Bill > HR685

This bill, called the "SAVE Moms and Babies Act of 2025", proposes significant restrictions on abortion drugs within the Federal Food, Drug, and Cosmetic Act. The bill prohibits the Food and Drug Administration (FDA) from approving new abortion drugs or granting investigational use exemptions for such drugs. For previously approved abortion drugs, the bill mandates stringent new regulations, including requiring in-person administration by a certified healthcare practitioner, restricting drug dispensing to clinics or medical offices, and implementing comprehensive reporting requirements for adverse events. The bill defines an "abortion drug" as any substance intended to terminate a pregnancy, with specific exceptions for producing live births, removing dead unborn children, or treating ectopic pregnancies. Healthcare practitioners would be required to be specially certified, possessing skills like accurately assessing pregnancy duration, diagnosing ectopic pregnancies, and providing surgical interventions if necessary. The bill also broadly defines "adverse events" to include fatalities, hospitalizations, blood transfusions, and various infections. Existing investigational drug exemptions related to abortion would be rescinded within three years of the act's enactment. The legislation emphasizes patient safety and imposes extensive documentation and reporting obligations on healthcare providers and drug manufacturers.

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https://www.congress.gov/bill/119th-congress/house-bill/685/all-info