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About POGO's Federal Contractor Misconduct Database (FCMD)
The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »
Ranking: 47
Novartis AG
Headquartered in Basel, Switzerland, Novartis is a multinational pharmaceutical company created in 1996 from the merger of Swiss companies Ciba-Geigy and Sandoz Laboratories. Its main business areas include pharmaceuticals, diagnostics and vaccines, and animal health. Novartis employs approximately 100,000 people in 140 countries.
Federal Contract $: $1576.8m
Total Number of Instances: 7
Total Misconduct dollar amount: $ 444.6m
- Annual Report
- Ethics Page
- Hoovers Profile
- Lobbying Information
- Political Activity
- Press Page
- SEC Form 20-F
- Website
- Contracting Information
Instances of Misconduct
1. Conrad v. Eon Labs (False Claims)
Novartis subsidiary Eon Labs Inc. agreed to pay the United States $3.5 million to resolve False Claims Act allegations relating to the company's drug Nitroglycerin Sustained Release (SR) capsules. In 1999, the Food and Drug Administration (FDA) determined that Nitroglycerin SR lacked substantial evidence of effectiveness and published a notice proposing to withdraw its approval of the product. The government claimed that, after the FDA notice, Nitroglycerin SR no longer was legally eligible for reimbursement by government health care programs, but Eon continued to submit false quarterly reports to the government that misrepresented Nitroglycerin SR's regulatory status and failed to advise that Nitroglycerin SR no longer qualified for Medicaid coverage.... more»
2. Off-Label Promotion of Trileptal
Novartis Pharmaceuticals Corporation (NPC) pleaded guilty to to a misdemeanor violation of the Federal Food, Drug and Cosmetic Act and agreed to pay a $185 million fine related to the company's off-label promotion of the epilepsy drug Trileptal. Novartis is also negotiating with federal prosecutors to resolve civil claims relating to Trileptal.... more»
3. Breeden v. Novartis (FMLA Retaliation)
A federal court ruled against Novartis Pharmaceuticals Corp. and in favor of employee Mary Kate Breeden on her claim of retaliation under the Family and Medical Leave Act (FMLA) and awarded her almost $300,000 in damages (automatically doubled under the FMLA). Breeden, who worked as a pharmaceutical sales representative for Novartis, claimed that after she told the company she was pregnant, Novartis gave her fewer and smaller accounts, and that when she returned from maternity leave her position was eliminated.... more»
4. Overcharging Dept. of Veterans Affairs
Novartis Pharmaceuticals paid $8 million to settle claims that its predecessor company, Ciba-Geigy, overcharged the Department of Veterans Affairs (VA). The government alleged that Ciba-Geigy failed to provide accurate pricing information to VA contract negotiators on four contracts awarded between 1987 and 1991.... more»
5. False Claims Involving TOBI Cystic Fibrosis Drug
Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation agreed to pay $72.5 million to the federal government and several states to resolve civil False Claims Act allegations arising from the marketing of the cystic fibrosis drug TOBI. The settlement resolved allegations that, between January 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 unapproved, off-label uses of the drug.... more»
6. FDA Review of Gleevec Promotional Material
In April 2010, the U.S. Food and Drug Administration issued a warning letter to Novartis Pharmaceuticals Corp. about two websites sponsored by Novartis promoting its cancer treatment drug Gleevec. The FDA found these websites “false and misleading because they promote the drug for an unapproved use, fail to disclose the risks associated with the use of Gleevec and make unsubstantiated dosing claims. Therefore, these websites misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act…and FDA implementing regulations.” It also found that these promotional materials were not submitted to FDA prior to publication in accordance with the law.... more»
7. Velez v. Novartis Corp. (Gender Discrimination)
Current and former female employees of Novartis AG claimed the company’s U.S. subsidiary, Novartis Pharmaceuticals Corp., discriminated against female members of its sales force in pay and promotions and discriminated against pregnant women. In July 2010, Novartis settled with 5,600 current and former saleswomen for $175 million, including $152.5 million in cash payments and $22.5 million in improvements to policies and programs.... more»
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