SAVE Moms and Babies Act of 2025

This bill, titled the "Support And Value Expectant Moms and Babies Act of 2025," seeks to significantly alter the regulation of abortion drugs under the Federal Food, Drug, and Cosmetic Act. It explicitly prohibits the Secretary of Health and Human Services from approving any new applications for marketing abortion drugs or granting investigational use exemptions for them. Furthermore, any existing investigational use exemptions for abortion drugs would be rescinded three years after the bill's enactment if they would otherwise be prohibited. For abortion drugs already approved, the bill imposes stringent new requirements. It forbids labeling changes that would allow use after 70 days gestation or dispensing by any means other than in-person administration by the prescribing healthcare practitioner. These drugs would also be subject to a mandatory Risk Evaluation and Mitigation Strategy (REMS) , requiring prescribing practitioners to be certified and possess specific medical abilities, such as assessing pregnancy duration and diagnosing ectopic pregnancies. The REMS would also limit dispensing to clinics, medical offices, or hospitals, mandate patient documentation of risks, and require comprehensive reporting of all known adverse events to the Food and Drug Administration.