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Drug Administration (FDA)-approved medication outside what is described in the product labeling does not violate the Food, Drug, and Cosmetic Act (FDCA). 1 Product labeling often fails to reflect the most up-to-date standard for patient care. Patients expect clinicians to use innovative practices when it is in the patient’s best interest to do so rather than adhering to a labeling document that often has not been modified for many years. Until recently, it has also been well established that a product manufacturer responsible for labeling a medication may not promote that medication for use in a way that has not been approved by FDA (ie, offlabel use). 2 A recent case from the US Court of Appeals for the Second Circuit calls into question this traditional thinking. 3 This case currently serves as precedent only within the states covered by that circuit (New York, Connecticut, and Vermont) but could be followed by other cir-