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.
Sponsors
Legislative Progress
IntroducedMrs. Harshbarger (for herself, Mr. Hern of Oklahoma, Mr. Bost, …
Summary
What This Bill Does
HR 679-119 nullifies changes the FDA made in January 2023 to the safety regulations for mifepristone, a medication used for abortion. The bill reinstates the stricter pre-2023 requirements and prohibits the Department of Health and Human Services from implementing similar relaxed rules in the future.
Who Benefits and How
Anti-abortion advocacy groups benefit as this bill makes access to medication abortion more difficult, advancing their policy goals. States with existing abortion restrictions may see reduced access to mifepristone within their borders. Healthcare providers who oppose providing abortion services are not required to comply with the now-nullified 2023 modifications.
Who Bears the Burden and How
Patients seeking medication abortion face higher barriers to access, as the pre-2023 rules likely required in-person doctor visits and more restrictive dispensing requirements. Reproductive healthcare providers must comply with the more burdensome pre-2023 REMS protocol, potentially including additional certification requirements and restrictions on prescribing. Pharmaceutical manufacturers of mifepristone and pharmacies that dispense it face increased compliance costs from the stricter safety requirements. The FDA's regulatory authority is constrained, as the agency cannot implement safety modifications similar to those it determined appropriate in 2023.
Key Provisions
- Nullifies all modifications the FDA made to the mifepristone Risk Evaluation and Mitigation Strategy (REMS) in January 2023
- Prohibits the Secretary of HHS or any HHS agency from establishing, implementing, or enforcing any REMS provision for mifepristone that is substantially similar to the nullified 2023 modifications
- Effectively reinstates the more restrictive pre-2023 safety protocols for prescribing, dispensing, and using mifepristone
- Applies to all federal regulation of mifepristone under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1)
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Nullifies FDA's January 2023 modifications to the Risk Evaluation and Mitigation Strategy for mifepristone (abortion medication) and prohibits similar future modifications
Policy Domains
Legislative Strategy
"Restrict access to abortion medication by reinstating more stringent FDA safety protocols that existed prior to January 2023"
Likely Beneficiaries
- Anti-abortion advocacy groups
- States with abortion restrictions
- Healthcare providers opposed to abortion services
Likely Burden Bearers
- Reproductive healthcare providers
- Pharmaceutical manufacturers of mifepristone
- Patients seeking medication abortion
- FDA regulatory authority
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
Risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1)
Medication subject to REMS under 21 U.S.C. 355-1 (commonly known as abortion pill)
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
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology