Leading with Science: FDA Is Reviewing Unnecessary Medication Abortion Restrictions   

WASHINGTON, D.C. — Tonight, the Biden-Harris administration told the court in Chelius v. Becerra — a case challenging the restrictions on medication abortion — that the U.S. Food and Drug Administration (FDA) is reviewing the unnecessary and harmful restrictions on mifepristone, a prescription drug used in medication abortion. The Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone impose medically unnecessary requirements on providers and 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. Today’s announcement follows FDA action last month to “exercise enforcement discretion” regarding the in-person requirement during the duration of the COVID-19 pandemic, which has been extended through the end of the year.

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

“This is an important step in the right direction to expand access to reproductive health care and achieve health equity. We appreciate FDA leaders for reviewing the science and taking these initial steps. We have long known that the decades-old restrictions on mifepristone are medically unnecessary. The FDA’s action to increase access to medication abortion during the pandemic was a critical first step, yet the systemic barriers to care that people of color, people in rural areas, and people with low incomes face existed long before the pandemic — and will remain long after. Given the evidence, this review should show that the restrictions on mifepristone are unwarranted, harmful and prevent people from accessing safe, legal, time-sensitive abortion. This announcement is a huge step toward ensuring all people are in full control of their bodies and their futures.”

In March, 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.

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. The REMS restrictions on mifepristone are not supported by research and are another example of reproductive health care — especially abortion — being treated differently than other kinds of health care in ways that only make access harder for patients. 

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.

###

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.