This legislation mandates the withdrawal of Federal Food, Drug, and Cosmetic Act approval for the drug mifepristone (Mifeprex, RU-486) when indicated for the termination of intrauterine pregnancy. This withdrawal becomes effective 14 days after the bill's enactment, making the introduction or delivery of mifepristone for this purpose into interstate commerce a violation of federal law. Furthermore, the drug would be considered misbranded if its labeling suggests use for pregnancy termination, effectively prohibiting its legal distribution for abortion. The bill also establishes a new Federal tort , creating liability for manufacturers of mifepristone if an individual suffers bodily injury or harm to mental health attributable to its use. This provision allows individuals to bring civil actions in federal or state courts to seek compensatory damages, punitive damages, and attorney's fees and costs. This tort takes effect 90 days after enactment and does not preempt any existing State laws that offer additional remedies to affected individuals, providing a new avenue for legal recourse.
This legislation mandates the withdrawal of Federal Food, Drug, and Cosmetic Act approval for the drug mifepristone (Mifeprex, RU-486) when indicated for the termination of intrauterine pregnancy. This withdrawal becomes effective 14 days after the bill's enactment, making the introduction or delivery of mifepristone for this purpose into interstate commerce a violation of federal law. Furthermore, the drug would be considered misbranded if its labeling suggests use for pregnancy termination, effectively prohibiting its legal distribution for abortion. The bill also establishes a new Federal tort , creating liability for manufacturers of mifepristone if an individual suffers bodily injury or harm to mental health attributable to its use. This provision allows individuals to bring civil actions in federal or state courts to seek compensatory damages, punitive damages, and attorney's fees and costs. This tort takes effect 90 days after enactment and does not preempt any existing State laws that offer additional remedies to affected individuals, providing a new avenue for legal recourse.