SAVE Moms and Babies Act of 2025
The SAVE Moms and Babies Act of 2025 would dramatically restrict the FDA’s ability to approve abortion drugs and to permit investigational use exemptions for those drugs. It also imposes a comprehensive set of new regulatory requirements on abortion drugs that are already approved at the time of enactment. Key elements include prohibiting new approvals and any investigational use exemptions for abortion drugs, and requiring a strict risk management framework (REMS) for existing abortion drugs (including in-person dispensing only, prescriber certification, and extensive adverse-event reporting). The bill also introduces broad definitions (notably of “abortion drug” and “unborn child”) to anchor regulatory scope and creates a 3-year sunset-style rescission for ongoing investigational use exemptions granted before enactment if they would no longer be permitted under the new law. In short, if enacted, the bill would substantially limit access to abortion drugs, tighten oversight and safety requirements for those drugs, and move the regulatory landscape toward in-person administration and enhanced reporting, while limiting research and new product approvals related to abortion.
Key Points
- 1Prohibitions on new abortion drug approvals and on investigational use exemptions
- 2- The Secretary may not approve marketing applications for abortion drugs, and may not grant investigational use exemptions for abortion drugs or for investigations in which the unborn child of a pregnant woman is knowingly destroyed.
- 3Restrictions and enhanced oversight for previously approved abortion drugs
- 4- For any abortion drug with an FDA approval in effect on enactment, the bill would bar labeling changes that would allow use after 70 days gestation and would require in-person administration by a prescribing clinician (no dispensing in pharmacies or other non-clinical settings).
- 5- The drug would be treated under the same framework as other prescription drugs requiring a REMS, with detailed conditions on prescriber certification, patient risk communication, and reporting.
- 6- The REMS would require prescribers to be certified, to assess gestation duration and diagnose ectopic pregnancies, to ensure access to facilities capable of surgical intervention and resuscitation, and to report deaths or adverse events to the FDA and the drug manufacturer with de-identified patient data and a serial number from each package.
- 7- Dispensing would be limited to clinical settings (clinics, medical offices, or hospitals) and would not occur in pharmacies; explicit risk documentation and patient acknowledgment would be required; adverse events and ongoing safety data would be reported in a defined way.
- 8Expanded adverse-event reporting by health practitioners
- 9- The bill would require all health care practitioners (beyond the prescription route) to report any adverse events connected to abortion drug use to the FDA, with protections for non-identifiable data.
- 10Definitions and scope
- 11- The bill provides definitions for “abortion drug,” “adverse event,” “gestation,” “health care practitioner,” and “unborn child,” creating a broad regulatory scope that governs how abortion drugs are classified and overseen.
- 12Ongoing investigational use exemptions rescission
- 13- Any investigational use exemption granted before enactment would be deemed rescinded three years after enactment if the Secretary would be prohibited from granting such exemption under the bill’s new provisions.