CMA Opposes Recent Petitions to Loosen Safety Regulations for Mifepristone
August 11, 2025
Three citizen petitions seeking to loosen safety provisions related to telemedicine chemical abortion were recently submitted to the FDA for consideration. The Catholic Medical Association, the largest association of Catholic physicians and healthcare professionals in the United States, opposed all three petitions, calling for further restrictions based on the most recent national and international findings outlined in the position statement released by CMA in June entitled, Telemedicine Chemical Abortion: A Catholic Medical Association Policy with Recommendations.
This position statement describes the numerous problematic impacts of telemedicine chemical abortion, with recommendations to eliminate or minimize such effects. These recommendations, however, should not be construed as approval or endorsement of direct abortion, which the Catholic Medical Association firmly and consistently rejects on moral and theological grounds.
The first petition is from the state of Massachusetts and includes New York, New Jersey and California, where abortion is legal through all nine months; the second from the American College of Obstetricians and Gynecologists, Society of Family Planning, and Society for Maternal-Fetal Medicine, which supports abortion, and the last petition is from GenBioPro Inc, a company that markets a generic version of mifepristone.
The petitioners seek to reduce or eliminate a number of the FDA’s current safety regulations on the chemical abortion drug mifepristone, specifically concerning the Risk Evaluation and Mitigation Strategy (REMS) and Elements to Assure Safe Use (EASU), including Prescriber, Patient, and Pharmacy Certification elements. Their response comes as a result of Robert F. Kennedy, Jr., Secretary of Health and Human Services (HHS), requesting FDA administrator Martin A. Makary to conduct a “complete review” of mifepristone and its labeling requirements.
The petitioners argue that mifepristone, as the most common method of ending early pregnancy in the United States, is extraordinarily safe, however, CMA argues that there is enough recent evidence to suggest the opposite is true and that the FDA should tighten safety regulations, not weaken them. CMA strongly opposes the requested changes to mifepristone’s REMS and EASU oversight based on two primary concerns: 1. Reliance on Inadequate and Biased Data; 2. Ethical and Societal Consequences of Chemical Abortion.
“Given the strong evidence demonstrating significant underreporting and biased presentation of adverse effects related to chemical abortions, combined with severe ethical and societal concerns inherent in current chemical abortion practices, we urge the FDA to reject the above-referenced petition,” stated President Michelle Stanford, M.D. in the letters opposing these petitions. “The CMA further recommends that the FDA reinstate previous, stronger REMS safety standards for mifepristone, which were regrettably relaxed in recent years.”
CMA believes that by doing so, these safety regulations “will minimize harm and ensure that women receive accurate, comprehensive information necessary for informed consent, even as we acknowledge with profound regret the tragic reality of abortion itself.”
CMA is asking its members to review the petitioners’ letters and comment while sharing CMA’s position statement and opposition letters. CMA members can review the petitions and comment at the following links:
1) FDA-2025-P-1576-0001
“Citizen Petition from Attorney General of Massachusetts, et al”– https://www.regulations.gov/commenton/FDA-2025-P-1576-0001
CMA Letter can be read here.
2) FDA-2025-P-0377-0001
“Citizen Petition from ACOG, Society of Family Planning, and Society for Maternal & Fetal Medicine”- https://www.regulations.gov/commenton/FDA-2025-P-0377-0001
CMA Letter can be read here.
3) FDA-2025-P-2162-0001
“Citizen Petition from GenBioPro, Inc.” – https://www.regulations.gov/commenton/FDA-2025-P-2162-0001
CMA Letter can be read here.