The Food and Drug Administration has long taken the position that while an off-label use of pharmaceuticals and medical devices is legal, off-label marketing or promotion is not legal.  However, recent jurisprudence calls into question whether merely marketing a product for an off-label use is sufficient to satisfy the requirement of making a “false statement” under the False Claims Act (FCA).  In this presentation, we will outline the elements of the FCA and the Anti-Kickback Statute (AKS), and discuss case law and agency guidance regarding whether off-label marketing or promotion truly puts healthcare companies at risk of violating the FCA and AKS.

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