FDA Announces Plans to Permanently Remove Unnecessary Barriers to Medication Abortion

Agency to repeal in-person dispensing requirement to receive mifepristone; requirement has been temporarily suspended during pandemic

Washington, D.C. — Today, the U.S. Food and Drug Administration (FDA) announced a permanent repeal of the in-person dispensing requirement for mifepristone, one of two medications used in a medication abortion. The requirement — part of a set of unnecessary restrictions known as the Risk Evaluation and Mitigation Strategy (REMS) — mandates that patients obtain the medication in person at a doctor’s office, hospital, or health center instead of from a pharmacy or by mail, which is allowed for other equally safe medications.

Amid widespread social distancing provisions during the pandemic health emergency, the FDA temporarily suspended this requirement last Spring. A patient's unnecessary in-person visits risks exposure to COVID-19 through transportation, child care, multiple health center trips, and more. Today’s decision comes after the FDA conducted a full review on the set of restrictions. However, the FDA left a few medically unnecessary restrictions on medication abortion in place.

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

“Today’s news is a victory for public health and health equity. Let’s be clear: The FDA followed the science in arriving at this decision. There is overwhelming evidence that medication abortion can be safely and effectively provided through telehealth. We’ve seen very clearly in the past two years that the logistical hurdle of unnecessary travel to health centers during a dangerous pandemic only creates more barriers to care, especially for people of color and people with low incomes. Abortion is time-sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Right now the constitutional right to abortion is at a crisis point across the country, as the U.S. Supreme Court considers a case that could overturn Roe v. Wade. Steps like today’s FDA decision are critical for maintaining and expanding access to medication abortion. The FDA’s decision is one way to make it easier for patients to access care.

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 evidence and do not benefit patients. In fact, out of 20,000 prescription medications regulated by the FDA, mifepristone is the only home-use medication required to be dispensed in person. Mifepristone has helped ensure that patients can make their own private medical decisions, and it has expanded access to essential, time-sensitive reproductive health care.

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 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.