Leading Medical Organizations, Members of Congress, State Attorneys General Join Challenge to FDA Restrictions on Medication Abortion

WASHINGTON — The nation’s leading medical experts, 157 members of Congress, and 22 state attorneys general and the District of Columbia have submitted friend-of-the-court briefs in the 4th Circuit Court of Appeals today in American College of Obstetricians and Gynecologists v. FDA.

Brought by the ACLU on behalf of preeminent medical and reproductive justice organizations, the case challenges a U.S. Food and Drug Administration policy that forces patients to risk unnecessary exposure to COVID-19 as a condition of accessing mifepristone, a safe and effective medication used for early abortion and miscarriage care.

Of the 20,000 drugs the FDA regulates, mifepristone is the only one the FDA requires patients to pick up in person at a health center even though they may take it later at a time and place of their choosing. Even as the government suspended other in-person requirements during the public health emergency, including for far less safe medications such as opioids, the Trump administration ignored repeated calls by leading medical authorities to do the same for mifepristone, instead continuing to subject patients seeking abortion and miscarriage care to a dangerous one-size-fits-all travel mandate. With patients and their families facing needless risk every day, it is urgent that the new administration act quickly to end this harm.

Quote from brief on behalf of the American Medical Association:

“Simply put, a mandate for in-person dispensing of mifepristone, regardless of the patient’s circumstances, is inconsistent with best practices for medical treatment under pre-pandemic circumstances, and particularly during the pandemic when unnecessary travel to a health care facility carries a risk of exposure to a deadly virus. The CDC and FDA have supported the medical community’s efforts to reduce the risk to patients requiring other treatments and their clinicians, including by advocating the use of telemedicine and mail order delivery of medications, where possible, and relaxing certain in-person and REMS [Risk Evaluation and Mitigation Strategies] requirements. There is no medical basis for mifepristone to be treated differently.”

During the pandemic, the FDA’s in-person pill pick-up requirement exposes patients to needless COVID-19 risks relating to transportation, childcare, and other interpersonal contact. It is particularly harmful for people of color and people with low incomes, who make up the majority of impacted patients and who are suffering severe complications and dying from COVID-19 at disproportionately high rates.

Quote from brief on behalf of Members of Congress led by Sens. Blumenthal, Feinstein, Hirono, and Wyden and Reps. Lee, DeGette, Nadler, Pressley, and Schakowsky:

“Upholding mifepristone’s in-person REMS requirements during the COVID-19 pandemic is at odds with public health guidance, statutory intent, and common sense — it is medically unnecessary, burdens patient access to mifepristone, and imposes irreparable harm on miscarriage and medication abortion patients and their medical providers.”

The plaintiffs in the case are the American College of Obstetricians and Gynecologists, the Council of University Chairs of Obstetrics and Gynecology, the New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and an individual family medicine physician.

More about this case can be found online here: https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration