S. 3697 — SAVE Moms and Babies Act of 2026

This section prohibits the Food and Drug Administration (FDA) from approving any new drug application under subsection (b) or abbreviated new drug application under subsection (j) for an abortion drug (i.e., any drug intended to terminate the pregnancy of a known pregnant woman, except to produce live birth, remove a dead unborn child, or treat an ectopic pregnancy) and from granting investigational new drug exemptions under subsection (i) for abortion drugs or investigations knowingly destroying the unborn child of a known pregnant woman. For abortion drugs with approvals in effect on the date of enactment of the Support And Value Expectant Moms and Babies Act of 2026, the section (1) bars labeling changes approving use after 70 days' gestation (period beginning on first day of last menstrual period) or dispensing other than in-person administration by the prescribing health care practitioner; (2) deems such drugs prescription drugs under section 503(b)(1); and (3) mandates a risk evaluation and mitigation strategy (REMS) under section 505-1 requiring, at minimum, prescriber certification (excluding pharmacists and confirming abilities to assess pregnancy duration, diagnose ectopic pregnancies, provide surgical intervention for incomplete abortion or severe bleeding, ensure access to transfusion/resuscitation facilities, and report deaths/adverse events using non-identifiable patient references and package serial numbers); in-person dispensing only in clinics, medical offices, or hospitals; patient receipt and acknowledgment of risk documentation; adverse event reporting (e.g., fatalities, ectopic pregnancies, hospitalizations, transfusion-requiring blood loss, severe infections) by manufacturers and prescribers; and administration reporting per state law or as for surgical abortions. The section further requires all other health care practitioners to report patient adverse events from abortion drugs to FDA (excluding identifiable information), clarifies it does not limit other federal or state restrictions, and rescinds ongoing investigational exemptions granted before enactment if prohibited under the new rules, effective three years after enactment.