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to have been withdrawn, to provide for the review by the Comptroller 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. 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known as RU–486 is deemed to have been withdrawn, 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 
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of the United States of the process by which the Food 

and Drug Administration approved such drug, and for 

other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘RU–486 Suspension 

5 and Review Act of 2003’’. 

6 SEC. 2. FINDING. 

7 The Congress finds that the use of the drug 

8 mifepristone (marketed as Mifeprex, and commonly known 

9 as RU–486) in conjunction with the off-label use of 

10 misoprostol to chemically induce abortion has caused a 

11 significant number of deaths, near deaths, and adverse re12 actions. 

13 SEC. 3. SUSPENSION OF APPROVAL OF DRUG COMMONLY 

14 KNOWN AS RU–486; REVIEW AND REPORT BY 

15 GENERAL ACCOUNTING OFFICE. 

16 (a) IN GENERAL.—Effective upon the expiration of 

17 14 days after the date of the enactment of this Act: 

18 (1) The approved application under section 

19 505(b) of the Federal Food, Drug, and Cosmetic Act 

20 for the drug mifepristone (marketed as Mifeprex, 

21 and commonly known as RU–486) is deemed to have 

22 been withdrawn under section 505(e) of such Act. 
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1 (2) For purposes of sections 301(d) and 304 of 

2 such Act, the introduction or delivery for introduc3 tion of such drug into interstate commerce shall be 

4 considered a violation of section 505 of such Act. 

5 (3) The drug misoprostol shall be considered 

6 misbranded for purposes of sections 301 and 304 of 

7 such Act if the drug bears labeling providing that 

8 the drug may be used for the medical termination of 

9 intrauterine pregnancy or that the drug may be used 

10 in conjunction with another drug for the medical ter11 mination of intrauterine pregnancy. 

12 (b) REVIEW AND REPORT BY GENERAL ACCOUNTING

13 OFFICE.—

14 (1) IN GENERAL.—The Comptroller General of 

15 the United States shall review the process by which 

16 the Food and Drug Administration approved 

17 mifepristone under section 505 of the Federal Food, 

18 Drug, and Cosmetic Act and shall determine wheth19 er such approval was provided in accordance with 

20 such section. The Secretary of Health and Human 

21 Services shall ensure that the Comptroller General 

22 has full access to all information possessed by the 

23 Department of Human Services that relates to such 

24 process. 
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1 (2) REPORT.—Not later than 180 days after 

2 the date of the enactment of this Act, the Comp3 troller General shall complete the review under para4 graph (1) and submit to the Congress and the Sec5 retary of Health and Human Services a report that 

6 provides the findings of the review. 

7 (c) CONTINGENT REINSTATEMENT OF APPROVAL OF

8 DRUG.—If the report under subsection (b) includes a de9 termination by the Comptroller General that the approval 

10 by the Food and Drug Administration of mifepristone was 

11 provided in accordance with section 505 of the Federal 

12 Food, Drug, and Cosmetic Act, the Secretary of Health 

13 and Human Services shall publish such statement in the 

14 Federal Register. Effective upon the expiration of 30 days 

15 after such publication, subsection (a) ceases to have any 

16 legal effect.

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