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Cephalon under investigation for Actiq marketing

Attorney general probes company’s promotions of Actiq; Gabitril, Provigil also under investigation - 11/21/06

According to Connecticut Attorney General Richard Blumenthal, drug maker Cephalon Incorporated has participated in questionable marketing practices of its powerful narcotic Actiq, which is approved only to treat cancer pain. The company may be accused of improperly promoting the off-label use of Actiq for other types of pain, including migraines.

The investigation could result in civil charges under Connecticut's patient and consumer protection laws. If Cephalon agrees to a settlement, Blumenthal may seek multi-million dollar fines for restitution and penalties on behalf of Connecticut's Medicaid program, whose costs to cover the drug have increased sharply.

Investigators are examining internal marketing documents and have found Cephalon pushed off-label use. Cephalon also flew doctors to seminars to promote the use of Actiq for headaches.

The Food and Drug Administration (FDA) allows doctors to prescribe a drug for uses that have not been approved, but pharmaceutical companies are not allowed to market their drugs for those purposes.

The investigation also involves off-label sales of two additional Cephalon drugs: Provigil, a narcolepsy pill, and Gabitril, used to treat epilepsy.

In addition to Blumenthal's investigation, Cephalon is being probed by the US attorney in Philadelphia and the FDA's office of Criminal Investigations. All of the investigations focus of the company's marketing of its drugs for off-label uses.

Blumenthal first made a request for information about Cephalon's marketing practices in 2004.

Source: John Carreyrou, "Cephalon used improper tactics to sell drug, probe finds," Wall Street Journal, November 21, 2006.