Show-Me State Times

U.S. Senator Josh Hawley (R-Mo.) has requested an explanation from the Food and Drug Administration (FDA) regarding its recent approval of a new generic version of the abortion drug mifepristone. In a letter sent to FDA Commissioner Marty Makary, Hawley expressed concern over what he described as a "surprise approval" of the drug before the completion of an ongoing safety review.

"I write with grave concern regarding your agency’s surprise approval of a new generic abortion drug. This decision appears to ignore the science while advancing a highly questionable ideological agenda. And I fear this decision may render moot your promise to conduct a safety review of mifepristone. I request your immediate assistance in explaining your agency’s decision," Hawley stated in his letter.

Hawley referenced recent data indicating that nearly 11% of women who use mifepristone experience serious adverse health events such as sepsis or hemorrhaging within 45 days, which he said is significantly higher than what is disclosed on the current FDA-approved label. He noted that, "In light of this data, your agency has committed to a thorough safety review of mifepristone and existing regulations… But this week, before any such review has been completed, your Food and Drug Administration approved a new generic abortion drug developed by Evita Solutions, LLC. This is a company with highly ideological, even extreme, views on gender and abortion."

The senator questioned whether approving the new generic ahead of changes to safety protocols could allow it to avoid future regulatory standards intended for mifepristone. "The timing of your agency’s approval raises further questions. FDA is supposed to be conducting a review of the safety regulations around mifepristone. But because this new generic has been approved before any changes to those safety protocols, this drug may be exempted from any new safety standards imposed on mifepristone in the future. That would render your safety review toothless and irrelevant. I invite you to explain your decision," he wrote.

Hawley also asked Commissioner Makary for details about his involvement in the approval process for ANDA 216616—the application number for the newly approved generic—and information about how recent safety data was considered during evaluation.

He requested answers by October 10, 2025.