H.R. 5850 (Introduced in House) — 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.

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.

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.

Section 1 Nullification of REMS modifications for mifepristone; no Federal funding to implement REMS for mifepristone

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Incoming references