RU-486 Suspension and Review Act of 2005

RU-486 Suspension and Review Act of 2005 - Deems the approved application for the drug mifepristone (marketed as Mifeprex, commonly known as RU-486, and used for the chemically induced termination of intrauterine pregnancy) to have been withdrawn.

Deems the drug misoprostol as misbranded under the Federal Food, Drug, and Cosmetic Act (FFDCA) if it bears labeling providing that the drug may be used for the medical termination of intrauterine pregnancy.

Directs the Comptroller General to review and report on the process by which the Food and Drug Administration (FDA) approved mifepristone. Provides for the reinstatement of the approved application for such drug if the report determines the approval to have been in accordance with FFDCA.

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 511 Introduced in Senate (IS)]







109th CONGRESS
  1st Session
                                 S. 511

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   have been withdrawn, to provide for the review by the Comptroller 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 3, 2005

  Mr. DeMint (for himself, Mr. Allen, Mr. Brownback, Mr. Coburn, Mr. 
Ensign, Mr. Enzi, Mr. Inhofe, Mr. Santorum, and Mr. Vitter) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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   have been withdrawn, to provide for the review by the Comptroller 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.

    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 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.
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