U.S. lawmakers demand FDA updates on mifepristone safety study

U.S. Representative Chip Roy and Senator Josh Hawley are seeking clarification from the Food and Drug Administration regarding an ongoing safety study of the abortion medication mifepristone. The inquiries follow a recent FDA filing indicating that the study's findings may not be published until March 2027.

Representative Roy, a Republican from Texas, expressed concern over the delayed timeline, noting that he had previously withdrawn an amendment to prohibit federal abortion funding based on the understanding that the study would be completed sooner. He is pressing the agency for updates on its actions and the publication schedule.

Senator Hawley of Missouri has questioned whether the research incorporates sufficient data, such as medical records and insurance claims, to evaluate the impact of the 2023 regulatory changes. These changes, implemented under the Biden administration, removed the requirement for mifepristone to be dispensed in person. Hawley specifically raised questions regarding the completeness and date ranges of the Sentinel database being used in the investigation.