Thomas W. Baker | Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
The pharmaceutical and medical device industries depend on relationships with physicians for both conducting clinical trials required for Food and Drug Administration (“FDA”) approval and prescribing or ordering pharmaceuticals and medical devices once they are approved. From these arrangements, however, substantial regulatory risk arises.
What Laws Generally Govern Relationships with Physicians? Arrangements that involve physician referrals and judgment are generally governed by two laws: the Ethics in Patient Referral Act (the “Stark Law”) and the federal Anti-Kickback Statute. While other laws may be implicated, these two laws, when complemented by the federal False Claims Act, continue to define permissible and impermissible conduct.