H.R. 5646 — Restoring Safeguards for Dangerous Abortion Drugs Act

This section directs the Secretary of Health and Human Services, not later than 90 days after the date of enactment, to (1) withdraw approval of the current risk evaluation and mitigation strategy (REMS) for mifepristone under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), and (2) approve a REMS identical to the one approved for mifepristone in June 2011. It further prohibits the Secretary from approving any REMS for mifepristone that differs from the June 2011 REMS. (As background, a REMS is an FDA-required risk management plan for drugs with serious safety risks, such as mifepristone used to terminate early pregnancy.)

This section establishes civil liability for 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—for bodily injury or mental health harm (including physical, psychological, emotional, or physiological harm) suffered by any individual attributable to such medication. It authorizes affected individuals to bring a private right of action in federal district court or state court of competent jurisdiction for (1) compensatory damages, (2) punitive damages, and (3) attorney's fees and costs. (As background, 18 U.S.C. §1462 prohibits using common carriers or interactive computer services to transport obscene or indecent materials, including drugs intended for producing abortion.) This section takes effect 90 days after enactment and does not preempt state laws providing other remedies.

This section amends the import provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) by (1) inserting mifepristone into the criteria for refusing admission of drugs, devices, or tobacco products from unregistered foreign establishments upon examination of samples; and (2) prohibiting, notwithstanding any other provision of law, any person from importing mifepristone into the United States, including by mailing such drug to individuals.