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FDA Opens Mifepristone Safety Review as 20 States Vow to Defend Access

Experts say any changes are likely to target telehealth and mail distribution rather than revoke approval.

Overview

  • Health and Human Services and the FDA confirmed an ongoing safety review of mifepristone in a Sept. 19 letter to 22 Republican attorneys general, citing new data and a contested analysis from the Ethics & Public Policy Center.
  • A coalition of 20 Democratic attorneys general, co-led by California, New York, and Massachusetts, issued a joint statement affirming the drug’s safety and pledging legal action to protect access.
  • Medical researchers and clinicians point to decades of evidence and more than 100 studies showing low rates of serious complications, disputing the EPPC’s non–peer-reviewed claim of nearly 11% serious adverse events.
  • State-level enforcement escalated as Louisiana disclosed an arrest warrant for a California physician accused of mailing abortion pills, while Louisiana and Texas moved to join a lawsuit seeking to roll back federal approvals.
  • Medication abortion now accounts for a majority of U.S. abortions and expanded through telehealth and mail supported by shield laws, and public-health experts expect any FDA changes to focus on those channels rather than a full withdrawal of approval.