Violation Tracker Individual Record

Company: 
Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation
Current Parent Company: 
Novartis
Penalty: 
$72,500,000
Year: 
2010
Date: 
May 4, 2010
Offense Group: 
healthcare-related offenses
Primary Offense: 
off-label or unapproved promotion of medical products
Secondary Offense: 
False Claims Act and related
Violation Description: 

Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation agreed to pay $72.5 million to resolve civil False Claims Act allegations arising from the marketing of the cystic fibrosis drug TOBI. The settlement resolved 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.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
civil
HQ Country of Parent: 
Switzerland
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
pharmaceuticals
Specific Industry of Parent: 
pharmaceuticals
Source Notes: 
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.