In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (5th Cir., Aug. 16, 2023), the U.S. 5th circuit Court of Appeals upheld the portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used from 49 to 70 days. It also lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors. Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds.
The court concluded that plaintiffs are likely to succeed on their Administrative Procedure Act challenges that the FDA's actions were arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law. This was the case as to the 2016 action because the FDA did not consider the cumulative effect of the changes it was proposing. They were likely to succeed on their challenge to the 2021 action because the FDA did not adequately study adverse event data.
However, as the court recognized, the U.S. Supreme Court has already ordered a stay of all the district court's orders until federal appeals are completed. Thus the 5th Circuit's action does not reinstate the district court's bans.
Judge Ho concurred in part and dissented in part, saying tht he would also hold that the initial approval of mifepristone in 2000 should be set aside.
NPR reports on the decision.
