118 HR 5850 IH: 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. U.S. House of Representatives 2023-09-29 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.

I118th CONGRESS1st SessionH. R. 5850IN THE HOUSE OF REPRESENTATIVESSeptember 29, 2023Mr. Mann (for himself and Mr. Moolenaar) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.

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.