For Immediate Release
Media Contact: Bob Cooper
(208) 334-4112

Date: December 29, 2008

Wasden Announces Settlement with Cephalon

(Boise) – Cephalon, Inc. paid the State of Idaho $171,755 in a settlement agreement with the Attorney General and the Department of Health and Welfare, Medicaid Division, Attorney General Lawrence Wasden announced. The settlement required the company to reimburse the state and resolved allegations of improper off-label marketing of three pharmaceutical drugs.

“It is always a concern when pharmaceutical companies promote the use of their drugs for purposes other than those the Food and Drug Administration has approved,” Attorney General Wasden said. “This settlement will help ensure that Idahoans are protected against unnecessary side effects and risks associated with these improper marketing tactics.”

The FDA approved the following drugs manufactured by Cephalon for specific treatments:

  • Provigil was approved to treat only narcolepsy and sleep disorders.
  • Gabitril was approved as a partial treatment for seizures.
  • Actiq was approved to treat cancer patients for whom morphine-based painkillers are no longer effective.

However, the states and the federal government alleged the Cephalon sales representatives marketed the drugs for these off-label uses:

  • Provigil as a non-stimulant drug to treat sleepiness, tiredness, decreased activity, lack of sleep and fatigue.
  • Gabitril as a remedy for anxiety, insomnia, and pain, which led to a risk of causing seizures in non-epileptic patients.
  • Actiq for conditions including migraines, sickle-cell pain crises, injuries, and in anticipation of changing wound dressing or radiation therapy despite the fact the drug as an opioid has a high risk of addiction, abuse and side effects.

Some of the unapproved uses promoted by Cephalon were not approved for reimbursement by the United States and Idaho Medicaid programs. Cephalon’s promotion of off-label uses caused false and/or fraudulent claims to be submitted to the United States and State Medicaid programs resulting in a loss of taxpayer dollars.

In addition, Cephalon provided millions of dollars in grants for continuing medical education programs to promote off-label uses of these three drugs, Idaho and the federal government alleged.

In a separate agreement with the federal government, which pays for 70% of the Idaho Medicaid program, Cephalon will pay $441,159 to cover the federal loss.

Cephalon also entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of Inspector General, requiring strict scrutiny of its future marketing and sales practices and pleaded guilty to one federal misdemeanor based on its actions.

In total, Cephalon, Inc. will pay a $50 million fine and $375 million in damages to the United States and various other states.

To report Medicaid provider fraud, contact the Attorney General’s Medicaid Fraud Control Unit at (208) 334–4100 or mfcu@ag.idaho.gov.

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