Judge temporarily suspends FDA’s in-person requirements on mifepristone
New York, NY — Today, a federal court ruled that the U.S. Food and Drug Administration (FDA) must temporarily suspend enforcement of the in-person requirements on the medication mifepristone, which unnecessarily subject patients to COVID-19 risks in order to access abortion during the pandemic. The lawsuit was filed by the American Civil Liberties Union (ACLU) on behalf of the American College of Obstetricians and Gynecologists (ACOG), SisterSong Women of Color Reproductive Justice Collective, and other leading medical organizations and reproductive health, rights, and justice advocates.
The court issued a nationwide preliminary injunction blocking part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) restrictions on mifepristone when it is used for medication abortion, yet failed to suspend the restrictions when the medication is used for managing an early miscarriage. The temporary easing of the in-person requirements allows mifepristone to be mailed from the health center to the patient where state law permits. The injunction will last for the duration of the litigation, or until the Trump administration ends the federal public health emergency declaration.
Statement from Alexis McGill Johnson, president & CEO, Planned Parenthood Federation of America:
“Today’s ruling is critical to ensure that people, especially people of color and people with low incomes — and those living at the intersections of these identities — can access abortion as safely as possible during the pandemic. The health risks of traveling to a health center to pick up medication that can otherwise be delivered to a patient’s home are especially acute for Black people, Indigenous people, and other people of color, who are currently suffering from higher rates of illness and death due to COVID-19. People should not be forced to risk unnecessary exposure to a deadly virus in order to access essential medication that has a proven track record of safety. Suspending the FDA’s in-person requirements on mifepristone is an important step toward health equity as we continue to weather this public health crisis.”
Mifepristone is safe, effective, and has been used by more than four million people since the FDA approved it twenty years ago. Leading medical associations have maintained that the FDA’s REMS restrictions on the distribution of mifepristone are not based on evidence and do not benefit patients. Research has repeatedly shown that mifepristone is safe and effective when prescribed through telehealth and self-administered at home.
PPFA joined the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP), and other leading health care organizations in signing on to an amicus brief in support of the lawsuit.
Planned Parenthood is the nation’s leading provider and advocate of high-quality, affordable health care for women, men, and young 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. 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.