Tag Archives: United States Department of Justice

7 New Insights to Preventing Off-Label Sales Promotion


I was invited to present at a recent meeting of the AdvaMed Emerging Growth Company Council. My presentation on “Preventing Off-Label Sales Promotion” generated much interesting discussion. One passionate individual debated that sales people were not to blame and that they were simply at the receiving end of internal strategies and dictates. While studies support that corporate strategies were to blame in the past, lawyers think that is becoming more rare, especially in pharma.

View the slides of my presentation here and share your thoughts:

Key Questions

  • Do you think sales is simply an easy target for government investigators pursuing illegal off-label activity?
  • Or, do you think sales is still on the receiving end of bad direction? Is the same true in pharma and medical devices or is it different?

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Who’s Afraid of the DOJ?


I was very much looking forward to hearing Lanny Breuer, Assistant Attorney General for the Criminal Division, U.S. Department of Justice, speak this morning at the Dow Jones Global Compliance Symposium. In prior speeches, he had offered fresh data and future direction for DOJ investigations. I had always found this information to be elucidating for training and actionable for compliance. Continue reading

17x Return on DOJ Fraud


Fraud and abuse has been a hot topic for Congressional oversight, and the DOJ is performing admirably by stockpiling revenues — $2.5B in FY2010 alone for civil healthcare fraud with $1.6MM courtesy of pharma and medical device companies.  Additionally, with the DOJ’s outstanding returns, $17 for every dollar spent on enforcement from FY2007-FY2009 (check out page 31 of their appropriations report), the DOJ’s ROI looks better than most pharma and medical device companies. Continue reading