The U.S. Dept. of Justice announced on Sept. 29 that biopharmaceutical company Cephalon 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 lawsuits, brought under the whistleblower provisions of the False Claims Act, alleged that Cephalon engaged in a scheme to market Gabitril, Actiq and Provigil for “off-label” uses. Doctors may prescribe drugs for uses not specified in a company’s FDA drug application, but drugs may not be marketed or promoted for any use not specified in an application and approved by FDA.
The suits alleged that, as a result of Cephalon’s off-label marketing campaign, false claims for payment were submitted to federal insurance programs such as Medicaid and the Federal Employee Health Benefits Program which did not provide coverage for such off-label uses.