On October 10, 2024, WLF urged the Supreme Court to affirm a Fifth Circuit holding that the Food and Drug Administration could not advise 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 regulatory bait-and-switch violates the respondents’ due-process rights. The brief also details how FDA’s denial orders are arbitrary and capricious because FDA did not consider certain evidence. Finally, the brief explains why FDA’s action could harm Americans’ health.
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