FDA Announces Long Sought-After Review of Harmful Restrictions on Medication Abortion

WASHINGTON — The U.S. Food and Drug Administration (FDA) announced that it is conducting a long-awaited review of its restrictions on mifepristone, a medication used for early abortion and miscarriage care. The announcement comes in a court filing in an ACLU lawsuit challenging the restrictions.

Though mifepristone is safe, effective, and has been FDA-approved for more than 20 years, it remains subject to a unique set of outdated, medically unnecessary restrictions known as a Risk Evaluation and Mitigation Strategy (REMS). The REMS causes serious harm to patients with no safety benefit, obstructing access to essential, time-sensitive health care and deepening health inequities for those who already face the most severe barriers to care — particularly people of color, people with low incomes, and those in rural communities.

“The FDA’s decision to review these senseless restrictions on mifepristone — though long overdue — is a critical move towards ensuring that patients can access this safe, effective medication without needless obstacles,” said Julia Kaye, staff attorney at the ACLU Reproductive Freedom Project. “The evidence is crystal clear that these restrictions provide zero safety benefit while severely burdening patients’ ability to access care. It is long past time for the FDA to heed the calls of leading national medical organizations and remove these unjustified barriers.”

Medical experts and advocates have long called for a comprehensive, evidence-based review of the FDA’s outdated restrictions on mifepristone. This spring, the ACLU joined reproductive rights, health, and justice organizations to send a letter and petitions signed by more than 200,000 supporters urging the administration to take immediate action to expand access to medication abortion. Leading medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, uniformly oppose the FDA’s restrictions on medication abortion.

Today’s announcement was made in a court filing in Chelius v. Becerra, an ACLU lawsuit challenging the REMS filed in 2017 on behalf of Hawai’i doctor Dr. Graham Chelius, the Society of Family Planning, and the California Academy of Family Physicians. The parties now ask the court to stay (i.e. pause) the litigation until Dec. 1, 2021, in light of the FDA’s current review.

On April 12, 2021, the FDA suspended one part of the REMS, an in-person dispensing requirement, during the COVID-19 public health emergency. This followed a separate legal challenge to that requirement, which forced abortion and miscarriage patients to needlessly risk COVID-19 exposure in order to get care, brought by the ACLU during the pandemic on behalf of leading medical and reproductive justice organizations.

More information about Chelius v. Becerra can be found here, including declarations from clinicians describing how the REMS harms their patients: https://www.aclu.org/cases/chelius-v-becerra

More information about ACOG v. FDA, the litigation challenging the mifepristone REMS in-person dispensing requirement during the COVID-19 public health emergency, is available here: https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration.