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Novartis To Pay Millions In Fines For Off-Label Marketing of Trileptal

Novartis To Pay Millions In Fines For Off-Label Marketing of drug [The Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (October 1, 2010)

Sept. 30--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 Thursday in Philadelphia.

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

Under the settlement, which requires approval by federal court in Philadelphia, Novartis agreed to plead guilty and pay a criminal fine of $185 million for off-label marketing of the antiepileptic drug Trileptal.

It also will pay $237.5 million in civil penalties for off-label marketing of that drug and for offering financial inducements for doctors to prescribe Trileptal and five other Novartis medicines -- Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin. The "kickbacks" included payments for speaker programs, advisory board memberships, entertainment, travel, and meals to encourage doctors to prescribe the drugs.

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.

Contact staff writer Stacey Burling at 215-854-4944 or

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Posted: October 2010