In 2023, the U.S. Food and Drug Administration (FDA) modified its Risk Evaluation and Mitigation Strategies for mifepristone to remove an in-person dispensing requirement (2023 REMS). That action is the subject of this litigation, in which Louisiana argues that the 2023 REMS was arbitrary and capricious.
Following the change in presidential administration, the FDA chose not to defend the action on the merits. Instead, in September 2025, Health and Human Services Secretary Robert F. Kennedy, Jr., and then-FDA Commissioner Martin A. Makary stated that the FDA’s decision suffered from a “lack of adequate consideration” and announced that it would reconsider the 2023 REMS.
Our amicus brief, filed in the U.S. Court of Appeals for the Fifth Circuit, explains that these statements should receive no weight in the Court’s analysis because they postdate the agency’s decision, are outside the administrative record, and are conclusory and fail to grapple with the agency’s prior findings. Drawing on longstanding principles of administrative law, our brief explains that an agency’s post hoc, extra-record statements about the sufficiency of evidence should bear no weight in a court’s arbitrary-and-capricious analysis.