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

29 Pages Posted: 24 Sep 2009 Last revised: 1 Feb 2014

Stephanie M. Greene

Boston College - Carroll School of Management

Date Written: 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.

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: https://ssrn.com/abstract=1478076

Stephanie M. Greene (Contact Author)

Boston College - Carroll School of Management ( email )

140 Commonwealth Avenue
Chestnut Hill, MA 02467
United States

Paper statistics

Downloads
172
Rank
142,226
Abstract Views
1,104