A federal judge ruled Friday in favor of abortion providers who asserted that the Food and Drug Administration unjustly restricted the abortion pill mifepristone in recent years.
Robert Ballou, U.S. District Judge for the Western District of Virginia, found the FDA failed to complete an adequate review of the drug before introducing new requirements via Risk Evaluation and Mitigation Strategies (REMS).
“The REMS modifications are arbitrary and capricious,” Ballou wrote. “The FDA has steadfastly found, over the past quarter century, that mifepristone is a safe and effective medication.”
Ballou directed the agency to reconsider its restrictions, but did not strike them down. He noted the agency’s restrictions violate the plaintiffs’ equal protection rights by treating mifepristone prescribers and patients worse than those who prescribe or take any other FDA-approved drug.
The FDA in 2023 retained requirements that mifepristone prescribing pharmacies and clinicians be specially certified, and that patients and their doctor sign a form acknowledging the treatment and its risks — a move abortion providers in Virginia, Kansas and Montana sued to block.
“This ruling is an important victory for our patients and a powerful reminder that healthcare policy should be driven by science, not politics,” plaintiff Kathryn Sanders of Blue Mountain Clinic in Montana said in a statement. “Removing these unnecessary barriers would help ensure pregnant people can access the essential, timely, and dignified care they deserve, while protecting and strengthening access to medication abortion as a safe and effective healthcare option.”
The FDA initially approved mifepristone in 2000 and has loosened restrictions on the drug in the last two decades, including a 2021 ruling allowing mail-order pharmacies to dispense the pill due to concerns that the coronavirus pandemic would prevent patients from receiving care.
The sending of abortion pills by mail has been challenged in court by several Republican-led states, but the Supreme Court ruled in May that the practice may continue while the case plays out in a lower court.
A panel of Fifth Circuit judges will soon hear arguments in a case where Louisiana is asking for previous FDA restrictions to be reinstated, blocking patients from getting mifepristone by mail or from a pharmacy.
Nancy Northup, president and CEO at the Center for Reproductive Rights, called Friday’s ruling a “win for science,” adding that mifepristone is being increasingly targeted for political reasons.
“This essential drug is in grave danger of being severely restricted or even taken off the market nationwide,” she said. “But as the court ruled today, mifepristone is exceedingly safe. The efforts to restrict it are not about science or safety—they are about making abortion harder to access.”