Novartis Vaccines & Diagnostics and Novartis Pharmaceuticals Corporation have agreed to pay $72.5m to resolve civil False Claims Act allegations over illegal marketing of the cystic fibrosis drug TOBI.
The settlement resolves allegations that Novartis and its predecessor CHIRON Corporation marketed TOBI for unapproved uses, for diseases other than cystic fibrosis, and for cystic fibrosis patients who did not meet the parameters of the FDA-approved indication.
Between Jan 2001 and July 2006, Novartis and Chiron caused false claims to be submitted to federal healthcare programmes for specific off-label uses of the drug.
The Food & Drug Administration (FDA) approved TOBI, an inhaled antibiotic, for the treatment of certain cystic fibrosis patients.
Under the agreement, the proceeds from the settlement will be divided between the federal government and various states, with the USA receiving $43.5m to resolve the federal claims, and the states receiving $29m to settle their respective claims.
This settlement is part of government efforts to combat healthcare fraud, which the False Claims Act has been used to recover approximately $2.3bn since January 2009.