[Congressional Record Volume 151, Number 23 (Thursday, March 3, 2005)]
[Senate]
[Pages S2020-S2021]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      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486 is deemed to have been withdrawn, to provide for the review by the 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.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 511

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``RU-486 Suspension and Review 
     Act of 2005''.

     SEC. 2. FINDING.

       Congress finds that the use of the drug mifepristone 
     (marketed as Mifeprex, and commonly known as RU-486) in 
     conjunction with the off-label use of misoprostol to 
     chemically induce abortion has caused a significant number of 
     deaths, near deaths, and adverse reactions.

     SEC. 3. SUSPENSION OF APPROVAL OF DRUG COMMONLY KNOWN AS RU-
                   486; REVIEW AND REPORT BY GOVERNMENT 
                   ACCOUNTABILITY OFFICE.

       (a) In General.--Effective on the date that is 15 days 
     after the date of the enactment of this Act:
       (1) The approved application under section 505(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) for 
     the drug mifepristone (marketed as Mifeprex, and

[[Page S2021]]

     commonly known as RU-486) is deemed to have been withdrawn 
     under section 505(e) of such Act (21 U.S.C. 355(e)).
       (2) For purposes of sections 301(d) and 304 of such Act (21 
     U.S.C. 331(d) and 334), the introduction or delivery for 
     introduction of such drug into interstate commerce shall be 
     considered a violation of section 505 of such Act.
       (3) The drug misoprostol shall be considered misbranded for 
     purposes of sections 301 and 304 of such Act if the drug 
     bears labeling providing that the drug may be used for the 
     medical termination of intrauterine pregnancy or that the 
     drug may be used in conjunction with another drug for the 
     medical termination of intrauterine pregnancy.
       (b) Review and Report by Government Accountability 
     Office.--
       (1) In general.--The Comptroller General of the United 
     States shall review the process by which the Food and Drug 
     Administration approved mifepristone under section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 
     shall determine whether such approval was provided in 
     accordance with such section. The Secretary of Health and 
     Human Services shall ensure that the Comptroller General has 
     full access to all information possessed by the Department of 
     Health and Human Services that relates to such process.
       (2) Report.--Not later than 180 days after the date of the 
     enactment of this Act, the Comptroller General of the United 
     States shall complete the review under paragraph (1) and 
     submit to Congress and the Secretary of Health and Human 
     Services a report that provides the findings of the review.
       (c) Contingent Reinstatement of Approval of Drug.--If the 
     report under subsection (b) includes a determination by the 
     Comptroller General of the United States that the approval by 
     the Food and Drug Administration of mifepristone was provided 
     in accordance with section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), the Secretary of Health and 
     Human Services shall publish such statement in the Federal 
     Register. Effective upon the expiration of 30 days after such 
     publication, subsection (a) shall cease to have any legal 
     effect.
                                 ______