Novartis to pay $422M for off-label marketing

Novartis Pharmaceuticals Corp. has agreed to pay $422.5 million in civil and criminal fines for promoting drugs for uses that had not been approved by the Food and Drug Administration, the U.S. Department of Justice announced today in Philadelphia.

The corporation is the U.S. subsidiary of Novartis AG, which is based in Switzerland.

Under the settlement, which requires court approval, Novartis agreed to plead guilty and pay a criminal fine of $185 million for off-label marketing of the anti-epileptic drug Trileptal. It also will pay $237.5 million in civil penalties for off-label marketing of that drug and financial inducement for doctors to prescribe Trileptal and five other Novartis medicines - Diovan, Exforge, Tekturna, Zelnorm and Sandostatin.

Four whistle-blowers in the case will share $26.7 million.

The case was prosecuted in the Eastern District of Pennsylvania because three of the four whistle-blowers filed suit here.

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

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