Sen. Hawley Opens Mifepristone Probe, Moves to Revoke FDA Approval

Sen. Josh Hawley, R‑Mo., as chair of the Senate Judiciary Subcommittee on Crime and Counterterrorism, has opened investigations into mifepristone manufacturers Danco Laboratories and GenBioPro, accusing them of profiting from an abortion drug he says poses "grave risks" to women. In letters obtained by Fox News and dated this week, Hawley demands by April 24 all adverse-event reports, internal databases and other records related to safety, hemorrhage, infection, sepsis and complications from the drug. The move accompanies Hawley’s introduction of the Safeguarding Women from Chemical Abortion Act, which would withdraw FDA approval of mifepristone, ban its use for abortion and create a federal cause of action allowing women to sue manufacturers. The bill builds on earlier Hawley proposals to tighten FDA safeguards and expand liability to telehealth providers and pharmacies, and directly targets a medication used in an estimated 63% of U.S. abortions in 2023, according to Guttmacher Institute data. Abortion-rights advocates and many medical groups argue existing data show mifepristone is comparatively safe, so this investigation sets up another clash between Republican lawmakers and federal regulators over how drug safety is assessed and who controls access to abortion medication.