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Novartis Vaccines & Diagnostics to Pay More Than $72 Million to Resolve False Claims Act Allegations Concerning TOBI
Date:5/4/2010

WASHINGTON, May 4 /PRNewswire-USNewswire/ -- Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation have agreed to pay $72.5 million to resolve civil False Claims Act allegations arising from the marketing of the cystic fibrosis drug TOBI, the Justice Department announced today. The settlement resolves allegations that, between Jan. 1, 2001 and July 31, 2006, Novartis and its predecessor, Chiron Corporation, caused false claims to be submitted to federal health care programs for certain off-label uses of the drug.

The Food and Drug Administration (FDA) approved TOBI, an inhaled antibiotic, for the treatment of certain cystic fibrosis patients. The United States alleges that Chiron, and then Novartis, marketed TOBI for unapproved uses, such as diseases other than cystic fibrosis, and for cystic fibrosis patients who did not meet the parameters of the FDA-approved indication and for which TOBI was not a medically accepted use. The government alleges that this conduct caused the submission of false claims to federal health care programs.

"Pharmaceutical companies must not promote their drugs for uses that have not been proven to be safe and effective," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "We are committed to pursuing False Claims Act violations and recovering taxpayer dollars lost to off-label marketing."

"This office is committed to safeguarding the federal health care programs against false claims caused by off-label marketing and other types of illegal conduct," said Joseph Russoniello, U.S. Attorney for the Northern District
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SOURCE U.S. Department of Justice
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