Navigation Links
United States Joins Suits Against Scios and Johnson & Johnson
Date:2/19/2009

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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... MD (PRWEB) , ... June 24, 2016 , ... ... protocols for human induced pluripotent stem (iPS) cells and other difficult to transfect ... G9™ Cloning Medium. The PluriQ™ G9™ Gene Editing System is a ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Belgium , June 24, 2016 ... today announced the appointment of Dr. Edward ... as a Non-Executive Director, effective June 23, 2016.Dr. ... Compensation and Nominations and Governance Committees.  As a ... will provide independent expertise and strategic counsel to ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... 52" report to their offering. ... creates a favourable commercial environment for MedImmune to enter. The ... that will serve to drive considerable growth for effective anti-influenza ... to cap sales considerably, but development is still in its ...
Breaking Medicine Technology: