Leading Medical Organizations Call for the FDA to Permanently Remove Restrictions on Mifepristone

The following statement is issued jointly by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Preventive Medicine, the American Medical Association, the American Society for Reproductive Medicine, the American Urogynecologic Society, the National Association of Nurse Practitioners in Women's Health, the Society for Academic Specialists in General Obstetrics and Gynecology, the Society of Family Planning, the Society for Maternal-Fetal Medicine, and the Society of General Internal Medicine:

For nearly two years, mifepristone has been under intense legal scrutiny as litigation that sought to restrict access to the drug, which is commonly used for medication abortion and miscarriage management, has moved through the court system. Throughout that judicial process, the medical community has repeatedly affirmed that mifepristone is safe and effective and that burdens and restrictions on mifepristone are not evidence-based.

The long-standing consensus about mifepristone’s record of safety makes clear that it is time for the FDA to permanently remove the remaining restrictions imposed on mifepristone under the risk evaluation and mitigation strategy (REMS). Our organizations urge the agency to do so with expedience.

Mifepristone is safe. Robust clinical evidence backed by decades of use by millions of patients has proven incontrovertibly that mifepristone is safe and effective for use in medication abortion and miscarriage management. Complications associated with mifepristone are exceedingly rare, minor, and easily treatable.

Critically, the REMS requirements do nothing to enhance the safety of an already safe drug; instead, they impose administrative burdens, exacerbate health inequities, and lead to delays in care.

Recent data have shown that more than six out of 10 people who seek abortion care opt for a medication abortion. Removing the REMS restrictions from mifepristone will help ensure that people who choose medication abortion can access the safe, effective care they need without needless barriers that are not grounded in science.

Throughout the legal process related to the mifepristone suit, the government’s own lawyers, speaking on behalf of the FDA, have repeatedly argued for the safety and efficacy of mifepristone. It is now time to make good on that testimony through regulatory change.

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About SMFM
SMFM The Society for Maternal-Fetal Medicine (SMFM), founded in 1977, is the medical professional society for obstetricians who have additional training in high-risk, complicated pregnancies. SMFM represents more than 7,000 members who care for high-risk pregnant people and provides education, promotes research, and engages in advocacy to reduce disparities and optimize the health of high-risk pregnant people and their families. SMFM and its members are dedicated to optimizing maternal and fetal outcomes and assuring medically appropriate treatment options are available to all patients.

For media interviews, contact: smfm@smfm.org