Mifepristone Access Under Threat

FDA Launches Mifepristone Study; Advocates Warn of Post-Roe Access Threat

The FDA has launched a six-month safety study of mifepristone, the abortion pill, following reporting that the effort could set up the Trump administration to impose tighter limits on how the drug is prescribed, distributed, and accessed. Officials say the study will rely on existing drug-safety monitoring systems and is designed to withstand potential legal challenges, with some preliminary internal results expected in July and full findings unlikely before the November midterm elections. The FDA is also considering hiring a contractor to collect and analyze real-world data on mifepristone use, expanding evidence beyond earlier clinical records. The FDA maintains that mifepristone remains safe and effective when used as directed. The move comes after the U.S. Supreme Court restored a 2023 rule that preserved access through telemedicine and by mail, even as legal disputes continue. Abortion-rights advocates warn that renewed scrutiny could pose the biggest threat to mifepristone access in the post-Roe landscape.

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