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In December 2012, the 2nd Circuit issued a groundbreaking 2-1 decision, holding that the First Amendment protects the truthful, non-misleading off label promotion of pharmaceutical products. In U.S. v. Caronia, the court vacated the conviction of Alfred Caronia, a pharmaceutical sales representative found guilty of conspiring to introduce a misbranded drug into commerce in violation of the Food, Drug and Cosmetic Act (FDCA), finding that his conviction, premised solely on his promotion of the drug for off label use, violated his free speech rights under the First Amendment. The court held that the FDCA does not prohibit “the truthful off-label promotion of FDA-approved prescription drugs.”

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