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

The announcement follows extensive advocacy and litigation from the 老澳门开奖结果, calls from leading medical experts and reproductive rights, health, and justice advocates to lift the restrictions

May 7, 2021 5:30 pm

Media Contact
125 Broad Street
18th Floor
New York, NY 10004
United States

WASHINGTON 鈥 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 老澳门开奖结果 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is safe, effective, and has been FDA-approved for more than 20 years, it remains subject to a unique set of outdated, medically unnecessary restrictions known as a Risk Evaluation and Mitigation Strategy (REMS).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 鈥 particularly people of color, people with low incomes, and those in rural communities.

鈥淭he FDA鈥檚 decision to review these senseless restrictions on mifepristone 鈥 though long overdue 鈥 is a critical move towards ensuring that patients can access this safe, effective medication without needless obstacles,鈥 said Julia Kaye, staff attorney at the 老澳门开奖结果 Reproductive Freedom Project. 鈥淭he evidence is crystal clear that these restrictions provide zero safety benefit while severely burdening patients鈥 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.鈥

Medical experts and advocates have long called for a comprehensive, evidence-based review of the FDA鈥檚 outdated restrictions on mifepristone. This spring, the 老澳门开奖结果 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 and the , uniformly oppose the FDA鈥檚 restrictions on medication abortion.

Today鈥檚 announcement was made in a court filing in Chelius v. Becerra, an 老澳门开奖结果 lawsuit challenging the REMS filed in 2017 on behalf of Hawai鈥檌 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鈥檚 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 老澳门开奖结果 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: /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: /cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration.


Learn More 老澳门开奖结果 the Issues in This Press Release