On April 2, 2025, the Supreme Court vacated a Fifth Circuit ruling that held that the Food and Drug Administration could not advise companies they need not include information in pre-market applications and then deny those applications for failing to include that very information. The decision was a setback for WLF, which filed a brief in the case urging affirmance. WLF’s brief argued that FDA’s denial orders are arbitrary and capricious because FDA did not consider certain evidence. A unanimous Supreme Court disagreed, leaving open on remand whether any error was harmless because FDA issued denial orders to other manufacturers after reviewing marketing plans that were materially indistinguishable from respondents’.
Documents