The significant Implications of the Caronia off-label promotion decision for US FDA-regulated firms

摘要

A decade and a half after US litigation in Washington Legal Foundation first raised questions about the constitutionality of the Food and Drug Administration's regulation of promotion, a court of appeals in United States v Caronia held that "[t]he government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug, and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug".