Safeguarding Women from Chemical Abortion Act

The bill orders that the Food and Drug Administration’s prior approval of mifepristone, when used to end an intrauterine pregnancy, is treated as withdrawn 14 days after the bill becomes law. This applies both to the original brand-name drug (Mifeprex/RU‑486) and to any generic versions that rely on mifepristone as the reference drug for that same use. After that, bringing these drugs into interstate commerce for that indication would count as a violation of the Food, Drug, and Cosmetic Act. The bill also says that mifepristone is considered “misbranded” if its label states that it may be used to end an intrauterine pregnancy or used with another drug for that purpose. Under existing law, misbranded drugs can be subject to enforcement actions such as seizure or other penalties. In addition, the bill creates a new federal cause of action (a type of lawsuit) against companies that make mifepristone for this use. A “covered entity” is any person or company that manufactures this medication for introduction into interstate commerce. If a person suffers bodily injury or harm to mental health that is linked, in whole or in part, to their use of the covered medication, the manufacturer is liable under this new rule. People who claim such injury can file a civil action in either a federal district court or a state court that has jurisdiction. They may seek compensatory damages, punitive damages, and recovery of attorney’s fees and costs. The bill states that it does not override any state law that offers other remedies, meaning state-level claims and protections can still apply. The new lawsuit provisions would start 90 days after the bill is enacted. Finally, the bill says it does not change or limit section 1461 of title 18 of the U.S. Code, which deals with certain criminal restrictions related to mailing specific materials.