Bill > HR5646

This bill aims to impose stricter regulations on mifepristone, a medication used for medical abortions. The bill requires the Secretary of Health and Human Services to revert the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone to its June 2011 version within 90 days of enactment, effectively reversing any recent changes to the drug's safety protocols. The bill also establishes a federal tort liability mechanism that allows individuals who experience bodily or mental health injuries from using mifepristone to sue telehealth providers, pharmacies, or entities that import or transport the medication in violation of federal law. Additionally, the bill amends the Federal Food, Drug, and Cosmetic Act to ban the importation of mifepristone into the United States, including prohibiting mailing the drug to individuals. The legislation defines mifepristone (also known by brand names Mifeprex and Korlym, and developmental code RU-486) as a "covered medication" and sets up a framework to significantly restrict its availability and use by creating new legal barriers and liability risks for providers and distributors.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/5646/all-info