II 

108TH CONGRESS 

1ST SESSION S. 1930

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to have been withdrawn, to provide for the review by the Comptroller 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

NOVEMBER 21, 2003

Mr. BROWNBACK (for himself, Mr. ENSIGN, Mr. ENZI, Mr. HAGEL, Mr. 

INHOFE, Mr. NICKLES, Mr. SANTORUM, and Mr. SESSIONS) 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known as RU–486 is deemed to have been withdrawn, 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 1930 IS 

1 SECTION 1. SHORT TITLE. 

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

3 and Review Act of 2003’’. 

4 SEC. 2. FINDING. 

5 The Congress finds that the use of the drug 

6 mifepristone (marketed as Mifeprex, and commonly known 

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

8 misoprostol to chemically induce abortion has caused a 

9 significant number of deaths, near deaths, and adverse re10 actions. 

11 SEC. 3. SUSPENSION OF APPROVAL OF DRUG COMMONLY 

12 KNOWN AS RU–486; REVIEW AND REPORT BY 

13 GENERAL ACCOUNTING OFFICE. 

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

15 14 days after the date of the enactment of this Act: 

16 (1) The approved application under section 

17 505(b) of the Federal Food, Drug, and Cosmetic Act 

18 for the drug mifepristone (marketed as Mifeprex, 

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

20 been withdrawn under section 505(e) of such Act. 

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

22 such Act, the introduction or delivery for introduc23 tion of such drug into interstate commerce shall be 

24 considered a violation of section 505 of such Act. 

25 (3) The drug misoprostol shall be considered 

26 misbranded for purposes of sections 301 and 304 of 
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•S 1930 IS 

1 such Act if the drug bears labeling providing that 

2 the drug may be used for the chemically induced ter3 mination of intrauterine pregnancy or that the drug 

4 may be used in conjunction with another drug for 

5 the chemically induced termination of intrauterine 

6 pregnancy. 

7 (b) REVIEW AND REPORT BY GENERAL ACCOUNTING

8 OFFICE.—

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

10 the United States shall review the process by which 

11 the Food and Drug Administration approved 

12 mifepristone under section 505 of the Federal Food, 

13 Drug, and Cosmetic Act and shall determine wheth14 er such approval was provided in accordance with 

15 such section. The Secretary of Health and Human 

16 Services shall ensure that the Comptroller General 

17 has full access to all information possessed by the 

18 Department of Health and Human Services and the 

19 Food and Drug Administration that relates to such 

20 process. 

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

22 the date of the enactment of this Act, the Comp23 troller General shall complete the review under para24 graph (1) and submit to the Congress and the Sec-
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•S 1930 IS 

1 retary of Health and Human Services a report that 

2 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 that the approval 

6 by the Food and Drug Administration of mifepristone was 

7 provided in accordance with section 505 of the Federal 

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

9 and Human Services shall publish such statement in the 

10 Federal Register. Effective upon the expiration of 30 days 

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

12 legal effect.

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