H.R. 7902 — Safeguarding Women from Chemical Abortion Act

This section deems FDA approval withdrawn under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), effective 14 days after enactment, for mifepristone (marketed as Mifeprex or RU-486) and any generic applications under section 505(j) referencing it, when indicated for termination of intrauterine pregnancy. (Thus, for purposes of FD&C Act sections 301(d) and 304, introduction of such drugs into interstate commerce violates section 505.) It further deems mifepristone misbranded under FD&C Act sections 301 and 304 if labeled for termination of intrauterine pregnancy or for use with another drug for that purpose.

This section establishes federal civil liability for any person manufacturing mifepristone (marketed as Mifeprex or RU-486; a "covered medication," i.e., approved under 21 U.S.C. 355(b) or (j) for terminating intrauterine pregnancy) that causes bodily injury or mental health harm (including physical, psychological, emotional, or physiological harm) attributable to an individual's use of the drug. It authorizes affected individuals to sue the manufacturer in federal or state court for compensatory damages, punitive damages, and attorney's fees and costs and specifies that the provision does not preempt state laws providing other remedies. The section takes effect 90 days after enactment.