SAVE Moms and Babies Act of 2026

This bill significantly amends the Federal Food, Drug, and Cosmetic Act to establish new regulations concerning abortion drugs. It explicitly prohibits the Secretary of Health and Human Services from approving any new abortion drugs for marketing or granting investigational use exemptions for such drugs. This means that no new medication abortion products could be introduced to the market or studied for potential approval. For abortion drugs already approved, the bill imposes stringent new requirements. It prohibits labeling changes that would allow use beyond 70 days gestation or dispensing by any means other than in-person administration by the prescribing healthcare practitioner. Furthermore, these drugs would be subject to a mandatory Risk Evaluation and Mitigation Strategy (REMS) , which includes specific certification requirements for prescribers, such as the ability to diagnose ectopic pregnancies and provide surgical intervention for complications. The REMS also dictates that dispensing must occur in a clinic, medical office, or hospital through in-person administration by the prescribing practitioner, explicitly excluding pharmacies. Prescribers would be required to provide patients with documentation on serious complications and obtain acknowledgment of receipt. Additionally, the bill mandates comprehensive reporting of all known adverse events associated with abortion drugs by manufacturers, prescribers, and other healthcare practitioners to the Food and Drug Administration.