HR679-119

1. Nullification of modifications to REMS for mifepristone The modifications made by the Food and Drug Administration in January 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. The Secretary of Health and Human Services (or any head of any office, department, or agency of the Department of Health and Human Services) shall not establish, implement, or enforce 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).