HR685-119

What This Bill Does

The SAVE Moms and Babies Act amends Federal Food, Drug, and Cosmetic Act section 505. It bars FDA from approving new brand or generic marketing applications for abortion drugs and from granting investigational-use exemptions for abortion drugs or investigations in which the unborn child of a known pregnant woman is knowingly destroyed. For abortion-drug approvals already in effect at enactment, FDA may not approve labeling changes for use after 70 days gestation or for dispensing by any means other than in-person administration by the prescribing health care practitioner. Existing abortion drugs must be treated as prescription drugs under section 503(b)(1) and must be subject to a REMS. At minimum, the REMS must certify prescribers, bar prescribers from acting in a pharmacist capacity, require ability to assess pregnancy duration and ectopic pregnancy, require ability to provide surgical intervention and access to facilities for blood transfusion and emergency care, and impose related patient-safety controls.

Who Benefits and How

Patients receiving in-person evaluation benefit from required prescriber capacity to assess gestational age, diagnose ectopic pregnancy, provide surgical intervention, and ensure access to emergency facilities. FDA drug safety reviewers benefit from explicit statutory limits and required REMS conditions for existing abortion-drug approvals. Health systems prepared to provide in-person abortion-drug administration and emergency backup may benefit from demand shifting away from mail or telehealth dispensing.

Who Bears the Burden and How

Patients seeking medication abortion face reduced access because new approvals are barred and existing drugs cannot be relabeled for use after 70 days gestation or non-in-person dispensing. Abortion-drug manufacturers face blocked new approvals and label expansions. Prescribing health care practitioners must satisfy REMS certification, clinical capability, and in-person administration requirements. FDA drug approval and REMS staff must enforce the new statutory restrictions.

Key Provisions

• Prohibits FDA approval of new abortion-drug marketing applications and investigational-use exemptions.
• Bars existing abortion-drug label changes for use after 70 days gestation or non-in-person dispensing.
• Requires existing abortion drugs to be treated as prescription drugs subject to a REMS.
• Requires certified non-pharmacist prescribers with capacity to assess gestational age, diagnose ectopic pregnancy, and manage severe complications.