110th CONGRESS
1st Session
H. R. 63
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to have been withdrawn, to provide for the review by the Comptroller General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
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to have been withdrawn, to provide for the review by the Comptroller General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.
Be it enacted by the Senate and House of Representatives 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 2007'.
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 reactions.
SEC. 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and commonly known as RU-486) is deemed to have been withdrawn under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.
END
