Cephalon Settles Drug Marketing Investigation for $425 Million
Cephalon will pay $425 million under an agreement with the U.S. attorney in Philadelphia and the Justice Department over an investigation of the company’s sales and marketing practices.
The company also agreed to a misdemeanor violation of the Federal Food, Drug and Cosmetic Act and will enter into a corporate integrity agreement with the HHS Office of Inspector General.
The company has been under fire this year from the FDA and lawmakers for off-label marketing of its products. Earlier this year, the FDA sent a warning letter to Cephalon for off-label promotion of Provigil (modafinil). A promotional piece said Provigil treated various disorders, including those associated with fatigue, although the drug is not indicated for fatigue.
At the time, Cephalon said the document was independently created by a consultant and was not reviewed by the firm or its medical directors.
The warning letter said Provigil also was being promoted for another condition shortly after Cephalon received a not-approvable letter for that specific indication.
Congress also investigated Cephalon’s promotional activities. House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) asked Cephalon for promotional and research information for its narcotic painkillers Actiq (oral transmucosal fentanyl citrate) and Fentora (fentanyl buccal).
The Connecticut attorney general is continuing to investigate Cephalon for off-label promotion of Actiq.