Novartis to pay over $72 Million to settle False Claims Act allegations related to TOBI; FDA warns of Gleevec and Altabax promo

Swiss drug major Novartis has agreed to pay $72.5 million to resolve civil False Claims Act allegations arising from the marketing of the cystic fibrosis drug TOBI, the US Justice Department announced yesterday. The settlement resolves allegations that, between January 1, 2001 and July 31, 2006, Novartis and its predecessor, Chiron Corp, caused false claims to be submitted to federal health care programs for certain off-label uses of the drug.

The Food and Drug Administration approved TOBI, an inhaled antibiotic, for the treatment of certain cystic fibrosis patients. The US alleges that Chiron, acquired by 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," he added.