Senator Hawley Challenges FDA Over Alleged Delay in Mifepristone Safety Review
Key Insights
Senator Josh Hawley has demanded answers from FDA Commissioner Marty Makary regarding reports that the agency delayed a promised comprehensive safety review of mifepristone until after midterm elections.
New studies from over 865,000 insurance claims indicate that nearly 11% of women using mifepristone experience serious adverse health events within 45 days, representing 22 times the risk listed on the drug's current black box warning.
The controversy centers on conflicting statements from Commissioner Makary, who initially said the FDA had "no plans to take action" on mifepristone, then committed to conducting a review, but allegedly ordered delays while approving a new generic version.
Senator Josh Hawley (R-Mo.) has sent a formal letter to FDA Commissioner Marty Makary demanding explanations for reports that the agency delayed a promised comprehensive safety review of the abortion drug mifepristone until after midterm elections. The letter, sent following news reports about the alleged delay, raises questions about the FDA's commitment to drug safety oversight and potential political considerations in regulatory decisions.
Safety Data Raises Concerns
According to Hawley's letter, new studies analyzing more than 865,000 insurance claims reveal that nearly 11% of women using mifepristone suffer serious adverse health events—including sepsis (search) or hemorrhaging (search)—within 45 days of use. This rate represents 22 times the likelihood of risk currently listed on mifepristone's "black box" warning, the most serious type of warning the FDA can require for prescription drugs.
The senator emphasized that "chemical abortions account for almost 70 percent of all abortions nationwide" and stated that "there are more abortions in America now than when Roe was still law," largely attributed to increased use of mifepristone and its generic versions.
Regulatory Timeline and Contradictions
The controversy stems from a series of conflicting statements from Commissioner Makary regarding the FDA's review plans. On April 24, Makary told an interviewer the agency had "no plans to take action" on mifepristone. However, in a June 2 letter to Senator Hawley, Makary stated he was "committed to conducting a review of mifepristone."
Despite this commitment, the FDA subsequently approved a new generic abortion drug without what Hawley characterized as "meaningful safety guardrails or conditions." The senator argued this approval "was in no way compelled by law."
When questioned about recent reports of delays, Makary responded that "there has been an ongoing review of mifepristone. It's actually required as part of a policy called REMS." However, Hawley contended this standard Risk Evaluation and Mitigation Strategy monitoring differs from the "new and comprehensive study taking account of all available safety data" that was promised.
Regulatory History and Safety Measures
The letter references changes in mifepristone's regulatory framework across different administrations. During President Trump's first term, HHS required an in-person visit with a licensed physician before dispensing the drug, along with in-person dispensing in clinical settings. These requirements were subsequently removed under the Biden administration.
Hawley has called for reinstatement of these safety regulations, arguing that the current regulatory approach lacks adequate safeguards for patient safety.
Demands for Transparency
The senator's letter includes specific questions requiring responses by December 15, 2025, including whether the FDA is conducting a comprehensive safety review separate from the REMS process, when such a review began, and whether Commissioner Makary ordered any delays. Additionally, Hawley seeks clarification on whether the FDA plans to update the Mifepristone Risk Evaluation and Mitigation Strategy to restore previous safety requirements.
The letter represents the latest development in ongoing congressional oversight of FDA drug approval and safety monitoring processes, particularly regarding medications with significant public health implications.