Sponsors (32)
The bill increases monitoring and informed‑consent requirements for medication abortion but also imposes restrictions, provider exclusions, research limits, and reporting/legal burdens that together substantially reduce access and impede scientific development.
Women receiving medication abortion would have adverse events more systematically tracked because manufacturers and prescribers must report known non‑identifying adverse events to the FDA, which could improve safety surveillance.
Patients would receive stronger informed‑consent documentation because prescribers must document and acknowledge that risk information was provided before treatment, increasing patient awareness.
Women would lose access to FDA approvals and the possibility of new or updated evidence‑based medication abortion approvals, preventing regulatory updates and limiting available medical options.
Existing access would be restricted by prohibiting use after 70 days and banning non‑in‑person dispensing, sharply curtailing telehealth and pharmacy routes and making it harder for many people to obtain care.
Many prescribers and clinics could be excluded from providing medication abortion because REMS requirements would demand surgical capability and access to transfusion/resuscitation, shrinking the provider network and local availability.
Based on analysis of 2 sections of legislative text.
Prohibits FDA approval and investigational exemptions for drugs intended to terminate pregnancy and imposes REMS, labeling, dispensing, and reporting requirements for existing abortion drugs.
Introduced January 27, 2026 by Cindy Hyde-Smith · Last progress January 27, 2026
Bars the FDA from approving or continuing investigational exemptions for drugs intended to intentionally terminate a known pregnancy or kill an unborn child, and imposes strict controls on any such drugs that are already approved. It forbids label changes to permit use after 70 days gestation, prohibits non‑in‑person dispensing, requires those drugs to be treated as misbranded and placed under a Risk Evaluation and Mitigation Strategy (REMS) with certification and reporting requirements, mandates adverse‑event reporting (without individually identifiable data), and defines key terms. Investigational use exemptions that would be prohibited by the new rules are automatically rescinded three years after enactment.