Pharma May See Brighter Enforcement Environment After US Justice Department Policy Changes

Recent changes and clarifications in US Department of Justice (DoJ) enforcement policy could make life a little bit easier for biopharma companies in the coming year, providing a clearer road to settling corporate wrongdoing cases, potentially fewer enforcement actions under the Anti-Kickback Statute and a faster path to getting False Claims Act cases dismissed.

Policy statements by several high-level justice department officials, and how they might impact the risk for enforcement actions in the biopharma space, were the focus of extensive discussion at the Food and Drug Law Institute’s (FDLI)