attention, many contradictory Transition rules were enacted to pro- date of approval to 20 years from the charges have been levelled which have vide fairness to all industries and par- filing date. In addition, the legislation served to create a sense of confusion ties—patentee and competitor—during allowed generic companies to market over whether or not certain entities transition to the new patent-term law. their products as of the 17 year expira- are receiving unfair advantage over the We must correct this rather technical tion date if they had made a substan- other. Unclear are such issues as: What error in the trade bill to ensure these tial investment and would pay a roy- was the intent of our GATT nego- rules are available to all industries. alty to the patent holder. The carefully tiators, and did this intent change as Both Mickey Kantor, U.S. Trade Rep- constructed transition rules were the negotiations went on? What was resentative, and David Kessler, FDA Commissioner, agree with this inter- meant to apply to all industries. How- the intent of Congress on this matter pretation and believe a legislative fix ever, because conforming language to or, as the Federal courts have found, is needed to allow generic companies to the Federal Food, Drug, and Cosmetic was there no intent expressed at all? go forward. This amendment is tightly Act was inadvertently omitted, this How do our trading partners feel about constructed and would have no impact provision does not apply to the generic our addressing this issue now, long on other trade issues included in the pharmaceutical industry. The drug in- after we approved the implementing legislation approving GATT? Who ben- GATT. dustry is the only industry that is While I am aware that this amend- efits and is that benefit justified or shielded from generic competition ment will dip into the profits of a few fair? under GATT during the extended pat- pioneer drug companies, I believe this The answers to these questions are ent term. error has already given them an unin- not clear at present. And given the The U.S. negotiators have indicated tended windfall. If left uncorrected, it enormous stakes on both sides, I find that it was not their intent to exclude is estimated that the delay of several that reaching a satisfactory conclusion the pharmaceutical industry from this generic medications could cost con- difficult given the incomplete record. provision, and that the omission of the sumers and government health pro- Moreover, this is not an abstract policy conforming language was an oversight. grams nearly $2 billion. According to U.S. Trade Representa- issue for me as a Senator from the We have a responsibility to pass this tive Mickey Kantor in a letter to Sen- State of Rhode Island, where Glaxo- amendment and help consumers gain ator CHAFEE, Wellcome, one of the pharmaceutical access to more affordable medications. This provision—the transition rules—was companies with much at stake here, For millions of Americans, especially written neutrally because it was intended to has a manufacturing facility. Prior to senior citizens, prescription drugs rep- apply to all types of patentable subject mat- making a decision that could affect so resent their largest out-of-pocket ter, including pharmaceutical products. Con- many Rhode Islanders, I feel that a health expense. Many life-sustaining forming amendments should have been made clear airing of the ramifications of this drugs are already out of their reach. to the Federal Food, Drug, and Cosmetic Act proposal is required. Given the assur- We can not let the desire of a few drug and Section 271 of the Patent Act, but were ances that these hearings will occur inadvertently overlooked. companies to let this error go uncor- within 120 days, I feel confident that rected place an even greater burden on This oversight means consumers will this issue will be addressed and when it consumers who struggle daily to pay pay more for their drugs than would does, we will have an adequate record for their prescription drugs. otherwise have been the case. If generic on which to base our decisions. Mr. SPECTER. Mr. President, I sup- drug companies cannot bring their I do wish to note that by supporting port the intent of Senator PRYOR to versions of drugs to market under the the effort to refer this to the Judiciary remedy what was apparently an unin- transition rules, consumers will be Committee for hearings, I am not stat- tended omission when the Senate rati- forced to pay more for their prescrip- ing my opposition to the proposal per fied the implementing legislation for tions. Nationwide, it is estimated this se. I will wait to come to the conclu- the General Agreement on Tariffs and may cost consumers $2.5 billion. West sion once the hearings have been com- Trade (GATT) in the 103d Congress. Virginians and the West Virginia State pleted and when the full weight of the However, I remain concerned with am- government will pay an additional $43 proposal is more clear. biguities in the Pryor amendment with million in drug costs. Those who will Mr. COHEN. Mr. President, I rise to respect to the definition of substantial likely be impacted greatly by this Con- support the Pryor generic drug amend- investment. gressional oversight are senior citizens. ment which will correct an oversight in When the GATT implementing legis- Although seniors comprise 12 percent the General Agreement on Tariffs and lation was approved last year, it con- of the population, they use one third of Trade [GATT] implementing legisla- tained a provision harmonizing U.S. prescription drugs. At the same time, tion that has unintentionally post- patent law with the rest of the world seniors live on fixed incomes and often- poned the date at which certain generic by changing patent terms to 20 years times experience difficulty in affording prescription drugs can enter the mar- from the initial patent application their prescriptions. it is outrageous ket. While this delay only affects a rather than 17 years after granting of that Congress would worsen their situ- handful of drug products, consumers the patent. In order to be fair to exist- ation by failing to enact legislation to who take these drugs are paying a big ing patent holders, the legislation gave correct this Congressional oversight. price for this technical mistake. them the option of utilizing the longer Mr. President, this situation can eas- This amendment would clarify the of the pre-GATT and post-GATT patent ily be remedied by adopting the Pryor intent of transition rules in the trade terms. amendment. I urge my colleagues to bill allowing manufacturers who had However, because the legislation af- support the Pryor amendment, and I made substantial investment in prod- fected many generic manufacturers would like to be added as a cosponsor uct development, based on pre-GATT who had been preparing to go to mar- of this amendment. patent expiration dates, to go to mar- ket with competing products upon the

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00091 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18208 CONGRESSIONAL RECORD — SENATE December 7, 1995 expiration of the original patent term, biotech organizations, and academic just because we think some companies Congress agreed to allow generic manu- researchers appeared before these two may benefit, then all the intellectual facturers who had already made a sub- combined committees. property work we have done over all stantial investment in that product to I do not want to take too long on these years is going to go down the utilize the original patent expiration this, but let me just take a moment or drain. date and commence marketing, upon two to read from this very important But let me talk again about the paying of a royalty to the patentee. joint hearing transcript. Hatch–Waxman bill. Some have argued that the courts Representative William Hughes, who There were two sides to it. There can interpret the definition of substan- then was the chairman of the House were those who were spending billions tial investment, and consequently, Subcommittee said to Mr. Bruce Leh- of critical dollars in research that is there is no need for legislative guid- man, Commissioner of Patents and going to help bring down health care ance on that definition. I disagree. By Trademarks: costs. These manufacturers are putting retaining this legislative ambiguity, There have been some concerns raised par- their money where their mouths are in we are ceding the legislative role to ticularly by the biotech industry, that order to find these breakthrough drugs the courts. We are also creating consid- grants of patents will be delayed because of that will reduce the costs of medicine erable costly litigation because of this unreasonable requests from the PTO for over the long run and help to relieve ambiguity which should be made clear human trials which, as you well know, could some human misery. take years for some biotechnology products But one of the problems these re- in the statute. These are resources to prove utility, a requirement of patent- which could be better devoted to devel- ability. Is that a legitimate concern on their search-based companies face is that the oping new products and making them part? FDA approval process has taken so available to the public. PTO Commissioner Lehman said: long. The agency is supposed to ap- I have discussed with Senator PRYOR prove drugs in 180 days, according to Well, to the extent that that is a legiti- my willingness to work with him to mate concern, Mr. Chairman, I think that is the statute. correct this ambiguity and then ac- addressed in the Patents Term Restoration That has not happened in fact. It has complish his intended remedy. and Drug Price Competition Act that ex- taken so long that the patent terms Mr. HATCH addressed the Chair. tends patent terms specifically to deal with are eaten up by the delays. The PRESIDING OFFICER. The Sen- regulatory delay. Perhaps that act should be So, there were those on the side of ator from Utah. adjusted if it is not addressing the concerns the research companies who said—and I Mr. HATCH. Mr. President, I take a of industry. was one of them—that what we must tremendous interest in this subject, in By the way, the Drug Price Competi- do is restore some of the patent term part because I chair the Judiciary tion and Patent Term Restoration Act lost through unnecessary regulatory Committee, which handles all patents, happens to be the bill that Representa- delays. The other side consisted of copyrights and trademark legislation tive HENRY WAXMAN and I wrote back those representing the interests of the and problems. Since the amendment in 1984, which is considered to be one of generic drug industry. would made changes in the patent the finest pieces of consumer legisla- I understand that those who support code, the matter would come before the tion in the last 30 years, if not in the the Pryor amendment do so because Judiciary Committee as it has in the entire history of the country. they are worried about consumer costs. past. I am very proud of that law. What their arguments neglect however, In addition, I want to point out that It is one of the reasons why I am say- are two simple questions: my colleague from Arkansas was mis- ing this is not a question of whether What are consumers going to con- taken when he said the Judiciary Com- somebody is going to get a windfall sume if we do not put money into re- mittee has never handled anything re- profit or not. search? garding FDA matters. In fact, I think This issue has very broad policy con- And what will consumers consume if he said, if I am correct, that the Judi- siderations. It is not just something there are not the incentives to produce ciary Committee never looked at the that can be couched in terms of the products they need? Food, Drug and Cosmetic Act. ‘‘gouging the consumers,’’ because The thing that has made the United Perhaps he was not aware that the there are two sides of this issue. States the greatest research country in 1962 Drug Amendments, which estab- The Drug Price Competition and Pat- the world is that we protect patents as lished the safety and efficacy standards ent Term Restoration Act, the Hatch– a property right in the Constitution for drugs reviewed by the FDA, were Waxman bill, brought the two sides to- itself. written in the Judiciary Committee. gether. This, again, is another Judiciary This is a result of the Kefauver hear- I know it. It was negotiated in my of- Committee concern for those who do ings, which led to adoption of new fice over a 2-week period, 18 hours a not seem to appreciate that point. amendments providing the efficacy day. One reason I remember it so well There are those on the consumer side standards which are often heralded as is because I had a root canal during who legitimately asked why it takes so the model standards for the world. that time, and by the time we got near long to get generic drugs approved If there is any one thing you can the end I threatened to kill everybody after the innovator drugs come off pat- point to at the FDA that protects in the room if they did get together ent. They suggested the availability of human beings and makes sure that the and get it done. an abbreviated new drug application so medical products Americans use are We finally did. they did not have to go through the safe and efficacious, it comes from It was a tense time. It was a tough whole safety and efficacy process. work done by the Judiciary Com- time. When we got it done, almost ev- It would have taken them 2 to 3 years mittee. But that is not the point. erybody agreed that this is one of the to take a product like Zantac—which I Before I go to the broader policy finest pieces of consumer legislation mention since that product has been issue, which is much more important ever. attacked here—and duplicate it so that than I think my colleagues would ac- It has saved an average of $1 billion a they can reduce the price for the ben- knowledge, let me just call their atten- year to consumers every year since its efit of consumers. tion to other Judiciary Committee enactment in 1984, as we predicted it So what did we do? We worked hard work on the GATT intellectual prop- would. to enable those generic companies to erty provisions. I am referring to a So, naturally, I am concerned when I be able to do what would be called in- joint hearing in the 103d Congress be- hear that that act is going to be fringement in any other industry. fore the House Judiciary Sub- amended in an unwise fashion. As a consequence of this change, committee on Intellectual Property If the USA, whose officials have these generic manufacturing compa- and Judicial Administration and the asked heads of states all over the world nies were able to borrow from the work Senate Judiciary Subcommittee on to live up to these hard-won inter- of the research-based companies who Patents, Copyrights and Trademarks. national intellectual property agree- are spending as much as half a billion Pharmaceutical industry representa- ments, changes this major treaty right dollars to produce one marketable tives, including those representing off the bat by reducing patent terms drug, and produce a bioequivalent of a

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00092 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18209 drug such as Zantac that becomes ef- bringing those ides to fruition. It is the basis recent court decisions, reflects sound fective the day Zantac comes off the of our patent system that allowed American policy and should not be disturbed. patent. ingenuity to prosper throughout the Indus- I am glad we are having this debate Or a better illustration might be Val- trial Age. Today, we are at the dawn of an today, as I welcome the opportunity to Information Age and now, more than ever, ium. When Valium’s patent expired, put the issue in better perspective. the rights of intellectual property holders This is a debate that cuts across the Hatch–Waxman bill provided that must be protected. all kinds of generic companies were Consider the enormous investment in time, party lines. able to produce their version of Valium money, and brainpower required to bring a Reasonable people may disagree that very day, rather than be delayed single new medicine to patients: 12 years and about the best course of action to take the 2 or 3 years through the whole more than $350 million is the average invest- on this amendment, but it is still the process again. ment. Only 20 percent of new compounds same debate: Who is going to benefit, That is important, because what we tested in a laboratory ever find their way the research companies or the generic onto pharmacy shelves. Only a third of those did is bring both sides together to cre- companies? ever earns a return on the colossal invest- The generics have benefited greatly ate the generic industry as we know it ment made to discover it. from what I have personally done for today. In fact, I am proud to have been Though risky and expensive, this process them, and so have the research compa- called on occasion ‘‘the father of the works. The U.S. is the world leader in the de- nies. generic drug industry.’’ velopment of innovative new medicines. Pro- But our overriding goal here must be So I have a tremendous interest in ceeds from the sales of these medicines sup- port the work and research invested in new to make sure we keep in place the in- making sure that the generic industry centives necessary for America to con- is solid and producing lower-cost drugs. successful drugs, as well as the thousands of drugs that never make it out of the lab. tinue as the world leader in developing But I also have a tremendous interest Patent protection makes that investment innovative medical technologies that in seeing that research companies are in research worthwhile—and possible. Re- can be delivered at competitive prices. given fair deals on their patents. cently, patent protection around the world The bottom line is that the Pryor Now, when we came up with the was strengthened and harmonized by GATT, amendment would undermine that Hatch–Waxman bill we knew there which required changes that equalized intel- goal. would be winners and losers. lectual property protection in all partici- At the end of this debate, I am hope- Both sides knew this. pating countries. These changes are impor- ful that my colleagues will share my They were willing to make trade-offs tant to encourage the risky, expensive re- strong conviction that two relevant in order to accomplish a greater goal. search necessary to provide new medicines to fulfill unmet medical needs. laws—the Drug Price Competition and We knew there were winners and los- Now, some generic drug companies are Patent Term Restoration Act, some- ers with the Waxman-Hatch bill, and challenging GATT’s advance in intellectual times known as Waxman-Hatch or we also knew that when GATT was fi- property protection. They are urging Con- Hatch-Waxman and the GATT Treaty— nalized there would be winners and los- gress to amend the 1984 Hatch-Waxman Act act together to advance important pub- ers. to give them an advantage under GATT that lic health and trade policies. Now, I think Dr. Koop’s position has no other industry enjoys. I believe it is clear that the Senate been misrepresented by the other side, A key provision of the Hatch-Waxman Act must reject the Pryor amendment if we some of whom do not think he under- gives generic drug companies a jump-start are to maintain that balance. on marketing by allowing them to use a pat- Let me summarize my three basic ob- stands what really went on. There ented product for development and testing seems to be some confusion about Dr. jections to this amendment: before the patent expires. This special ex- First, many experts in international Koop, our former Surgeon General, who emption from patent law is not allowed for is probably the leading doctor in the any other industry. trade believe that the adoption of this history of this country. In return for these special benefits, the amendment would send precisely the I think Dr. Koop has a pretty good Hatch-Waxman Act requires generic drug wrong signal to our trading partners, reputation in the field of public health. companies to wait until the expiration of the some of whom have had notorious He was a most outstanding Surgeon research companies’ patents before they can track records of being patent-un- begin marketing their drugs. Now, the ge- General. I did not always agree with friendly. neric drug industry is asking Congress to A major gain we made with GATT him, but I always respect his views. give it a special exemption from that restric- was to win international harmoni- Dr. Koop wrote a letter to clarify tion as well. zation with a 2-year patent term. Adop- that those on the other side could not In my opinion, that would be unwise. tion of the Pryor amendment could misrepresent his position any more. Treatment discovery has already slowed; we cause backsliding on the part of foreign That letter is printed in today’s issue should reverse that process, not ensure it. Generic drugs play an important role in countries required to implement and of Roll Call. It makes, I believe, an elo- enforce their obligations under GATT. quent case against the Pryor amend- helping lower the cost of medicines. But it is the pharmaceutical research industry that Let us not steal defeat from the jaws of ment. discovers and develops those medicines in victory. I will submit for my colleagues’ con- the first place, investing billions of dollars Second, the Waxman-Hatch Act sideration this letter to Morton in research and development that can span achieved a careful balance between the Kondracke, Executive Editor of Roll decades without any guarantee of success— generic and innovator sectors of the Call, from Dr. C. Everett Koop, former an investment made possible by our system pharmaceutical industry. Surgeon General of the United States. of patent protection. The proponents of the Pryor amend- I ask unanimous consent that the full Mr. HATCH. Preserve patent protec- ment urge that only one industry is letter be printed in the RECORD at this tion and you preserve the opportunity singled out for different treatment point. for the discovery of future cures and under the GATT implementing legisla- There being no objection, the mate- treatment for disease. Undercut that tion. rial was ordered to be printed in the protection and you undercut America’s What is absent from that line of ar- RECORD, as follows: hope for new and better answers to our gument is the fact that only one indus- KOOP ON PHARMACEUTICALS health care needs. try, the generic drug industry, is per- To the Editor: It is for this reason that I must rise mitted by current law to engage in ac- In your Food & Drug Policy Briefing (Oct. tonight in opposition to the amend- tivities that in any other industry 9), an article appeared concerning patent ment offered by Senators PRYOR, would constitute patent infringement, protection under the General Agreement on CHAFEE, and BROWN. as I have said before. Tariffs and Trade. I am of the firm belief Whenever Senator PRYOR and I join A recent Federal district court re- that any action on the part of the Senate to in debate over pharmaceutical issues, I viewed the relevant provisions of law weaken the hard-fought patent protections am sure some of our colleagues want to and concluded, ‘‘This was no more a of GATT would imperil the future of intellec- say, ‘‘Here we go again.’’ windfall to the * * * [pioneer firms] tual property rights and undermine the re- search activities of pioneering pharma- Well, here we go again. * * * than the windfall which benefited ceutical companies. Mr. President, I oppose this amend- many patent holders when the seven- The right to claim ideas as property allows ment because the current statutory teen year term of patents was extended innovators to invest their time and money framework, as interpreted by several to twenty years.’’

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00093 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18210 CONGRESSIONAL RECORD — SENATE December 7, 1995 Third, if the Pryor amendment is time in the history of GATT during the Uru- For all of these reasons, the AEI analysts adopted, it may run afoul of the guay Round. As a result of hard-fought com- conclude that USTR Kantor’s contention takings clause of the fifth amendment promises, worldwide standards for protecting that the amendment would not undermine to the Constitution. Patents are recog- and enforcing intellectual property rights America’s position in international trade ne- were established, and intellectual property nized and protected by American gotiations ‘‘would seem to come under the protection was significantly improved. heading of ‘‘ ‘whistling in the wind.’’’ courts and by our Constitution as prop- The decision to tackle patent rights during Significantly, USTR Kantor’s position has erty. the Uruguay Round, despite the reluctance been strongly countered by his predecessors, By repealing patent extensions of some developing countries, reflects the former-Ambassadors Clayton Yeutter and granted under the GATT legislation complexity of international trade and the Bill Brock. Ambassador Brock asserts that and reducing vested patent terms, the international significance of patent rights. nations which in the past have denied Amer- Pryor amendment could trigger the As the principal source of inventive activ- ican investors patent protection ‘‘will see guarantee that affected property hold- ity, the U.S. stands to gain substantially this retreat on our part as a ready excuse to from the Agreement on Trade-Related As- implement their own minimalist versions of ers receive just compensation. pects of Intellectual Property (TRIPs) im- I ask unanimous consent that a copy intellectual property protection.’’ Thus, Am- provements in patent protection worldwide. bassador Brock concludes, we would be un- of an October 24 ‘‘Dear Colleague’’ let- In countries that previously provided limited ter signed by a bipartisan group of 11 able ‘‘to force other nations to adhere to the patent protection, a minimum 20-year patent TRIPs agreement if we set this unfortunate Senators, and a December 6 ‘‘Dear Col- term must be granted immediately upon precedent.’’ league’’ letter discussing these issues their acceptance of the TRIPs obligations. Similarly, the Emergency Committee for be printed in the RECORD at this point. Enhanced patent protection overseas will American Trade (ECAT) concludes, ‘‘A U.S. There being no objection, the letters have a significant impact on the commercial retreat from its own commitments to in- interests of the United States and the result- were ordered to be printed in the creased intellectual property protection for ing economic gains and job creation in the RECORD, as follows: all patented products would be a destructive United States will be considerable. U.S. SENATE, The Uruguay Round agreement was a land- precedent that could lead to an unraveling of Washington, DC, October 24, 1995. mark achievement, but the real test comes hard-won gains.’’ DEAR COLLEAGUE: We are writing to indi- when countries implement their multilateral The European Community (EC) has ex- cate our bipartisan opposition to an amend- obligations under GATT. Since the U.S. in- pressed similar ‘‘serious concerns’’ about any ment which may be offered during Senate sisted on the inclusion of enhanced patent such precedent. The Vice-President of the consideration of S. 1357, the Balanced Budget protections in the Uruguay Round agree- European Commission believes the amend- Reconciliation Act of 1995. That amendment ments and historically has been the leading ment ‘‘would contradict our mutual aim of would deny U.S. innovator pharmaceutical international advocate for broadening patent providing a reasonably high and secure pro- manufacturers international patent protec- rights, it is essential that the U.S. be a world tection for the huge investments made by EC tions provided under key provisions of the leader on GATT implementation. and US research-based pharmaceutical com- GATT implementing legislation. Enhanced patent protection will be dimin- panies’’ and ‘‘send a negative and highly visi- The Uruguay Round Agreements Act ished abroad if the United States itself vio- ble signal to those numerous countries which (URAA) implemented the United States’ ob- lates the patent term embodied in TRIPs. It are still in the process of preparing new leg- ligations under GATT by providing that the is almost certain that such an action would islation on the protection of pharmaceutical term of any patent in force on June 8, 1995, provide foreign-based pirates and patent in- inventions.’’ be the greater of 20 years from the applicable fringers with potent ammunition in seeking As America’s trading partners implement filing date or 17 years from the date of grant. to have their domestic governments devise GATT, it is vital that the U.S. be in a posi- These critically-important patent provisions measures that are inconsistent with TRIPs— tion to demand that they adopt legislation benefit all industries and all patent holders. thereby denying U.S. patent holders their consistent with the requirements embodied Nevertheless, a handful of generic drug rights secured by TRIPs. in the Uruguay Round agreements. In order companies have urged Congress to rewrite A report just released by two American to do so, we cannot be childed into adopting the law in effect to eliminate the 20-year Enterprise Institute (AEI) analysts con- an ill-considered amendment that vitiates term for certain prescription drug patents by cludes that such ‘‘weaken[ing] [of] the pat- patent protection for American patent hold- allowing generic companies to sidestep exist- ent system during this critical period of im- ers. ing statutory provisions under the Drug plementing the TRIPs agreement could well THE GATT PATENT AMENDMENT WILL CHILL R&D Price Competition and Patent Term Restora- give developing countries a pretext for back- IN RESEARCH-INTENSIVE INDUSTRIES tion Act of 1984 (‘‘Hatch-Waxman’’) that pre- ing away from their GATT commitments to Intellectual property rights are critical to clude the generic from entering the market strengthen the protection of intellectual all American industries and should not be until the full term of the pioneer’s patent property.’’ They point out several developing lightly disregarded. They are particularly has expired. nations, including India, Singapore, and important to the pharmaceutical industry Repealing this provision of the URAA Thailand, which are already attempting ‘‘to because they fuel the engine that drives the would: weaken the U.S. position in negoti- dilute and evade’’ the patent protection com- biomedical research enterprise and result in ating and enforcing strong international pat- mitments they accepted during the Uruguay numerous therapeutic advances. ent protection which was a major achieve- Round. ment of the GATT; have a chilling effect on It is clear that, in this patent-unfriendly An amendment that eliminates the GATT biomedical research in the pharmaceutical context, the proposed amendment would be patent benefits for pharmaceutical products industry; and be subject to legal challenge as interpreted internationally as encouraging a would undermine a critically important in- an unconstitutional taking of property. minimalist’s interpretation of GATT’s im- centive for research and development. It is inappropriate to consider a change of provements in patent protection. As the AEI As with other research-incentive industries this magnitude in the context of budget rec- analysts conclude, America’s trading part- in the United States, the pioneer pharma- onciliation. Both Hatch-Waxman and the ners will construe the amendment as a green ceutical industry has benefited significantly Uruguay Round were hard-won compromises light to act inconsistently with GATT: from America’s patent system. Due to the which were negotiated very carefully. The ‘‘Thus, any signal that the United States high costs and significant risks associated amendment has both trade and intellectual itself is contemplating weakening its TRIPs with developing and marketing prescription property implications, as well as substantial obligations will undoubtedly be seized upon drugs, patents have allowed pharmaceutical implications for food and drug law. Further- by these countries as a pretext to resist pres- manufacturers to attract the risk capital more, this issue is now before the Federal sure to put in place strong intellectual prop- necessary to develop and clinically test inno- courts in ongoing litigation and any action erty protections.’’ Having redefined patent vative new therapies. at this time would be premature. terms domestically in order to secure en- The results of such ground breaking bio- For these reasons, as discussed in detail in hanced patent rights overseas, it would be medical research flows directly to patients the attachments, we urge you to oppose con- imprudent for this Congress to send any such who have access to drugs for complex and sideration of the GATT patent amendment signal. life-threatening diseases which are developed during debate on budget reconciliation. The international trade ramifications ex- only by pioneer pharmaceutical companies. Sincerely, tend beyond questions of intellectual prop- We should continue to reward their inge- Christopher J. Dodd; Orrin G. Hatch; Jo- erty protection. The positions advocated by nuity and encourage their innovation. seph I. Lieberman; Alfonse M. proponents of this amendment ‘‘are likely to If Congress encourages a curtailment of D’Amato; Charles E. Gressley; Lauch be turned against the United States in future biomedical R&D by limiting incentives, it Faircloth; Mike DeWine; Carol Mosely- trade negotiations,’’ according to the AEI inevitably will cause a downturn in the rate Braun; Ernest F. Hollings; Jesse Helms; analysts. The AEI report concludes that ar- at which biomedical inventions will become Dan Coats. guments advanced in support of the amend- available to the public. For this reason, an THE GATT AMENDMENT WOULD UNDERMINE ment ‘‘will come to haunt U.S. negotiators’’ array of patient and research groups—includ- AMERICA’S TRADE POSITION and ‘‘play rights into the hands of developing ing the American Association for Cancer Re- Intellectual property rights were addressed countries who still maintain and defend com- search, the Alliance for Aging Research, the on a multilateral trade basis for the first pulsory licensing.’’ Cystic Fibrosis Foundation, the Allergy and

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00094 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18211 Asthma Network/Mothers of Asthmatics, and two weeks ago. An amendment on this issue because of the advent of the latest ‘‘miracle the Autism Society—oppose the amendment. would be premature at this time. drug.’’ These breakthrough treatments have THE GATT PATENT AMENDMENT COULD EFFECT brought hope and, in many cases, renewed AN UNCONSTITUTIONAL TAKING OF PROPERTY U.S. SENATE, health to thousands of patients. They are the Legal analysis supports the view that the Washington, DC, December 6, 1995. product of an increasingly important con- DEAR COLLEAGUE: We are writing to urge proposed GATT amendment ‘‘would clearly cept: the sanctity of intellectual property. your opposition to the Pryor amendment to deprive the patent holders of their property The right to claim ideas as property allows H.R. 1833, the partial birth abortion ban bill. rights. . . .’’ Patents have traditionally been innovators to invest their time and money This amendment would deny the benefits of recognized and protected by American courts bringing those ideas to fruition. it is the GATT to U.S. innovator pharmaceutical as property. basis of our patent system that allowed companies. Based upon existing precedents, it can be American ingenuity to prosper throughout The Pryor amendment is bad policy. It un- argued that any legislation affecting either the Industrial Age. Today, we are at the dermines the purposes of GATT, and it fun- the exclusive use of a product to which a pat- dawn of an Information Age and now, more damentally upsets the delicate balance we ent holder is entitled, or the time during than ever, the rights of intellectual property forged in 1984 upon adoption of the Drug which the patent holder is entitled to that holders must be protected. Price Competition and Patent Term Restora- Consider the enormous investment in time, exclusive use, affects core elements of the tion Act (‘‘Hatch-Waxman’’). That Act was money, and brain power required to bring a property right represented by a patent. designed to ensure that innovator companies By repealing patent extensions granted single new medicine to patients: 12 years and continue to have sufficient incentive to in- under the URAA, and reducing vested patent more than $350 million is the average invest- vest the billions of dollars necessary to terms to which existing patent holders are ment. Only 20% of new compounds tested in produce new medicines while at the same currently entitled, this amendment could a laboratory ever find their way onto phar- time allowing generic companies a quick and trigger the Fifth Amendment guarantee that macy shelves. Only a third of those ever inexpensive way to get their versions of the the property holders receive just compensa- earns a return on the colossal investment drugs on the market after the patent has ex- tion. made to discover it. In this era of fiscal constraints, and par- pired. The Hatch-Waxman Act also gave generic Though risky and expensive, this process ticularly in the context of the budget rec- drug companies an advantage possessed by works. the U.S. is the world leader in the de- onciliation debate, it would be ironic indeed no other industry in either the United States velopment of innovative new medicines. pro- for Congress to impose such financial obliga- or the industrialized world. It specifically re- ceeds from the sales of these medicines sup- tions on an already-strained federal budget. pealed those provisions of patent and case port the work and research invested in new We should carefully consider whether the law that forbade any testing, plant construc- successful drugs, as well as the thousands of amendment would have such an effect. tion, or investment in something which is drugs that never make it out of the lab. IT IS INAPPROPRIATE TO CONSIDER THE GATT still under patent, thus enabling the generic Patent protection makes that investment PATENT AMENDMENT DURING RECONCILIATION industry to conduct its bioequivalency tests in research worthwhile—and possible. Re- Regardless of one’s views about its merits, and even produce a drug before the patent cently, patent protection around the world it is clear that a GATT patent amendment expires. It is generally agreed that this re- was strengthened and harmonized by the would be inappropriate at this point. duces the effective life of a drug patent GATT, which required changes that equal- The proposed amendment is not a tech- about three years. This is in addition to the ized intellectual property protection in all nical amendment as it has been character- fact that Hatch-Waxman allows generics to participating countries. These changes are ized by its proponents, who suggest they are avoid the lengthy, multiyear approval proc- important to encourage the risky, expensive simply trying to correct a ‘‘simple mistake ess by using the safety and efficacy testing research necessary to provide new medicines in legislative drafting’’ that resulted in a data of the innovator company. This is esti- to fulfill unmet medical needs. ‘‘legal loophole’’ in the URAA. The facts are mated to save the generics between $350 mil- Now, some generic drug companies are quite different. lion and $500 million per drug. challenging the GATT’s advance in intellec- The amendment would result in substan- We are enclosing a previous dear colleague tual property protection. They are urging tial changes in two statutes—the URAA and letter which provides you with information Congress to amend the 1984 Hatch-Waxman the 1984 Hatch-Waxman Act. The Hatch-Wax- on this subject, as well as a letter to the edi- Act to give them an advantage under the man Act represents a careful balance be- tor that will appear in tomorrow’s Roll Call GATT that no other industry enjoys. tween the interests of innovator manufactur- from Dr. C. Everett Koop, the former Sur- A key provision of the Hatch-Waxman Act ers and generic drug companies. It has geon General of the United States. We urge gives generic drug companies a jump start on worked well for over 10 years and should not you to read this letter carefully as it elo- marketing by allowing them to use a pat- be amended lightly. Even minor changes to quently and persuasively argues our case. We ented product for development and testing Hatch-Waxman could have profound effects are also including a collection of statements before the patent expires. This special ex- on all segments of the pharmaceutical indus- from various patient groups who also oppose emption from patent law is not allowed for try. the Pryor amendment because these individ- any other industry. For example, a tele- Under Hatch-Waxman, generic drug compa- uals know first-hand that intellectual prop- vision manufacturer who wants to market or nies are already given significant advan- erty is the key to new discoveries which use its own version of a patented component tages. They are allowed to begin develop- mean life or death for millions of people. must wait until the patent expires; other- ment of their generic drugs while the pio- We urge you to join us in opposing the wise, it risks liability for patent infringe- neer’s patent remains in effect, and they can Pryor amendment. ment. rely on the safety and efficacy data devel- Sincerely, in return for these special benefits, the oped by the innovator. The proposed GATT CHRISTOPHER J. DODD, Hatch-Waxman Act requires generic drug amendment would negate a complementary United States Senator. companies to wait until the expiration of the provision in the Hatch-Waxman Act; that ORRIN G. HATCH, research companies’ patents before they can provision requires generic companies to re- United States Senator. begin marketing their drugs. Now, the ge- spect the pioneer’s full patent term, and neric drug industry is asking Congress to thereby upset the balance codified in that November 30, 1995. give it a special exemption from that restric- statute. Mr. MORTON KONDRACKE, tion as well. The dramatic changes that would result Executive Editor, from the proposed amendment would occur Roll Call, Washington, DC. In my opinion, that would be unwise. without the benefit of prior congressional In your special supplement on the FDA Treatment discovery has already slowed; we consideration. The proposed amendment (October 9, 1995), an article appeared con- should reverse that process, not ensure it. would have a direct and significant effect on cerning patent protection under the General While the generic drug industry continues patent rights, which fall squarely within the Agreement on Tariffs and Trade (GATT). I to prosper as a result of the benefits received jurisdiction of the Judiciary Committee. am of the firm belief that any action on the in the 1984 Act, medical research has contin- We should not rush to legislate in this area part of the U.S. Senate to weaken the hard- ued to become more complex, more costly, before all Committees of relevant jurisdic- fought patent protections of the GATT and more time consuming, further limiting tion have had a reasonable opportunity to would imperil the future of intellectual prop- the effective market life for patented prod- hold hearings and give careful consideration erty rights and undermine the research ac- ucts. to all of the proposed amendment’s potential tivities of pioneering pharmaceutical compa- Generic drugs play an important role in ramifications. nies. helping lower the cost of medicines. But it is Finally, questions relating to implementa- A little-known revolution has taken place the pharmaceutical research industry that tion of the URAA are currently in litigation. in my lifetime. When I started practicing discovers and develops those medicines in One lawsuit addressing the precise issue cov- medicine, only a fraction of the drugs that the first place, investing billions of dollars ered by the proposed amendment has been we now take for granted existed. Over the in research and development that can span expedited for consideration by the U.S. Court years, I have witnessed great suffering en- decades without any guarantee of success— of Appeals for the Federal Circuit (CAFC). dured by patients and their families that, an investment made possible by our system The CAFC heard arguments in that case just just a few years later, could have been eased of patent protection. Preserve protection and

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00095 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18212 CONGRESSIONAL RECORD — SENATE December 7, 1995 you preserve the opportunity for the dis- As my colleagues are aware, the Uru- They have explained that changing covery of future cures and treatments for guay Round Agreement Act—the the implementing legislation now disease. undercut that protection, and you URAA—is the statute that implements sends exactly the wrong message. undercut America’s hope for new and better the GATT Treaty. Mr. President, both of these inter- answers to our health care needs. Some have said today that the GATT Sincerely yours, national trade experts were active par- patent amendment merely corrects a C. EVERETT KOOP, M.D. ticipants in the TRIPS negotiations simple oversight made in drafting the during their respective stewardships at PATIENT ADVOCATES OPPOSE EFFORTS TO GATT implementation bill. the U.S. Trade Representatives’ Office WEAKEN STRONG PATENT PROTECTION This is simply not true. as U.S. Trade Representatives. ‘‘At a time when health care delivery, re- And wishing will not make it so. As Mr. Yeutter wrote to the Finance search and development are evolving faster Negotiations on the GATT Treaty Committee in September of this year: than anyone can accurately monitor, Sen- were exceedingly detailed and complex. In the Uruguay Round, one of the principal ator Pryor’s efforts to lead Congress down a They took place over many years—in objectives of the United States was to road that chips away at patent protections fact, across the terms of four American strengthen international protection of pat- for U.S. pharmaceutical products will dig a Presidents. ents, trademarks, copyrights, trade secrets, health care grave for Americans.’’—Nancy Given the ample opportunity for this and semiconductor lay-outs. The United Sander, President, Allergy and Asthma Net- issue to have arisen previously, it States leads the world in ideas and innova- work/Mothers of Asthmatics, Inc. seems to me that those who argue we tion, particularly in cutting-edge tech- ‘‘Congress cannot expect the private sector should adopt this after-the-fact tech- nologies such as pharmaceuticals and bio- to continue making high-risk investments in technology. Thus, . . . TRIPS . . . was a research and development if there is no as- nical correction amendment should face a heavy burden. major breakthrough for the United States. surance of strong patent protection...’’— He goes on to say: Daniel Perry, Executive Director, Alliance Their case is, and should be, severely for Aging Research. undercut by the fact that the Congress In my view, adding further preferential ex- ‘‘The risk of supporting [Senator Pryor’s] made changes in the very sections of ceptions to the Uruguay Round’s 20-year legislation would be to weaken the incen- the relevant laws that we are now minimum patent term, for the generic drug tives for innovation in academia, research industry or anyone else, would set an unfor- being told were not amended as a sim- tunate precedent and seriously undermine institutions, and medical research-based ple matter of oversight. companies. We believe that this will impede U.S. efforts to secure stronger International One of the chief benefits that the IPR disciplines. Many developing countries our capacity to address the growing epidemic GATT Treaty can achieve for the of cancer.’’—Joseph R. Bertino, M.D., Presi- have long opposed effective patent protec- dent, American Association for Cancer Re- American people is to increase inter- tion for pharmaceuticals and agricultural search, Inc. national protection of intellectual chemicals in order to protect domestic in- ‘‘The ASTMH members have dedicated property. dustries engaged in illicitly copying Amer- their lives to easing the suffering of patients These important agreements are set ican products. under their care and returning them to forth in the Agreement on Trade-Re- As Mr. Yeutter clearly indicates, health whenever possible. In this effort, mod- lated Aspects of Intellectual Property, there are strong trade policy argu- ern medicines are among our most effective the so-called TRIPS provisions. A key ments for standing firmly behind this tools. Congress’ steadfast support of strong aspect of TRIPS was to require that all new 20-year rule. These concerns were patent protection has encouraged the invest- also shared by another former U.S. ments in research and development that 123 GATT signatory countries adopt a make these medicines possible.’’—Carole A. minimum 20-year patent term, meas- Trade Representative, William Brock. Long, Ph.D., President, American Society of ured from the date that a patent appli- In a recent letter, Senator Brock ex- Tropical Medicine and Hygiene. cation is filed. plained the significance of the GATT ‘‘While we certainly support patient access Strengthening international recogni- intellectual property provisions: to lower cost treatments for disease and dis- tion of intellectual property rights When I first proposed international agree- ability rehabilitation, that short-term ben- such as patents was one of the most ments to extend intellectual property pro- efit pales if it comes at the long-term ex- important gains we made in the adop- tection worldwide under the GATT, no one pense of finding cures to life-threatening ill- tion of the GATT Treaty. These rights believed it could be done. Yet it was the nesses.’’—Sandra H. Kownacki, President, act to protect innovative American crowning achievement of the recently suc- Autism Society of America. cessful Uruguay Round. . . Now I hear that ‘‘Because of the discoveries born of these firms, which all to often have been the some pending proposals could imperil the investments [in pharmaceutical research], victims of unscrupulous behavior by implementation of that agreement. I refer the patients we come in contact with every foreign competitors who have expropri- specifically to legislation recently intro- day benefit through saved lives and improved ated American know-how. duced by David Pryor.... quality of life.’’—Robert J. Beall, Ph.D., Obviously, all World Trade Organiza- Proponents suggest that this legislation is President and CEO, Cystic Fibrosis Founda- tion member countries must take seri- only a ‘‘technical’’ correction to the . . . tion. ously their obligations to respect intel- URAA . . . and neither weakens patent pro- ‘‘Patients afflicted with disease look to lectual property rights under the tection . . . nor diminishes the United biomedical research, especially research tak- States’ ability to fight for stronger inter- ing place in America’s pharmaceutical indus- GATT Treaty and ensure that there national patent protection. I disagree! try, for new and better treatments to restore will be no back sliding. It is vital that America must also be Senator Brock goes on to say as them to health.’’—Patti Munter, President, former Trade Representative: The National Organization on Fetal Alcohol perceived as honoring its obligation as Syndrome. a World Trade Organization member. It will be difficult, if not impossible for the ‘‘Our patients have experienced the direct I recognize that Ambassador Kantor United States to force other nations to ad- benefits of the tremendous investments that has been identified as one who is sup- here to the TRIPS agreement if we set this unfortunate precedent. the pharmaceutical industry has made in re- portive of this type of Pryor amend- search and development. Research-based In sum, in exchange for the hope of short ment. term savings, the PRYOR proposal could cost companies need and deserve the incentives In a September 18 letter to Senator provided by strong intellectual property pro- all U.S. firms and workers the enormous tection.’’—Judith Simpson, R.N., Ed.S., PRYOR, Mr. Kantor takes a view that long term gains we worked so hard to President, United Patients’ Association for the approach advocated by the Pryor achieve in the Uruguay Round. That is penny Pulmonary Hypertension, Inc. amendment does not weaken the cam- wise and pound foolish. paign for stronger patent protection When the comments of these two Mr. HATCH. As the ‘‘Dear Colleague’’ abroad and reflects the intent of the former U.S. Trade Representatives are letters point out, what is at stake here drafters of the URAA. I disagree with contrasted with the views of Mr. is not just the patent status of a few him, and I disagree with Senator Kantor, and my friend from Arkansas, drugs, but also our international trade PRYOR on both scores. Senator PRYOR, it is clear that this is posture and the complex set of incen- First, I would like to point out that the type of issue upon which reason- tives and regulations that govern our two former U.S. Trade Representatives, able and honorable people may dis- Nation’s biomedical research and de- William Brock and Clayton Yeutter, agree. velopment network. have stated that the recently adopted I understand that the proponents of Let me turn to a more detailed expla- GATT Treaty is a major improvement this amendment are motivated by good nation of my position. that benefits the American public. intentions, but I think they are on the

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00096 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18213 wrong side of both the law and the pol- I am therefore very much concerned with chemicals in order to protect domestic in- icy on this issue. the potential impact of the adoption of such dustries engaged in illicitly copying Amer- In further support of my viewpoint I legislation on third counties. For several ican products. This is one reason the United point out that Ambassador Kantor’s years both the US and the Community have States finally agreed to extremely long tran- made major efforts, jointly in the GATT but sition periods in TRIPS. The proposed counterpart at the European Commis- also in the context of our respective bilateral amendment would provide further aid and sion finds the Pryor approach ex- negotiations with third countries, to im- comfort to foreign pirates that want to con- tremely troublesome. Now, if you know prove the protection of intellectual property tinue infringing American patents. It would the British, when they say ‘‘extremely rights. This effort has been successful, both be thrown back at U.S. trade negotiators troublesome,’’ that is about as strong a in the GATT where the TRIPs Agreement every time they complain that a foreign gov- statement as they can make. has now been adopted as part of the Uruguay ernment is not adhering to its TRIPS obliga- Sir Leon Brittan has informed the Round, but also in our relations with many tions. In Section 532(a)(1) of the URAA, Congress current U.S. Trade Representative: third countries. This includes not only sig- nificant improvements with respect to the made the right choice by rejecting proposals I am therefore concerned that the adoption adoption of higher substantive standards for to in effect shorten the 20 year minimum of these proposals (or for that matter, any patent protection but also so-called pipeline patent term established in TRIPS. To recon- other bill which aims at achieving the same protection for pharmaceutical and agro- sider that decision now would be a mistake; objectives) would send a negative and highly chemical product inventions. Nevertheless, the proposed amendment would clearly un- visible signal to those numerous countries there is still a long way to go before the dercut future U.S. efforts to enforce strong which are still in the process of preparing TRIPs Agreement is implemented by our international IPR disciplines. new legislation on the protection of pharma- WTO partners, and we both have further ob- Sincerely, ceutical innovation. jectives to pursue at the bilateral level in CLAYTON YEUTTER. This information should dispel the terms of improved protection of our intellec- myth that there are no important tual property rights. I am therefore con- THE BROCK GROUP, LTD., trade implications at stake in this de- cerned that the adoption of these proposals Washington, DC, September 20, 1995. Senator WILLIAM V. ROTH, JR., bate. (or, for that matter, any other bill which aims at achieving the same objective) would Hart Senate Office Building, It should dispel the myth that the send a negative and highly visible signal to Washington, DC. Pryor amendment has no potential those numerous countries which are still in DEAR SENATOR ROTH: When I first proposed negative impact on our efforts to en- the process of preparing new legislation on international agreements to extend intellec- hance international respect for intel- the protection of pharmaceutical inventions. tual property protection worldwide under lectual property laws. I very much hope that you share my wor- the GATT, no one believed it could be done. I ask unanimous consent that the re- ries and the United States Administration Yet it was the crowning achievement of the will convey these concerns to the United recently successful Uruguay Round—thanks marks of Clayton Yeutter, Bill Brock, almost solely to the persistent and active and Sir Leon Brittan be printed in the States Congress. Sincerely, support of the U.S. business community and ECORD R . LEON. U.S. governmental leaders. There being no objection, the mate- Now I hear that some pending proposals could imperil the implementation of that rial was ordered to be printed in the HOGAN & HARTSON L.L.P., RECORD, as follows: Washington, DC, September 26, 1995. agreement. I refer specifically to legislation Re amendment to shorten pharmaceutical recently introduced by David Pryor, called THE RIGHT HONOURABLE SIR LEON the Consumer Access to Prescription Drugs BRITTAN, OC, VICE-PRESIDENT OF patent terms under Uruguay Round Agree- ments Act. Act (S. 1191). S. 1191 creates special rules so THE EUROPEAN COMMISSION, that the generic pharmaceutical manufac- Brussels, Belgium, October 20, 1995. Hon. WILLIAM V. ROTH, Jr., turers can take advantage of preferential Hon. MICKEY KANTOR, Chairman, Committee on Finance, treatment under the Drug Price competition U.S. Trade Representative, U.S. Senate, Washington, DC. and Patent Term Restoration Act of 1984 Washington, DC. DEAR MR. CHAIRMAN: I am writing at the (‘‘Hatch/Waxman Act’’) without adhering to DEAR MICKEY: My attention has been request of Glaxo-Wellcome, Inc. to offer my the 20 year patent term negotiated during drawn to draft legislation recently intro- views on the application of the Uruguay the GATT Uruguay Round negotiations. duced in the United States Senate (S. 1191 Round Agreements Act (‘‘URAA’’) to certain Proponents suggest that this legislation is and S. 1277), concerning the marketing of ge- pharmaceutical patents. As I understand it, only a ‘‘technical’’ correction to the Uru- neric pharmaceutical products. As I under- an amendment may be offered by Senator guay Round Agreements Act (URAA) and stand it, the effect of these Bills would be to Pryor in the Finance Committee to extend neither weakens patent protection under deprive the owner of a pharmaceutical pat- the transition rules of Section 532(a)(1) of the URAA nor diminishes the United States’ ent of the full benefits of the patent term URAA to generic drug manufacturers that ability to fight for stronger international provided for in the TRIPs Agreement of the already receive preferential treatment under patent protection. I disagree! This issue is Uruguay Round. the Hatch-Waxman Act. The Pryor Amend- far too important to risk on the basis of This threat causes serious concern to the ment (S. 1191) would in effect shorten the hoped-for ‘‘good intentions’’ in nations European research-based pharmaceutical in- terms of these patents in order to safeguard which have never favored intellectual prop- dustry and to the Commission, and seems to the activities of generic drug manufacturers erty protection. be in contradiction with the long-standing that would otherwise be deemed to be in- Countries around the world are still in the US policy of providing strong protection for fringing under U.S. law. process of implementing the Uruguay Round research-based intellectual property rights, In the Uruguay Round, one of the principal Agreement. A number have withheld their both at home and abroad. objectives of the United States was to own action to wait and see what we do. We The United States and the European Com- strengthen international protection of pat- all know those whose prior actions have cost munity combined their forces during the ents, trademarks, copyrights, trade secrets, American inventors and entrepreneurs bil- Uruguay Round on patent questions. We and semiconductor lay-outs. As you will re- lions. The will see this retreat on our part as fought successfully together, for example, call, we fought long and hard even to get this a ready excuse to implement their own for the principle that existing subject matter issue on the Uruguay Round agenda. The minimalist versions of intellectual property should benefit fully from the reinforced United States leads the world in ideas and protection. It will be difficult, if not impos- standards included in the TRIPs Agreement. innovation, particularly in cutting-edge sible for the United States to force other na- The unqualified adoption of these provisions technologies such as pharmaceuticals and tions to adhere to the TRIPS agreement if by our trading partners, especially in the de- biotechnology. Thus, the Agreement on we set this unfortunate precedent. veloping countries, is of great importance for Trade-Related Intellectual Property Rights In sum, in exchange for the hope of short American and European industry alike. Any (‘‘TRIPS’’), which established effective legal term savings, the Pryor proposal could cost deviation from these principles should there- protection for patents (including a minimum all U.S. firms and workers the enormous fore be treated with utmost care. This also 20 year patent term), was a major break- long term gains we worked so hard to applies to the use of the exceptions clause through for the United States. achieve in the Uruguay Round. That is penny contained in Article 70(4) of the TRIPs In my view, adding further preferential ex- wise and pound foolish. The United States Agreement. In my view, these proposals have ceptions to the Uruguay Round’s 20 year must continue to be a leader on full imple- several significant shortcomings, and the minimum patent term, for the generic drug mentation of every aspect of the agreement basic philosophy which they translate into industry or anyone else, would set an unfor- on intellectual property in both substance legislative language would contradict our tunate precedent and seriously undermine and in form. mutual aim of providing a reasonably high U.S. efforts to secure stronger international One final additional point. Domestically, and secure protection for the huge invest- IPR disciplines. Many developing countries this legislation would upset the delicate bal- ments made by EC and US research-based have long opposed effective patent protec- ance provided for in the Hatch/Waxman Act, pharmaceutical companies. tion for pharmaceuticals and agricultural which already grants generic pharmaceutical

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00097 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18214 CONGRESSIONAL RECORD — SENATE December 7, 1995 firms special treatment in the area of pat- In the present matter, therefore, the plain Yet, as the Supreme Court stated in Eli ents not available to other industries. S. 1191 meaning of the URAA is dispositive. Lilly Co. v. Medtronic Inc., the Hatch-Wax- would further the bias against pioneer phar- This is quite a contrast from the re- man Act created an important new mecha- maceutical firms. cent letter from Mr. Shultz which can nism designed to guard against infringement Please give careful consideration to the be called nothing less than political. of patents relating to pioneer drugs, with en- negative impact this legislation would have. In the May letter, this FDA official forcement provisions that apply only to I would be delighted to give you additional drugs and not to other products. specifics if it would be helpful. makes some very compelling and cat- egorical findings which support my ar- 2. The Court also observed, citing as Sincerely, authority the 1990 Federal Circuit deci- WILLIAM E. BROCK. guments about the proper interpreta- tion of the relevant statutes. A number sion in the VE Holding Corp. case: ‘‘We Mr. HATCH. I also take exception to presume ‘that Congress is knowledge- those such as Senator PRYOR and Am- of courts have issued rulings consistent with this interpretation. able about existing law pertinent to bassador Kantor who suggest this legislation it enacts.’’’ amendment achieves a result clearly For example, on August 8, 1995 the United States Court of Appeals for the 3. The Court went on to say that: intended by the URAA. We believe that if Congress had intended This is the position that was taken in Federal Circuit issued a ruling in the case of DuPont Merck Pharmaceutical that the URAA affect the Hatch-Waxman a September 27 letter from the FDA Act’s finely crafted ANDA approval process Deputy Commissioner for Policy, Wil- Company versus Bristol-Myers Squibb. Upon reviewing the relevant statutes in the manner urged by [generic manufactur- liam Schultz. ers], at the very least it would have referred I must highlight with great skep- the court found that, ‘‘* * * the URAA to 21 U.S.C. 355(j) and 35 U.S.C. 271(e) in the ticism the portion of the FDA letter does not clash with the Hatch–Waxman URAA. that states in part: ‘‘the URAA does Act,’’ and precluded the generic manu- 4. Finally, the Federal Circuit boiled not address the effect of the URAA pat- facturers from entering the market via down the situation as follows: the Waxman-Hatch route until the ex- ent term extensions on the drug ap- The statutory scheme does not say, as [the proval process under the Federal Food, piration of the affected patent. Like- generic manufacturer] argues..., ‘‘If nor- Drug, and Cosmetic Act * * *’’ wise, as I stated earlier, on October 16, mally you would infringe, you do not in- It may be true that the URAA does the United States District Court for fringe during the Delta period.’’ Rather, it not address the question in a way the the Eastern District of Virginia issued says, ‘‘If normally you would infringe, you also infringe during the Delta period.’’ FDA and proponents of the Pryor an opinion in a group of four consoli- amendment would like, but let us be dated cases that raised similar but not So let there be no doubt in anyone’s crystal clear that the relevant statutes identical URAA/Hatch-Waxman issues. mind about the clarity of the law or In this case, Merck versus Kessler, do, in fact, address this question. the intent of Congress in this area. the court was unpersuaded by the argu- I find the characterization in the Having discussed the trade policy ar- ments made by the generic drug indus- September FDA letter particularly in- gument and the ‘‘it-is-merely-an-unin- try and stated ‘‘This was no more a teresting in light of the earlier May 25, tended-technical- oversight’’ argu- windfall * * * than the windfall which 1995 FDA response to a citizen petition ment, I would like next to address this benefited many patent holders when filed by several innovator drug firms. windfall issue since it goes to the heart the 17-year term of patents was extend The May FDA statement of policy is of the argument advanced by those be- to 20 years.’’ hind this amendment. quite explicit on what the law address- I think the District Court got the law es. In that statement, the FDA ac- Let me say to my colleagues that my on the windfall issue exactly right. involvement in the Hatch-Waxman Act knowledged that the Supreme Court’s Finally, I would note that on Novem- 1984 Chevron decision provides guid- of 1984 compelled me to think carefully ber 1, the Federal Circuit, the court about the need for balancing incen- ance in the area of statutory construc- that handles patents, copyrights, and tion. In Chevron, the Supreme Court tives. trademark issues, overturned a deci- The American public should enjoy instructed ‘‘If the intent of Congress is sion rendered by the United States Dis- clear, that is the end of the matter; for the benefits both of low-cost generic trict Court for the Southern District of medications and breakthrough prod- the court, as well as the agency, must Florida in the case of Bristol-Myers give effect to the unambiguously ex- ucts developed by R&D-based firms. I Squibb versus Royce Labs. have worked hard to see that both pressed intent of Congress.’’ Although, as I have laid out, various Consider the following five direct sides are taken care of. Let me repeat officials in the current administration that: Both lower-cost generic drugs and quotes from the May FDA statement and the proponents of the amendments signed by Deputy Commissioner breakthrough drugs ought to be avail- now flatly assert that Congress clearly able to American consumers. Schultz: intended the result they wish to No. 1: The challenge is to devise incentives achieve, it is instructive that the Fed- that foster the availability of both The agency believes that interpretation of eral Circuit ruling—this is last Novem- the interrelationship between the transi- breakthrough and generic drugs. That ber 1, just a little over a month ago— is precisely what Hatch-Waxman at- tional provisions of section 532(a)(1) of the noted: URAA and 35 U.S.C. is governed by the plain tempts to do and has done. language of the URAA. The parties have not pointed to, and we Let there be no doubt that I am a have not discovered, any legislative history supporter of both the generic and the The second direct quote from the on the intent of Congress, at the time of pas- FDA May statement signed by the very sage of the URAA, regarding the interplay innovator sectors of the pharma- same Deputy Commissioner Schultz: between the URAA and the Hatch-Waxman ceutical industry. One of my great re- The URAA is not ‘silent or ambiguous’ on Act. Therefore, we limit our inquiry to the grets is that neither sector has as large the question of applying the transitional wording of the statute. a presence in my State of Utah as they provision to the generic drug approval proc- I wonder what tangible information do in many other States across the Na- ess. that Ambassador Kantor and the FDA tion. But both are there. Let me give you the third: possess on this issue of intent and why Nevertheless, both of these players in Moreover, this apparently is not an exam- neither the litigants nor the Federal the pharmaceutical market produce ple of Congress having overlooked a statu- Circuit appear to have it at their dis- products that have enormous benefit tory provision that might have been changed posal? for citizens in Utah and everywhere. It had it been aware of its existence . . . In finding against the generic manu- is for that reason that we must weigh No. 4: facturer the Federal Circuit makes a heavily any legislation that would ad- . . . the agency does not believe that it can number of points in the Bristol-Myers versely affect their ability to deliver assert that Congress was unaware of the ex- Squibb versus Royce Labs case that I these products to the public. istence of these remedies for infringement of wish to bring to my colleagues’ atten- The fact that I oppose this particular patents on drug products, and, therefore, did tion: amendment does not change the fact not include them among the unavailable 1. The decision notes the unique that I am, and will remain, a devoted remedies. . . of the URAA. treatment afforded to new drugs by the supporter of the generic drug industry. And finally, No. 5: 1984 law. The Federal Circuit said: Unlike my colleagues proposing this

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00098 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18215 amendment, however, I am convinced rights. As one of the authors of Wax- ceuticals. Between 1989 and 1994, the that it would be unwise to adopt this man-Hatch and as an advocate for both sum of these annual positive balances measure. the generic and pioneer sectors of the was over $5.2 billion. The proponents of the Pryor amend- industry, I have a special interest in Maybe if other industries would in- ment urge that only one industry is the legislation under debate. vest as much in R&D as the drug indus- singled out in current law for different But since this debate is taking place try, the United States could once again treatment under the URAA transition now, I believe that I have a responsi- have a favorable overall balance of rules. What is absent from this line of bility to provide perspective on some of trade. reasoning is the fact that only one in- the changing pressures on the bio- A favorable balance of trade means dustry, the generic drug industry, is medical research and development that jobs for Americans, and that is an im- permitted by current law to engage in have occurred since the passage of portant consideration in today’s eco- activities that would ordinarily con- Hatch-Waxman back in 1984. nomic climate. stitute patent infringement—and I am Let me turn to some charts which I Let me go to the next chart. This one of the people who helped them get believe illustrate this, and I will do next chart shows how many research there. this to try to move along. However, misses it takes for pharmaceutical Mr. President, I remind my col- this is an important issue, which companies to find a hit that is com- leagues that before we so hastily throw should not just be tossed aside. Nor mercially viable. This shows how many around the terms ‘‘windfall’’ and ‘‘un- should we act like this is just a simple chemically synthesized drugs there are. just enrichment’’ let us clearly under- little issue between consumers and The reason we have the break here is stand the laws and policies at issue and gouging drug companies. because the poster is not large enough how they affect incentives for bio- Let me turn now to some charts to show how high this bar would really medical research. which I believe illustrate the broader go—5,000 drugs identified. Of those One of the centerpieces of this debate context in which this amendment must 5,000, only 500 were tested in organ is the operation of the so-called ‘‘Bolar be evaluated. preparations. Of those, only 250 were Amendment’’ contained in the Hatch- There are a number of complex fac- tested in animals, 5 in human clinical Waxman Act and codified at 35 U.S.C., tors that shape the environment of the studies, and only one was eventually section 271. biomedical research enterprise in this approved for use in humans by the In the 1984 Roche versus Bolar case, country. FDA. One out of 5,000 tries becomes a the Federal Circuit held that the man- By placing their sole focus at the hit—one. ufacture or use of a patented product back end of the R&D pipeline and on These companies take tremendous for the development of data to submit those few products that are success- risks in trying to come up with a mar- to FDA constituted patent infringe- fully commercialized, the proponents ketable drug, one that will return what ment. of the amendment do not take into ac- it costs for the research and develop- It is this provision of the Hatch-Wax- count the nature of the risks involved ment to develop it. man Act that treats generic drug man- in conducting the necessary research As you can see, for every successful ufacturers differently from every other leading to development of new drugs. drug that emerges out of the pipeline, industry in our economy. If the United States is to remain the 5,000 potential products drop by the Under the Hatch-Waxman Act ge- world’s leader in health care tech- wayside. neric drug firms may legally use a pio- nology and our citizens are to continue One other fact to note as we go from neer product to help secure FDA ap- to receive the latest in medical ad- activity to activity across the bottom proval and can gear up production to vances, it seems to me that the Senate of this chart is that these activities get go on the market before the pioneer has a responsibility to look at the fac- costlier as we move from test tube to product patent expires. Normally such tors that influence participation in the the patient’s bedside. activities would constitute patent in- front end of the development pipeline. Let me go to the next chart because fringement, clear and simple. In my view, it is critical that we these are things you should not ignore. There is nothing similar to the spe- work to create the incentives nec- This chart shows that this is a bigger cial treatment afforded the generic in- essary to attract trained personnel and policy issue than the belief by some dustry elsewhere in the patent code. resources into biomedical research and that these companies are gouging. This unique status is sufficient to jus- development. This next chart shows the drug devel- tify treating generic drug products dif- This first chart shows pharma- opment cost rising over time. In 1986, ferently treatment under the URAA ceutical research and development as a the cost to develop a new drug was $151 transition rules. percentage of sales. As you can see, the million. In 1990, the average cost for One of the things that I find trou- electrical products industry spends 2.5 the approval of a new drug was $359 bling about this amendment today, percent on research and development million. like the previous amendment offered at as a percentage of sales, the tele- As you can see, it costs a lot of the Finance Committee mark-up, is communications industry 3.7 percent, money to bring a new drug to market. that the Senate floor—when debating a the aerospace industry 4.2 percent, the In addition, these costs have risen bill to ban partial-birth abortions— scientific instruments industry 5.4 per- since the passage of the Hatch-Waxman may not present the best time or place cent, and the office/computer machin- law in 1986. And these costs continue to to reconsider the details of such care- ery industry 8.0 percent. On the other rise today. fully crafted bills such as the URAA hand, in 1993 the pharmaceutical re- Clinical and preclinical tests are and the Hatch-Waxman Act. search and development companies costly. They are difficult. And they are The FDA policy statement issued in spent 18.3 percent of their total sale on highly regulated activities. May states: research and development. As you can see, a significant amount The 1984 Waxman-Hatch Amendments to That is what is involved here—re- in gross sales must be generated by the Federal Food, Drug, and Cosmetic Act search, research, research—the hope each one of these research companies, represent a careful balance between the poli- for the future that we might solve like any one of the ones they are com- cies of fostering the availability of generic some of these immense medical prob- plaining about here, to recover the drugs and of providing sufficient incentives for research on breakthrough drugs . . . lems. huge drug development costs. There There is certainly a strong argument to be As you can see, the ratio of R&D in- has to be in the billions of dollars of made that such a compromise should not be vestment as a percentage of product sales to recuperate their research and upset without hearings and careful delibera- sales is significantly higher than for development companies. tion as to the impact on the twin interests other representative R&D industries If they do not recuperate those mon- served by the Waxman-Hatch Amendments. such as electronics, computers, aero- eys at least a part of the time—and As Chairman of the Judiciary Com- space, and telecommunications. they do not a lot of the time—they are mittee, I can say that the Committee As a result of this investment, the not going to stay in business. If this has an interest in any legislation, such United States still enjoys a positive happens, we will not have these block- as Senator PRYOR’s, that affects patent balance of trade in the area of pharma- buster drugs, and we will not have the

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00099 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18216 CONGRESSIONAL RECORD — SENATE December 7, 1995 life-saving pharmaceuticals that are That chart shows one of the most sig- That takes 10 to 18 weeks, and an ab- saving people’s lives every day. nificant developments in the bio- breviated new drug process which is 6 We will not have a cure for AIDS, and medical research enterprise since the months. That is all they have to do. we will not have a cure for Alzheimer’s passage of Hatch-Waxman in 1984. They do not have to spend $359 million. disease or any other number of dis- The R&D expenditures by pioneer They can copy that drug the minute it eases. drug companies now—for the first time comes off patent and eliminate the The next chart shows that there is a in recent history—exceeds the funding costs. This has made and built the public/private partnership in drug re- of the National Institutes of Health. whole generic industry and has bene- search and development. One of the major reasons that the fited consumers through saving billions Mr. CHAFEE. Mr. President, I won- United States is the world’s recognized and billions of dollars since 1984. der if I might ask the Senator a ques- leader in biomedical research is the Are we going to just make it even tion, if it is possible to reach a time public investment made in NIH since more difficult for these companies that agreement on this? World War II. have made this whole industry by now, Mr. HATCH. There sure is. I will be American citizens have enjoyed the under Hatch-Waxman, and let them through in a few minutes. I do not benefits of the close partnership that just take these drugs and run with think that I will have any more to say, has developed among pharmaceutical them? I fought to get this done. I be- unless somebody asks questions. I am and medical device firms, academic lieve in generics. I think this ought to happy to reach a time agreement. medical centers, and the NIH. continue. Let us be very, very clear The basic research conducted at and Mr. CHAFEE. I ask the sponsor. We about it. This is a privilege that we supported by the NIH is complemented are all here. Can we arrive at a time give no one else in patent law, and we by the private sector R&D efforts. agreement? do it for consumers. Mr. HATCH. Why don’t you get your This is the type of public-private Now, are we going to now to make it side together, let me finish my re- partnership that we can all take pride very, very difficult to produce the marks and then we will agree on a time in and should fight to retain in the fu- drugs that these people have to have to agreement? ture. be able to survive? I hope not. Mr. CHAFEE. You are in such flying We do not want to take away the in- form. You have all of your engines run- centives of R&D. That is what this A study by the Tufts University Cen- ning. amendment does. ter for the Study of Drug Development Mr. HATCH. That is why I want to We all know of too many instances in estimated that it takes on average $359 finish my remarks. This is an impor- which our foreign competitors have ex- million and 12 years to get a new drug tant issue. As the author of the Hatch- ploited their close linkages between approved by the Food and Drug Admin- Waxman Act, I am very concerned Government and industry to wrest istration. I know that is insane, but about it. However, I do not intend to away U.S. industrial leadership. If we that is what it takes. take too much longer. We are going Americans leverage together our public A lot of time elapses in the labora- through the salient points. and private sector resources, we can tory just determining the best drug This particular chart shows R&D ex- compete against anyone in the world. candidates through test tube and ani- As we tighten our budget belt to put penditures. NIH expenditures are the mal studies. Three complex and time- the Nation’s fiscal house in order, I do blue bars. The private sector expendi- consuming phases of human clinical not think it is realistic to expect that tures are the green bars. The private trials are required to develop the nec- we will continue to see the growth rate sector means the pharmaceutical re- essary safety and efficacy data that in the NIH budget that is represented search company. must be submitted to the FDA. This In 1985 we spent more on research and on this chart. testing takes time and money. But I want to see this growth rate of development in the NIH —$4.8 billion— the research companies continue. It is essential in this debate to under- than was spent by the pharmaceutical Since 1988, the NIH budget has al- stand that the generic drug manufac- companies —$4.1 billion on R&D. most doubled. turers are not required to undertake In 1988, R&D for the pharmaceutical If we are to retain our world leader- any of this extensive and expensive companies started to surpass NIH—$6.3 ship in biomedical research it will be testing. billion for NIH, and $6.5 billion for the important to retain the incentives that Let no one undervalue the impor- pharmaceutical companies. will encourage drug firms and the cap- tance that this testing process has for In 1991, the NIH spent $7.7 billion, and ital markets to invest their resources the health and safety of every Amer- the pharmaceutical companies jumped in this research. ican. to $9.7 billion. This chart shows that industry is In contrast to the rigorous safety and In 1995, the NIH will spend $11.3 bil- stepping up to the plate. efficacy requirements placed on the lion on research and development. The American citizens and families pioneer drug firms—these up here that pharmaceutical companies will spend around the world will benefit from this takes 12 years and $359 million to de- almost $15 billion. research. velop a drug,—the Hatch-Waxman law Pharmaceutical companies are doing What is the difference between the provides for a much simpler and easier the job. Do not undercut them. This regulatory review requirements for ge- approval standard for generic drugs. amendment undercuts them. This neric versus pioneer drugs? amendment appears to be a populist Let me show the difference for those Generic drug manufacturers can rely amendment. It seems to have appeal to of you who may not have a knowledge upon the safety and efficacy data of those who think they are on the con- of FDA law. These are the steps to es- pioneer firms and must only show that sumer side. But the consumer really is tablish safety and efficacy for inno- their product is bioequivalent to the on both sides—one side would lead to vator drugs for these research compa- pioneer product. That can be done in a lower drug costs on the short run, our nies, which take 12 years to complete. matter of weeks, not years, at a frac- side would lead to continued support of In 1990, this process cost $359 million. tion of the cost and none of the risks the research and development of drugs Lab and animal studies, 3.5 years; that are faced by these pioneer firms. for the long term. phase one safety studies, 1 year; phase According to a 1992 Frost & Sullivan Research and development benefit 2, testing effectiveness of studies, 2 study, after the passage of the Hatch- the generic companies because if they years; phase 3, extensive clinical test- Waxman Act, the average cost for a ge- do not get to blockbuster drugs, the ge- ing, 3 years; FDA review, 2.5 years. neric drug company to prepare and file neric companies will not be able to Under Hatch-Waxman, look at how an abbreviated new drug application is copy them. the generic benefit. We provide a short- ‘‘well below the million mark.’’ I have already shown that the drug cut for generic drugs. All they have to A large part of the reason why ge- industry spends a relatively large pro- do to take their drug to market is to neric drugs can be sold for less than portion of its earnings in R&D and that complete a bioequivalency test and es- brand-name products is that the ge- the cost of bringing the successful drug tablish that their drug is bioequiva- neric companies do not have to perform to market is high and rising. lent. That takes 10 to 18 weeks. the extensive research and clinical

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00100 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18217 trials required of innovator drug com- for the right to keep these products which the language of the amendment panies. Nor do generic drug firms have coming to these generic companies, for is drafted. These concerns include: On to finance all the products that fall by the right of all Americans to have ac- substantive grounds, as I have argued the wayside. cess to reasonable and good and life- earlier, I am opposed to the manner in Generic drug companies piggyback saving drugs and to have the incentives which sections (a) and (b) of the on the fruits of the pioneer’s research. to get us there. amendment, respectively, act to over- We permit that. We want that to occur. By the way, just to choose Zantac as turn the 17 year from grant/20 year But we should not ignore what a great an illustration, Zantac is a therapeuti- from filing choice of the URAA transi- thing the pioneer companies do for us. cally important drug. It is one of the tion rules and the elimination of sec- There is a tremendous amount of ap- best antiulcer medications in the world tion 271(e) of title 35, United States peal to an amendment which appears today. Of course, there are other drugs Code, as the sole and unique remedy to provide consumers with the oppor- of this class. Tagamet, for instance, is provided by the Hatch-Waxman Act. tunity to greater access to lower-cost already subject to generic competition. I am also concerned about the oper- drugs. If Senator PRYOR’s proposal It just so happened that the company ation of the equitable remuneration were that simple, I would be for it. It is that makes Zantac, Glaxo, had gone provisions contained in section (c) of easy to get up and make it look like through this long, expensive research the proposed amendment. It appears to your approach is the only approach for and development process, and they me that this provision puts the cart be- consumers. were left with an effective patent term fore the horse. Under the Hatch-Wax- But if the companies that go through of around 121⁄2 years after FDA ap- man law patent rights are carefully de- these 12 years, $359 million, 5,000 tries proved this product. The URAA will ex- termined before a generic drug product to get one drug are undercut, we are all tend its patent life for an additional 20 may be approved for marketing. undercut, and the generics will not months or thereabouts. Section (c) of the amendment ap- have any drugs to copy so that they The fact is that the drug Zantac pears to reverse the operation of the can keep their industry going. came out in 1983, 1 year before the URAA transition rules. Specifically, It is penny-wise and pound-foolish to Hatch-Waxman bill, and therefore had the amendment seems to allow a ge- treat this like it is some simple little it been approved 1 year later it would neric drug manufacturer to infringe consumer versus gouger issue. It is a have qualified for, as I understand it, 2 and only allows a patent holder to seek lot more than that. full years of further patent protection equitable remuneration after the in- Senator PRYOR’s proposal is not that under the transition rules of Hatch- fringement has taken place. This is op- simple. You cannot accept it on face Waxman. posite of current law which makes a value. You have to delve into all the In fact, Zantac was a loser under potentially patent-infringing ANDA facts and the case law. Failure to ex- Hatch-Waxman. Well, it happens to be applicant subject to an infringement amine this information about the na- a winner under the GATT Treaty and action and an equitable remuneration ture of these two industries would be Uruguay Round Agreement, and if we determination prior to the commission shortsighted at best. undercut that, yes, you might be able of any infringing act. In fact, there could be some short- to say, well, they are going to make I also will seek clarification of term financial gains for some if we did some additional revenues—I see your whether this amendment would permit the marketing of generic versions of not provide full patent term for a chart here—$3 billion, but let me tell products that vary slightly from inno- whole range of products. By that logic, you something. They spent millions of vator products without triggering the however, we ought to just make every- dollars developing this product, and equitable remuneration provisions. thing generic—generic appliances, they lost a substantial time of their Specifically, I will seek clarification of automobiles, electronics, everything. patent term before the product was ap- whether the phrase in section (c), ‘‘an It would save the consumers all kinds proved. Even with the time it receives approved drug that is the subject of an of money. under the URAA, it still does not get a application described in subsection It would also dry up all research and full 17-year patent term. (a)’’, refers to the innovator drug or development, all technology, all the in- There is another side to the coin. I do the generic copy. vestment in quality and efficient pro- not want anybody to get an unfair I am also concerned about the lack of duction, including jobs and the vast windfall, but it is hardly a windfall guidance on the question of what con- array of choices Americans have as when firms are investing billions of stitutes a ‘‘substantial investment’’ consumers. dollars in research annually. I have to under this amendment and whether an We would no longer have break- say that there were winners and losers innovator firm may contest such an as- through drugs which are improving and under Hatch-Waxman, and there will be sertion made be a generic firm. In addi- saving the lives of so many millions of winners and losers under the GATT tion, I will seek a better understanding Americans. Treaty. of what standards a court should apply As I have said, I have a tremendous But the bigger policy concern is how when reviewing the apparently unilat- affection for both the brand name and not to undercut the treaty and send the eral finding on the part of a generic generic industries. They are both im- wrong message to the rest of the world. manufacturer that it has made a sub- portant to our Nation’s health care. Undercutting intellectual property pro- In my view, it is clearly in the best stantial investment. tection would be injurious to the whole So, there are many technical ques- interests of consumers that both pio- world, or at least the 123 nations that tions that can be raised about this neer and generic drug companies exist agreed to GATT, and not undermining amendment. harmoniously in our competitive drug the incentives for pharmaceutical re- At this point, I hope I have made the and medical marketplace. search that enables our country to be case for this side, and I personally hope It serves neither the public nor this the leader in the world in this impor- that Senators will defeat the Pryor body well for us to berate continually tant endeavor. amendment and that we go about keep- the R&D-based pharmaceutical indus- I do not think there is any reason for ing the industry going the way it has try which is doing so much good in this the generic companies to come in here been going in both areas for the benefit world and ironically is the industry and complain since their whole indus- of all mankind. upon which the generic companies try was created by the very bill that I yield the floor. themselves rely. they are now trying to amend and take Mr. CHAFEE addressed the Chair. I believe we have to defeat this even further advantage when, in fact, The PRESIDING OFFICER. The Sen- amendment. I understand the distin- they have a tremendous advantage ator from Rhode Island. guished Senator from Ohio has an today and will have every year that the Mr. CHAFEE. Mr. President, with the amendment to this amendment. My Hatch-Waxman bill is in effect. So this principals in the Chamber here, I won- personal preference would be to defeat is not some simple little gouging issue der if it would be possible to set a spe- this amendment and to stand up for or some simple little equity issue. cific time that we might vote. American trade, American technology, Mr. President, I have a number of I know a lot of Senators are out, so I American research and development, concerns relating to the manner in do not think we are in the position

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00101 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18218 CONGRESSIONAL RECORD — SENATE December 7, 1995 where we can go immediately to a vote issue—not like some demagoged issue, In fact, Madam President, according in 15 minutes or so. I would offer the but treat it like it should be treated, to former Surgeon General Dr. C. Ever- suggestion that we agree to vote at that is, as one of the most important ett Koop, who my colleague from Utah 8:30, while allowing time for the Sen- issues in the history of trade negotia- has already quoted, to bring a new sin- ator from Ohio and others to speak. tions. gle medicine to patients requires on I defer to the Senator from New So it is up to the Senator. It is his the average an investment of 12 years Hampshire. amendment. But I will be happy to put and $350 million. Of the components Mr. SMITH. I would say to the Sen- it within a certain timeframe. If the tested in a laboratory, only 20 percent ator from Rhode Island, we are work- Senator will tell me what he wants, I ever make it onto pharmacy shelves, ing on that. We are very close. We are will be happy to try to do that. If the and only a third of those ever earn a not quite there. We need to confer with majority leader tells me, I will be return on the investment made Senator HATCH for a few moments. We happy to do that. through the discovery. may very well be able to come up with Mr. DEWINE. It would be my under- Madam President, if we weaken pat- an agreement very similar to what the standing, from the statement made by ent protections on these products, we Senator just indicated, if he could give the chairman, that he would be willing will stifle innovation, and slow down us a few more minutes. to hold these hearings, and Members of further the discovery of new treat- Mr. CHAFEE. Fine. I am just I sup- the Senate could be advised these hear- ments for diseases such as possibly pose a catalyst here. But I do know ings would take place sometime within AIDS or cancer. that people are away, so that as much the next 120 days. Is that correct? Two former U.S. Trade Representa- notice as can be given the better. Mr. HATCH. If I understand the dis- tives, Clayton Yeutter and William Mr. DEWINE addressed the Chair. tinguished Senator, I would be willing Brock, argue that passage of the Pryor The PRESIDING OFFICER. The Sen- to set it within 120 days, and notify all amendment would set a bad precedent. ator from Ohio. Members when it will occur, of course. It would cost all U.S. firms and work- Mr. DEWINE. Mr. President, Senator I have no problem with that. I will give ers the enormous long-term gains that DODD and my second-degree amend- advance notice about it. the Trade Representatives worked so ment to the Pryor amendment ex- Mr. DEWINE. I thank the Senator hard for in Uruguay. It would do this presses the sense of the Senate that the very much. by making it nearly impossible for the (Mrs. HUTCHISON assumed the Senate should, through the Committee United States to force other nations to chair.) on the Judiciary, conduct hearings to adhere to the intellectual property pro- Mr. DEWINE. Madam President, let tections of this agreement. investigate the effect of these new pat- me continue briefly in regard to this ent provisions in title 35. I think it Robert L. McNeill, executive vice matter. Chairman of the Emergency Com- makes eminent sense to do this. Let Madam President, I think it is abun- me just, while I see my colleague from mittee of American Trade, said the fol- dantly clear after we have listened to lowing: Utah on the floor, get his attention for this debate—my colleague from Rhode a moment and ask him if he could re- . . . enhanced protection of intellectual Island, my colleague from Arkansas, property rights will be diminished abroad if spond to a question. both have been very, very eloquent in the United States itself violates the patent Mr. HATCH. Sure. regard to this issue—I think it is clear, term contained in the [intellectual property Mr. DEWINE. The second-degree after listening to my colleague from rights protections] agreement. It is almost amendment Senator DODD and I have Utah, the chairman of the Judiciary certain that such an action would provide offered provides that this issue would Committee, that there are two sides to foreign-based pirates and patent infringers be referred to the Judiciary Committee with potent ammunition in seeking to have this issue, that there is a very com- their domestic governments devise measures for hearings. And as chairman of the plicated, a very serious issue, and it is Judiciary Committee, I wonder if the that are inconsistent with [these protec- the type of issue, quite frankly, that tions.] Senator could give the Members of the we should have hearings. Madam President, on the other hand, Senate some indication of how he in- We should, as the chairman of the supporters of the Pryor amendment tends to conduct the hearing or what Judiciary Committee just said, hold argue that failure to amend the Hatch- time there would be in that event. those expeditiously. We should hear Waxman Act would place a substantial There have been some questions on the from both sides of the particular issue. burden on consumers. Moreover, ac- floor. And I think we should respond to And then I believe we will be in a much cording to U.S. Trade Representative the Members before the voting in re- better position for this Senate to take Kantor, amending the act would ‘‘in no gard to that. a position and to actually hold a vote. way increase the ability of our trading Mr. HATCH. I am not adverse to I think as we listen to this debate it partners to justify their failure to pro- hearings. I think this is that impor- is just abundantly clear that there are vide * * * consistent patent protection tant. In fact, I think it is an appro- legitimate issues, arguments on both [for intellectual property rights.]’’ priate way to proceed. I have to tell sides of the debate and that we should So clearly, Madam President, this the Senator that we have about all we examine those. Frankly, the only way amendment is not as straightforward— can handle for the rest of the year on this Senate has to examine them at the underlying amendment by my col- the Judiciary Committee. I do not length is not just by debate on this league from Arkansas is not as think anybody doubts that. We have floor, but it is also by actual hearings. straightforward as it might appear on the judges, the matters on the floor, So I think Members of the Senate the surface. This is legislation that and hearings scheduled. should understand that the vote in should be debated fully and not thrown So I would be very happy to agree to favor of the DeWine-Dodd amendment in as an amendment to the partial- some sort of date certain, at least would, in fact, guarantee that these birth abortion bill. within a time period. I think you ought hearings would take place and the Sen- Madam President, I yield the floor. to give us, I would say, at least 120 ate would have the opportunity to have Mr. DODD. Regardless of one’s view days in which to hold a hearing. But I the benefit of hearings. about the merits of the issue, an abor- will try to hold it as expeditiously as There are two sides to this. On the tion bill is not the appropriate place to possible within that period. We will be one hand opponents of the Pryor take up the GATT patent issue. This fair to both sides, because I think both amendment argue that shortening the amendment is complicated, involving sides need to be fully aired on this mat- patent term contained in the agree- issues of patent law, trade, innovation ter. ment on trade related aspects of intel- and new drug therapies. This issue If we hold such a hearing, if the Sen- lectual property rights, that provision needs a full hearing, so that we can get ator prevails on his amendment, I in the Uruguay round of GATT would past demagoguery and really look at would do that expeditiously. It would have detrimental effects on both the the issues carefully. probably be some time after the first of development of new and innovative That is why Senator DEWINE and I the year, but hopefully within 120 days. medicines and also the global patent are suggesting that we hold at least The hearing will give both sides a protections gained for United States one hearing on the issue before adopt- real airing of this. We will treat this manufacturers in Uruguay. ing an amendment that would deny the

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00102 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18219 benefits of GATT to U.S. innovator would strongly encourage that. I do the Senate Judiciary Committee, there pharmaceutical companies. not know of any other speakers we might be, for example, a 120-day period The underlying amendment would re- have on our side. I have a few more when the report from the committee sult in substantial changes in two stat- comments I would like to make about comes back to the floor of the Senate. utes—the GATT implementing statute this subject. I wonder if the Senator Madam President, with all due re- and the 1984 Hatch-Waxman Act. The from New Hampshire, the manager of spect to that idea, let us just look for first is a trade treaty that we nego- the bill, might have any comments on a moment at what that would do. We tiated in good faith with many other a time agreement, or a time certain? have done a little calculation here. If countries who are relying on our com- Mr. SMITH. Mr. President, I believe we extend 120 days of protection to mitment to abide by the strong inter- everyone on our side has spoken who Glaxo for Zantac alone—and this does national patent protections that were a wishes to speak. How much time does not include the other dozen or so drug major achievement of GATT. The the Senator wish? companies under this umbrella— 120 Hatch-Waxman Act provided special Mr. PRYOR. I might suggest that we days of not resolving this problem will rules for generic drugs that give the ge- vote at 8:35. If there are no speakers on give them unlimited opportunities to neric drug industry an advantage pos- the other side, I would like to take the charge the highest price for their drug. sessed by no other industry in the remaining time. They will have unlimited protection United States or the industrialized Mr. BIDEN. If the Senator will yield, from any generic that wants to come world. These two statutes were devel- is it possible to consider—I guess it is to the market. Simply put, we are oped carefully to ensure that this coun- a leadership decision—starting the vote going to be depositing $720 million to try continues to lead the world in inno- at 8:25 and let the vote extend, so that the bank account of Glaxo, because by vative drugs and new therapies. those of us who are trying to get trans- next Christmas of 1996, which is just These are not issues to be treated portation out of the city on an 8:30 about 121⁄2 months from now, Glaxo will lightly. The proposed Pryor amend- train could make the train? I will not have made an extra $2.328 billion if we ment is not a technical amendment to insist on that, but if it is possible, that fail to close this loophole. the GATT law, though that’s how its would be nice—since no one else wants Madam President, I, as a U.S. Sen- been characterized. The GATT lan- to speak and we are worried about get- ator, am not a stockbroker. I will guage was carefully negotiated and ting people in here to vote. A couple of never advise anybody to buy any stock should not be amended without careful us want to get out of here. Is it possible or make investment because I have thought and consideration of the impli- to do that? never been very successful at that my- cations. Mr. SMITH. Did the Senator say 8:30? self. But if we extend this for 120 days, The Hatch-Waxman Act represents a Mr. BIDEN. I only need 7 minutes to or even another 30 days, without clos- careful balance between the interests make it to the train. ing this loophole, I suggest that we all of innovator manufacturers and ge- Mr. SMITH. That depends on whether go out in the morning and buy Glaxo neric drug companies. It has worked or not the Senator wants to miss the stock because they are going to con- well for more than 10 years and should vote. tinue receiving an enormous windfall not be amended lightly. Mr. BIDEN. No. that they had no idea they would re- The proposed amendment also would Mr. PRYOR. I think, more impor- ceive. have a direct and significant effect on tantly, is the Senator going to vote? Madam President, second, I ask patent rights, which fall squarely with- Mr. BIDEN. Yes. unanimous consent to add three addi- in the jurisdiction of the Judiciary Mr. SMITH. The Senator from Ar- tional original cosponsors: Senator Committee. The dramatic changes that kansas asked for how much time? BRYAN, Senator LEAHY, and Senator would result from the proposed amend- Mr. PRYOR. Here is what our policy DORGAN. ment would occur without the benefit committee has requested. We think it The PRESIDING OFFICER. Without of prior congressional consideration. is going to take at least 30 minutes to objection, it is so ordered. We should not rush to legislate in get our Members here. Therefore, I Mr. PRYOR. Next, Madam President, this area before we hold hearings and would like to respectfully suggest that there has been a discussion this give careful consideration to all of the we vote at 8:45 on the motion to table evening and quotes by my friend from proposed amendment’s potential rami- the second-degree amendment. Ohio, Senator DEWINE, and from Sen- fications. I urge my colleagues to sup- Mr. HATCH. If the Senator will yield, ator HATCH of Utah, about Dr. Koop. port holding a hearing on this issue be- can we protect a few minutes on this Well, Dr. Koop got drawn into this fore voting on a measure that could side? I understand Senator HELMS may issue in a very interesting way, and it send a very dangerous signal to our want to speak. I might want to say one appears to me, after talking to Dr. trading partners or two things. Koop some days ago, that Dr. Koop Mr. PRYOR. Madam President, I now Mr. PRYOR. If we can divide the may not have been aware of—or the ask for the yeas and nays on the sec- time equally, we can have 15 minutes Glaxo people may not have presented ond-degree amendment. and you could have 15 minutes. the true case to—Dr. Koop when they The PRESIDING OFFICER. Is there a Mr. HATCH. We may yield back sub- had him sign a particular advertise- sufficient second? sequent to that time if it helps our col- ment which appeared in The Hill news- There appears to be. The yeas and leagues. paper. It also appeared earlier in the nays are ordered. Mr. SMITH. I will propound a unani- Washington Post. This is the advertise- The yeas and nays were ordered. mous consent request. ment that Dr. Koop signed on October The PRESIDING OFFICER. Is there I ask unanimous consent that a vote 25, 1995. The advertisement appears to further debate? occur on or in relation to the Smith have been purchased by Dr. Koop to say Mr. PRYOR. Madam President, do I amendment at 8:45 and the time be- that ‘‘Senator PRYOR’s bill would have the floor at this time? tween now and 8:45 be equally divided weaken the patent protection needed The PRESIDING OFFICER. You have between the two sides. for the next generation of pharma- been recognized. The PRESIDING OFFICER. Is there ceuticals.’’ Mr. PRYOR. Madam President, I do objection? I called him up and I said, ‘‘Dr. Koop, not know where the time agreement Without objection, it is so ordered. I am probably your No. 1 fan in this stands. We have been negotiating dur- Mr. PRYOR. Madam President, I country. I have supported you, I have ing the course of the evening. I know think this has been a very educational revered you, and now you have signed Members of the Senate are at home for debate, to say the least. During the this advertisement in all these papers dinner and need at least 30 minutes no- course of the evening, it has been pro- saying that you are opposed to my tification. posed that we try to have a time cer- amendment.’’ He says, ‘‘What amend- I would like to say, and I think I can tain placed on the sense-of-the-Senate ment?’’ I said, ‘‘The amendment with speak for Senator CHAFEE, that we are resolution offered by the Senator from which we are trying to close this loop- reaching a point where we are ready to Ohio and others. It has further been hole.’’ He said, ‘‘I did not know that determine a time certain to vote. I proposed that if this issue goes before was what it was all about.’’

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00103 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18220 CONGRESSIONAL RECORD — SENATE December 7, 1995 Well, on December 3, a Journal of Mickey Kantor, said, ‘‘This provision Many believe this debate is prompted Commerce appeared about Dr. Koop. [the transition rules] were written neu- by the patent status of one drug, ‘‘In a brief interview, Dr. Koop said he trally because it was intended to apply Zantac. I do not know if that is true or did not know the details of the lob- to all types of patentable subject mat- not. It has certainly been a tremen- bying campaign by Glaxo-Wellcome ter, including pharmaceutical prod- dously successful drug which has lit- when he agreed to lend his name to ucts. Conforming amendments should erally helped millions of people and what was described to him as an effort have been made to the Federal Food, would not have been developed if the to preserve patent drugs from foreign Drug, and Cosmetic Act and section 271 logic of the other side had been adopted piracy.’’ In fact, the lobbying was an of the Patent Act, but were inadvert- years ago. effort by a British drug company to re- ently overlooked.’’ One of the facts that has been ob- tain an inadvertent million-dollar That is a direct statement, Madam scured in this debate is that, iron- loophole in last year’s trade bill at the President, from our trade Ambassador ically, this patent has never been ex- expense of generic drug companies. Dr. who negotiated the GATT Treaty and tended. Let me give the facts on this Koop said he was unaware that a gen- who is there to protect not only our drug. Keep in mind it takes up to 12 eral statement he had made on patent patent rights but also our intellectual years, between $359 million and a half rights would be used in the Glaxo cam- property rights. billion dollars to put a drug like paign. When asked by a reporter if he Madam President, I am going to re- Zantac through. had been done a disservice by Glaxo of- serve the balance of my time. I look Here are the facts: the patent appli- ficials, Dr. Koop responded, ‘‘I would forward to hearing additional state- cation for Zantac was submitted July have to say I was,’’ and expressed re- ments from my colleagues. 5, 1977. That patent was issued Decem- gret that he had ever been involved in Mr. SMITH. I yield whatever time ber 5, 1978 and an investigational new the fight over Glaxo’s loophole. the Senator from Utah consumes. drug application was filed with FDA on Mr. HATCH. I do not know why some Madam President, I have heard my December 3, 1979. On June 9, 1983, 31⁄2 very good friend from Utah talking on the other side said that Dr. Koop years after initial submission to FDA, about all of the research dollars that said he was sorry he was ever involved. more than 6 years after the patent ap- are being expended to find all of these Dr. Koop’s letter, dated November 30, plication was made, the drug was ap- cures for all of the problems and ail- makes it very clear he wants to be in- proved. ments and diseases that we have today. volved, that this is an important issue. Upon approval, this product only had I want to compliment the pharma- Here is the letter he wrote. an effective patent term of about 12.5 I know Dr. Koop as well, if not bet- ceutical companies for doing a wonder- years on the day that FDA approved ter, than anybody in this body. I was ful job. They are second to none in the this product. the one who, as ranking member on the world. Now, the concern that the regulatory But, Madam President, I do not think Labor and Human Resources Com- review period at FDA was eating sub- we need to shed any crocodile tears for mittee, fought for his nomination stantially into the patents of new the company Glaxo. One, it is the big- through a full 9 months, if my recollec- drugs was a major motivating force be- gest drug company in the world, and tion serves me correctly. I am very hind the Waxman-Hatch Act. when the Glaxo research was done on close to him. The Food, Drug and Cosmetic Act I did not ask Dr. Koop to write this Zantac alone, which was over two dec- specifies that the drug review period is letter. He voluntarily wrote the letter. ades ago—and they have had patent 180 days. But this, as in the case of Anybody who reads that letter and protection, no competition whatever Zantac, is virtually never met by the thinks there is an argument on the for a period of 17 years, no competition, FDA. In fact, to the contrary, it takes other side, just does not enjoy good Madam President—when that research years to get these drugs through, at a reason. Dr. Koop is extremely clear. I was done, not only was most of it done tremendous cost. think he probably would not appreciate by NIH and farmed out to universities Only because Zantac was approved being misrepresented. about a year earlier than the Hatch- throughout the educational system Now, with regard to congressional in- Waxman law was passed, it was not eli- across the land, but taxpayers’ dollars tent, the Federal Circuit Court of Ap- gible for the patent term extension helped dramatically in finding the re- peals backs my position. It says: search and the answers that this par- part of the bill. The parties have not pointed to and we In other words, it was an unfortunate ticular drug/pharmaceutical was in- have not discovered any legislative history tended to cure. on the intent of Congress at the time of pas- fact that it did not benefit from the Let’s don’t shed too many crocodile sage of the URAA regarding the interplay be- Hatch-Waxman bill. Had Zantac been tears when we are talking about re- tween the URAA and the Hatch-Waxman approved after Hatch-Waxman was en- search. First, Glaxo is probably much Act. Therefore, we limit our inquiry to the acted, it could have been qualified for like the other drug companies. They actual wording of the statute. patent extensions that this law calls are spending more today to market and That is a Federal Circuit Court of for and provides. advertise their drugs than they are to Appeals, the court that has the exper- So, Zantac, a loser under Hatch-Wax- research the new—as they say, block- tise to decide these issues. I do not man because it could not qualify for buster—drug breakthroughs. They are think anybody can doubt for a minute the patent extensions that have been spending more now for marketing than that the arguments I have made do not routinely granted as a matter of con- they are for research. have legal backing, legislative backing, gressional policy since 1984, is now Let’s look at Glaxo itself, and at the and good, commonsense backing, be- under sharp criticism for trying to pretax profits for the last 12 months: cause they do. take advantage of the same benefit $3.3 billion—not millions of dollars, but Recently, a Federal district court, as that millions of patent holders were ac- $3.3 billion. And much of this came I mentioned before, reviewed the rel- corded under GATT. from the best-selling drug in the world evant provisions of law and concluded, Not only is this ironic, it does not today, Zantac, which, unless we close ‘‘This was no more a windfall to the’’— strike me as fair, that a product with this loophole, we are going to provide and he names the pioneer firms which only 12.5 years of effective patent life, further protection from competition. include Glaxo—‘‘then the windfall that which expected to have 17 years upon Madam President, we have also heard benefited many patent holders when FDA approval, is being castigated as a lot of discussion about patent rights the 17-year term of patents was ex- somehow ‘‘unfairly’’ manipulating the and intellectual property rights. Let tended to 20 years.’’ No more of a wind- patent system. me once again refer, as I have in the fall now than that was then. Even under the GATT transition past and as Senator CHAFEE has, to a I might add that it is not a windfall rules, Zantac will receive much less letter that I received, or actually Sen- because, in all honesty, the generic than the 17-year patent life that it was ator CHAFEE received. drugs will benefit greatly and have supposed to receive. I think I received an identical letter, benefited greatly from the pioneer Yet, here we face suggestions that it dated September 25, in which our U.S. companies’ development of these is greedy for a patent holder to want to Trade Representative, Ambassador blockbuster drugs like Zantac. take full advantage of its patent.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00104 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18221 The proponents of the amendments longer than the so-called average patent to The PRESIDING OFFICER. The Sen- are circulating talking points that issue. ator has 5 minutes 43 seconds. state: She concludes: Mr. PRYOR. Thank you, Madam But the Waxman-Hatch amendments did a Finally, no one should be led to believe the President. second thing: They gave brand companies a 20-year-from-filing rule will lengthen effec- Madam President, this debate is com- 5-year patent extension. In other words, tive patent life. Most of the time, for high ing to conclusion at long last. We are Glaxo can receive up to 25 years of patent technology patents, it will shorten the life about to make a tentative decision on protection under current law. And now this and, more importantly, will shorten the re- company receives the GATT patent protec- maining life of patent protection after the this matter. tion as well. It is trying to block the generic long development period is finally over and Let me say to my colleagues, Madam competition Congress calls for in the GATT products are on the market. President, that somehow or another, treaty. The fact is this. Zantac has never had sooner or later, we have to correct this Now, let us just be honest about it. a patent extension until the GATT problem. We have to close this loop- That information has been sent out transition rules, because it did not—it hole. If we fail to table the second-de- to people here in Congress as though it simply did not—qualify under the gree amendment, sometime or another were true. Hatch-Waxman statute. I am going to be back. I want my col- In fact, the statement is misleading So, to indicate that it is going to leagues to know that this is not the in several ways. reap the benefits of some sort of wind- last they will hear of this amendment First, let us be clear that Zantac, as fall is not only a misrepresentation, and this issue, because I think it is so a pre-Hatch-Waxman product, did not but it ignores several significant facts. absolutely atrocious that this could qualify for any of the benefits of It ignores all of the research costs happen, is happening, and that we have Hatch-Waxman. which go into the pharmaceuticals we yet not closed this loophole. Like Mac- Second, to suggest that a company use. It ignores all of the incentives for Arthur, Madam President, I shall re- can receive up to 25 years of patent research which must be a part of our turn. protection under current law is not intellectual property laws. It ignores This has been a fascinating debate. It only misleading, it is false. all of the balancing we did in the 1984 has lasted 21⁄2 hours, about as long as a It would seem to me that the normal law in order to accommodate the inter- typical Senate hearing would last. And patent term will have to be a period of ests of these two great industries. now, at the end, we see the facts have something less than 20 years, unless At the same time, it attacks our not changed. They have not changed at you make the unlikely assumption international agreements for which we all. Those facts are as follows: the Con- that the Patent Office approves the fought so hard for decades, as reflected gress made a mistake and we have a patent on the day the application is in the GATT agreement and Uruguay very rare opportunity to correct that submitted. Round agreement. It does this in a way mistake. Also, since Hatch-Waxman time is that sends a signal to all those coun- Let us look now at who is on the side only calculated after a patent issues, I tries that do not believe in patents or who thinks that we made a mistake do not see how you can ever reach 25 have difficulties with our position on and who believes that we should rectify years, even hypothetically. patents that they do not have to honor that mistake. I would welcome an explanation of it. It shows that the United States is First, our U.S. Trade Representative, this 25-year period. I think every pat- not serious about this agreement ei- Mickey Kantor, said that Congress ent lawyer in the country would be just ther. made a mistake, that it was never in- fascinated with it, if it could be given. The fact of the matter is this: There tended that these drug companies It is also the case that many believe are winners, there are losers in the would be given this extra amount of the biotechnology patents are among Hatch-Waxman Act. There are winners unearned protection to market without those that might actually routinely and there are losers in GATT, and ev- any competition. The Food and Drug lose time under the new 20-year-from- erybody knew it. Administration said the Congress made time-of-filing rule established by Now we have one industry that has a mistake. FDA tried to rectify the sit- GATT. been given special privileges, privileges uation but they failed, and it is too bad This is because these products often that I personally have helped them to that they did. Our U.S. Patent Office present difficult, novel issues of pat- get, coming in and saying we want said that a mistake has been made by entability. implication, and their decision was I cite with particularity that joint more special privileges and we want to taken to court. Because of the tech- hearing between the two intellectual amend the very act that benefited nical aspects of the language, the Pat- property committees of the House and them and created their industry. ent Office was overruled. Senate, where Lita Nelsen, Director of Frankly, I do not think that what If we review the CONGRESSIONAL the Technology Licensing Office of the specific company benefits and what RECORD we will find that at no time Massachusetts Institute of Technology, company does not should be our focus during the debate on the issue of the said: here. Our focus should be on the right thing to do, which is to uphold GATT GATT Treaty, leading to the adoption The 20-year-from-filing change proposed in of the GATT Treaty, at no place do we the current bill runs the risk of substan- and vote down the Pryor amendment. tially reducing the patent protection avail- I reserve the remainder of our time. find reference to this issue by anyone— able for companies investing in university The PRESIDING OFFICER. Who not by any of the drafters or the debat- technology. yields time? ers, nor by those opposed to or in favor She goes on to say: Mr. SMITH. Madam President, I sug- of that treaty. At no time did anyone Any shortening of patent life most seri- gest the absence of a quorum. even hint that we were going to carve ously impacts the most forward-thinking The PRESIDING OFFICER. The time out a special exception for a few drug technologies, which are the very types of of the quorum would be charged to companies in order to give them extra technologies which universities should spe- both sides equally? Without objection, monopolistic opportunities to compete cialize in and which we believe will most it is so ordered. unfairly in the marketplace, and to benefit the country’s future technical and The clerk will call the roll. keep generic drugs from competing. economic development. The legislative clerk proceeded to The State Medicaid directors, Madam The 20-year-from-initial-filing rule cur- rently being proposed offers a significant call the roll. President, have written in support of danger of shortening the time available for Mr. PRYOR. Madam President, I ask our efforts. They say that unless we patent protection and therefore may have a unanimous consent that the order for correct this loophole, the Medicaid pro- detrimental effect on development of univer- the quorum call be rescinded. grams in each of the 50 States are sity technologies. The PRESIDING OFFICER. Without going to continue to suffer and pay the She also goes on to say: objection, it is so ordered. highest price for these particular Also, leading-edge technology patents, Mr. PRYOR. Madam President, may I drugs, especially Zantac, and will be such as those in biotechnology, software and inquire as to how many minutes I have kept from buying generic drugs for the microelectronics usually take significantly left? poorest of the poor population.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00105 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18222 CONGRESSIONAL RECORD — SENATE December 7, 1995 The elderly, the consumers—none We will hold hearings on this issue Gregg Lautenberg Shelby will benefit from the efforts of the ge- before the end of 120 days. I will com- Harkin Lieberman Smith Hatch Lott Specter neric drug companies to reduce the mit to that as chairman of the Judici- Helms Mack Stevens cost of drugs like Zantac by as much as ary Committee, and I do not think any- Hollings McConnell Thomas 50 percent or 60 percent. Yet, we may body doubts in this body that I will not Hutchison Moseley-Braun Thompson Inhofe Murkowski be about to vote and say that we are live up to that commitment, because I Thurmond Johnston Nickles Warner going to continue to give these enor- will. Kempthorne Pell mous profits, these windfall profits, to I think that is the way we should Kyl Santorum a few pharmaceutical companies, and handle it and I hope my colleagues will ANSWERED ‘‘PRESENT’’—1 to take those profits, to give them vote against the motion to table. Simpson those profits at the expense of taking Mr. SMITH. Madam President, is NOT VOTING—1 those dollars from the consumer and there any time remaining? Moynihan the taxpayers of America. The PRESIDING OFFICER. There This amendment that we are about are 29 seconds. So the motion to lay on the table the to vote on is very simple. It is an at- Mr. SMITH. Madam President, let me amendment (No. 3088) was rejected. tempt to kill our desire to close this just say that no matter what the pros AMENDMENT NO. 3082 WITHDRAWN loophole. That is what it is. and cons are of this amendment it is ir- Mr. PRYOR. Mr. President, if I may I respect my colleagues who offer it. relevant to the issue at hand. Regard- have just a few seconds, I know this I realize that some may believe that less of how you feel about GATT or the was a very hard vote, a very close vote. this particular issue is complex. But I patent protections, let us not load this I want to compliment those on the op- must say, as my colleagues have said, historic bill up with this controversial posing side. They made a very, very that this is, in fact, a very simple unrelated amendment. strong argument, and they prevailed issue. We have made a mistake. And I urge my colleagues to vote ‘‘no’’ on this evening. But I will make it pos- now it is time to rectify it. the motion to table. sible for the Senate to revisit this issue Madam President, I have frequently Mr. PRYOR. Madam President, I ask in the very, very near future, Mr. used the following analogy: You are unanimous consent that Senator President. I want to thank those who walking down the street on the side- DASCHLE, Senator LEAHY, Senator supported us, and at this time I with- walk, or wherever, and find a billfold, BRYAN, and Senator FEINSTEIN be added draw my amendment. and you open that billfold up. And as original cosponsors of my amend- AMENDMENT NO. 3085 there is a $100 bill in there, and there is ment. The PRESIDING OFFICER (Mr. also the name of the owner. Do you The PRESIDING OFFICER. Without SANTORUM). The question recurs on the take that billfold and the $100 to the objection, it is so ordered. Brown amendment No. 3085. owner? Do you try to find the lawful Mr. PRYOR. Madam President, I Mr. BROWN. Mr. President, may we and rightful owner of that billfold that move to table the pending amendment, have order. contains the $100, or, do you put it in the second-degree amendment, and I The PRESIDING OFFICER. The Sen- your pocket? ask for the yeas and nays. ate will please come to order. Mr. SMITH. Will the Senator yield In this case, these drug companies The PRESIDING OFFICER. Is there a for a unanimous-consent request? have found a billfold. It has a lot of sufficient second? Mr. BROWN. Yes. money in it. Rather than returning it There is a sufficient second. UNANIMOUS-CONSENT AGREEMENT to the rightful owner—the taxpayer The yeas and nays were ordered. Mr. SMITH. Mr. President, I have a and the consumer, in this case—Madam The PRESIDING OFFICER. The unanimous-consent request here, and I President, they are taking that bill- question is on agreeing to the motion think Members will be interested in fold, they are taking the money, and of the Senator from Arkansas to lay on they are putting it right in their pock- hearing it. the table the amendment of the Sen- Mr. President, I ask unanimous con- et. ator from Ohio. On this question, the I urge the defeat of the second-degree sent that following the disposition of yeas and nays have been ordered, and amendment. the Pryor amendment, the following be the clerk will call the roll. Mr. HATCH. Madam President, if we the only amendments remaining in The bill clerk called the roll. want a cure for Alzheimer’s, or for order and limited to the following time Mr. SIMPSON (when his name was AIDS, or for so many other dreaded restraints: The Brown amendment No. called). Present. diseases, we had better not undercut 3085, 5 minutes equally divided; a Fein- the patent process. Mr. FORD. I announce that the Sen- stein amendment, supporting current We had better not undercut the ator from New York [Mr. MOYNIHAN] is law, 35 minutes, 20 minutes under the necessarily absent. GATT process. control of Senator FEINSTEIN, 15 min- If we want free and fair trade The result was announced—yeas 48, utes under the control of Senator throughout this world, we had better nays 49, as follows: SMITH; a Brown limiting liability make sure that we do not undercut [Rollcall Vote No. 594 Leg.] amendment, 15 minutes equally di- something we fought to obtain for so YEAS—48 vided; a Smith affirmative defense many years. Akaka Exon Levin amendment, 5 minutes equally divided. If we want to keep America’s medical Baucus Feingold Lugar I further ask that the votes be research base premier among world na- Bingaman Feinstein McCain stacked to occur on or in relation to Bond Ford Mikulski tions, and continue to bring forth Boxer Glenn Murray the above-listed amendments at the promising technologies which help our Bradley Graham Nunn conclusion or yielding back of all time, senior citizens and so many others, Breaux Hatfield Pressler and that prior to the votes, there be 4 Brown Heflin Pryor this body should vote down the Pryor Bryan Inouye Reid minutes equally divided for closing re- amendment. Bumpers Jeffords Robb marks on the bill, with the votes oc- It would send our world trading part- Byrd Kassebaum Rockefeller curring in the order in which they were ners the wrong message, and in the end Chafee Kennedy Roth debated, and following disposition of Cohen Kerrey Sarbanes put a huge dent in what is already a Conrad Kerry Simon the amendments, the bill be advanced well-functioning system that benefits Daschle Kohl Snowe to third reading, and final passage both the research company and the ge- Dorgan Leahy Wellstone occur, all without further action or de- neric companies in a fair way. NAYS—49 bate. That is what is involved here. Abraham Cochran Domenici The PRESIDING OFFICER. Without Let me just say one other thing. Ashcroft Coverdell Faircloth objection, it is so ordered. I commit here and now that we will Bennett Craig Frist Mr. SMITH. Mr. President, to recap hold hearings on this should the Biden D’Amato Gorton for all Members, we expect two addi- Burns DeWine Gramm amendment of the Senators from New Campbell Dodd Grams tional votes to occur within the next 40 Hampshire and Ohio pass. Coats Dole Grassley minutes. That is the essence of it.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00106 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18223 AMENDMENT NO. 3085 ‘‘(2) As used in this section, the term ‘phy- Although I believe the underlying Mr. BROWN. Mr. President, the bill sician’ means a doctor of medicine or osteop- bill is leading us down a terrible path as it is now drafted creates a new cause athy legally authorized to practice medicine where we are going to haul doctors into of action and allows a variety of par- and surgery by the State in which the doctor performs such activity, or any other indi- prison for saving a woman’s life, I cer- ties to bring suit against those who vidual legally authorized by the State to per- tainly believe what the Senator is have been involved in the restricted form abortions. Provided, however, That any doing to at least narrow it to the doc- prohibited abortion practice. individual who is not a physician or not oth- tor is something we should support. Among those allowed to bring suit is erwise legally authorized by the State to I will be supporting his amendment. I the father. Unfortunately, the bill does perform abortions, but who nevertheless di- yield the floor. not now restrict which father can bring rectly performs a partial-birth abortion, Mr. SMITH. We have no objection to suit. Literally, someone who is the fa- shall be subject to the provisions of this sec- the Brown amendment. tion. ther of the fetus but has not acknowl- The PRESIDING OFFICER. If there edged the child, has not married the Mr. BROWN. Mr. President, this par- is no further debate on the amendment, woman, and has not supported the ticular amendment was allowed 15 min- the Chair would advise the Senator the child in any way or any process can utes equally divided. I do not intend to yeas and nays have been ordered. bring legal action and get a bonanza by take a significant amount of time with Mr. BROWN. Mr. President, I ask suing the physician. it. I do want to make it clear to the unanimous consent to vitiate the re- In my mind, to provide a financial Members what is involved. quest for the yeas and nays. The current bill makes liable or po- benefit to someone who has fathered a The PRESIDING OFFICER. Without tentially liable not only for the attend- child and not acknowledged it nor mar- objection, it is so ordered. ing physician in this case but also, in ried the woman is a mistake. I don’t The question is on agreeing to the reading the language of the bill, the think we ought to be about providing a amendment. hospital where the procedure took The amendment (No. 3090) was agreed new avenue of financial reward for a place. Both could be subject to civil to. man who does not live up to his respon- and criminal actions. Also included Mr. SMITH. I move to reconsider the sibilities. could be the nurses, as well other peo- vote. The amendment is very simple. It re- ple called in to help with other medical Mrs. BOXER. I move to lay it on the stricts the fathers who can bring legal procedures that may stem from the table. actions in this case to ones who have abortion procedure. In my mind, to The motion to lay on the table was married the mother. have hospital administrators, to have agreed to. Mr. President, I think it is a pretty hospital trustees, to have hospitals AMENDMENT NO. 3091 straightforward amendment. I yield themselves, to have nurses, to have (Purpose: To strike the affirmative defense) the floor. I believe this has been other medical personnel who may be Mr. SMITH. Mr. President, I say to cleared on both sides. I think a voice called in to assist if something goes the Senator from California who is vote may well be appropriate. wrong, subject to possible prosecution waiting to go on her amendment, brief- Mr. SMITH. The Senator from Colo- ly I will do the affirmative defense rado is correct. As far as I know, there and civil liability is a great mistake. This amendment limits the liability, amendment and then be ready for her is no objection on this side, and I do amendment. not believe there are any objections on and limits the people who can have ac- tions brought against them to the phy- I send an amendment to the desk and the other side. ask for its immediate consideration. Mrs. BOXER. Mr. President, that is sician or to someone who takes the place of the physician such as the per- The PRESIDING OFFICER. The right. I applaud the Senator for this clerk will report. amendment. son who directs the abortion procedure. Specifically, we are trying to get at The assistant legislative clerk read The PRESIDING OFFICER. The the person who performs the abortion as follows: question is on agreeing to the amend- itself. The whole purpose of this is to The Senator from New Hampshire [Mr. ment. make sure that nurses and other at- SMITH] proposes an amendment numbered The amendment (No. 3085) was agreed tending personnel who are not the deci- 3091. to. sionmakers here are not subject to Mr. SMITH. I ask unanimous consent Mr. BROWN. I move to reconsider the civil and criminal liability. reading of the amendment be dispensed vote. Mr. President, I believe the amend- with. Mr. SMITH. I move to table the mo- ment is fairly clear. I believe it is The PRESIDING OFFICER. Without tion. cleared on both sides. My hope is at the objection, it is so ordered. The motion to lay on the table was appropriate time we could have a roll- The amendment is as follows: agreed to. call vote on it. On page 3, strike lines 8 through and in- AMENDMENT NO. 3090 I ask for the yeas and nays. cluding 16. (Purpose: To limit liability under this act to The PRESIDING OFFICER. Is there a Mr. SMITH. Mr. President, in view of the physician performing the procedure in- sufficient second? the fact that the Senate adopted the volved) There is a sufficient second. life-of-the-mother exception amend- Mr. BROWN. Mr. President, I rise to The yeas and nays were ordered. ment, the affirmative defense section offer an amendment and ask for its im- Mr. BROWN. I yield the floor. of the bill is no longer necessary and I mediate consideration Mrs. BOXER. Mr. President, I want had agreed that we would remove that The PRESIDING OFFICER. The to say to my friend from Colorado I in- provision, providing the life-of-the- clerk will report. tend to support his amendment. mother exception prevailed. The assistant legislative clerk read I believe it is tragic that we are Since it did prevail, this amendment as follows: about to criminalize a medical proce- would strike the entire subsection E of The Senator from Colorado [Mr. BROWN] dure which many doctors say is nec- the bill which talks about the affirma- proposes an amendment numbered 3090. essary to save the life of a woman or to tive defense to a prosecution or a civil Mr. BROWN. Mr. President, I ask protect her from serious adverse health action. unanimous consent that reading of the consequences. I think it is tragic we So, it is my understanding that the amendment be dispensed with. are going to put doctors through this Senator from California agrees with The PRESIDING OFFICER. Without Kafkaesque expense of winding up in this amendment, so unless the Senator objection, it is so ordered. prison for saving the life of a woman. wishes to speak, I urge its adoption. However, what the Senator from Col- The amendment is as follows: The PRESIDING OFFICER. The orado is pointing out to us, as cur- question is on agreeing to the amend- On page 2, line 6, strike ‘‘Whoever’’ and in- rently written, we might wind up put- sert ‘‘Any physician who’’. ment. On page 2, line 10 strike ‘‘As’’ and insert ting other people in jail—other people The amendment (No. 3091) was agreed ‘‘(1) As’’. associated with the hospital, other peo- to. On page 2, between lines 13 and 14, insert ple who clearly should stay clear of Mr. SMITH. I move to reconsider the the following: this. vote.

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00107 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18224 CONGRESSIONAL RECORD — SENATE December 7, 1995 Mrs. BOXER. I move to lay it on the does not appear in medical literature, a sist practitioner and patient decisions table. procedure that is worded vaguely. about appropriate health care for a spe- The motion to lay on the table was All I ask is that the Members of this cific clinical circumstances.’’ They are agreed to. body read the actual legislation. Many guidelines—guidance—not enforceable AMENDMENT NO. 3092 Members who have spoken in favor of rules. There are over 24,000 developed (Purpose: To provide for a substitute the legislation point to the use of scis- by over 75 organizations. amendment) sors, the cutting of tissue, the draining Medical practice guidelines are de- Mrs. FEINSTEIN. Mr. President, I of fluid from the brain. Nowhere does signed to improve patient outcomes. send an amendment to the desk for the legislation itself specifically refer They help medical practitioners and Senator SIMPSON and myself and ask to that kind of procedure. In its very patients make decisions about preven- for its immediate consideration. vagueness, it affects more than one tion, diagnosis and treatment of spe- The PRESIDING OFFICER. The procedure and it can affect more than cific clinical conditions. For example, clerk will report. postviability abortions. guidelines have been developed for the The assistant legislative clerk read So, my point is twofold. One, that treatment of benign prostatic as follows: this body is not the appropriate place hyperplasia, pressure ulcers, and The Senator from California [Mrs. FEIN- to be making medical decisions and stroke rehabilitation. STEIN], for herself, Mr. SIMPSON, Mrs. BOXER, that, two, under current Federal law, Developing practice guidelines is a Mr. SIMON, and Ms. MOSELEY-BRAUN, pro- States can choose to regulate, restrict, complicated process. To develop a poses an amendment numbered 3092. or prohibit postviability abortions as guideline, panels of experts are con- Strike out all after the enacting clause and 41 do now. vened. They review all available lit- insert in lieu thereof the following: When physicians make a decision to erature, all available evidence of pa- SECTION 1. SENSE OF THE SENATE. use a particular treatment, they very tient outcomes, a review that can take (a) FINDINGS.—The Senate finds that— thoroughly evaluate a number of fac- (1) the United States has the most ad- up to 9 months. They are subjected to vanced medical training programs in the tors: evidence from scientific lit- peer review for scientific validity and world; erature, the risks and benefits for the pilot testing. Development of one (2) medical decisions should be made by patient—for example, possible side ef- guideline can take from 11⁄2 to 31⁄2 trained medical personnel in consultation fects—future health, quality of life, the years. with their patients based on the best medical efficacy of the treatment—what the The point here is that there is an or- science available; outcome will be—the safety of the derly, scientific, deliberative, profes- (3) it is the role of professional medical so- treatment, the patient’s preferences. sional, and balanced approach for mak- cieties to develop medical practice guide- lines and it is the role of medical education These are often complicated decisions, ing medical decisions. It is com- centers to provide instruction on medical representing a systematic strategy de- plicated. It is based on the patient’s procedures; veloping from multiple decisional best interest. (4) the Federal Government should not su- building blocks. Medical decision- Medical decisionmaking is not and persede the medical judgment of trained making is not simple and these are not should not be a legislative or political medical professionals or limit the judgment decisions we should or can make. process. of medical professionals in determining We should also understand that med- UNPRECEDENTED medically appropriate procedures; ical decisionmaking is individualized. (5) the Federal criminal code is an inappro- Congress has legislated medical bene- priate and dangerous means by which to reg- Every case is different. Every human fits, reimbursement policies, quality ulate specific and highly technical medical body is different. Every patient brings standards, training requirements. But procedures; and a unique medical history into the doc- Congress has never banned or (6) the laws of 41 States currently restrict tor’s office. Physicians have to evalu- criminalized a specific medical proce- post-viability abortions. ate every situation as it presents itself dure. This is the first time Congress (b) SENSE OF SENATE.—It is the sense of the and often at the last minute. has tried to outlaw a medical proce- Senate that Congress should not criminalize The risks of a particular procedure a specific medical procedure. dure. depend, often, on the patient. For ex- My amendment is quite simple. It SEC. 2. RULE OF CONSTRUCTION. ample, a hip replacement that restores says, in essence, that Congress should Nothing in Federal law shall be construed function in one patient can be life- to prohibit the States, local governments, not be making medical decisions and local health departments, medical societies, threatening to another, for example, to that States can regulate post-viability or hospital ethical boards from regulating, one who has heart disease. Medical abortions. restricting, or prohibiting post-viability science and treatments are constantly I can go on, but in the interest of abortions to the extent permitted by the evolving. Medicine is becoming in- time, and giving my cosponsors the op- Constitution of the United States. creasingly specialized. Technology is portunity to speak, I want to just say The PRESIDING OFFICER. The Sen- advancing. Today’s standard of prac- one other thing. I have followed this ator from California is recognized for tice can be out of date in 5 years. The debate very carefully. I want particu- 20 minutes. The Senator from New human body will always have some de- larly to commend my friend and col- Hampshire is recognized for 15 minutes. gree of mystery, as science stretches to league, the junior Senator from Cali- Mrs. FEINSTEIN. Mr. President, I understand how the body works and fornia. I think she has been quite elo- want to make clear that this amend- does not work. Congress cannot keep quent in defining what this procedure ment is presented as a substitute. up with these changes. That is not our is, and what this procedure is not, the I am pleased it was read because it job. enormous vagueness of the bill and the makes clear the following: First, that Mr. President, physicians go to col- human tragedies involved. it is the sense of the Senate that Con- lege for 4 years, to medical school for 4 Post-viability abortions can be gress should not criminalize a medical years, to residency training for 3 to 6 banned by every State and 41 have cho- procedure. years. In some States, to keep their li- sen to do so. This legislation is not Second, that nothing in Federal law censes current, they are required to un- necessary. This legislation puts the should be construed to prohibit the dergo continuing education annually. Congress in the position of deciding States, local governments, local health They get extensive training. Medical medical procedures, and I do not be- departments, medical societies, or hos- decisionmaking, I believe, is a job for lieve we can or should do this. This pital ethical boards from regulating, trained physicians. substitute amendment clearly states restricting, or prohibiting postviability AN EXAMPLE OF DECISIONMAKING: MEDICAL what I believe is right. abortions to the extent permitted by PRACTICE GUIDELINES Mr. President, I yield 10 minutes to the U.S. Constitution. For almost 60 years, the medical pro- the Senator from Wyoming. The U.S. Congress is not the appro- fession in this country has been devel- The PRESIDING OFFICER. The Sen- priate place to be making decisions oping medical practice guidelines. Ac- ator from Wyoming is recognized for 10 about medical procedures, whatever cording to the Institute of Medicine, minutes. they are. The bill before us would crim- clinical practice guidelines are ‘‘sys- Mr. SIMPSON. Mr. President, I rise inalize one procedure, a procedure that tematically developed statement to as- in support of the Feinstein substitute

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00108 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18225 which is a reiteration of current law. My respect for this very real facet of say, I do not have to take that guff Under the substitute, nothing in Fed- the human condition has led me to the from you. So I have been there. eral law shall be construed to prohibit conclusion that abortion presents a In my fine State of Wyoming—and I the States, local governments, local deeply personal decision for any am going to conclude my remarks health departments, and medical soci- woman—decisions which should not within my limit—listen to what we eties from regulating, restricting, or and realistically could not be pre- have to do in this. It should not be par- prohibiting post-viability abortions to scribed or directed through the legisla- tisan. And in our State, the Wyoming the extent permitted by the Constitu- tive process in any way. Republican Party passed a platform tion. Let me say it again, this is cur- We in the Senate should never be plank in 1994 at its State convention rent law and this substitute explicitly criminalizing a specific medical proce- that said this: ‘‘The Wyoming Repub- states what the law of the land is. dure. That is what the substitute lican Party welcomes individuals on Under Roe versus Wade, States may states. each side of the abortion issue, encour- proscribe post-viable abortions except So here we are overstepping court ages their open discussion, solicits when it is necessary to preserve the life cases. There is a strong absence of Gov- their active participation in the party, or health of the mother—41 States cur- ernment interest in this legislation. It and respects their positions and be- rently regulate post-viable abortions. is not here. It purports to prohibit liefs.’’ We do not need H.R. 1833 because we al- abortions using a particular procedure, Then, do you know what we did? We ready have current laws which address and then says abortions will be per- did a resolution because we had a No- the central issue of the pending legisla- formed only in a particular manner. vember resolution on the ballot which tion. There is no reasonable Government in- was soundly rejected. Here is what it I have been pro-choice throughout terest served by forcing a patient to said: ‘‘The Republican Party believes my entire public life, never wavered, undergo one type of abortion instead of that Republicans are people of prin- never waited to take a poll, ever since another, especially if the prohibited ciple on each side of the abortion issue that first wrenching debate in the Wyo- procedure is safer for the health of the who firmly and intractably hold their ming State Legislature because our woman. beliefs; by establishing a party posi- law was the same as Missouri’s, which We in this Congress should not be tion, we recognize that a resolution was struck down by Roe versus Wade. legislating in this area. This is over- will never change these beliefs, but it And so we had to change it, and we did, reaching in every sense. Under this will serve to divide the party on other and I shall never forget the debate. bill, it would remain legal. Get this— Abortion is such a deeply personal and, issues, and we urge all Republicans to somebody has to really explain this to to some, a spiritual issue. It is not one firmly debate these beliefs.’’ That passed unanimously by voice that belongs in the public domain. me. It would remain legal for a woman vote. We ought to do more of that in That is my view. It is not one that to obtain this procedure only if she did should be in a legislative body, to me, not cross State lines. This seems to me America. And men, in my mind, should as a man—not a legislator, but a man, too clever by half. I thought this was never be in this intensely intimate per- I cannot presume to limit the options the most horrendous, searing, mur- sonal struggle for a woman. I urge my colleagues to vote in favor of any woman who is anguishing over a derous, vicious procedure that we have of the substitute. crisis pregnancy. That is what I have seen in modern times, and yet you are Mr. JEFFORDS. Mr. President, I rise always believed, and what I have al- going to be able to do it in your own today in support of the amendment ex- ways tried to state so clearly. And as a backyard, in your own State. That is pressing the sense of the Senate that man, I do not think a man should even absurd. the Congress should not criminalize a vote on this issue. That is how I feel Now we have a new Federal court specific medical procedure, and that about this. case, the Lopez decision. That is how I do not advocate or promote abor- they got clever by half on this one. the States should not be prohibited tion. It is obviously one of the most This bill also uses a term I have from regulating or restricting difficult choices or options that any never before seen in the statute, and I postviability abortions to the extent woman should ever, ever make. I really have been doing this for 30 years. Any- that the Constitution permits them to do not know many folks who advocate one who knowingly performs a partial- do so. I also want to state again my or promote abortion, nor does anybody birth abortion ‘‘and thereby kills a firm belief in the wisdom of the Su- else in this land. That is not what peo- human fetus.’’ That is what it says. preme Court decision Roe versus Wade, ple do—promote abortion. It is an al- ‘‘Abortion is thereby killing.’’ On line which held that under the constitu- ternative. It is an option. It is obvi- 15 of the bill, the language reads, ‘‘par- tional right to privacy, a woman has a ously one of the most difficult choices tially vaginally delivers a living fetus right of self-determination with regard or options that any man or women— before killing the fetus.’’ I have never to her pregnancy and reproductive sometimes men must make—buy prin- seen that in my life in a statute. Where health. cipally the woman. I have always sup- did it come from? It is a manifestation In November I spoke in support of re- ported alternatives to abortion—and of a manipulative group trying to des- ferring this bill to the Judiciary Com- think it is so very important to assure perately knock off Roe v. Wade. That is mittee for a hearing, and I’d like to a pregnant woman that there are many what it is. It is exceptionally unclear thank my colleagues for joining me to alternatives to abortion and that there about the precise nature of the proce- support the passage of that motion. I are many fine support systems avail- dure. Six doctors testified they never think we learned a great deal from the able for those who may choose any of heard of the procedure before. hearing. One of the things that struck the alternatives. And yes, yes, absti- I sat and listened to that. I have seen me was that the term ‘‘partial birth’’ is nence is still the best, and Who would all of the pictures before. We are going not a term that is clearly defined in disagree with that? But that is not to have all of them—one-eyed children, the medical profession. This bill pur- what we are talking about. brains on the outside, compressed ports to be a very narrow measure that And I respect and am acutely con- skulls. I have seen it all. I have seen outlaws only one alternative to a scious of the fact that many persons the whole works, always with the eter- woman who learns late in her preg- who grapple with the issue of abortion nal difficulty of imposing restrictions nancy that it is not possible for her to do so from very different moral or reli- on a decision which must be made from carry her child to term. But we’ve gious or philosophical differences, and one’s only very unique position, and learned that there is not a medical pro- I do not spend any part of my life try- principally by a woman, from one’s cedure known as a partial birth abor- ing to inflict—and that is the word I own culture, one’s own history, and tion. I suppose you can argue that want to use—inflict my personal views one’s own deep personal and spiritual those of us on this side of the issue on others. I see that happening here. viewpoint. shouldn’t have a problem criminalizing Not with the Senator from New Hamp- All through the years I have had the a procedure that doesn’t really exist. shire, a lovely friend, but from others, accolades sometimes of being called a My response to that argument is pre- especially in the hallways, who do it baby killer. I really do not appreciate dictable: why bother to criminalize a with steely-eyed zealotry that I tire of. that. I handle it very well now. I just procedure that doesn’t really exist?

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00109 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18226 CONGRESSIONAL RECORD — SENATE December 7, 1995 Moreover, rules of statutory interpre- pregnancy and reproductive health are Senate, and he is not an OB-GYN. Are tation will demand that the courts find concerned—especially, the Court said, we qualified to make a medical judg- some meaning in this law, because Con- ‘‘when her right to life is threatened.’’ ment—a medical recommendation— gress is assumed to do nothing in vain. The bill we are now considering is a di- that could leave a woman sterile, or se- Somehow, the courts will have to put rect challenge to that historic deci- verely ill, or, worse yet, dead? I think some definition on the term ‘‘partial sion’s protection of a woman’s life and not. birth abortion,’’ even though a clear health. Concern about a woman’s life I know, frankly, that if I were ill, or understanding of what we’re outlawing has been abandoned in the partial birth the Presiding Officer were ill, his fam- has eluded many of us. abortion legislation we’ve been dis- ily would take him to a doctor, not to I’d like to quote briefly Dr. J. cussing, but Roe versus Wade requires another Senator, unless, of course, that Courtland Robinson, who spoke at the that even where a state chooses to out- Senator was a doctor, and there is only hearing a couple of weeks ago and law post-viability abortions, it may one of those. highlighted this point: not under any circumstances outlaw The fact of the matter is that this is I have to wonder what you are really try- abortions necessary to preserve the life a medical decision, and the decision ing to ban with this legislation. It sounds as or health of the mother. here that a woman makes regarding if you are trying to leave any later abortions I will say again that I believe doctors her pregnancy should be made with her open to question. must be able to put the welfare of their family in consultation with her doctor Dr. Robinson continues: patients first. Doctors should be able and, of course, her faith. Yesterday, I talked about this as an I know that a number of physicians who to use whatever procedure will, in their have performed abortions for years, who are issue of fundamental liberty for female professional judgment, be safest for the citizens. Let me submit to you that it experts in the field, look at this legislation mothers, their patients. Toward this and do not understand what you mean or is not only a matter of a woman’s lib- goal, I wholeheartedly support the erty and right to control her own body what you are trying to accomplish. It seems sense-of-the-Senate amendment that as if this vagueness is intentional, and I, as that is at stake with this legislation; it a physician, cannot countenance a vague law Congress should not criminalize a spe- is also a doctor’s right to treat—to that may or may not cut off an appropriate cific medical procedure, and the rule of treat his patient, and to treat his pa- surgical option for my patients. Sometimes, Construction permitting the States to tient under very difficult cir- as any doctor will tell you, you begin a sur- regulate post-viability abortions to the cumstances indeed. gical procedure expecting it to go one way, extent permitted by the Constitution. It seems to me that as we dabble only to discover that the unique demands of The PRESIDING OFFICER. Who around we are in the process of lim- the case require that you do something dif- yields time? ferent. iting the liberties of the unborn that Mrs. FEINSTEIN. Mr. President, how have been spoken of will be born to. I Dr. Robinson highlights a point I’ve much time remains? think, Mr. President, that is a grievous made many times before. We can’t ade- The PRESIDING OFFICER. Six min- error for which we will all have great quately define the procedure we mean utes and thirty seconds. regret. to outlaw because we’re not doctors. I Mrs. FEINSTEIN. Mr. President, I I thank the Senator from California. share Dr. Robinson’s fear that because ask unanimous consent that the fol- The good news about this amendment this law is so vague and because we are lowing be added as cosponsors: Senator is that it can improve what is a bad denying doctors the ability to use their BOXER, Senator SIMON, Senator bill. The bad news about it, or maybe best medical judgment, physicians will MOSELEY-BRAUN, and Senator BRYAN. the good news about it, is hopefully be deterred from performing any late The PRESIDING OFFICER. Without medical science will overcome this sit- term abortion procedure. Late term objection, it is so ordered. uation. But, quite frankly, for the abortions will be unavailable and Mrs. FEINSTEIN. I yield the remain- present we should not be dabbling women will die. der of my time to the junior Senator where we have no knowledge, where we This is an unprecedented intrusion from Illinois. have no expertise, and in a way that into the practice of medicine. In my The PRESIDING OFFICER. The Sen- will injure and jeopardize the health, view decency and common sense would ator from Illinois. safety, and indeed even the lives of require us to recognize that it is not Ms. MOSELEY-BRAUN. Thank you, millions of American women. the job of the Congress to come be- Mr. President. I will be brief. Thank you. I yield the floor. tween physicians and their patients. I want to thank the Senator from Mr. President, I do not know if this I also want to speak briefly in sup- California for the amendment, and I letter has been made a part of the port of section two of Senator FEIN- am delighted to be a cosponsor of it. RECORD. I ask unanimous consent that STEIN’s amendment. I think her amend- Mr. President, this bill represents the it be printed in the RECORD. It is a let- ment is entirely consistent with the first time, to my knowledge, that the ter dated November 6 from the Amer- thinking in much of the legislation we Congress has attempted to tell a doctor ican College of Obstetricians and Gyne- have debated recently. On a number of that he or she cannot perform a spe- cologists in opposition to this legisla- matters we are choosing to leave regu- cific medical procedure. tion. lation to the States; indeed, we are de- Let us be clear about what Congress There being no objection, the mate- regulating at the Federal level so that is proposing to do with this legislation. rial was ordered to be printed in the we may leave the States the flexibility We are proposing to criminalize a med- RECORD, as follows: to enact their own laws on welfare, ical procedure against the rec- THE AMERICAN COLLEGE OF Medicaid, and so forth. I must admit ommendation of this Nation’s OB- OBSTETRICIANS AND GYNECOLOGISTS, Washington, DC, November 6, 1995. that it seems strange to me that in GYN’s and against the recommenda- Hon. ROBERT DOLE, this area alone we are undertaking tion of this Nation’s 2.2 million reg- Majority Leader, The Capitol, Federal regulation where there has istered nurses. Washington, DC. been none. In doing so we are taking This bill arbitrarily prohibits one DEAR MAJORITY LEADER DOLE: The Amer- away from the States the right to leg- type of procedure even when the proce- ican College of Obstetricians and Gyne- islate on this issue as they see nec- dure best protects the life and health cologists (ACOG), an organization rep- essary. In fact, we know that 41 of the and fertility of a woman, a citizen of resenting more than 35,000 physicians dedi- cated to improving women’s health care, States already have laws regulating ac- this country. If a woman has a late- does not support H.R. 1833, the Partial-Birth cess to post-viability abortions. term abortion, her decision relies on Abortion Ban Act of 1995. The College finds I have expressed before my support the best medical advice of the doctor, very disturbing that Congress would take for the enduring wisdom of Roe versus advice based on years of medical train- any action that would supersede the medical Wade decision. I think Senator FEIN- ing and service. judgment of trained physicians and crim- STEIN’s amendment is consistent with None of us, or few of us in this body, inalize medical procedures that may be nec- essary to save the life of a woman. Moreover, that decision. In Roe, the Court found have spent years studying and prac- in defining what medical procedures doctors that under the constitutional right to ticing medicine. How many of the may or may not perform, H.R. 1833 employs privacy, a woman has the right to Members of this body are physicians? terminology that is not even recognized in make her own decisions where her We have only one doctor serving in the the

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00110 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS December 7, 1995 CONGRESSIONAL RECORD — SENATE S18227 medical community—demonstrating why vaginally delivers a living fetus before ators in the Chamber who desire to Congressional opinion should never be sub- killing the fetus and completing the vote? stituted for professional medical judgment. delivery.’’ The result was announced—yeas 44, Thank you for considering our views on It is my understanding that ‘‘par- this important matter. nays 53, as follows: tially vaginally delivers’’ means the Sincerely, [Rollcall Vote No. 595 Leg.] RALPH W. HALE, MD, person performing the abortion ac- YEAS—44 Executive Director. tively removes a portion of the fetus Mr. SMITH. Mr. President, so we all from the uterus, through the cervyx Akaka Glenn Mikulski Baucus Graham Moseley-Braun understand, the Feinstein substitute and into the birth canal. And I would ask the manager if this is his under- Bingaman Harkin Murray amendment is the killer amendment. It Boxer Hollings Nunn simply guts the bill. The earlier standing as well? Bradley Inouye Pell amendment was the Boxer amendment, Mr. SMITH. The Senator from Colo- Bryan Jeffords Pryor Bumpers Kassebaum which was defeated. rado is correct. ‘‘Partially vaginally Robb delivers’’ means the physician delivers Byrd Kennedy Rockefeller This amendment, no less than the Campbell Kerrey Sarbanes part of the baby through the cervyx Chafee Kerry Boxer amendment before it a short Simon and into the birth canal. Cohen Kohl while ago, is the partial-birth abortion- Simpson Mr. BROWN. At the Judiciary Com- Daschle Lautenberg on-demand amendment. And this Snowe mittee hearing, Dr. Robinson, of the Dodd Leahy amendment would totally eliminate Specter Johns Hopkins University, mentioned Feingold Levin the Partial-Birth Abortion Ban Act. Feinstein Lieberman Wellstone So if you support the bill, and you that it is possible for a portion of the NAYS—53 voted no on the Boxer amendment, you fetus, such as a hand or foot, to slip ac- should vote no on the Feinstein amend- cidentally through the cervyx and into Abraham Exon Lott Ashcroft Faircloth Lugar ment because it would replace the bill the birth canal without active removal by the physician. I assume the man- Bennett Ford Mack with current law. Current law is par- Biden Frist McCain tial-birth abortion on demand—I might ager does not intend to include those Bond Gorton McConnell cases in the definition of partial-birth Breaux Gramm Murkowski add, through all 9 months of pregnancy Brown Grams for whatever reason. abortion. Am I correct? Nickles Mr. SMITH. The Senator from Colo- Burns Grassley Pressler In other words, Mr. President, if you Coats Gregg Reid rado is correct. This bill would only Cochran Hatch want to go back on what you voted for, Roth cover those circumstances where some- Conrad Hatfield what you support, the partial-birth Santorum Coverdell Heflin abortion ban, then you would have to one intentionally delivers part of a liv- Smith ing baby through the cervyx and into Craig Helms vote for Feinstein. D’Amato Hutchison Stevens In essence and in conclusion, this is a the birth canal. DeWine Inhofe Thomas gutting amendment. It goes back to Mr. BROWN. The definition also Dole Johnston Thompson states that it only applies to ‘‘partial Domenici Kempthorne Thurmond current law. It just eliminates the en- Dorgan Kyl Warner tire bill. vaginal delivery of a living fetus.’’ In For that reason, obviously, we oppose other words, if the fetus had died be- NOT VOTING—2 it, and I encourage all of those who fore being partially removed from the Moynihan Shelby voted no on Boxer who want the par- uterus, this measure would not pro- So the amendment (No. 3092) was re- tial-birth abortion ban as described in hibit a physician from safely removing jected. our legislation to vote no on the Fein- the dead fetus from the mother. Is that stein amendment. correct? Mr. SMITH. Madam President, I At this point, unless my colleagues Mr. SMITH. The Senator is correct. move to reconsider the vote. would like some of my time—I would That is correct. Mr. GRAMM. I move to table the mo- be happy to yield it—I have no further Mr. BROWN. Finally, Mr. President, tion. it is my understanding this bill applies desire for time. The motion to lay on the table was only to those who knowingly perform a Mrs. FEINSTEIN. I thank the Sen- agreed to. partial-birth abortion. In other words, ator. I yield the time. The PRESIDING OFFICER. The Mr. SMITH. I yield back the remain- a physician must intentionally par- tially deliver a living fetus and then question is on the engrossment of the der of my time. amendments and third reading of the The PRESIDING OFFICER. The Sen- deliberately kill the fetus to be subject bill. ator yields back the remainder of his to criminal or civil liability. For exam- time. ple, under this bill, if a doctor fully in- The amendments were ordered to be The question is on agreeing to the tends to deliver a living baby but due engrossed, and the bill to be read a amendment. to an accident during delivery the fetus third time. Mrs. FEINSTEIN. Mr. President, I dies, the doctor would not be subject to The bill was read a third time. ask for the yeas and nays. criminal or civil liability. Is that cor- Mr. DOLE. I ask for the yeas and The PRESIDING OFFICER. Is there a rect? nays. sufficient second? Mr. SMITH. The Senator is correct. The PRESIDING OFFICER. Is there a There is a sufficient second. Mr. BROWN. I thank the Senator for sufficient second? The yeas and nays were ordered. his time and particularly for what I Mr. SMITH. Mr. President, I would think will be a helpful colloquy in There is a sufficient second. just ask unanimous consent that Sen- being very specific as to what the The yeas and nays were ordered. ator BROWN and I be allowed to do a words and terms used in the bill mean. The PRESIDING OFFICER. We now brief colloquy on a matter that I ne- Mr. President, I yield the floor. have 4 minutes of debate equally di- glected to mention and then we will The PRESIDING OFFICER. The vided. vote. question is on agreeing to amendment Mrs. BOXER. Madam President, I ask The PRESIDING OFFICER. Without No. 3092 offered by the Senator from my colleagues if they could give me objection, it is so ordered. California. The yeas and nays have their attention for 2 minutes of what Mr. BROWN addressed the Chair. been ordered. The clerk will call the The PRESIDING OFFICER. The Sen- has been a very difficult debate. Just roll. for 2 minutes. ator from Colorado. The assistant legislative clerk called I ask you to vote ‘‘no’’ on the final Mr. BROWN. Mr. President, this bill the roll. would expose physicians to criminal Mr. LOTT. I announce that the Sen- passage of this radical bill. It outlaws and civil liability for performing a par- ator from Alabama [Mr. SHELBY] is an emergency medical procedure which tial-birth abortion, and I believe it is necessarily absent. doctors have testified is used to save critical that we be very clear as to Mr. FORD. I announce that the Sen- the life of a woman or to avert serious what is covered by the bill. The bill de- ator from New York [Mr. MOYNIHAN] is adverse health consequences. fines a ‘‘partial-birth abortion’’ as ‘‘an necessarily absent. A woman like this, Coreen Costello, abortion in which the person per- The PRESIDING OFFICER (Mrs. who asks us to put aside our party af- forming the abortion partially HUTCHISON). Are there any other Sen- filiation and remember her. Despite

VerDate Aug 31 2005 03:35 May 29, 2008 Jkt 041999 PO 00000 Frm 00111 Fmt 0624 Sfmt 0634 J:\ODA15\1995_F~1\S07DE5.REC S07DE5 mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS S18228 CONGRESSIONAL RECORD — SENATE December 7, 1995 the other side saying she did not have The result was announced—yeas 54, get it up, and we might not be able to the procedure outlawed in this bill, she nays 44, as follows: get cloture. But my view is we ought to did. She wrote us and told us that [Rollcall Vote No. 596 Leg.] accommodate where we can the execu- today and she testified that she did. YEAS—54 tive branch, and I have always tried to My colleagues, I am down to the last Abraham Exon Lott do that. 60 seconds. This is what Coreen Ashcroft Faircloth Lugar Mr. BINGAMAN. I appreciate that Costello said. Please listen: Bennett Ford Mack very much. I certainly agree that that Biden Frist McCain is an important thing to do. When families like ours are given this kind Bond Gorton McConnell of tragic news the last people we want to Breaux Gramm Murkowski The other issue I wanted to clarify is seek advice from are politicians. We talk to Brown Grams Nickles that the agreement calls for us to pro- our doctors, lots of doctors. We talk to our Burns Grassley Pressler ceed to consider START II before we go families and other loved ones, and we ponder Coats Gregg Reid out of session this year. Yesterday, long and hard into the night with our God. Cochran Hatch Roth Conrad Hatfield Santorum again the majority leader said that it Coreen asks us to vote against this Coverdell Heflin Shelby was his intent that we complete action bill. Craig Helms Smith on START II. I think it is very impor- D’Amato Hutchison Stevens It will deny women a life saving and health DeWine Inhofe Thomas tant that we do that. saving option in a tragic emergency situa- Dole Johnston Thompson Again, I would just ask if it is his tion. You would not do it to your own wife. Domenici Kempthorne Thurmond view that we can go ahead and get that You would not do it to your own daughter. I Dorgan Kyl Warner treaty voted on and sent on before we ask you, please, do not do it to America’s NAYS—44 wives and to America’s daughters. go off on the holidays. Akaka Glenn Mikulski Mr. DOLE. Again, let me indicate There is no true life exception. It was Baucus Graham Moseley-Braun that I hope to take it up before Christ- a partial exception. It was different Bingaman Harkin Murray mas. I would like to complete action Boxer Hollings than the normal Hyde language. So Nunn before Christmas. If not, we will do it Bradley Inouye Pell this is indeed a radical proposal. Please Bryan Jeffords as quickly as we can when we are back vote ‘‘no’’ on final passage. President Pryor Bumpers Kassebaum Robb here. Clinton will veto this bill. Byrd Kennedy Rockefeller Campbell Kerrey But I think we need to take a look at The PRESIDING OFFICER. The Sen- Sarbanes Chafee Kerry the calendar. A week from today will Simon ator from New Hampshire is recognized Cohen Kohl Simpson be the 15th. One week later is the 22d. for 2 minutes. Daschle Lautenberg Next week we have this State Depart- Mr. SMITH. Madam President, the Dodd Leahy Snowe Feingold Levin Specter ment reorganization, Bosnia, and House of Representatives recently Feinstein Lieberman Wellstone rangeland reform. Again, it is a ques- voted overwhelming by a two-thirds NOT VOTING—1 tion of whether we can do it. majority to ban partial-birth abortion. I am advised by the distinguished Moynihan The vote on the ban was 288–139. chairman of the Foreign Relations This is not a radical extreme bill. It So the bill (H.R. 1833), as amended, Committee that he does not know of was supported by liberal Democrats was passed. any amendments to the START II such as PATRICK KENNEDY; liberal Re- Mr. SMITH. Madam President, I Treaty. There may be amendments. publicans, moderate Republicans, such move to reconsider the vote by which But it may not take more than a cou- as SUSAN MOLINARI; pro-choice, pro- the bill was passed. ple of hours. life. It is not a radical bill. RICH GEP- Mr. FORD. I move to lay that motion So, certainly, I would like to dispose HARDT supported it and others. on the table. of it before we leave from here this We have added a life-of-the-mother The motion to lay on the table was year. We will make every effort to do exception which was requested by some agreed to. so. of my colleagues on both sides of the Mr. BINGAMAN addressed the Chair. Mr. BINGAMAN. Madam President, aisle. We did that. I hope we can get a The PRESIDING OFFICER. The Sen- let me just say that I appreciate the similar, bipartisan overwhelming ma- ator from New Mexico. fact that we do have an agreement in jority here in the Senate like we had in f this unanimous-consent agreement to the House to stop what I believe is a ORDER OF PROCEDURE bring it up before we conclude the ses- very cruel practice. sion and move to the consideration of Let me conclude on this point, be- Mr. BINGAMAN. Madam President, I it. cause Senator BOXER and I have been wish to state a couple of questions and I am encouraged by the statement debating this on and off for several ask for the majority leader’s response, and by the indication of the Senator days now. The photograph that is being if I could, at this time. from North Carolina, the chairman of displayed here is of a woman who went Madam President, I know that there the Foreign Relations Committee, that through a terrible ordeal. We all know has been an agreement worked out he thinks we can move to it very expe- that. We have great sympathy for what with regard to the voting on the nomi- ditiously. she went through. But she did not have nations and on the START II Treaty. I I appreciate the majority leader’s the partial-birth abortion. She did not know that yesterday we had another very good work on the issues. I appre- have a partial-birth abortion. This discussion on the Senate floor, and the ciate the Senator from North Carolina, would not have stopped the procedure majority leader referred to his inten- and I also, of course, appreciate the that Coreen Costello had. tion to, also in addition to the nomina- Senator from Massachusetts, who I I urge my colleagues to vote for final tions for ambassadors, clear the rest of know has worked very hard to get this passage. I yield the floor. the items on the Executive Calendar agreement and, of course, the Demo- The PRESIDING OFFICER. All time before we left. cratic leader as well. has expired. I just wanted to once again ask for So thank you all. The bill having been read the third his assurance that that is his desire I no longer object to proceeding on time, the question is, Shall the bill and his intention before we adjourn the flag amendment. I know the major- pass? this fall. ity leader intends to do that tomorrow. The yeas and nays have been ordered. Mr. DOLE. Madam President, if the I have no objection. The clerk will call the roll. Senator will yield, I will just say, as I f The legislative clerk called the roll. did yesterday, that it is certainly my Mr. FORD. I announce that the Sen- hope that we can clear everything on UNANIMOUS-CONSENT AGREE- ator from New York [Mr. MOYNIHAN] is the Executive Calendar before we leave MENT—SENATE JOINT RESOLU- necessarily absent. this year. TION 31 The PRESIDING OFFICER. Are there I cannot give a 100 percent guarantee. Mr. DOLE. If there is not, I ask at any other Senators in the Chamber de- Somebody might have a hard hold on this time then that the cloture vote siring to vote? something. They may not be able to scheduled for Friday be vitiated, and I

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