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

 
• By Sue Sutter

Policy revisions on individual liability for corporate misconduct, noncompliance with agency guidance documents and dismissal of False Claims Act cases suggest a greater willingness by DoJ leadership to reconsider arguments often raised by life sciences companies, attorneys say at a Food and Drug Law Institute conference.

LONDON, UK - MARCH 26TH 2018: The symbol of the United States Department of Justice portrayed with the US flag, on 26th March 2018. - Image

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...

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