I 
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to have been withdrawn, to provide for the review by the Comptroller 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. EVER-
ETT, Mr. FEENEY, Mr. FORBES, Mr. FRANKS of Arizona, Mr. GARRETT 
of New Jersey, Mr. GUTKNECHT, Ms. HART, Mr. HAYES, Mr. HOEK-
STRA, 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known as RU–486 is deemed to have been withdrawn, 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 Representa-
tives 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 re-
actions. 
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 introduc-
tion 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 ter-
mination 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 wheth-
er 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.