ACOG Leads Amicus Brief Calling Mifepristone Conclusively Safe and Effective

Washington, D.C.—Today, the American College of Obstetricians and Gynecologists, joined by the American Medical Association, Society for Maternal-Fetal Medicine, and nine other prominent medical organizations, submitted an amicus brief to the U.S. District Court for the Northern District of Texas, Amarillo Division, in the case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, a case challenging the FDA’s 2000 approval of mifepristone.

The amicus brief outlines the overwhelming evidence demonstrating that mifepristone—which has undergone rigorous testing and review and has been safely used in the United States for 23 years—is conclusively safe and effective. The amicus brief presents more than two decades of scientific evidence and medical data, based on hundreds of medical studies and millions of uses of mifepristone for medication abortion.

The amicus brief asks the court to recognize that the plaintiff’s arguments are fundamentally ideological, not scientific, and provide no legal justification to reverse 23 years of precedent and a wealth of scientific evidence. 

“Our brief makes clear that mifepristone is a critical part of the practice of obstetrics and gynecology, and that forcing the FDA to rescind its marketing authorization would be a grievous mistake,” said Iffath Abbasi Hoskins, MD, FACOG, president of ACOG. “ACOG’s position is based on medical evidence and the clinical expertise of tens of thousands of obstetricians and gynecologists, and taking mifepristone off the market will force doctors to practice medicine in a way that doesn’t reflect the standard of care. This is both wrong and bad medicine.”

The data overwhelmingly illustrate the safety of this essential medication. As the brief states, “serious side effects occur in less than 1% of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3% of patients. The risk of death is almost non-existent.” There is a greater risk of complications from wisdom tooth removal, colonoscopy, and Viagra use. The brief also explains the extreme burden that reversing the approval of mifepristone would place on an already overburdened and under-resourced reproductive health care system. 

“Reversing the FDA’s approval of mifepristone, in whole or in any part, would cause profound and irreparable harm to patients across the country,” the brief states. “This harm will be most severe for people of color and low-income patients who have higher rates of maternal mortality and morbidity and less access to alternative procedures.”

Mifepristone is used to treat a wide variety of conditions unrelated to abortion and is recommended in combination with misoprostol as the superior treatment for the management of early pregnancy loss for patients experiencing a spontaneous, missed, inevitable, or incomplete miscarriage.

The brief asks the judge to recognize that removing mifepristone is at odds with more than two decades of medical data and evidence, and that enjoining its use would have devastating effects on reproductive health care as a whole and to the health, safety, and lives of millions of patients and their families across the country.