Congressional Record—Senate S11841
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September 20, 2007 CONGRESSIONAL RECORD — SENATE S11841 Mr. HATCH. One concern that I I would ask the chairman of the intend to clarify how Federal health raised, which we all agreed would have HELP Committee, Senator KENNEDY, agencies may use and release Medicare been included in the conference report whether he would agree to this request. data and make the appropriate amend- language had we filed such a report was Mr. KENNEDY. It is a great pleasure ments in the Social Security Act. At a clarification about the meaning of to work with my distinguished col- that point, it will be important that ‘‘scientific or regulatory issues.’’ It leagues from the Finance Committee the use of Medicare data be appro- was our agreement during negotiations on this reauthorization of important priately tied into the drug safety provi- on FDARA about what is perhaps an programs at the FDA. I know they sions of the FDA bill under consider- obvious point: if the law requires a have a deep interest in seeing that the ation today. We would hope that our delay in approval of an ANDA or medicines that Americans take are colleague, Senator KENNEDY, would 505(b)(2) application, for example be- safe and effective. agree to make conforming amendments cause of a patent or an exclusivity, this Senator BAUCUS and Senator GRASS- to the Federal Food, Drug and Cos- new provision will not change that re- LEY have rightly raised a question re- metic Act as needed to make FDA law quired legal result. The law is the law, garding the interpretation of section consistent with appropriate Medicare and its effect should not depend on 905 of this bill. Section 905 adds a new law. whether or not it was brought up in a paragraph (3) to section 505(k) of the Mr. KENNEDY. I appreciate that petition to FDA. I would appreciate the Federal Food, Drug and Cosmetic Act. conforming amendments in the Federal chairman clarifying if that was the This new paragraph establishes a sys- Food, Drug and Cosmetic Act may be agreement we had. tem for FDA to query databases re- necessary as you point out. I agree to Mr. KENNEDY. I do agree. Let us be garding information that may help de- work with the Senator in the future on clear: The citizen petition provision is tect adverse drug effects. It is essential this issue. designed to address attempts to derail to detect drug safety problems early, Mr. KENNEDY. Mr. President, I ask generic drug approvals. Those at- so that they may be corrected before unanimous consent that the bill be tempts, when successful, hurt con- people are hurt and an electronic drug read a third time, passed, the motion sumers and the public health. The cit- safety system is one important tool for to reconsider be laid upon the table, izen petition provisions are not in- doing so. and that any statements relating to tended to alter laws not amended by The Medicare claims database is list- the bill be printed in the RECORD, with- the provision. I thank the Senator. ed as one of several possible sources of out further intervening action or de- MEDICARE CLAIMS DATA data in section 505(k)(3)(C)(i)(III)(aa). I bate. Mr. BAUCUS. Mr. President, today want to assure my friends from Mon- The PRESIDING OFFICER. Without we have before us an important piece of tana and Iowa that our intent is that objection, it is so ordered. legislation, the FDA Amendments Act Medicare’s participation will be deter- The bill (H.R. 3580) was ordered to a of 2007. It has come to my attention mined by provisions of the Social Secu- third reading, was read the third time, that this bill includes a section that rity Act, over which the Finance Com- and passed. makes an effort to authorize the FDA mittee has exclusive jurisdiction. Mr. KENNEDY. Mr. President, the to use and release Medicare claims Nothing in this section is intended to New England Journal of Medicine, data for use in postmarket surveillance infringe on that jurisdiction or to in which is probably the most distin- of drugs approved by the FDA. I fully any way preempt the ability of the Fi- guished medical journal in not only support the goal of making drugs safer nance committee to act to specify the this country, probably in the world, for all Americans. participation or nonparticipation of has made the comment that this legis- As chairman of the Finance Com- the Medicare claims data base in the lation is the greatest progress, in mittee, however, I am obligated to system established under section 905. terms of drug safety, in a century. This point out that any use of Medicare The matter before the Senate amends ought to be reassuring for every family data is exclusively governed by title the Federal Food, Drug and Cosmetic as to the safety of their prescription XVIII of the Social Security Act, and Act. The section to which you have drugs and also in terms of their food. that the Finance Committee has exclu- raised concerns authorizes use of Medi- The PRESIDING OFFICER. The Sen- sive jurisdiction over title XVIII. I care data ‘‘as available.’’ I acknowl- ator from Massachusetts. would ask the distinguished chairman edge that under current law, that is Mr. KERRY. Mr. President, I con- of the Health, Education, Labor and not possible. gratulate my colleague from Massa- Pensions Committee, Senator KEN- Mr. BAUCUS. I thank the chairman. chusetts on another landmark piece of NEDY, to acknowledge that the Senate I intend to continue working with my legislation that he has been able to Finance Committee has sole jurisdic- good friend Senator GRASSLEY to ad- shepherd through this institution. It tion over Medicare data and title XVIII dress the release and use of Medicare adds to a remarkable string of legisla- of the Social Security Act and ask that data by Federal health agencies and tive accomplishments. he endeavor to consult us on matters private researchers soon through legis- We are all pleased this important re- before the HELP Committee that touch lation written by the Finance Com- form effort and advance is going to be on the Senate Finance Committee’s ju- mittee. made. It is a terrific step forward. I risdiction. I make the same commit- Mr. GRASSLEY. I agree with my col- congratulate Senator KENNEDY, Sen- ment to him that he makes to me: I league, Senator BAUCUS. I have been ator ENZI, and others on the committee will commit to consult on matters be- working a long time on legislation to who worked so hard to make it happen. fore the Finance Committee that touch permit the use of Medicare data to im- f on the Senate HELP Committee’s ju- prove drug safety. After all this is risdiction. some of the best and most complete NATIONAL DEFENSE AUTHORIZA- To avoid unnecessary confusion as to data available. In fact, Senator BAUCUS TION ACT FOR FISCAL YEAR the jurisdiction of the Finance Com- and I joined together to introduce leg- 2008—Continued mittee or further delay in the consider- islation to accomplish just that during Mr. KERRY. Mr. President, I have ation of this important conference the 109th Congress, S. 3987, the Medi- been listening to my colleagues on the agreement, I would agree to accommo- care Data Access and Research Act, other side of the aisle, and sometimes I date your request to withhold any ob- and this Congress, S. 1507, the Access think we are talking past each other jection to the Senate’s consideration of to Medicare Data Act of 2007. Improv- and about different legislation. it with the acknowledgement that the ing drug safety is a top priority of The proposal in the Levin-Reed- release and use of Medicare data are mine and the appropriate use of Medi- Kerry and other Senators legislation governed by title XVIII of the Social care data will likely enhance drug safe- says nothing about precipitous. I don’t Security Act and are under the exclu- ty. That will benefit all Americans. I know how one interprets ‘‘precipitous’’ sive jurisdiction of the Finance Com- look forward to completing our goals when we leave the President the discre- mittee. This does not represent any for Medicare data later this year and tion to decide how many troops he is waiver of jurisdiction on the part of including this on legislation within the going to have there for training, for the Finance Committee on this subject. purview of the Finance Committee. We prosecuting the war on terror against VerDate Mar 15 2010 22:19 Mar 13, 2014 Jkt 081600 PO 00000 Frm 00067 Fmt 0624 Sfmt 0634 E:\2007SENATE\S20SE7.REC S20SE7 mmaher on DSKCGSP4G1 with SOCIALSECURITY S11842 CONGRESSIONAL RECORD — SENATE September 20, 2007 al-Qaida, and for the job of protecting Then after the Iraq Study Group re- While we have waited for General American facilities and forces. ported, everybody said: OK, we are Petraeus to report, a lot of young The fact is that for many people in going to wait and give General Americans have died. Meanwhile, today the country, this is inadequate. It is Petraeus an opportunity to report; we in the Senate, we were distracted by not precipitous. To have a debate about are going to wait for September, and this much discussed, much condemned buzz words that excite the base does we will see whether we are going to ad in a newspaper 2 weeks ago. Some not serve our troops well, and it cer- change the strategy.