Abstract

http://ssrn.com/abstract=1478076
 


 



False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products


Stephanie M. Greene


Boston College - Carroll School of Management

2005

Penn State Law Review, Vol. 110, pp. 41-68, 2005

Abstract:     
This article details pharmaceutical company liability for off-label promotional marketing strategies. Despite near record revenues, the pharmaceutical industry faces struggles relating its business cycle of research, development, patenting and then inevitable competition from generics. This boom-bust scenario forced companies to seek profits from both increased marketing and through expanding the markets for their drugs. The twin phenomena of direct-to-consumer advertising and off-label promotions prompted regulatory action and resulting in legislation of the False Claims Act. The author reviews pharmaceutical tactics that have triggered review by the government, and concludes with recommendations on compliance and best practices for pharmaceutical companies.

Number of Pages in PDF File: 29

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Date posted: September 24, 2009 ; Last revised: February 1, 2014

Suggested Citation

Greene, Stephanie M., False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products (2005). Penn State Law Review, Vol. 110, pp. 41-68, 2005. Available at SSRN: http://ssrn.com/abstract=1478076

Contact Information

Stephanie M. Greene (Contact Author)
Boston College - Carroll School of Management ( email )
140 Commonwealth Avenue
Chestnut Hill, MA 02467
United States
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