Representative Chip Roy (R) is demanding answers from the Food and Drug Administration after the agency indicated its safety review of mifepristone will not be completed until March 2027, months later than the timeline he said he relied on when withdrawing a proposed funding restriction.
In a letter sent to FDA Acting Commissioner Kyle Diamantas, Roy criticized the delay in reviewing the January 2023 changes to the drug's Risk Evaluation and Mitigation Strategy (REMS). Those changes removed the in-person dispensing requirement and allowed certified pharmacies to dispense mifepristone by mail.
"House Republicans cannot be expected to continue funding the implementation of the January 2023 REMS modifications indefinitely while FDA repeatedly extends its review without committing to corrective action," wrote Roy.
Earlier this year, Roy agreed to withdraw an amendment that would have barred federal funds from implementing the revised dispensing rules. He said he made that decision in good faith based on an understanding that the FDA would complete and publish its safety study in fall 2026.
"I did not withdraw an amendment so that FDA could conduct an open-ended review while continuing to administer the Biden Administration's policy," wrote Roy.
The FDA has said it is conducting a safety study and plans to complete its analysis as soon as possible while ensuring the work meets scientific standards. The agency has not committed to reversing the 2023 changes, saying it will determine whether regulatory modifications are warranted after completing its analysis.
Roy warned that Congress could intervene if the FDA does not restore the in-person dispensing requirement. He said he would seek to attach his funding amendment to the next continuing resolution, which would prohibit federal funds from being used to implement, administer, or enforce the January 2023 modifications.
The dispute adds to the ongoing political and legal debate over access to mifepristone, which the FDA approved in 2000 for use with misoprostol to end an intrauterine pregnancy through 10 weeks of gestation.
