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Ohio Sales Rep's Information Launched Massive Government Investigation of Cephalon
Date:9/29/2008

of substantial kickbacks, that the federal government has used the False Claims Act to go after a pharmaceutical company for marketing drugs for off- label indications for which there were no credible published scientific research supporting these drugs' safety or effectiveness," said Peter W. Chatfield, a Washington, DC, attorney whose firm, Phillips & Cohen LLP, represents Boise. "Not only were these uses marketed by Cephalon not approved by the FDA, there was absolutely no literature published in any medical compendia that supported them."

The FDA approves drugs for specific uses, which are noted in the drugs' labeling. Doctors may prescribe those drugs for other "off-label" therapeutic uses, but the law prohibits drug companies from promoting drugs for uses beyond those found to be safe and effective by the FDA.

While Medicare, Medicaid and other federally funded healthcare programs often will pay for off-label use of drugs supported by credible medical research and prescribed based on the medical judgment of physicians, Cephalon's marketing efforts pushed well beyond those constraints.

Cephalon's off-label sales strategies were very effective. The government's investigation found that more than 80 percent of the sales of Provigil, Gabitril and Actiq were for off-label uses.

The FDA approved the use of Provigil to help keep awake patients with certain disorders, such as sleep apnea or shift-work sleep disorder. To boost sales, Cephalon marketed Provigil for off-label uses including fatigue associated with mental illnesses, such as schizophrenia, and children with attention deficit hyperactivity disorder, according to Boise's lawsuit.

Gabitril was approved for the treatment of partial seizures in epileptic patients. Yet Cephalon was pushing doctors to prescribe it for anxiety and insomnia, Boise's lawsuit said.

The most dangerous Cephalon drug when used for "off-label" uses is Actiq, an opioid that is approved only to tr
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SOURCE Phillips & Cohen
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