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Hawley Seeks to Revoke FDA Approval of Abortion Pill Mifepristone With New Senate Bill

Supporters cite EPPC insurance-claims findings; FDA and HHS say a safety review is ongoing.

Overview

  • The Safeguarding Women from Chemical Abortion Act would withdraw FDA approval of mifepristone for abortion, ban its distribution for pregnancy termination under federal drug law, and create a private right of action for women to sue manufacturers.
  • Rep. Diana Harshbarger plans a House companion, as Hawley unveiled the measure at a Capitol Hill event featuring testimonies from women who reported complications after using the drug.
  • Backers point to an EPPC analysis of 865,727 insurance claims from 2017–2023 that reported roughly 11% serious or life‑threatening adverse events, a rate critics dispute given far lower figures historically cited on the FDA label.
  • Federal regulators say their safety review of mifepristone is underway, following years of FDA policy changes that enabled telehealth prescribing and mail distribution and after a 2024 Supreme Court ruling left the drug available on standing grounds.
  • The push highlights Republican divisions over new federal abortion restrictions and targets Danco Laboratories’ offshore structure, yet the legislation faces steep legal, evidentiary, and political hurdles in Congress.