Cape News

U.S. Senator Josh Hawley (R-Mo.) has sent a letter to Food and Drug Administration (FDA) Commissioner Marty Makary, expressing concern over the agency’s recent approval of a new generic version of the abortion drug mifepristone. The approval was granted to Evita Solutions, LLC, before the FDA completed its planned safety review of mifepristone.

In his letter, Senator Hawley stated, “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.”

Senator Hawley referenced data indicating that nearly 11% of women who use mifepristone experience serious adverse health events within 45 days, which he claims is significantly higher than what is disclosed on the FDA-approved label. He noted that the FDA had previously committed to reviewing the safety of mifepristone and related regulations.

He continued, “As you know, recent data shows that nearly 11% of women who use the chemical abortion drug, mifepristone, experience a serious adverse health event—like sepsis or hemorrhaging—within 45 days. That is an adverse-event rate at least 22 times greater than currently disclosed on the FDA-approved drug label. 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.”

Senator Hawley also questioned whether approving the new generic before updating safety protocols could allow it to bypass future regulatory changes intended for mifepristone.

He concluded: “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.”

Senator Hawley requested responses from Commissioner Makary by October 10, 2025 regarding his involvement in the approval process for ANDA 216616 (the application for the generic), details about its submission timeline and evaluation process—including consideration of recent safety data—and whether Evita Solutions’ stated mission was considered during approval.