Off-Label Promotion Under Scrutiny by DOJ

In a continuing shift of enforcement strategy, the U.S. Department of Justice has firmly taken control of off-label use allegations against pharmaceutical, biotechnology, and medical device manufacturers. Various U.S. attorneys’ offices around the country and especially in Washington, D.C., now enforce existing legalities in the life science industry through the Food, Drug and Cosmetic Act, the Anti-Kickback Statute, and the False Claims Act.

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