Criminal Prosecutions of Novartis Pharmaceuticals Corporation

In May 2010, Novartis Vaccines & Diagnostics, Inc. and Novartis Pharmaceuticals Corporation paid $72.5 million to resolve civil FCA allegations arising from off-label marketing of the cystic fibrosis drug TOBI for diseases other than cystic fibrosis for patients who did not meet the parameters of the FDA-approved indication. The United States alleged that this conduct, carried out by Novartis and a predecessor company Chiron Corporation, caused false claims to be submitted to federal health care programs for certain off-label uses of the drug between January 1, 2001 and July 31, 2006.

In September 2010, Novartis Pharmaceuticals Corporation agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products. The company agreed to plead guilty to a misdemeanor and pay a $185 million combined criminal fine and forfeiture for off-label marketing of the anti-epileptic drug Trileptal. In addition the company agreed to pay $237.5 million to resolve civil allegations that it unlawfully marketed Trileptal and five other drugs, Diovan, Zelnorm, Sandostatin, Exforge, and Tekturna. Specifically, the civil settlement resolves allegations of off-label promotion with regard to Trileptal and provision of kickbacks to health care professionals in connection with Trileptal and the five other drugs.

Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2010

This article was posted on July 15, 2012.

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