On May 31, 2023, WLF urged the Supreme Court to hear an important case about the regulatory process. The Fourth Circuit held that the Food and Drug Administration could tell companies they need not include information in applications and then deny those applications for failing to include that very information. WLF’s brief argues that this bait-and-switch violates the petitioners’ due-process rights. The brief also details how FDA’s denial orders are arbitrary and capricious because FDA did not consider the petitioners’ evidence. Finally, the brief explains why FDA’s action could endanger American lives.


WLF amicus brief