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

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.