Novartis ordered to pay $422.5 million fine for off-label marketing | Philadelphia Inquirer

Novartis Pharmaceuticals Corp. was officially ordered today to pay $422.5 million in civil and criminal fines for promoting an antiepileptic drug for non-approved uses, the U.S. Attorney's Office in Philadelphia announced.

The company had pleaded guilty Nov. 2 to marketing Trileptal, which had federal approval as an epilepsy drug, for additional uses that included bipolar disorder and neuropathic pain, the U.S. Attorney's Office said.

The U.S. Food and Drug Administration had not approved those latter uses.

Prosecutors said that Novartis made hundreds of millions of dollars from its off-label marketing.

The company was fined $185 million.

A separate civil settlement has Novartis paying $237.5 million over invalid claims submitted to government medical reimbursement programs for the use of Trileptal and five other drugs.

Novartis said last year that it had set aside money for the settlement, and that it had agreed to five years of additional federal monitoring, auditing, training, education, reporting, and disclosures.

In a statement late Friday afternoon, the company said: "The court imposed the previously agreed sentence pursuant to the resolution announced Sept 30, 2010. NPC is pleased to have this matter behind us, and will continue to work with the government and other organizations to improve health care for all Americans.

"We are committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products."

Novartis Pharmaceuticals, which is based in East Hanover, N.J., is the U.S. subsidiary of Novartis AG, which is based in Switzerland.

Three of the four whistle-blower cases were filed with the U.S. Attorney's Office in Philadelphia, which has prosecuted a number of major pharma cases.    - Roslyn Rudolph

via philly.com

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