Drug maker Cephalon has paid $425 million to the states to settle allegations of off-label marketing of three pharmaceutical products. The settlement resolves allegations that Cephalon marketed drugs for uses not approved by the Federal Drug Administration. The drugs are Actiq, a highly addictive painkiller; the anti-seizure drug Gabitril; and the sleep-disorder drug Provigil. The national settlement relates to Cephalon’s dealings with state Medicaid programs.

The settlement reimburses the federal government and the participating states for excessive amounts paid by the Medicaid program alleged to have resulted from Cephalon’s off-label marketing campaign. While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. Therefore, claims to the Medicaid programs as a result of the off-label marketing are improper.

Provigil is a drug used for improving wakefulness in patients with excessive sleepiness. Gabitril is an antiepilepsy drug. Actiq is intended to be used only in the care of cancer patients to treat pain. Cephalon has also 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 addition to the civil investigation and settlement, the U.S. Attorney for the Eastern District of Pennsylvania filed criminal charges against the company, alleging a violation of the Food, Drug and Cosmetic Act. In a plea agreement with the United States, Cephalon has agreed to pay $50 million to resolve those charges. The national settlement resolves a number of state- and federally-filed whistleblower lawsuits. All 50 states, including Alabama, and the District of Columbia, have approved the agreement.

Source: Associated Press

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