STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - March 03, 2005)
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By Mr. DEMINT (for himself, Mr. ALLEN, Mr. BROWNBACK, Mr. COBURN, Mr. ENSIGN, Mr. ENZI, Mr. INHOFE, Mr. SANTORUM, and Mr. VITTER):
S. 511. A bill to provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU-486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
Mr. DEMINT. Mr. President, I rise today to reintroduce ``Holly's Law,'' a bill that would suspend FDA's approval of RU-486 and direct the GAO to conduct an independent review of the process used by the FDA to approve the drug.
Holly's Law is named in memory of Holly Patterson, an 18-year old woman who died after taking the drug in 2003. RU-486 has killed three women in the United States and many more have been hospitalized with a severe bacterial infection known as septic shock.
RU-486 was approved by the FDA in September of 2000. The FDA approved RU-486 under a special ``restricted distribution'' approval process known as ``Subpart H,'' reserved only for drugs that treat ``severe or life-threatening illnesses,'' like cancer and AIDS.
Subpart H allows an expedited approval of certain drugs by not subjecting them to the testing and review standards required of all other new drugs. These are important tests necessary to determine the safety and long-term effects of a drug. Clearly, the fact that these tests were not done on RU-486 was a damaging omission considering the death and illness associated with use of the drug.
Due to the serious threat RU-486 poses to women's health, we are asking that Congress suspend FDA's approval of RU-486 until the GAO can provide a report on whether RU-486 should have been deemed ``safe and effective'' by the FDA.
I am grateful to Senators Allen, Brownback, Coburn, Ensign, Enzi, Inhofe, Santorum and Vitter who have joined me as original cosponsors of this bill. They understand that RU-486 is a dangerous drug that cannot remain on the market while more women die. I urge my colleagues to support Holly's Law to take RU-486 off the market before more women are harmed by it.
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