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Anxiety Disorders
Biopharmaceutical Company, Cephalon, To Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing
October 18th, 2008
Cephalon Inc. will enter a criminal plea and pay $425 million to resolve claims that it marketed three drugs for uses not approved by the Food and Drug Administration (FDA), the Justice Department announced. The lawsuits were brought by former Cephalon employees and filed under the qui tam provisions of the False Claims Act. The suits alleged that Cephalon engaged in a scheme to market Gabitril, Actiq and Provigil for unapproved uses in violation of the Food, Drug and Cosmetic Act, which requires a company to specify the intended uses of a product in its new drug application to the FDA. Once approved, the drug may not be marketed or promoted for so-called "off label"...
Source: Law & Health Weekly (2008-10-18)
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