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.

Bill: 118-hr-5850
Sponsor: full_name: Rep. Mann, Tracey [R-KS-1]
Introduced: 2023-09-29
Policy area: Health
Subjects: Abortion

Drug safety, medical device, and laboratory regulation

Prescription drugs
Latest action: action_date: 2023-10-06
text: Referred to the Subcommittee on Health.

Summaries:

tv_txt: I 118th CONGRESS 1st Session H. R. 5850 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 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.

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.