Novartis to pay millions in fines for off-label marketing of drug

In a news release, Novartis said it had disclosed earlier this year that it had set aside money for the settlement. The company said it had agreed to five years of additional federal monitoring, auditing, training, education, reporting, and disclosures.

"NPC will continue its commitment to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products," Andy Wyss, president of Novartis Pharmaceuticals, said in the release.

Zane David Memeger, the U.S. attorney for the Eastern District of Pennsylvania, said Trileptal was approved for the treatment of epilepsy. After it was launched in January 2000, sales were disappointing. Company employees then began visiting doctors who would not normally treat epilepsy, such as psychiatrists and pain specialists, to promote the drug as a treatment for bipolar disorder and neuropathic pain, he said. It had not received FDA approval for those uses.

Memeger said off-label promotion could "undermine the doctor-patient relationship."

While doctors are permitted to prescribe drugs off-label, he said, drug companies can only legally promote approved uses. Memeger said Novartis made "hundreds of millions of dollars" from the illegal marketing.

Four whistle-blowers will share $26.7 million from the settlement.

The case was prosecuted in this region because three of the four whistle-blower cases were filed here.