A Victory for Health Care Access: FDA Suspends Medically Unnecessary Barrier to Abortion During Pandemic

WASHINGTON, D.C. — Tonight, the U.S. Food and Drug Administration (FDA) notified medical provider groups that it would “exercise enforcement discretion” regarding a medically unnecessary barrier to medication abortion for the duration of the COVID-19 pandemic. The Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone mandate that patients pick up the medication directly from a doctor’s office, hospital, or health center, rather than from a pharmacy or by mail, as allowed for other equally safe medications. The announcement recognizes that unnecessary in-person interaction exposed patients to COVID-19 risks related to transportation, child care, multiple health center trips, and more.

Statement from Alexis McGill Johnson, president & CEO, Planned Parenthood Federation of America:

“This is a victory for access to reproductive health care and health equity, and we thank FDA leaders for following the science to come to this decision. We have long known the decades-old restrictions on mifepristone are medically unnecessary. But they have become dangerous during this pandemic, as patients have had to risk their health and the health of others just to obtain essential, time-sensitive health care. Unsurprisingly, these requirements have served only to create more barriers to care for those already suffering from higher rates of illness, and economic hardship due to COVID-19 — people of color, people in rural areas, and people with low incomes. But we must remember that these systemic barriers to care existed long before the pandemic and will continue to exist long after. It’s critical that the FDA now conduct a comprehensive review of the full set of restrictions on mifepristone. We must ensure all patients can access the essential health care they need — during the pandemic and beyond.”

Last month, Planned Parenthood joined a coalition of 55 reproductive rights, health, and justice groups in a letter calling on the administration to immediately remove the medically unnecessary in-person dispensing requirement during the pandemic and to initiate a comprehensive review of the full set of restrictions. More than 200,000 supporters joined the urgent call by signing petitions to the administration. While today’s announcement is an important first step, the FDA must now move to complete the review needed to undo these unnecessary restrictions once and for all.

Mifepristone is safe, 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 are not based on medical evidence and do not benefit patients. In fact, out of 20,000 prescription medications regulated by the FDA, mifepristone is the only one that the FDA requires to be dispensed in person, but permits patients to self-administer at home.

Planned Parenthood is proud to offer medication abortion via telehealth in 21 states. As a leading sexual and reproductive health care provider, Planned Parenthood is committed to making sure all patients receive the high-quality health care they need, when they need it — including safe, legal abortion. By providing medication abortion safely and effectively via telehealth, we can keep patients, providers, and health center staff safer during the pandemic and expand access to abortion for people, no matter where they live.

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Planned Parenthood is the nation’s leading provider and advocate of high-quality, affordable health care for all people, 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, striving to create equitable access to health care. Through health centers, programs in schools and communities, and online resources, Planned Parenthood is a trusted source of reliable education and information that allows people to make informed health decisions. We do all this because we care passionately about helping people lead healthier lives. Planned Parenthood Federation of America (PPFA) is a 501(c)(3) charitable organization that supports the independently incorporated Planned Parenthood affiliates operating health centers across the U.S.