Alliance for Hippocratic Medicine v. FDA
(U.S. Court of Appeals for the 5th Circuit, August 16, 2023) The Fifth Circuit Court of Appeals found that it was too late for the plaintiffs to challenge the Food and Drug Administration’s (FDA) approval of the abortion drug Mifepristone in 2000 but found that the plaintiffs presented sufficient evidence that FDA’s 2016 changes to the protocol for use of Mifepristone violated the Administrative Procedures Act. As a result, the Court ordered that the pre-2016 protocols should remain in place pending trial. This not only removed the 2016 protocols, but it also invalidated the 2023 changes to the protocols. The Court’s decision makes access to Mifepristone more difficult as multiple in-person visits are required before the mandatory in-person administration of the medication. The Court’s decision is not in effect, however, as the U.S. Supreme Court has stayed all action in the case pending consideration of a petition for certiorari filed by the FDA. Additionally, a federal district court in Washington State found that the FDA’s 2023 protocols may be too stringent and issued an order prohibiting the FDA from altering the 2023 protocols to be more stringent while the case proceeds to trial. That decision covers 18 states that sued the FDA. The Alliance for Hippocratic Oath decision, though stayed, purports to apply nationally. Read the full Opinion here.