FDA to finish mifepristone safety review by September

U.S. senators and members of the House Appropriations Committee were told that the Food and Drug Administration plans to complete its safety evaluation of the abortion medication mifepristone by September. The review comes amid pressure from conservative lawmakers and pro‑life groups to rescind a Biden‑era rule that permits the pill to be mailed without an in‑person medical visit. When the FDA first approved mifepristone in 2000, pregnancy was classified as a disease and the drug was subject to strict Risk Evaluation and Mitigation Strategies (REMS), requiring three office visits and physician‑only prescribing. Those requirements were gradually eased, with reporting requirements reduced in 2016 and the in‑person mandate suspended in 2021 and made permanent in 2023 after the Supreme Court overturned Roe v. Wade. The mail‑order system enables providers in states with liberal abortion laws to ship pills into restrictive states, and shield laws protect them from prosecution. A Louisiana woman who says her boyfriend coerced her into taking the medication has sued the FDA, and the Supreme Court recently allowed the mail‑order program to continue while litigation proceeds. If the FDA concludes the pill is unsafe, it could reinstate the in‑person dispensing requirement.