- Associated Press - Thursday, September 30, 2010

PHILADELPHIA (AP) - Novartis Pharmaceuticals Corp. will plead guilty to charges it marketed an epilepsy medicine for unapproved uses and pay $422.5 million in civil and criminal penalties, federal officials announced Thursday.

The company agreed to pay a criminal fine and forfeiture totaling $185 million for the off-label promotion of Trileptal, U.S. Attorney Zane Memeger said at news conference in Philadelphia.

Novartis will also pay $237.5 million to resolve civil liabilities over off-label marketing of Trileptal and for paying kickbacks to health care providers in an effort to get them to prescribe that and five other drugs.

“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 illegally marketed Trileptal as a treatment for bipolar disorder and nerve pain, sending sales reps to the offices of neurologists, psychologists and pain specialists, Memeger said.

While doctors are permitted to prescribe medications for unapproved 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.

“That legal obligation takes priority over generating profits,” he said.

Federal prosecutors do not allege any patients were harmed by the off-label marketing.

The announcement Thursday also resolves four whistle-blower lawsuits filed by former Novartis employees who reported the off-label marketing. They will share $25.6 million of the penalty money.

Novartis Pharmaceuticals, based in East Hanover, N.J., is a subsidiary of Swiss company Novartis AG, the world’s third-biggest drug maker by revenue.

A spokeswoman did not immediately return a call seeking comment.