On September 27, 2007, the Food and Drug Administration issued a warning about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action came less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths. Cephalon has just recently agreed to settle the U.S. Justice Department investigation of its allegedly illegal off-label marketing of Fentora (fentanyl buccal) and Actiq outside the indications on their labels. Cephalon denied it marketed the drugs improperly and claims the problems are a result of improper prescribing.
In settling, they have agreed to pay $425 million, plead guilty to a misdemeanor violation of the U.S. Food, Drug, and Cosmetic Act; and will enter into a corporate-integrity agreement with the Department of Health and Human Services. Doctors are free to prescribe FDA-approved medications as they see fit, including off-label.
It is off-label marketing of FDA-approved medication-marketing for uses not approved by the FDA-which is illegal and misleading. In the case of Fentora, a pain-management cancer medication, off-label marketing has been linked to four deaths, none of which occurred in cancer patients. Cephalon admitted that some of these deaths were the result of off-label use. The FDA reports that other Fentora deaths have been due to doctors prescribing higher-than-recommended doses of the drug, a dangerous situation in light of the fact that over 80,000 prescriptions have been written for Fentora, a suspiciously large amount given the very limited population able to take the drug.
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