Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals will pay $72.5 million to settle civil False Claims Act allegations that the company caused false claims to be submitted to federal health care programs through its marketing of the drug TOBI.

The Food and Drug Administration (FDA) approved the antibiotic TOBI for certain cystic fibrosis patients.  The United States alleges that Novartis and its predecessor Chiron caused the submission of false claims to federal health care programs by marketing TOBI for uses unapproved by the FDA.  These included marketing TOBI for diseases other than cystic fibrosis and to cystic fibrosis patients for whom TOBI was not a medically accepted drug. 

The settlement will be divided among the federal government and several states.  The U.S. will receive $43.5 million and the states will receive $29 million to resolve their respective claims. 

This lawsuit was filed by three former Chiron employees – Robert Lalley, Courtney Davis, and William Manos – under the qui tam provisions of the False Claims Act.  The whistleblowers will receive $7.825 million of the federal share of the settlement. 

Click Here to Read the Full Article, “Novartis Vaccines & Diagnostics to Pay More Than $72 Million to Resolve False Claims Act Allegations Concerning TOBI”