Restoring Safeguards for Dangerous Abortion Drugs Act
The Restoring Safeguards for Dangerous Abortion Drugs Act would (1) revert the safety framework for the abortion drug mifepristone (also known as Mifeprex, Korlym, RU-486) to the version approved in June 2011 and prevent any new or modified risk evaluation and mitigation strategy (REMS) for this drug, (2) create a federal civil liability regime that lets individuals sue “covered entities” (such as telehealth providers and pharmacies) for harms they allege come from mifepristone when the drug is imported or transported illegally, and (3) bar importation of mifepristone into the United States, including mail-order shipments. The bill would impose a 90-day deadline after enactment to implement the REMS reversion and would allow private lawsuits for damages, penalties, and legal fees. In short, it aims to lock in an older safety regime for mifepristone, expand legal accountability for harms linked to the drug, and prohibit its importation. Potential impact includes reduced access to mifepristone via telemedicine or mail-order channels, increased legal exposure for providers and others involved with the drug’s distribution, and a higher barrier to bringing mifepristone into the U.S. market. These provisions interact with ongoing debates over abortion access, drug safety regulation, and interstate commerce.
Key Points
- 1The bill defines “covered medication” as mifepristone (brand names Mifeprex, Korlym) and RU-486.
- 2REMS reset: Within 90 days of enactment, the Secretary of Health and Human Services must withdraw any current REMS for mifepristone and approve a REMS that is identical to the June 2011 REMS, with a ban on approving any REMS that differs from that 2011 version.
- 3Federal tort liability: Establishes a private right of action against a “covered entity” (telehealth provider, pharmacy, or any person who knowingly imports or transports mifepristone in violation of federal law) for bodily or mental-harm damage tied to the use of the drug. Plaintiffs could seek compensatory and punitive damages plus attorney’s fees; state laws providing additional remedies are not preempted.
- 4Import ban: Amends the FD&C Act to prohibit importation of mifepristone into the United States, including by mail, effectively blocking interstate and international shipments.
- 5Effective date: The import ban and REMS changes would take effect in a defined period after enactment (e.g., 90 days for REMS; similar timing for other provisions), with the tort provisions applying as described.