A federal judge upheld the safety of the abortion medication mifepristone and ordered the Trump administration to examine and consider overturning restrictions on the drug as barriers to abortion access mount across the country.
Robert S Ballou, a US district judge in Virginia, ordered the Food and Drug Administration’s (FDA) on Friday to reconsider mifepristone restrictions, which the judge found to be arbitrary and capricious.
Previous FDA reviews have “steadfastly found” that mifepristone is safe and effective, Ballou wrote in his decision.
Fifth circuit judges are set to hear arguments in a separate case, with Louisiana asking the FDA to reinstate previous restrictions that would block mail-order mifepristone and put limits on pharmacy prescriptions.
The FDA, which currently has no permanent commissioner, says it is conducting a review of abortion pill regulations that has been pushed by conservative lawmakers and activists.
The case, Whole Woman’s Health Alliance v FDA, was filed in May 2023 by the Center for Reproductive Rights, representing abortion providers in Virginia, Kansas and Montana.
“The efforts to restrict it are not about science or safety – they are about making abortion harder to access,” said Nancy Northup, president and CEO at the center, in a statement. She called Friday’s ruling “a win for science”.
The court’s findings are consistent with decades of scientific and clinical studies in this country and internationally, said Joanne Rosen, director of Center for Law and the Public’s Health at the Johns Hopkins Bloomberg School of Public Health.
“This decision, however, will not settle the pitched debate over the safety of mifepristone and the conditions under which it should be available, and will be far from the last word,” Rosen said.
Several states, including Louisiana, are currently challenging the safety and availability of mifepristone in courts across the country and seeking to have it removed from the market nationwide, or to restrict its access, despite that long record of safety, she added. “So, stay tuned.”
The plaintiffs asked the court to remove three medically unnecessary restrictions, including a requirement for providers and pharmacies that prescribe and dispense mifepristone to have a special registration and certification, and for patients to sign “duplicative, inaccurate, and confusing” paperwork, Linda Goldstein, senior counsel at the center, said in the statement.
“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,” said Amy Hagstrom Miller, president and CEO of Whole Woman’s Health Alliance.
The “red tape” kept her clinic from seeing patients – the number of whom has increased as patients have been forced to leave their homes in states with bans to seek care elsewhere, she said.
“In Kansas, we’ve become a vital access point for people forced to travel long distances for abortion care,”said Kathryn Boyd, president and CEO of Trust Women. “Every barrier lifted would mean fewer delays, less stress and more dignity for our patients.”
Abortion pills now account for nearly two-thirds of all abortions in the US, and a quarter-century of studies have indicated the safety and effectiveness of mifepristone.
