Use of the RICO Act in Off-label Promotion Cases

November 8, 2010 at 11:40am
Q1 Productions: Pharmaceutical Compliance: Off-Label Drug Promotion Conference
Philadelphia, PA

As regulatory authorities continue to increase their scrutiny of off-label drug use and promotion, pharmaceutical and bio-technology corporations are finding themselves in a challenging position; working to not only understand evolving regulatory policies, but bridging a significant gap between compliance departments and sales and marketing teams. While there are many compliance conferences flooding the market; these programs do little justice to a major contributing factor to compliance infractions; the off-label promotion of therapies. Through focusing specifically on the challenges and issues associated in compliant handling of off-label drug use, companies will realize tangible take-a-ways from the conference program, enabling them to immediately implement new policies to reduce the risk of regulatory infractions.

Use of the RICO Act in Off-label Promotion Cases

In March 2010, Pfizer was found guilty of violating the Racketeer Influenced and Corrupt Organizations Act (RICO) and ordered to pay $142 million to Kaiser Foundation Health Plan, Inc. related to the off-label promotion of Neurontin. This session will examine the RICO Act and the elements needed to make a case under RICO. We will then look at Pfizer’s promotion of Neurontin and how the activities violated RICO. Finally, we will discuss what this case may mean for the future of off-label prosecutions.


Janice Cunningham
Director Policies and Procedures, Abbott Laboratories

Patrick Egan
Partner, Fox Rothschild LLP