HR 679119th CongressIn Committee

To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

Introduced: Jan 23, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

H.R. 679 would reverse the January 2023 changes the FDA made to the risk evaluation and mitigation strategy (REMS) for mifepristone, the abortion pill. It nullifies those modifications and bars the Department of Health and Human Services (and any of its offices or agencies) from implementing or enforcing any REMS for mifepristone that is substantially similar to the 2023 changes. In effect, the bill seeks to restore the regulatory framework for mifepristone to what existed before the 2023 modifications, potentially limiting new or similar REMS changes in the future. The bill was introduced in the House on January 23, 2025, and referred to the Committee on Energy and Commerce.

Key Points

1Nullification of FDA’s January 2023 REMS modifications for mifepristone under section 505-1 of the Federal Food, Drug, and Cosmetic Act.
2Prohibition on establishing, implementing, or enforcing any REMS provisions for mifepristone that are substantially similar to the 2023 modifications.
3The REMS provisions in question relate to mifepristone’s regulatory framework under 21 U.S.C. 355-1.
4The bill directs that no head of the Health and Human Services Department or its offices/departments may enforce REMS for mifepristone that closely mirrors the 2023 changes.
5Legislative status: Introduced in the 119th Congress on January 23, 2025; referred to the Committee on Energy and Commerce.

Impact Areas

Primary group/area affected: Individuals seeking access to mifepristone and healthcare providers (including clinics, pharmacies, and telemedicine providers) who dispense or prescribe it, due to potential changes in how strictly REMS are applied.Secondary group/area affected: Regulators and manufacturers of mifepristone, as well as pharmacists and distributors who must navigate REMS requirements.Additional impacts: Potential effects on access to abortion medications, telemedicine and mail-order dispensing arrangements, and the regulatory landscape for REMS; possible policy and legal disputes between Congress and FDA/Department of Health and Human Services over drug safety controls and access.

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