Maker of Cephalon pays $431 million to compromise whistleblower claims
The drug maker was settling multiple claims by former employees that it had broken the law in pushing off-label use of the drug. It has also settled claims brought by the states of Massachusetts and Connecticut. It plead guilty to a criminal misdemanor charge of distribution of misbranded drugs and paid a $50 million dollar fine.
The maker had promoted three different drugs, the pain-killer Actiq, the narcolepsy drug Provigil and an epilepsy medication, Gabitril, for uses far broader than the FDA had approved. The U.S. Attorney said Cephalon "subverted the very process put in place to protect the public from harm, and put patients' health at risk for nothing more than boosting its bottom line." Although doctors are free to prescribe a medication for purposes for which the FDA has not approved the drug, drug companies are not allowed to promote or market such non-approved "off label" uses.