II 

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to have been withdrawn, to provide for the review by the Comptroller 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known as RU–486 is deemed to have been withdrawn, 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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•S 511 IS

1 SECTION 1. SHORT TITLE. 

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

3 and Review Act of 2005’’. 

4 SEC. 2. FINDING. 

5 Congress finds that the use of the drug mifepristone 

6 (marketed as Mifeprex, and commonly known as RU–486) 

7 in conjunction with the off-label use of misoprostol to 

8 chemically induce abortion has caused a significant num9 ber of deaths, near deaths, and adverse reactions. 

10 SEC. 3. SUSPENSION OF APPROVAL OF DRUG COMMONLY 

11 KNOWN AS RU–486; REVIEW AND REPORT BY 

12 GOVERNMENT ACCOUNTABILITY OFFICE. 

13 (a) IN GENERAL.—Effective on the date that is 15 

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

15 (1) The approved application under section 

16 505(b) of the Federal Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 355(b)) for the drug mifepristone (mar18 keted as Mifeprex, and commonly known as RU– 

19 486) is deemed to have been withdrawn under sec20 tion 505(e) of such Act (21 U.S.C. 355(e)). 

21 (2) For purposes of sections 301(d) and 304 of 

22 such Act (21 U.S.C. 331(d) and 334), the introduc23 tion or delivery for introduction of such drug into 

24 interstate commerce shall be considered a violation 

25 of section 505 of such Act. 
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•S 511 IS

1 (3) The drug misoprostol shall be considered 

2 misbranded for purposes of sections 301 and 304 of 

3 such Act if the drug bears labeling providing that 

4 the drug may be used for the medical termination of 

5 intrauterine pregnancy or that the drug may be used 

6 in conjunction with another drug for the medical ter7 mination of intrauterine pregnancy. 

8 (b) REVIEW AND REPORT BY GOVERNMENT AC9 COUNTABILITY OFFICE.— 

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

11 the United States shall review the process by which 

12 the Food and Drug Administration approved 

13 mifepristone under section 505 of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 355) and shall 

15 determine whether such approval was provided in ac16 cordance with such section. The Secretary of Health 

17 and Human Services shall ensure that the Comp18 troller General has full access to all information pos19 sessed by the Department of Health and Human 

20 Services that relates to such process. 

21 (2) REPORT.—Not later than 180 days after 

22 the date of the enactment of this Act, the Comp23 troller General of the United States shall complete 

24 the review under paragraph (1) and submit to Con-
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1 gress and the Secretary of Health and Human Serv2 ices a report that provides the findings of the review. 

3 (c) CONTINGENT REINSTATEMENT OF APPROVAL OF

4 DRUG.—If the report under subsection (b) includes a de5 termination by the Comptroller General of the United 

6 States that the approval by the Food and Drug Adminis7 tration of mifepristone was provided in accordance with 

8 section 505 of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355), the Secretary of Health and Human 

10 Services shall publish such statement in the Federal Reg11 ister. Effective upon the expiration of 30 days after such 

12 publication, subsection (a) shall cease to have any legal 

13 effect. 

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