In Alliance for Hippocratic Medicine v. Food & Drug Administration,(5th Cir., April 12, 2023), the U.S. 5th Circuit Court of Appeals granted a partial stay of a Texas federal district court's decision invalidating the FDA's approval of the abortion drug mifepristone. The appeals court held that the statute of limitations barred a challenge to the FDA's initial approval of the drug in 2000. However, the court refused to stay the district court's disapproval of changes the FDA made in 2016. Those changes significantly reduced prior restrictions on the administration and use of the drug. The court said in part:
Here, applicants have failed to carry their burden at this preliminary stage to show that FDA’s actions were not arbitrary and capricious. We have two principal concerns in that regard. First, FDA failed to “examine the relevant data” when it made the 2016 ... changes.... That’s because FDA eliminated ... safeguards based on studies that included those very safeguards....
Second, the 2016 ... Changes eliminated the requirement that non-fatal adverse events must be reported to FDA. After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is “safe.”... This ostrich’s-head-in-the-sand approach is deeply troubling.... It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.
Reuters reports on the decision.
Earlier today, the Justice Department announced that it would seek emergency relief from the U.S. Supreme Court.
