Mifepristone in the Courts

This article was published on February 7, 2023, and was updated on May 17, 2023, to reflect new information.

ACOG understands that the challenge to mifepristone approval in the lawsuit Alliance for Hippocratic Medicine v. FDA has created and perpetuated legal complexity and caused widespread confusion among patients and clinicians, including ACOG members. ACOG continues to remind all members, all clinicians, the courts, and all people and patients in the United States that the overwhelming scientific evidence has conclusively determined that mifepristone is safe and effective. That is a fact, regardless of beliefs or arguments to the contrary.

On Friday, April 21, the U.S. Supreme Court stayed the lower court’s decision upon appeal, leaving mifepristone’s federal regulatory status unchanged. In states where abortion is banned or restricted, mifepristone may be unavailable for medication abortion. Mifepristone may also be subject to state-level restrictions in different locations. For now, the litigation has not changed anything with respect to mifepristone access.

ACOG remains deeply involved in this case and ensuring that the courts receive evidence-based, reliable information from medical experts. On May 1, ACOG’s legal experts led a coalition of 13 medical organizations, including the AMA, in submitting an amicus brief to the Fifth Circuit Court of Appeals explaining why mifepristone is safe, effective, and essential and how clinicians must be able to provide patients with the full range of clinically appropriate treatment options.

The brief reads, in part: “Denying or limiting access to mifepristone will not make patients safer—it will actively jeopardize their health. Pregnancy can be dangerous. The risks of maternal mortality in the U.S. are alarmingly high and drastically higher for Black women, poor women, and all those whose access to reproductive care has been historically and geographically limited. Pregnancy can cause hemorrhaging, infection, dangerously high blood pressure, and many other critical physiological conditions. These dangers directly impair the health and well-being of pregnant patients, often in material ways. Abortion, including medication abortion involving mifepristone, is an essential component of reproductive care that is protected in many states—including for the management of miscarriage.”

Just days after the oral arguments before the Fifth Circuit Court of Appeals, the Annual Clinical & Scientific Meeting will feature a late-breaking session including legal experts and a prescriber of mifepristone sharing their insights into the case and the ongoing impact on patients and clinicians. Taking place at 11:15 a.m. ET on Sunday, May 21, the fireside chat-style event will help demystify the current legal situation and will contextualize the legal attacks within the broader threats to abortion care.

Members with specific legal questions about mifepristone or abortion should consult their institution’s lawyers and can also reach out to the Abortion Defense Network, a program that connects people who have legal questions related to abortion care with attorneys who provide legal advice and representation in civil and criminal proceedings.

ACOG also understands that patients have questions. ACOG’s patient website now includes a helpful Q&A with Darney-Landy Fellow Kristyn Brandi, MD, MPH, FACOG, about what the case means for patients.

ACOG continues to monitor this rapidly evolving situation and will update our members in response to any additional changes regarding mifepristone.