Senators Ask Nominee to Support FDA Safety Review of Mifepristone After New Claims of Higher Adverse Events
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Summary
Senator Josh Hawley and others pressed Jim O'Neil to back a thorough FDA safety review of mifepristone following a large insurance-claims study; O'Neil said he supports a safety review and would back the secretary's work on the matter.
Senator Josh Hawley asked Jim O'Neil about a large insurance-claims study covering 865,727 mifepristone prescriptions from 2017 to 2023 that the senator said shows substantially higher rates of serious adverse events than FDA data. Hawley asked whether it was time for FDA to reinstate certain safety protocols and reporting requirements that were removed in 2016.
O'Neil said FDA is responsible for ensuring drug safety and that mifepristone has a REMS designation requiring periodic safety review. He said he ‘‘strongly support[s] that review’’ and would back the secretary's commitment to a ‘‘full scale safety review.’’
Hawley asked whether the review should consider reinstating in-person dispensing and physician follow-up requirements that were removed, and O'Neil said such issues are part of FDA's review authority and should be assessed based on the full record.