Law.com - Novartis Agrees to Pay More Than $422 Million to Settle Disputes Over Off-Label Marketing

Pharmaceutical giant Novartis has agreed to pay more than $422 million in criminal fines and a global settlement of a spate of whistleblower lawsuits to resolve allegations that it engaged in illegal marketing practices, including the alleged payment of kickbacks to health care providers to induce them to prescribe Novartis drugs.

U.S. Attorney Zane Memeger said Novartis Pharmaceuticals Corp. -- the U.S. subsidiary of Novartis AG in Switzerland -- has agreed to pay a criminal fine and forfeiture of $185 million, and also agreed to pay $237.5 million to resolve civil liabilities for its off-label marketing of six drugs.

Under the terms of the agreement, five whistleblowers are to share a reward of more than $25.6 million.

The criminal information charges that NPC introduced misbranded drugs into interstate commerce between July 2000 and December 2001, and that the company paid kickbacks to health care providers to induce them to prescribe Trileptal, as well as Diovan, Exforge, Tekturna, Zelnorm and Sandostatin.

According to court papers, the Food and Drug Administration had approved Trileptal only for the treatment of epilepsy patients. But according to the criminal charges, NPC's management created marketing materials promoting Trileptal for off-label uses, including neuropathic pain and bipolar disease, which were not FDA-approved.

NPC allegedly targeted psychiatrists and pain specialists, who were known to use anti-epileptic drugs like Trileptal off-label. The company also allegedly funded continuing medical education programs, using other medical professionals to promote off-label uses of Trileptal.

Memeger said in a statement that such off-label marketing "can undermine the doctor-patient relationship and adversely influence the clear judgment that a doctor's patients have come to rely on and trust."

Pharmaceutical companies, Memeger said, "have a legal obligation to promote the drugs they manufacture only for uses that the FDA has deemed are safe and effective. That legal obligation takes priority over a company's bottom line."

Andy Wyss, president of NPC and head of Novartis Pharma North America, said in a statement that the company is "pleased to have reached resolution on this matter" and that it "will continue to work with the government and other organizations to improve healthcare for all Americans."

via law.com

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