Cephalon, Inc., a Pennsylvania drug manufacturer, will pay $425 million to settle several lawsuits against it. The lawsuits allege that Cephalon had engaged in illegal marketing of three of its drugs, Actiq, Gabitril and Provigil. Actiq is approved for severe pain in cancer patients whose pain is not controlled by other painkillers. However, Cephalon was promoting Actiq for migraines and injuries. Gabitril was marketed for anxiety and insomnia, though it is approved for treating epilepsy. Cephalon promoted Provigil for fatigue, though its approved use is for narcolepsy.
Cephalon encouraged off-label marketing at lavish physician-education conferences and through its compensation and bonus structure, authorities said. The company also had its sales force call on doctors who would not normally prescribe the three drugs, they said.
Though FDA approved drugs can be prescribed by doctors for other uses beyond what they were approved for, drug companies are not allowed to promote their drugs for such off-label uses. The Cephalon settlement includes some money to be paid to whistleblowers, who are former Cephalon sales representatives. State and federal Medicaid programs, which paid for many of the prescriptions, will get most of the $425 million. The settlement also criminal fines and forfeitures, and a guilty plea by Cephalon to a criminal misdemeanor charge related to the off-label marketing. Contact Sheller, P.C. if you have questions about your off-label use of Cephalon medications.