110 HR 63 IH: RU–486 Suspension and Review Act of U.S. House of Representatives 2007-01-04 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 110th CONGRESS 1st Session H. R. 63 IN THE HOUSE OF REPRESENTATIVES January 4, 2007 Mr. Bartlett of Maryland 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application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU–486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for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.

1.

Short title

This Act may be cited as the RU–486 Suspension and Review Act of 2007.

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.

3.

Suspension of approval of drug commonly known as RU–486; review and report by Government Accountability 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and Cosmetic Act for the drug mifepristone (marketed as Mifeprex, and commonly known as RU–486) is deemed to have been withdrawn under section 505(e) of such Act.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 government accountability 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 Health and 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.