The Second Circuit Court of Appeals recently reversed the conviction of a pharmaceutical sales representative for off-label drug promotion because it violated his right to free speech.  See client advisory.  The Court in United States v. Caronia held that the government cannot prosecute pharmaceutical manufacturers and their representatives for misbranding violations under the Food Drug and Cosmetic Act (FDCA) for speech promoting the lawful, off-label use of an FDA-approved drug.  The decision is helpful in determining when off-label promotion may be protected as opposed to criminal in the Second Circuit, but ambiguity remains in this area and continuing to closely monitor off-label promotion by sales representatives is advised.