If you’ve been paying attention to the news the last several months, you’ve likely heard about a lawsuit entitled AHM vs. FDA in which a group of prolife healthcare professionals is suing the U.S. Food and Drug Administration (FDA) over removal of safety standards for the abortion drug mifepristone. The lawsuit was in the news again in December 2023 because the U.S. Supreme Court agreed to hear the case. That group of prolife healthcare professionals includes CMDA. AHM stands for the Alliance for Hippocratic Medicine, and CMDA is one of five founding members of AHM, along with the Catholic Medical Association (CMA), the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG), the American College of Pediatricians (ACPeds) and the Coptic Medical Association of North America (CMANA).

The complaint, which can be found online,[1] was initially filed in November 2022 in the U.S. District Court of Northern Texas and has worked its way through the federal court system to reach the point that the Supreme Court has agreed to hear the case, with oral arguments scheduled for March 26, 2024. They will likely issue their decision in the latter part of June 2024. This article will focus on the case's merits rather than the convolutions of the legal journey to arrive where we are today.

When the FDA initially approved mifepristone in 2000, the agency recognized the inherent dangers associated with the drug and included safety standards for its use. But starting in 2016, the FDA removed many of these safeguards for mifepristone. These major changes included removing the requirement for an in-person follow-up examination after the abortion, allowing non-physician healthcare professionals to prescribe mifepristone, increasing the permissible gestational age during which mifepristone could be prescribed from seven to 10 weeks’ gestation and altering the dose of mifepristone to be prescribed. Finally, despite removing these safety standards for mifepristone, FDA removed the requirement that prescribers report ANY serious non-fatal complication from mifepristone,

The FDA made these major changes without including a single study that evaluated the safety and effectiveness of all the conditions outlined in the 2016 changes concurrently. Instead, the FDA relied on data from studies in which only one or a few of the changes were evaluated to provide evidence to support their new relaxed safety standards. What’s more, the FDA ignored the fact that several of their cited studies screened their patients with ultrasound to establish accurate dates and rule out an ectopic pregnancy, thus evaluating a screened population that was very different than the patient population that would be exposed to mifepristone under their new regulations—since the FDA never required prescribers to perform an ultrasound before giving out the drug. Further problems with these studies included significant loss to follow-up, small size and bias, detailed further in the original complaint.¹

And then in December 2021, FDA permanently removed the in-person dispensing requirement for mifepristone. In the epitome of duplicity, one of the FDA’s justifications for this nonenforcement was the lack of reported adverse events from mifepristone, failing to acknowledge that the agency had eliminated the reporting requirement for nonfatal adverse events in its 2016 major changes. The FDA’s collective actions on mifepristone led to the current prescribing regime, which allows abortion drugs to be prescribed via telemedicine and dispensed through the mail without the patient ever personally encountering a healthcare professional at any point in the abortion process.

Healthcare professionals with expertise in the care of early pregnancy recognize the inherent inaccuracy of pregnancy dating based on menstrual history, thus leading to mifepristone administration beyond the approved gestational age, resulting in significant failure rates and subsequent harm. Further, one in 50 pregnant women experience an ectopic pregnancy, and they are in grave danger that the symptoms of a ruptured ectopic pregnancy will be attributed to the cramping and pain caused by mifepristone, delaying the diagnosis of a life-threatening complication. In other words, the lives of pregnant women who contemplate using abortion drugs are at far greater risk under these lax and reckless safety standards. To protect these women and young girls, we had little choice but to sue the FDA.

About the Author

Jeffrey Barrows, DO, MA (Ethics), as Senior Vice President of Bioethics and Public Policy for CMDA. Dr. Barrows is an obstetrician/gynecologist, author, educator, medical ethicist and speaker. He completed his medical degree at the Des Moines College of Osteopathic Medicine and Surgery in 1978 and his residency training in obstetrics and gynecology at Doctors Hospital in Columbus, Ohio. In 2006, he completed a master’s in bioethics from Trinity International University in Chicago, Illinois. Dr. Barrows served as the director of CMDA’s Medical Education International (MEI) from 2002 to 2005 before transitioning into the fight against human trafficking. He dedicated 15 years of his career to fighting against human trafficking within the intersection of trafficking and healthcare, as well as the rehabilitation of survivors of child sex trafficking. In 2008, Dr. Barrows founded Gracehaven, an organization assisting victims of domestic minor sex trafficking in Ohio. In 2020, Dr. Barrows published a novel entitled Finding Freedom that realistically portrays child sex trafficking in the U.S.

[1] https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf