This bill, titled the "Restoring Safeguards for Dangerous Abortion Drugs Act," mandates significant changes to the regulation of mifepristone , defined as a "covered medication." It requires the Secretary of Health and Human Services to withdraw the current Risk Evaluation and Mitigation Strategy (REMS) for mifepristone within 90 days and reinstate the strategy identical to the one approved in June 2011 . Furthermore, the bill permanently prohibits the Secretary from approving any future REMS for mifepristone that deviates from this reinstated 2011 version, effectively imposing stricter regulatory controls on its distribution. The legislation also establishes a new federal cause of action, holding "covered entities" liable for harm caused by mifepristone. These entities include telehealth providers or pharmacies knowingly importing or transporting the drug in violation of federal law, and they can be sued for bodily injury or mental health harm attributable to such illegally distributed medication. Individuals may seek compensatory and punitive damages, as well as attorney's fees, with this provision taking effect 90 days after enactment and not preempting state remedies. Finally, the bill amends the Federal Food, Drug, and Cosmetic Act to impose a comprehensive ban on the importation of mifepristone into the United States, explicitly including its mailing to individuals.
Restoring Safeguards for Dangerous Abortion Drugs Act
USA119th CongressS-1631| Senate
| Updated: 5/6/2025
This bill, titled the "Restoring Safeguards for Dangerous Abortion Drugs Act," mandates significant changes to the regulation of mifepristone , defined as a "covered medication." It requires the Secretary of Health and Human Services to withdraw the current Risk Evaluation and Mitigation Strategy (REMS) for mifepristone within 90 days and reinstate the strategy identical to the one approved in June 2011 . Furthermore, the bill permanently prohibits the Secretary from approving any future REMS for mifepristone that deviates from this reinstated 2011 version, effectively imposing stricter regulatory controls on its distribution. The legislation also establishes a new federal cause of action, holding "covered entities" liable for harm caused by mifepristone. These entities include telehealth providers or pharmacies knowingly importing or transporting the drug in violation of federal law, and they can be sued for bodily injury or mental health harm attributable to such illegally distributed medication. Individuals may seek compensatory and punitive damages, as well as attorney's fees, with this provision taking effect 90 days after enactment and not preempting state remedies. Finally, the bill amends the Federal Food, Drug, and Cosmetic Act to impose a comprehensive ban on the importation of mifepristone into the United States, explicitly including its mailing to individuals.