On April 21, 2024, the Supreme Court declined to hear an important case about the regulatory process. The denial was a disappointment for WLF, which filed an amicus brief in the case urging review. The Ninth 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 argued that this regulatory bait-and-switch violated the petitioner’s due-process rights. The brief also detailed how FDA’s denial orders were arbitrary and capricious because FDA did not consider the petitioner’s evidence. Finally, the brief explains why FDA’s action could harm Americans’ health.
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