The Justice Department is expected to appeal the decision. In April, the Supreme Court issued an order pausing any changes to regulating mifepristone while litigation continues.
Judge Jennifer Walker Elrod, in the majority opinion, wrote that “in loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it.”
The agency did not consider the cumulative effect of removing different restrictions to the drug’s risk profile and did not present the court with evidence that the drug could be used safely when prescribed and dispensed remotely, the opinion states.
In 2016, the FDA eased regulations to allow mifepristone to be prescribed up to 10 weeks of pregnancy, by telehealth and by advanced practice practitioners. In 2021, FDA temporarily removed the in-person examination requirement. It made that change permanent in 2023.
Judge James C. Ho, concurring and dissenting in part, wrote that FDA had also erred in its initial approval of the drug in 2000 and pushed back on the DOJ argument that the plaintiffs lacked standing to bring suit.