The Honorable Martin A. Makary, M.D., M.P.H.
Commissioner, U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
The Honorable Robert F. Kennedy Jr.
Secretary, U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201
Dear Commissioner Makary and Secretary Kennedy,
As representatives of tens of thousands of pro-life obstetricians/gynecologists, pediatricians, family physicians, and other medical professionals dedicated to evidence-based care for women and their preborn children, we are deeply concerned to hear the news that the U.S. Food and Drug Administration (FDA) may be delaying its full review of the safety of mifepristone.
In congressional hearings and subsequent letters to state attorneys general and members of Congress over the past year, the FDA committed to conducting a thorough, independent review of real-world safety data for this abortion drug—data that recent papers indicate reveal serious complication rates far higher than previously disclosed on the FDA label, including hemorrhage, sepsis, and incomplete abortions requiring surgical intervention.
Two reports analyzing insurance claims for 330 million U.S. patients (2017–2023) identified more than 860,000 mifepristone prescriptions and tracked adverse events within 45 days of use. Alarmingly, 10.93% of women experienced severe complications, including infection, hemorrhage, surgical intervention, or undiagnosed ectopic pregnancy.1 This rate is consistent with what our clinicians observe and suggests the true risk may be 22 times higher than previously disclosed…