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Cephalon Marketing Under Investigation By Philadelphia U.S. Attorney

Executive Summary

The Philadelphia U.S. Attorney's investigation into Cephalon's marketing practices covers the entire commercial life of Provigil

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Cephalon settles with DOJ

Cephalon will plead guilty to a single federal misdemeanor violation of the Food, Drug and Cosmetic Act and pay a $425 million fine to settle a federal investigation into promotional practices for Provigil, Actiq and Gabitril, firm announces Nov. 8. The settlement also requires the company to enter into a corporate integrity agreement with the HHS Office of Inspector General, details of which are not yet finalized. Investigation by Philadelphia U.S. Attorney's Office was first reported in 2004 (1"The Pink Sheet" Sept. 13, 2004, p. 29). Settlement amount is on par with fines paid in recent years by companies like Pfizer ($430 million) and Schering-Plough ($435.5 million) to resolve similar charges. Cephalon has $700 million in the bank, more than enough to cover the costs, firm notes during third quarter earnings call...

Cephalon settles with DOJ

Cephalon will plead guilty to a single federal misdemeanor violation of the Food, Drug and Cosmetic Act and pay a $425 million fine to settle a federal investigation into promotional practices for Provigil, Actiq and Gabitril, firm announces Nov. 8. The settlement also requires the company to enter into a corporate integrity agreement with the HHS Office of Inspector General, details of which are not yet finalized. Investigation by Philadelphia U.S. Attorney's Office was first reported in 2004 (1"The Pink Sheet" Sept. 13, 2004, p. 29). Settlement amount is on par with fines paid in recent years by companies like Pfizer ($430 million) and Schering-Plough ($435.5 million) to resolve similar charges. Cephalon has $700 million in the bank, more than enough to cover the costs, firm notes during third quarter earnings call...

Off-Label Use “Predictions” May Be Scrutinized, Prosecutor Sheehan Says

Companies may include predictions of off-label use in their business plans but should be careful not to cross the line into encouraging off-label promotion, Philadelphia Associate U.S. Attorney James Sheehan suggested at a Food and Drug Law Institute advertising conference in Washington, D.C

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