ACOG Leads Coalition of 15 Medical Organizations in Amicus Brief Supporting Safety of Mifepristone

Washington, D.C.-The American College of Obstetricians & Gynecologists (ACOG) on Friday led a coalition of 15 organizations in filing an amicus brief in The State of Louisiana v. U.S. Food and Drug Administration in support of the FDA's 2023 change to the risk evaluation and mitigation strategy (REMS) program for mifepristone, which removed the in-person dispensing requirement and allowed the medication to be prescribed through telehealth and delivered by mail. The overwhelming weight of scientific evidence and two decades of medical practice show that mifepristone is safe and effective, and that its strong safety profile persists whether distributed in person or by mail.

"We are deeply troubled by these ongoing efforts to restrict patients' access to an essential medication that the body of scientific data and clinical evidence proves to be safe and effective," said Steven J. Fleischman, MD, MBA, FACOG, president of ACOG.

Removing the requirement for in-person distribution has been vital in improving access to care for patients who are unable to attend in-person appointments-particularly those from vulnerable populations with limited access to care. The brief notes that reimposing unnecessary restrictions on mifepristone will worsen existing inequities among marginalized communities, such as women of color, women with low income, and women living in rural areas, all of whom are more likely to rely on telehealth care.

"Undoing FDA's 2023 decision to remove the in-person dispensing requirement will turn back the clock on equitable access to evidence-based ob-gyn care and place pregnant patients at risk, with the greatest harm falling on those in marginalized communities," Dr. Fleischman said.

The FDA has continuously monitored and evaluated the safety of mifepristone since its initial approval more than two decades ago and 7.5 million uses of the drug. The decision to eliminate the in-person dispensing requirement in 2023 was determined through careful evaluation of overwhelming evidence demonstrating the safety of mifepristone and the consistent strong safety profile of telehealth dispensing.

Data has soundly confirmed that the risk of a major adverse event-such as significant infection, excessive blood loss, or hospitalization-is very low for patients and that the risk of death is nearly nonexistent. The coalition stresses that mifepristone is statistically safer than nearly any other major drug approved by the FDA and yet is regulated more stringently.

"Ob-gyns and clinicians nationwide prescribe mifepristone each day as a safe and effective option for their patients experiencing pregnancy loss and those in need of abortion care," said Dr. Fleischman. "ACOG supports the safety and efficacy of this medication as part of the evidence-based care our members provide to patients every day."

Read the full amicus brief.