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Email In 2012, the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”) and held that the government’s prosecution of Caronia for engaging in truthful promotion of an approved drug, albeit for off-label uses, violated Caronia’s right of free speech under the First Amendment. In the wake of Caronia, many commentators questioned whether the government’s efforts to prosecute the off-label marketing of drugs would be substantially impaired. Recognizing the potential for such impairment, the government appears to have modified its approach to off-label enforcement by arguing that commercial speech regarding off-label usages is being introduced simply as evidence of fraud or misbranding, and not to prove that the speech itself violated the law. https://www.cadwalader.com/resources/clients-friends-memos/first-amendment-and-off-label-promotion-prosecute-what-i-do-not-what-i-say