Sponsors (56)
The bill increases oversight and standardizes use of medication-abortion drugs to improve safety monitoring, but it does so by restricting approvals and remote access, adding provider burdens, raising costs, and curtailing research—trading broader access and innovation for stricter controls and monitoring.
Pregnant people and health providers: Establishes stronger safety oversight—requires adverse-event reporting and stricter REMS with practitioner certification and facility-capability requirements—so providers are more prepared to manage complications and regulators can better monitor safety.
Pregnant people: Sets a clear gestational cutoff (70 days) for medication use, standardizing when these drugs may be used.
People seeking medication abortion (especially those in areas relying on remote services): Significantly restricts access by banning new approvals and limiting existing ones and prohibiting non–in-person and pharmacy dispensing, reducing availability and remote options.
Medical providers and clinics: Imposes new certification, reporting, and in‑person administration requirements that increase administrative burden and may deter clinicians or facilities from offering medication abortion.
Patients, insurers, and taxpayers: By shifting care toward in‑person clinic or hospital settings, the restrictions could raise out‑of‑pocket and system costs for patients, insurers, and taxpayers.
Based on analysis of 2 sections of legislative text.
Prohibits FDA approval and investigational use of drugs defined as "abortion drugs," restricts labeling and non‑in‑person dispensing, and mandates REMS with certification, dispensing, and reporting rules for covered drugs.
Prohibits the FDA from approving new drug applications or allowing investigational use for drugs defined as "abortion drugs," and restricts how already‑approved drugs of that type may be labeled, dispensed, and overseen. For drugs already on the market, it forbids label changes that allow use after 70 days' gestation or non‑in‑person dispensing, treats those drugs as subject to an identified statutory provision, and requires the FDA to impose a Risk Evaluation and Mitigation Strategy (REMS) with specific certification, dispensing, practitioner capability, and adverse‑event reporting requirements. Investigational exemptions in place at enactment that would be prohibited under the new rule are rescinded three years after enactment.
Introduced January 23, 2025 by Robert E. Latta · Last progress January 23, 2025