On January 8, AAPLOG sent another formal letter to U.S. Food & Drug Administration (FDA) Commissioner Martin Makary and U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., urging immediate action to protect women’s health and preborn children.
The Catholic Medical Association, the Alliance for Hippocratic Medicine, the Christian Medical and Dental Associations, and the American College of Pediatricians joined us in sending a strong, clear message: the FDA must stop delaying its promised safety review of mifepristone and restore critical safeguards that were dismantled in recent years.
Real-world data paints a troubling picture. Two major analyses of insurance claims covering 330 million patients identified over 860,000 mifepristone prescriptions between 2017 and 2023. Alarmingly, 10.93% of women experienced severe complications—including hemorrhage, infection, surgical intervention, and undiagnosed ectopic pregnancy. This complication rate is 22 times higher than what the FDA currently reports and is consistent with other studies.
Despite these findings and previously stating that a thorough safety review was in process, the FDA is reportedly delaying its review and continuing to allow mail-order distribution of this high-risk drug without in-person evaluation or follow-up care. Women are left vulnerable and injured, often seeking emergency care without adequate support, which is a clear violation of informed consent and patient safety that should be addressed with urgency. This negligent scheme also is leading to the loss of an increasing number of preborn lives in every state in the country – regardless of state laws on abortion.
Our letter calls for four urgent actions:
- Immediately reinstate the in-person dispensing requirement (restoring what was standard prior to the Biden administration’s reckless actions)
- Immediately reinstate reporting of all adverse events (not just deaths)
- Conduct urgent safety review using real-world data
- Restore and strengthen pre-2016 safeguards:
- Limit use to seven weeks gestation
- Require ultrasounds to accurately determine gestational age and rule out ectopic pregnancy
- Require in-person follow-up so women receive ongoing care
As physicians committed to evidence-based care, we cannot allow politics to override patient safety. We stand ready to provide expert input and data to support this process and we will not rest until our patients are protected. Together, let’s ensure women and children receive the care and protection they deserve.
