Judge orders FDA to reconsider mifepristone restrictions

A federal judge in Virginia has ordered the Food and Drug Administration to take another look at its remaining restrictions on mifepristone, finding that the agency’s latest rules for the abortion medication are not supported by its own safety reviews.

U.S. District Judge Robert S. Ballou ruled in favor of Whole Woman’s Health Alliance in a challenge to the FDA’s Risk Evaluation and Mitigation Strategy, or REMS, for mifepristone. Ballou found the restrictions arbitrary and capricious and sent the 2023 REMS back to the agency for further proceedings.

Previous FDA reviews have “steadfastly found” that mifepristone is safe and effective, Ballou wrote, according to The Guardian.

The case targets rules that remain in place even after the FDA, under the Biden administration in 2023, loosened access to the drug by allowing it to be prescribed through telehealth, dispensed by certified pharmacies and sent by mail. The remaining requirements include special certification for prescribers and pharmacies, as well as a patient consent form.

Ballou said the FDA had not shown that mifepristone is unusually dangerous compared with other commonly prescribed medications. “Plaintiffs note that other commonly prescribed drugs, comparable in safety to mifepristone, have been approved without any REMS requirements,” he wrote. He cited an analysis finding a mortality rate of 0.65 deaths per 100,000 medication abortions, compared with 2 deaths per 100,000 patients administered penicillin, which does not have a REMS.

He also noted that in 2012 the FDA approved mifepristone, marketed as Korlym, to treat Cushing’s syndrome at a higher dosage and for a longer duration without imposing REMS requirements or additional safety-use elements.

The lawsuit, Whole Woman’s Health Alliance v. FDA, was filed in May 2023 by the Center for Reproductive Rights on behalf of abortion providers in Virginia, Kansas and Montana. The plaintiffs sought to remove three restrictions they described as medically unnecessary, including special registration and certification for providers and pharmacies and paperwork for patients that Linda Goldstein, senior counsel at the center, called “duplicative, inaccurate, and confusing.”

“The efforts to restrict it are not about science or safety – they are about making abortion harder to access,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement. She called the ruling “a win for science.”

Amy Hagstrom Miller, president and CEO of Whole Woman’s Health Alliance, said the rules have affected patient care. “I have worked in abortion care for over 30 years, and I can attest that these regulations serve no medical purpose, nor do they add value to our patients’ experience of abortion,” she said.

Kathryn Boyd, president and CEO of Trust Women, said clinics in states where abortion remains legal are seeing patients who travel from places with bans. “In Kansas, we’ve become a vital access point for people forced to travel long distances for abortion care,” Boyd said. “Every barrier lifted would mean fewer delays, less stress and more dignity for our patients.”

The ruling comes as legal fights over mifepristone continue. Louisiana is pursuing a separate case asking the FDA to reinstate earlier restrictions that would block mail-order mifepristone and limit pharmacy prescriptions. A Fifth Circuit Court of Appeals panel sided with Louisiana, Talking Points Memo reported, but the Supreme Court blocked that ruling while litigation continues.

The FDA, which The Guardian reported currently has no permanent commissioner, says it is reviewing abortion pill regulations after pressure from conservative lawmakers and activists. Abortion pills now account for nearly two-thirds of abortions in the United States, and studies over 25 years have indicated mifepristone’s safety and effectiveness.