Navigation Links
Novartis Vaccines & Diagnostics to Pay More Than $72 Million to Resolve False Claims Act Allegations Concerning TOBI
Date:5/4/2010

WASHINGTON, May 4 /PRNewswire-USNewswire/ -- Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation have agreed to pay $72.5 million to resolve civil False Claims Act allegations arising from the marketing of the cystic fibrosis drug TOBI, the Justice Department announced today. The settlement resolves 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.

The Food and Drug Administration (FDA) approved TOBI, an inhaled antibiotic, for the treatment of certain cystic fibrosis patients. The United States alleges that Chiron, and then 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."

"This office is committed to safeguarding the federal health care programs against false claims caused by off-label marketing and other types of illegal conduct," said Joseph Russoniello, U.S. Attorney for the Northern District of California.

Under the agreement announced today, the proceeds from the settlement will be divided between the federal government and various states, with the United States receiving $43.5 million to resolve the federal claims, and the states receiving $29 million to settle their respective claims.

"The Defense Criminal Investigative Service (DCIS) is thoroughly committed to pursue any and all allegations of fraud that drain precious resources from America's war fighters," said Richard W. Gwin, Special Agent in Charge of the DCIS Western Field Office. "This particular fraud was directly related to the healthcare of our brave soldiers, sailors, airmen, marines and their families throughout the world. The settlement with Novartis was only made possible by the hard work of the prosecutors from the Department of Justice, agents from the DCIS and all the other joint investigative agencies."

This settlement resolves a lawsuit brought by three former Chiron employees – Robert Lalley, Courtney Davis and William Manos – under the qui tam or whistleblower provisions of the False Claims Act, which permit private individuals known as relators to bring a lawsuit on behalf of the United States and to share in any recovery. The relators will receive $7.825 million of the federal share of the settlement announced today.

This settlement is part of the government's emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $2.3 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in False Claims Act cases since January 2009 have topped $3 billion.

The settlement was the result of a coordinated effort among the Commercial Litigation Branch of the Justice Department's Civil Division; the U.S. Attorney's Office for the Northern District of California; the U.S. Department of Health and Human Services, Office of Inspector General; the Office of Personnel Management, Office of Inspector General, the Department of Veterans' Affairs, Office of Inspector General; the Defense Criminal Investigative Service; the Federal Bureau of Investigation; the FDA; and the National Association of Medicaid Fraud Control Units.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Jury Verdict Against Novartis Pharmaceuticals For Retaliating Against Drug Sales Rep Who Took Maternity Leave
2. Novartis Tasigna(R) (nilotinib) Trial Shows Superior Results to Glivec(R) (imatinib) in Newly Diagnosed, Chronic Phase Chronic Myeloid Leukaemia
3. Significant potential of late- and mid-stage Novartis hematology portfolio to be showcased at upcoming ASH meeting
4. Novartis drug Tasigna(R) meets primary endpoint in pivotal trial against Gleevec(R) as first-line treatment in chronic myeloid leukemia patients
5. Novartis Pharmaceuticals Corporation Prevails in Medicaid Pricing Case Before Alabama Supreme Court
6. Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia
7. Results In The New England Journal Of Medicine Confirm Novartis Drug Femara(R) Is Superior To Tamoxifen After Breast Cancer Surgery
8. US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
9. Juvenile Diabetes Research Foundation, The Genomics Institute of the Novartis Research Foundation Announce Innovative Diabetes Drug Discovery and Development Partnership
10. Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
11. More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... June 27, 2016  VMS Rehab Systems, Inc. ( ... take whatever measures required to build a strong and ... is currently listed on the OTC Markets-pink current trading ... and CEO, "We are seeing an anomaly in market ... not only by the Company, but shareholders and market ...
(Date:6/24/2016)... June 24, 2016  Global Blood Therapeutics, Inc. (GBT) ... developing novel therapeutics for the treatment of grievous ... the closing of its previously announced underwritten public ... the public offering price of $18.75 per share. ... offered by GBT. GBT estimates net proceeds from ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... blind and certified personal trainer is helping to develop a weight loss fitness plan that ... the two major problems leading the fitness industry today:, , All ... They don’t eliminate all the reasons people quit their exercise program , ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
Breaking Medicine News(10 mins):