[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3453 Introduced in House (IH)]






108th CONGRESS
  1st Session
                                H. R. 3453

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   have been withdrawn, to provide for the review by the Comptroller 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 HOUSE OF REPRESENTATIVES

                            November 6, 2003

   Mr. DeMint (for himself, Mr. Bartlett of Maryland, Mr. DeLay, Mr. 
   Blunt, Mr. Aderholt, Mr. Akin, Mr. Barrett of South Carolina, Mr. 
  Beauprez, Mr. Bishop of Utah, Mr. Boozman, Mr. Brady of Texas, Mr. 
 Brown of South Carolina, Mr. Cantor, Mr. Carter, Mr. Cole, Mr. Crane, 
Mrs. Jo Ann Davis of Virginia, Mr. Doolittle, Mr. Everett, Mr. Feeney, 
   Mr. Forbes, Mr. Franks of Arizona, Mr. Garrett of New Jersey, Mr. 
   Gutknecht, Ms. Hart, Mr. Hayes, Mr. Hoekstra, Mr. Hostettler, Mr. 
   Hunter, Mr. Istook, Mr. Sam Johnson of Texas, Mr. Jones of North 
 Carolina, Mr. Keller, Mr. Kennedy of Minnesota, Mr. King of Iowa, Mr. 
  Manzullo, Mr. McCotter, Mr. Miller of Florida, Mrs. Musgrave, Mrs. 
  Myrick, Mr. Pence, Mr. Pickering, Mr. Pitts, Mr. Renzi, Mr. Ryan of 
 Wisconsin, Mr. Ryun of Kansas, Mr. Schrock, Mr. Shadegg, Mr. Shimkus, 
   Mr. Smith of New Jersey, Mr. Souder, Mr. Stearns, Mr. Stupak, Mr. 
Sullivan, Mr. Tancredo, Mr. Terry, Mr. Tiahrt, Mr. Toomey, Mr. Vitter, 
and Mr. Wilson of South Carolina) introduced the following bill; which 
          was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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   have been withdrawn, to provide for the review by the Comptroller 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 
2003''.

SEC. 2. FINDING.

    The 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 GENERAL ACCOUNTING OFFICE.

    (a) In General.--Effective upon the expiration of 14 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 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.
            (2) For purposes of sections 301(d) and 304 of such Act, 
        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 General Accounting 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 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 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 shall complete 
        the review under paragraph (1) and submit to the 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 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, 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) ceases to have any legal effect.
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