A federal judge has ruled that the Food and Drug Administration’s 2023 restrictions on the abortion drug mifepristone are “arbitrary and capricious,” ordering the agency to better justify rules requiring special certification for prescribers and pharmacies.
The two drugs mifepristone and misoprostol together make up the most common abortion regimen in the United States.
On July 23, U.S. District Judge Robert Ballou in Charlottesville, Virginia, said the FDA had failed to explain why the requirements adopted in 2023 were necessary, after the agency had repeatedly affirmed mifepristone’s safety and effectiveness.
The suit, filed in 2023 by abortion advocates Whole Woman’s Health Alliance and other abortion providers in Virginia, Kansas, and Montana, challenged the FDA’s 2023 mifepristone restrictions as unwarranted under federal law, as they require prescribers and dispensing pharmacies to be specially certified and require patients to sign a written acknowledgment of the drug’s risks….