Senator Hawley Condemns FDA Approval of New Generic Abortion Drug Citing Safety Concerns

Senator Josh Hawley has strongly criticized the FDA's recent approval of a new generic version of the chemical abortion drug mifepristone, produced by Evita Solutions LLC, calling the decision premature and unsafe. Hawley highlighted data indicating that nearly 11% of women who use mifepristone experience serious adverse health events, a rate much higher than previously disclosed, and expressed concern that the approval was made before the FDA completed its promised comprehensive safety review. He accused FDA Commissioner Marty Makary of misleading him regarding commitments to President Trump's anti-abortion agenda and said he has lost confidence in the FDA's leadership. Hawley also raised alarm about the ideological stances of Evita Solutions, particularly its refusal to define "woman" in its materials, suggesting possible regulatory failures. The FDA has not publicly responded to these criticisms, while other officials like Health and Human Services Secretary Robert F. Kennedy Jr. had supported the safety review. The controversy underscores ongoing tensions over chemical abortion safety and regulatory oversight amid increasing use of medication abortions in the U.S.