PHARMACEUTICAL COMPANY CEPHALON PAYS $5.1 MILLION FOR WISCONSIN MEDICAID OFF-LABEL DRUG MARKETING VIOLATIONS

Attorney General J. B. Van Hollen announced today that pharmaceutical manufacturer Cephalon, Inc., has paid the state $2,071,741.60 as Wisconsin's share of a settlement to resolve allegations that it improperly promoted the drugs Provigil, Gabitril, and Actiq for uses other than those for which they had been approved. The state and federal shares totaled $5,133,689.28 for the illegal marketing practices that resulted in excessive amounts paid by the Wisconsin Medicaid program.

"By this off-label marketing scheme Cephalon was increasing its sales in an unsafe and irresponsible manner," said Wisconsin Attorney General J.B. Van Hollen. "It is important for any pharmaceutical provider to strictly follow Medicaid program rules. Only then can the recipients get the help they need and taxpayers get what they pay for."

The Wisconsin payment is part of a comprehensive $425 million settlement reached by the federal government, the National Association of Medicaid Fraud Control Units and Cephalon. The Food and Drug Administration of the federal government had approved the prescription drugs for limited purposes, but Cephalon allegedly promoted them for these other uses.

• Provigil: Although FDA-approved to treat only narcolepsy and sleep disorders, Cephalon marketed Provigil as a non-stimulant drug to treat sleepiness, tiredness, decreased activity, lack of energy and fatigue.
• Gabitril: Although FDA-approved as a partial treatment for seizures, Cephalon marketed Gabitril as a remedy for anxiety, insomnia and pain. Following reports of seizures in patients taking Gabitril that did not have epilepsy, the FDA required Cephalon to send a warning to physicians advising them of the risks of seizures in connection with off-label Gabitril use.
• Actiq: Although FDA-approved to treat opioid-tolerant cancer patients or those patients for whom morphine based painkillers are no longer effective, Cephalon marketed Actiq for conditions including migraines, sickle-cell pain crises, injuries, and in anticipation of changing wound dressing or radiation therapy.

As a result of the allegations, Cephalon will pay the states $375 million in damages and penalties for Medicaid and other health care programs. Cephalon also agreed to pay $50 million as part of a plea agreement to resolve a one count Information in the United States District Court for the Eastern District of Pennsylvania alleging a misdemeanor violation of the Food, Drug and Cosmetic Act.

This settlement reimburses the federal government and the participating states for liabilities incurred by the Medicaid program as a result of Cephalon's improper off-label marketing campaign. Additionally, Cephalon entered into a corporate integrity agreement with the Department of Health and Human Services, Office of the Inspector General, requiring strict scrutiny of its future marketing and sales practices.

In Wisconsin, the case was handled by the Wisconsin Department of Justice's Medicaid Fraud Control Unit. A copy of the settlement is available below: