Defining Off-Label Marketing Of Prescription Drugs: Conduct Likely To Trigger Government Scrutiny

Posted on April 4, 2011 by Antonia F. Giuliana

Here is a copy of the off-label marketing presentation that I prepared for ACI's conference on Fraud and Abuse in the Sale and Marketing of Drugs held last week in New York.  The presentation slides include:

  • A summary chart of off-label marketing settlements with drug companies between 2004 and 2010. (Slide Nos. 1-4)
     
  • A summary chart showing which U.S. Attorney's Offices have been most active in pursuing off-label marketing investigations against drug companies, and the success rates of each office (as measured by felony pleas, misdemeanor pleas, and settlement amounts).  (Slide Nos. 5-6)
     
  • Recent government interventions and subpoenas in off-label marketing investigations. (Slide Nos. 7-11)
     
  • The pipeline for future off-label marketing cases based on information about sealed qui tam cases recently disclosed by the DOJ. (Slide No. 12)
     
  • 18 different types of conduct that are likely to trigger an off-label marketing investigation by the government.  (Slide Nos. 13-38) 
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