Navigation Links
Schwarz Pharma Pays $22 Million to Settle False Claims Allegations Concerning Reimbursement for Unapproved Drugs
Date:4/29/2010

WASHINGTON, April 29 /PRNewswire-USNewswire/ -- Schwarz Pharma Inc. will pay $22 million to resolve False Claims Act allegations that the company failed to advise the Centers for Medicare and Medicaid Services (CMS) that two unapproved products did not qualify for coverage under federal health care programs, the Justice Department announced today. Schwarz, now a subsidiary of Belgium-based UCB S.A., is alleged to have submitted false quarterly reports to the government related to a pair of drugs, Deponit and Hyoscyamine Sulfate Extended Release (Hyoscyamine Sulfate ER).

Deponit is a nitroglycerin skin patch that has been used to prevent angina. Hyoscyamine Sulfate ER is an antispasmodic medication that has been used to treat various stomach, intestinal, and urinary tract disorders that involve cramps, colic, or other painful muscle contractions. While the active ingredients in Deponit and Hyoscyamine Sulfate ER had been in products on the market for many years, the Food and Drug Administration made determinations in 1997 and 1999 that resulted in the drugs being ineligible for reimbursement by government health care programs such as Medicaid.

The United States alleges that Schwarz misrepresented the regulatory status of both drugs and failed to advise CMS that these unapproved drugs did not qualify for coverage under federal health care programs. As a result, the government contends, Schwarz knowingly caused false claims to be submitted for Deponit and Hyoscyamine Sulfate ER. Ultimately, neither Deponit nor Hyoscyamine Sulfate ER ever received full regulatory approval for safety and effectiveness, and neither product is currently on the market.

"Pharmaceutical companies must provide accurate and complete information to the government about the drugs they manufacture," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "There will be consequences for companies who provide false information to obtain taxpayer dollars for their drugs."

The settlement resolves allegations against Schwarz in two separate multi-defendant whistleblower actions captioned United States ex rel. Constance Conrad v. Schwarz Pharma, et al., No. 02-11738-NG (D. Mass.), and United States ex rel. James Conrad v. Schwarz Pharma et al., Civil No. 08-cv-428 (S.D. Tex.). The federal share of the settlement is $12,243,836 and the state Medicaid share is $9,756,164. The lawsuits were brought under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private parties with knowledge of fraud to sue on behalf of the United States and share in any recovery. Under the settlement, the two whistleblowers will receive a total of $1,836,575 from the federal share and additional amounts from the state share.

"This False Claims Act agreement shows that the Department of Justice will not allow manufacturers to evade the drug approval process and expect the government to pay for less than effective drugs," said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.

"We will continue to pursue companies that submit false information to obtain payment for unapproved drugs that are ineffective or on the market illegally," said Jose Angel Moreno, U.S. Attorney for the Southern District of Texas.

This case was investigated by the Justice Department's Civil Division, the U.S. Attorneys' Offices for the District of Massachusetts and the Southern District of Texas, and the Office of Inspector General of the Department of Health and Human Services.

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 $2.38 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.


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

Related medicine technology :

1. Consumer Group Urges Gov. Schwarzenegger to Sign Stem Cell Bill Into Law
2. Jazz Pharmaceuticals to Announce First Quarter 2010 Financial Results on May 5, 2010
3. Bio-Pharma Industry Experts Deliver M&A Value Through Integration Excellence
4. Cumberland Pharmaceuticals Partners in Canada With Alveda Pharmaceuticals to Commercialize Caldolor(R)
5. WuXi PharmaTech Schedules First-Quarter 2010 Earnings Release
6. Kincannon & Reed Names David G. Jensen as Managing Director, Biopharma Life Sciences
7. Onyx Pharmaceuticals Announces First Quarter 2010 Financial Results Teleconference and Webcast
8. Largest Civil Settlement in Pharmaceutical Case Announced by U.S. Department of Justice
9. Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
10. Jazz Pharmaceuticals to Present at Deutsche Banks 35th Annual Health Care Conference
11. Anthera Pharmaceuticals to Present at Deutsche Bank Securities 35th Annual Health Care Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  Venice,s newest ... is the first of its kind in the ... tattoos through advanced laser treatment. The physician-owned and ... Suncoast by storm with its revitalizing ... and advanced multi-wavelength Astanza Trinity technology. ...
(Date:2/5/2016)... -- Henry Schein, Inc. (NASDAQ: HSIC ), the world,s largest ... dental, animal health and medical practitioners, announced today that ... majority ownership interest in Dental Cremer S.A., a distributor ... . --> ... dental distribution business of Cremer S.A. With 2015 sales ...
(Date:2/4/2016)... IRVINE, Calif. , Feb. 4, 2016  Edwards ... in patient-focused innovations for structural heart disease and critical ... an accelerated share repurchase (ASR) agreement with Morgan Stanley ... common stock.  This repurchase is part of the Company,s ... of the Company,s common stock.  ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... In sleep, when the defenses of the day ... feature of patients with eating disorders is significant self-criticism, and consequently these patients experience ... are regarded as maladaptive means for coping with this unease, but also leads to ...
(Date:2/5/2016)... ... 05, 2016 , ... California Mobile Kitchens , a ... their latest mobile kitchen model, featuring customizable stainless steel interiors and a new, ... for use anywhere in the U.S. Many of their units can be seen ...
(Date:2/5/2016)... ... ... Calls Blacklist has just been updated by mobile app developer Vlad Lee. ... fixed known bugs within the app. Calls Blacklist allows its users to only have ... of their device’s battery power or memory. It provides a powerful call blocker that ...
(Date:2/5/2016)... ... February 05, 2016 , ... –This week, Atascadero water heater ... having a tankless water heater. To view the report, click here or ... tankless. While each has their pros and cons, the type chosen is almost entirely ...
(Date:2/5/2016)... ... ... is tired of trying to cram belongings into spare space that just isn’t there, a ... but before hastily spending money on a unit, take these tips into consideration. , Self-storage ... is often not told when utilizing these services are some tips on how to use ...
Breaking Medicine News(10 mins):