Restoring Safeguards for Dangerous Abortion Drugs Act

This bill requires the Secretary of Health and Human Services to replace the current risk evaluation and mitigation strategy (REMS) for mifepristone with the one approved in June 2011, and creates a federal tort for harm from abortion drugs imported illegally, while banning importation of mifepristone.

Sec. 2, Definition: The term "covered medication" means mifepristone, also known as Mifeprex, Korlym, and RU-486.

Sec. 3, Mifepristone REMS: Within 90 days of enactment, the Secretary must withdraw the current REMS for the covered medication and approve a REMS identical to the one approved in June 2011. The Secretary must require a REMS for the covered medication and may not approve any REMS different from the June 2011 version.

Sec. 4, Federal tort for harm to women caused by abortion drugs: A "covered entity" (a telehealth provider, pharmacy, or person who knowingly imports or transports the covered medication in violation of 18 U.S.C. 1462) is liable for bodily injury or mental health harm attributable to use of the medication imported or transported as described. An injured individual may sue for compensatory and punitive damages, plus attorney's fees and costs. This does not preempt any State law providing other remedies. This section takes effect 90 days after enactment.

Sec. 5, Ban on importation: The Federal Food, Drug, and Cosmetic Act is amended to prohibit importation of mifepristone into the United States, including by mailing it to individuals.