GSK $3 Billion Settlement Reflects Continued Expansion in Scope of Pharma Plea Agreements

9 July 2012
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Key takeaways:

  • On July 2, 2012, DOJ announced a settlement with GlaxoSmithKline ("GSK") that includes three misdemeanor pleas and a payment of $3 billion to resolve criminal and civil liability relating to allegations concerning off-label promotion, safety reporting, and reporting of "best price."
  • In addition to an omnibus Corporate Integrity Agreement ("CIA") with a number of innovative features, GSK's plea agreement is noteworthy in that it continues a trend introduced with the Abbott Laboratories DOJ settlement in May 2012. Similar to Abbott's plea agreement, the GSK plea agreement incorporates compliance provisions that typically appear in CIAs, and which in fact duplicate some of the provisions in GSK's own CIA. GSK's plea agreement also requires that the Company submit regular reports about its compliance activities directly to the Boston U.S. Attorney's Office and the DOJ Consumer Protection Branch, thus injecting DOJ directly into oversight of the Company's compliance activities in a troubling and potentially important development.
  • GSK's plea agreement also continues the government's focus on the compliance oversight function and responsibility for compliance of senior executives and directors by requiring that GSK's U.S. President and Board of Directors conduct annual compliance program effectiveness reviews and report directly to DOJ. In addition, GSK’s CIA includes a novel Executive Financial Recoupment Program, which requires that GSK seek to recoup from a senior executive an amount equivalent to up to three years of annual performance pay in the event of significant misconduct by the executive or by the employees whom the executive supervises, thus adding a new pressure point to executive responsibility for compliance oversight.