Navigation Links
United States Joins Suits Against Scios and Johnson & Johnson

Pharmaceutical Companies Allegedly Marketed the Drug Natrecor for a Use Not Approved By the Food and Drug Administration

WASHINGTON, Feb. 19 /PRNewswire-USNewswire/ -- The United States has intervened in two whistleblower suits filed in the Northern District of California against the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs, the Justice Department announced today. Such an unapproved use is also known as an "off-label" use because it is not included in the drug's FDA approved product label.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug company may not market or promote the drug for off-label uses.

In August 2001, the FDA approved Natrecor for "the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea [shortness of breath] at rest or with minimal activity." The study upon which this approval was based involved hospitalized patients who had severe heart failure and who received infusions of Natrecor over an average 36-hour period. The government's investigation revealed that shortly after receiving this approval in 2001, Scios began an aggressive campaign to market Natrecor for scheduled, serial outpatient infusions for patients with less severe heart failure -- a use not included in the FDA-approved label. These patients were prescribed Natrecor infusions for less than six hours on a scheduled basis over an extended period of time.

Medicare does not cover drugs used for off-label uses unless such off-label use is established to be medically necessary. The federal health care programs -- in particular, Medicare -- paid substantial amounts for the serial outpatient off-label use of Natrecor.

In mid-2005, a panel of leading cardiologists told Scios that it should stop promoting the scheduled, serial outpatient use of Natrecor. Scios subsequently sent a letter to healthcare providers in which it acknowledged that there was insufficient clinical evidence supporting the safety and efficacy for scheduled, serial outpatient use of the drug. In 2007, Scios released the results of a clinical study that showed no significant benefits of serial outpatient Natrecor infusions.

The two separate civil False Claims Act suits -- called qui tam actions -- were filed by former Scios sales managers against Scios and Johnson & Johnson in the Northern District of California. The False Claims Act allows for private persons to file whistleblower suits to provide the government information about wrongdoing. Under the statute, if it is established that a person has submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and $5,500 to $11,000 for each false or fraudulent claim filed. If the government is successful in resolving or litigating its claims, the whistleblower who initiated the action can receive a share of between 15 percent to 25 percent of the amount recovered.

The qui tam or whistleblower actions contain additional allegations. However, the United States is only intervening with regard to allegations that Scios marketed the drug Natrecor for serial infusions in the outpatient setting.

The investigation was conducted by the Civil Division of the U.S. Department of Justice, the U.S. Attorney's Office for the Northern District of California, the Federal Bureau of Investigation, and the Offices of Inspector General of the Department of Health and Human Services, the FDA, the Department of Veterans Affairs, the Office of Personnel Management, and the Department of Defense.

SOURCE U.S. Department of Justice
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Coalition for Pulmonary Fibrosis Launches Aggressive Ad Campaign Directed at United States Congress
2. United States continues to have highest level of health spending
3. United Medicorp, Inc.s Shareholders Approve All Proposals
4. Proven Terumo Coronary Guidewire Technology Is Now Available in the United States
5. Medical Services International Received Its First Order for Testing By Regulatory Agencies in the United States
6. Peoples United Financial CEO Has Surgery
7. Statement by Mike Leavitt Secretary of Health and Human Services on the United States-China Bilateral Meetings on Food and Drug Safety
8. More Than 100 Organizations Call for a National AIDS Strategy to End the Epidemic in the United States
9. Akers Biosciences, Inc. ABI or the Company Receipt of Further United States Military Contracts
10. Universal Health Care Coverage in the United States
11. Women Deliver Conference to Feature United Nations Leaders
Post Your Comments:
(Date:6/27/2016)... ... June 27, 2016 , ... ... payment industry today announced its strategic partnership with Connance, a healthcare industry ... The two companies’ proven, proprietary technology combine to provide health systems, hospitals ...
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
(Date:6/23/2016)... 2016 Research and Markets has ... Global Analysis (United States, China, Japan, Brazil, United Kingdom, ... their offering. Surgical ... business planners, provides surgical procedure volume data in a ... an in-depth analysis of growth drivers and inhibitors, including ...
Breaking Medicine Technology: