S. 1631 — Restoring Safeguards for Dangerous Abortion Drugs Act

This section directs the Secretary of Health and Human Services, not later than 90 days after enactment, to withdraw the current risk evaluation and mitigation strategy (REMS) for mifepristone (i.e., the drug used with misoprostol to terminate early pregnancy) under the Federal Food, Drug, and Cosmetic Act and to approve a REMS identical to that approved in June 2011. It further requires a REMS for mifepristone and prohibits approval of any different REMS.

This section establishes a federal tort liability regime holding "covered entities"—defined as telehealth providers, pharmacies, or other persons who knowingly import or transport a covered medication (i.e., abortion drugs) in interstate or foreign commerce in violation of 18 U.S.C. 1462—liable to any individual suffering bodily injury or mental health harm attributable to use of such medication. (As background, 18 U.S.C. 1462 criminally prohibits importation or interstate carriage of obscene materials and drugs, medicines, or articles intended or adapted for producing abortion.) Affected individuals may bring a private civil action in federal or state court for compensatory damages, punitive damages, and attorney's fees and costs; the section does not preempt state remedies and takes effect 90 days after enactment.

This section amends the import provisions of the Federal Food, Drug, and Cosmetic Act (1) by adding mifepristone to the list of articles from unregistered foreign establishments that may be refused admission and (2) by prohibiting any person from importing mifepristone into the United States, including by mailing such drug to individuals, notwithstanding any other provision of law.