HR679-119

What This Bill Does

This bill reverses the Food and Drug Administration January 2023 modifications to the risk evaluation and mitigation strategy for mifepristone under section 505-1 of the Federal Food, Drug, and Cosmetic Act. The bill states that those modifications are nullified. It also prohibits the Secretary of Health and Human Services, and any head of any HHS office, department, or agency, from establishing, implementing, or enforcing any mifepristone REMS provision that is substantially similar to the nullified January 2023 modifications. The practical effect is to block FDA and HHS from using the loosened 2023 REMS approach and push the regulatory framework back toward stricter pre-2023 access conditions for medication abortion involving mifepristone.

Who Benefits and How

Anti-abortion advocacy organizations benefit because the bill advances their goal of restricting medication abortion access. States and officials favoring tighter abortion regulation benefit from a federal rule that limits FDA ability to maintain the 2023 REMS changes. Pharmacies and clinicians that oppose medication abortion may benefit from less pressure to participate in a broader dispensing system. HHS and FDA officials favoring stricter controls gain statutory direction to avoid similar REMS modifications.

Who Bears the Burden and How

Patients seeking medication abortion bear the burden because access to mifepristone would become more restricted. Reproductive health providers, telehealth providers, pharmacies dispensing mifepristone, and pharmaceutical manufacturers must adjust to the restored restrictions and cannot rely on substantially similar 2023-style REMS provisions. FDA and HHS regulatory staff must unwind the modifications, enforce the prohibition, and avoid future REMS provisions that are substantially similar. Federal courts and compliance staff may face disputes over what counts as substantially similar.

Key Provisions

• Nullifies the FDA January 2023 mifepristone REMS modifications.
• Prohibits HHS and HHS component agencies from implementing substantially similar mifepristone REMS provisions.
• Restricts FDA flexibility to preserve or recreate the 2023 medication-abortion access changes.
• Requires regulated manufacturers, pharmacies, and providers to operate under the remaining REMS framework.