Novartis Pharmaceuticals Corp. will pay $422.5 million in penalties for marketing an epilepsy medicine for unapproved uses and for paying kickbacks to doctors to prescribe it and five other drugs, federal officials announced Thursday.
The company agreed to plead guilty to distribution of a misbranded drug, a misdemeanor, and pay a criminal fine and forfeiture totaling $185 million in the case involving Trileptal, U.S. Attorney Zane Memeger said at news conference in Philadelphia.
"Every day in this country, patients rely on sound advice from their doctors," Memeger said. "Off-label marketing ... can undermine the doctor-patient relationship."
Novartis will also pay $237.5 million to resolve civil liabilities over the kickbacks and the off-label marketing of Trileptal, an anti-epileptic medicine, according to a settlement agreement.
The drug maker illegally marketed Trileptal as a treatment for bipolar disorder and nerve pain, sending its sales force to the offices of neurologists, psychiatrists and pain specialists, Memeger said.
While doctors are permitted to prescribe medications for off-label uses based on their medical experience, pharmaceutical companies are not allowed to market or promote drugs for uses not approved by the Food and Drug Administration, Memeger said.
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