Cephalon fights allegations of falsely promoting drugs for the wrong use

FRAZER, Pa. Cephalon has finalized an agreement with the United States Attorney’s Office for the Eastern District of Pennsylvania, the Department of Justice and other federal agencies concerning allegations that it promoted three drugs for uses that the Food and Drug Administration had not approved, the company announced Monday.

The allegations concerned the cancer-related pain drug Actiq (oral transmucosal fentanyl citrate), the sleep-disorder drug Provigil (modafinil) and the seizure drug GabitRil (tiagabine hydrochloride). Under the terms of the agreement, Cephalon will pay $425 million reserved last year plus $12 million interest and plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act. It will also enter into a five-year Corporate Integrity Agreement with the Office of the Inspector General of the Department of Health and Human Services.