On October 10, 2023, the Supreme Court declined to hear an important case about the regulatory process. This decision was a setback for WLF, which filed an amicus curiae brief urging review of a Fourth Circuit decision holding 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 argued that this bait-and-switch violated the petitioners’ due-process rights. The brief also detailed how FDA’s denial orders were arbitrary and capricious because FDA did not consider the petitioners’ evidence. Finally, the brief explained why FDA’s action could endanger American lives.


WLF amicus brief