No CRS summary available for this bill.
This section deems FDA approval withdrawn, effective 14 days after enactment, for any new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) for the drug mifepristone (marketed as Mifeprex, also known as RU-486) indicated for termination of intrauterine pregnancy, and for any abbreviated new drug application under section 505(j) (21 U.S.C. 355(j)) for a drug with the same indication referencing mifepristone. It further deems the introduction or delivery for introduction into interstate commerce of such a drug a violation of section 505 (21 U.S.C. 355) for purposes of prohibited acts under sections 301(d) and 304 (21 U.S.C. 331(d), 334); and deems mifepristone misbranded under sections 301 and 304 (21 U.S.C. 331, 334) if its labeling states it may be used for termination of intrauterine pregnancy or in conjunction with another drug for that purpose. (Thus, after 14 days, distributing mifepristone for abortion use or with such labeling becomes prohibited.)
This section establishes a federal tort cause of action against any manufacturer introducing mifepristone (marketed as Mifeprex or RU-486; a drug approved under the Federal Food, Drug, and Cosmetic Act for terminating intrauterine pregnancies) into interstate commerce for bodily injury or mental health harm (including physical, psychological, emotional, or physiological harm) attributable to an individual's use of the drug. An affected individual may sue the manufacturer in federal district court or state court of competent jurisdiction for (1) compensatory damages, (2) punitive damages, and (3) attorney's fees and costs. The provision does not preempt state laws providing other remedies and takes effect 90 days after enactment.