[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5850 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5850
To nullify modifications made by the Food and Drug Administration on
January 3, 2023, to the risk evaluation and mitigation strategy under
section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355-1) for mifepristone, and for other purposes.
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IN THE HOUSE OF REPRESENTATIVES
September 29, 2023
Mr. Mann (for himself and Mr. Moolenaar) introduced the following bill;
which was referred to the Committee on Energy and Commerce
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A BILL
To nullify modifications made by the Food and Drug Administration on
January 3, 2023, to the risk evaluation and mitigation strategy under
section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355-1) for mifepristone, 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. NULLIFICATION OF REMS MODIFICATIONS FOR MIFEPRISTONE; NO
FEDERAL FUNDING TO IMPLEMENT REMS FOR MIFEPRISTONE.
(a) In General.--The modifications made by the Food and Drug
Administration on January 3, 2023, to the risk evaluation and
mitigation strategy under section 505-1 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355-1) for mifepristone are hereby nullified.
(b) Prohibition on Federal Funds.--No Federal funds may be used to
establish, implement, or enforce--
(1) any provision of a risk evaluation and mitigation
strategy under section 505-1 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355-1) for mifepristone that is
substantially similar to any of the modifications nullified by
subsection (a); or
(2) any non-enforcement or enforcement discretion policy
for any provision of a risk evaluation and mitigation strategy
under such section for mifepristone.
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