Criminal Prosecutions of Cephalon, Inc.

Cephalon, Inc., entered a global criminal, civil, and administrative settlement under which the company agreed to pay a total of $425 million plus interest; plead guilty to a misdemeanor violation of the Federal Food, Drug and Cosmetic Act; and enter into a comprehensive 5-year CIA with HHS/OIG. The civil settlement resolves allegations filed in four separate qui tam cases, which alleged that Cephalon promoted the drugs Actiq, Gabitril, and Provigil for "off-label" uses (that is, uses other than those approved by FDA). Cephalon's off-label promotional practices involved a variety of techniques, including training its sales force to disregard restrictions of the FDA-approved label and promote the drugs for off-label uses. In addition to the $375 million civil settlement, Cephalon entered into a criminal plea agreement with the United States under which it will pay $50 million.

Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2008

This article was posted on July 15, 2012.

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