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FDA Confirms Safety Review of Mifepristone With No Regulatory Changes Yet

The inquiry follows a disputed analysis that opponents cite to press for tighter limits.

Overview

  • HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told 22 pro-life state attorneys general on Sept. 19 that a safety review is underway.
  • The agencies have not announced changes to mifepristone’s approval status or its Risk Evaluation and Mitigation Strategy requirements.
  • A Daily Wire opinion argues the review should end in revocation or a return to prior prescribing limits.
  • An Angry Bear commentary defends the drug’s safety record, citing more than 7.5 million uses and its role in enabling telehealth access.
  • Key context: the FDA approved mifepristone in 2000, eased in‑person rules in 2016 and 2021, and medication abortions accounted for 63% of U.S. abortions in 2023 as reported by The Daily Wire.