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FDA Launches Mifepristone Safety Review as 25th Anniversary Focuses Attention on Access

Critics say the review rests on a disputed study.

Overview

  • HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told Republican state attorneys general the agency will reexamine mifepristone’s safety and dispensing rules.
  • The announcement cites an Ethics and Public Policy Center analysis claiming nearly 11% serious adverse events, a non–peer‑reviewed report that clinicians have criticized for opaque methods and expansive definitions.
  • Medication abortion now accounts for more than 60% of U.S. abortions, with about one in four provided via telehealth and many protected under state shield laws.
  • Republican-led efforts continue on multiple fronts, including a renewed push to revive litigation over FDA actions, Louisiana’s controlled‑substance classification, and a new Texas law enabling private lawsuits of at least $100,000 over abortion pill distribution.
  • Access networks remain robust, with telehealth providers, offshore services like Aid Access, and e‑commerce sources mailing pills into restricted states as documented by advocates such as Plan C.