Sponsors (9)
The bill clarifies that mifepristone is the covered drug and centralizes/regulates its distribution (including reinstating an older REMS and granting a federal remedy for harms), but it locks in an outdated regulatory regime, expands provider liability, and blocks imports in ways that are likely to reduce access, raise costs, and increase legal risk for patients and providers.
Pregnant people and clinicians: the bill explicitly names mifepristone as the medication covered, removing ambiguity about which drug the statute applies to.
Clinicians, pharmacies, and patients: the bill reverts to the June 2011 REMS and bars approval of a different REMS, producing uniform, predictable regulatory requirements for providers and dispensers.
People harmed by the medication: the bill creates a federal civil cause of action allowing injured individuals to sue in federal court and recover compensatory and punitive damages and attorney’s fees, while preserving stronger state remedies.
People seeking medication and providers (telehealth services, pharmacies, importers): the bill creates broad federal liability (including punitive damages and fee awards) for distribution/importation that will likely deter telehealth and interstate provision, causing providers to restrict services or refuse prescriptions.
People in restrictive states and those relying on cross‑border mail (including immigrants): the bill's import restrictions and customs mandate may deny or criminalize cross‑border access to mifepristone, increasing barriers, delays, and costs for people who depend on mail-order or foreign supply.
Patients and regulators: reverting to a dated REMS and forbidding HHS from approving a different REMS locks in older safety/regulatory rules, prevents updates based on new evidence, could reintroduce distribution limits, and may include reporting that raises privacy concerns.
Based on analysis of 5 sections of legislative text.
Restores the FDA's June 2011 REMS for mifepristone, bans importation of mifepristone into the U.S., and creates federal civil liability for harms from unlawfully imported abortion medications.
Requires the Department of Health and Human Services (HHS) to restore the FDA’s June 2011 Risk Evaluation and Mitigation Strategy (REMS) for the abortion drug mifepristone within 90 days and forbids any alternative REMS. Creates a federal civil cause of action for individuals who suffer bodily or mental-health injury tied to knowingly imported or transported abortion medications, allows compensatory and punitive damages and attorney fees, and adds an express statutory ban on importing mifepristone into the United States by any means.
Introduced September 30, 2025 by Mary E. Miller · Last progress September 30, 2025