Catholic Medical Groups Urge FDA to Reinstate Safeguards on Abortion Pill Mifepristone
July 9, 2025
The Catholic Medical Association (CMA), alongside several prominent Catholic health and ethics organizations, has formally requested that the U.S. Food and Drug Administration (FDA) conduct a comprehensive review of the abortion drug mifepristone, citing rising safety concerns—especially in cases involving telemedicine.
In a joint letter addressed to FDA Commissioner Dr. Marty Makary, the coalition urges the agency to reinstate critical Risk Evaluation and Mitigation Strategies (REMS) that were previously rolled back. These safeguards had required in-person physician visits, pelvic ultrasounds, and rigorous adverse event reporting, which the groups argue are essential for ensuring patient safety.
The letter follows the CMA’s recent release of a policy paper titled “Telemedicine Chemical Abortion: A Catholic Medical Association Policy with Recommendations,” published on June 12, 2025. The document outlines growing evidence of medical complications associated with chemical abortions using mifepristone, particularly when accessed remotely without direct medical oversight.
Joining CMA in the appeal are the Catholic Healthcare Leadership Alliance (CHCLA), Christ Medicus Foundation (CMF), the U.S. Conference of Catholic Bishops’ Secretariat of Pro-Life Activities, the National Catholic Bioethics Center (NCBC), and the National Association of Catholic Nurses (NACN-USA).
“The FDA is tasked with protecting the public from lax oversight of medications resulting in physical, emotional, and societal damages,” said Dr. Michelle Stanford, President of the CMA. “Only a thorough review and stricter regulation of chemical abortions will provide those protections.”
Dr. Tim Millea, Chair of CMA’s Health Care Policy Committee, also emphasized the urgency of the issue. “The disturbing outcomes data related to chemical abortions leave no question that the FDA must reexamine its guidance and restrictions for this dangerous intervention,” he said.
Citing a recent study by the Ethics and Public Policy Center, the letter references data from over 865,000 chemical abortion cases between 2017 and 2023. The study found that nearly 11% of women experienced serious adverse events—including hemorrhage, sepsis, and incomplete abortion—rates significantly higher than those reported by the FDA.
The organizations stress that the elimination of safety protocols has coincided with a 137% increase in chemical abortions since 2016, now accounting for 63% of all abortions in the U.S. They warn that the lack of medical supervision is putting vulnerable women at increased risk and undermining informed consent.
The signatories concluded by requesting a meeting with FDA leadership this summer to further discuss policy recommendations and potential collaboration. They say such action is necessary to restore public trust and prioritize women’s health in line with the administration’s broader commitment to improving healthcare outcomes.
