September 10, 2024 | 12:00 PM - 1:00 PM EST
Overview (Program Summary)
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.
Join the Conversation:
Health Law Network Community
Sponsored by:
Interest Area(s):
Health Law