Criminal Prosecution of Allergan Inc.
In August 2010, Allergan, Inc agreed to plead guilty to misdemeanor misbranding and pay $600 million (including a $375 million criminal fine and forfeiture and a $225 million civil settlement) to resolve criminal and civil liability arising from the company’s promotion of Botox® for indications that had not been approved as safe and effective by the FDA, including headache, pain, spasticity and juvenile cerebral palsy. In addition to off-label marketing, the civil settlement resolves allegations that Allergan misled doctors about the safety and efficacy of Botox® for off-label indications, instructed doctors to miscode uncovered Botox® claims to ensure payment by government healthcare programs, and paid kickbacks to doctors. Allergan also entered into a 5-year Corporate Integrity Agreement (CIA) with HHS/OIG.
Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2011
This article was posted on July 15, 2012.