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Requires the Department of Health and Human Services to restore the 2011 FDA safety program (REMS) for the abortion drug mifepristone within 90 days, bans importation and mailing of mifepristone into the United States, and creates a private civil cause of action allowing people harmed by illegally imported or transported abortion medications to sue for damages and attorney’s fees (civil claims effective 90 days after enactment). The law defines “covered medication” as mifepristone and makes covered entities that import or transport the drug in violation of federal law liable for physical or mental-health harm.
Defines the term "covered medication" to mean mifepristone, also known by the brand names Mifeprex and Korlym, and by the developmental code name RU–486.
Not later than 90 days after the date of enactment, the Secretary of Health and Human Services must withdraw approval of the risk evaluation and mitigation strategy (REMS) for the covered medication that is in effect on the date of enactment.
Not later than 90 days after the date of enactment, the Secretary of Health and Human Services must approve a REMS for the covered medication that is identical to the REMS the Secretary approved in June 2011.
Notwithstanding any provision of section 505–1 of the FD&C Act, the Secretary shall require a REMS pursuant to section 505–1 for the covered medication.
The Secretary may not approve a REMS for the covered medication that is different from the strategy described (the June 2011 REMS).
People seeking medication abortion with mifepristone are directly affected because the law restores a specific FDA safety program and prohibits importation and mailing of the drug into the U.S. Health care providers, clinics, and telemedicine programs that prescribe or facilitate access to mifepristone will face changes in how they must comply with FDA rules and may lose access to cross-border supply routes. Pharmacies, mail-order dispensers, distributors, and international suppliers that import or mail mifepristone into the U.S. would be subject to the import ban and to civil liability if their shipments are deemed unlawful. HHS and FDA must act quickly to withdraw and reapprove the specified REMS within 90 days, which narrows their regulatory flexibility. Individuals harmed by mifepristone that was imported or transported in violation of federal law gain a federal civil remedy to seek damages and attorney’s fees, increasing litigation risk for covered entities. The law does not create federal funding streams or explicit criminal penalties in the text provided, but it changes regulatory controls and private liability exposure, which could alter how providers, pharmacies, and distributors operate or whether they supply the drug at all. Access differences are likely to fall hardest on people who rely on mail-order, cross-border, or other non‑domestic supply mechanisms, including people in states with limited clinic availability or restrictive state laws. Enforcement and litigation could shift costs to private entities and may increase administrative burdens for HHS/FDA as they implement the mandated REMS restoration.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced May 6, 2025 by Joshua David Hawley · Last progress May 6, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate