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Hawley Seeks Congressional Oversight of Mifepristone After FDA Offers No Timeline on Safety Review

The move follows a private FDA briefing that offered no timeline for its safety review.

Overview

  • Sen. Josh Hawley called for Congress to tighten oversight of mifepristone and to reinstate in-person dispensing safeguards he described as minimal.
  • Hawley said FDA Commissioner Marty Makary previously promised a safety study that has not been completed or given a timetable.
  • The FDA says it is conducting a safety review of the drug, but lawmakers reported no clear timeline or details after this week’s closed-door briefing.
  • A new Ethics and Public Policy Center analysis of insurance claims estimates roughly 11% of users experienced serious adverse events within 45 days, a finding Hawley cites in urging action.
  • Medical clinicians, including Dr. Rob Davidson, counter that decades of research show mifepristone’s safety and warn that political interference and new restrictions would curb access to established care.