Washington, D.C. — Today, the U.S. Food and Drug Administration (FDA) permanently lifted some of the burdensome requirements placed on medication abortion, allowing mail-order pharmacies and pharmacies with physical locations to be certified to dispense mifepristone, the first of two drugs generally used in a medication abortion. After an evidence-based review, in 2021, the FDA announced modification to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone that previously required it to be dispensed only in clinical settings. These changes were finalized today, removing the in-person dispensing requirement and adding a new certification requirement for pharmacies dispensing the drug. The revised REMS clarify that pharmacies may dispense abortion medication in-person or by mail as long as they become certified and follow FDA-guidelines.
Statement from Alexis McGill Johnson, president & CEO, Planned Parenthood Federation of America:
“Today’s news is a step in the right direction for health equity. Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care. While we’re still fighting against bans and restrictions on medication abortion at the state level, it’s critical that people in states where abortion is legal have access to care. Today’s changes will help millions of people have more access to the care they need, when they need it.”
Mifepristone is safe and effective, and has been used by more than 4 million people since the FDA approved it more than 20 years ago. Leading medical associations, such as the American College of Obstetricians and Gynecologists and American Academy of Family Physicians, have maintained that the FDA’s long-standing restrictions on mifepristone, including the in-person dispensing requirements, provide no safety benefit.
Planned Parenthood is the nation’s leading provider and advocate of high-quality, affordable sexual and reproductive health care, as well as the nation’s largest provider of sex education. With more than 600 health centers across the country, Planned Parenthood organizations serve all patients with care and compassion, with respect and without judgment. Through health centers, programs in schools and communities, and online resources, Planned Parenthood is a trusted source of reliable health information that allows people to make informed health decisions. We do all this because we care passionately about helping people lead healthier lives.