Pharmaceutical Compliance Program Elements

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Pharmaceutical Compliance Program ElementsPharmaceutical Compliance ForumSeptember 15, 2009Bridgewater, NJJohn T. BentivoglioSkadden, ArpsMatthew D AmbrosioProstrakan, of Discussion sentencing guidelines HHS OIG Guidance DOJ Guidance on Compliance programs Advanced Pharma Compliance Issues DiscussionA Brief History of Corporate Federal sentencing Guidelines1996CaremarkDecision2001Enron Collapse &TAP Settlement2002PhRMACode&SOX2004Amended SentencingGuidelines1997OIGModel ComplianceGuidelines(Clinical Labs)2003OIGPharmaGuidelines&DOJ sThompsonMemoCompliance Time Line2005Corporate sentencing guidelines provide reduction in fines for effective Compliance programs . Seven Elements a cause of action against board members for failing to take minimal steps to achieve legal Compliance now known as a Caremark Claim.

2 Topics of Discussion • U.S. Sentencing Guidelines • HHS OIG Guidance • DOJ Guidance on Compliance Programs • Advanced Pharma Compliance Issues • Discussion

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