FDA REMS restrictions limit mifepristone despite Dobbs ruling

The FDA reversed course on abortion pills Mar. 7, 2025. Commissioner Dr. Robert M. Califf signed the order. Patients must now pick up mifepristone in person. The 2023 policy allowing mail delivery ended. Women need two in-person visits for the full regimen. The FDA cited safety concerns. Studies show telemedicine abortion is safe.

The reversal uses REMS authority under 21 U.S.C. § 355-1. Risk Evaluation and Mitigation Strategies govern dangerous drugs. The FDA classifies mifepristone as high-risk. This contradicts decades of safety data. Over 5 million women used it safely since 2000. Serious complications occur in less than 0.4% of cases. The classification appears politically motivated.

Women's Day protests erupted nationwide Mar. 8, 2025. 🗽New York City saw 80,000 marchers according to Reuters. Chicago drew 45,000. Los Angeles had 60,000. Police cited protesters in five states. They used sound-amplification ordinances. Megaphones and speakers triggered violations.

Rural patients face the harshest impact from new rules. Travel distances average 100+ miles to abortion providers. The Guttmacher Institute projects a 15% reduction in medication abortions. Low-income women can't afford travel costs. Time off work becomes impossible. Childcare adds another barrier. Geographic inequality defines access now.

The American Civil Liberties Union filed suit immediately. Planned Parenthood v. FDA challenges the in-person requirement. They argue it violates Fourteenth Amendment due process. The case cites discrimination against rural women. Federal courts will decide if travel burdens are unconstitutional. Preliminary injunctions got requested. Emergency relief remains pending.

The Electronic Frontier Foundation entered the fight differently. They'll sue any state criminalizing online abortion advice. Free speech protections cover medical information. The First Amendment protects discussing healthcare options. States threaten prosecution for sharing pill information. EFF links reproductive rights to digital rights. The battlefield expands beyond clinics.

Medical organizations condemned the FDA reversal unanimously. The American College of Obstetricians and Gynecologists called it anti-science. The American Medical Association cited patient harm. Emergency medicine doctors warned about ER overcrowding. Pharmacists questioned the safety rationale. Scientific consensus opposes the restrictions. Politics overruled medicine.