H.R. 685 — SAVE Moms and Babies Act of 2025

This section prohibits the 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 intentionally kill an unborn child or terminate a pregnancy of a known pregnant woman, excluding treatments to produce live birth, remove a dead unborn child, or treat ectopic pregnancy) and from granting investigational new drug exemptions under subsection (i) for abortion drugs or investigations knowingly destroying the unborn child of a pregnant woman. For abortion drugs approved as of enactment, the section (1) bars FDA approval of labeling changes to permit use after 70 days gestation or dispensing other than in-person by the prescribing health care practitioner; (2) deems such drugs subject to prescription-only requirements 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) with capabilities to assess pregnancy duration, diagnose ectopic pregnancies, provide surgical intervention for incomplete abortion or severe bleeding, ensure access to transfusion/resuscitation facilities, and report adverse events (i.e., fatalities, ectopic pregnancies, hospitalizations, transfusion-requiring blood loss, infections); in-person dispensing only in clinics, medical offices, or hospitals; patient receipt of complication risk documentation; manufacturer and prescriber adverse event reporting to FDA; and state-law-compliant administration reporting (or equivalent to surgical abortion reporting). The section further requires all other health care practitioners to report patient adverse events from abortion drugs to FDA and rescinds any pre-enactment investigational exemptions under subsection (i) three years after enactment if prohibited under the new rules. (Thus, the changes restrict future approvals and market entry of abortion drugs while imposing stringent in-person prescribing, dispensing, reporting, and gestational limits on existing approvals such as mifepristone.)