The American Civil Liberties Union filed a federal lawsuit challenging an FDA rule that subjects patients to unnecessary risks of contracting COVID-19 as a condition of receiving a medication used for early abortion and miscarriage treatment.
Mifepristone is a drug used to safely and effectively end early pregnancies and treat early miscarriage. For more than 20 years, people in the United States have used mifepristone, in combination with another drug, misoprostol, to end an early pregnancy. The FDA, however, has long subjected mifepristone, when used for pregnancy termination, to a set of unnecessary requirements that make it more difficult for patients to access care.
During the COVID-19 pandemic, the FDA has continued to enforce those requirements, including one in particular — the in-person dispensing requirement — that puts patients’ health and lives at risk as a condition of obtaining abortion and miscarriage care. Patients are forced to make an unnecessary trip to a hospital, clinic, or medical office to pick up the mifepristone pill—even when they will be receiving no in-person medical services at that time and will swallow the pill later at home (as the FDA permits). Out of more than 20,000 FDA-approved drugs, mifepristone is the only drug that the FDA requires to be dispensed only in clinical settings while permitting patients to self-administer it at home. The FDA permits patients taking mifepristone for reasons other than pregnancy termination to receive the drug through the mail in much higher doses and quantities.
By continuing to enforce the In-Person Dispensing Requirement during the pandemic, the FDA unnecessarily exposes patients and clinicians to heightened COVID-19 risks, jeopardizing their health and lives for no medical purpose. These unjustified risks are magnified for low-income people and people of color, who comprise a majority of impacted patients, and who are already suffering outsized rates of severe illness and fatality from COVID-19.
The case was filed in the U.S. District Court in the District of Maryland on behalf of the American College of Obstetricians & Gynecologists, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and an individual family medicine doctor.