Navigation Links
KV Pharmaceutical Subsidiary Pleads Guilty to Two Felonies Regarding Oversized Drugs
Date:3/2/2010

Judge Sentences St. Louis-Based Company to Pay $27.6 Million in Fines, Restitution and Forfeitures

WASHINGTON, March 2 /PRNewswire-USNewswire/ -- Ethex Corporation, a wholly owned subsidiary of St. Louis-based drug manufacturer, KV Pharmaceutical Company, pleaded guilty to two felonies and was sentenced today in connection with the manufacturing of oversized prescription drug tablets, the Justice Department announced today. The government had charged that, despite having knowledge that the two drugs did not meet required specifications, Ethex violated the law by intentionally withholding this information from the Food and Drug Administration (FDA). Given the seriousness of Ethex's conduct and the risk it posed to consumers of its drugs, the Justice Department pursued felony charges.

According to charges presented in U.S. District Court in St. Louis today, Ethex failed to submit required "field alert reports" to the FDA in 2008 concerning two drugs, propafenone and dextroamphetamine sulfate. Following the recommendations of a plea agreement that was filed today, Judge E. Richard Webber sentenced Ethex to pay a fine of more than $23.4 million, pay approximately $2.3 million in restitution to Medicare and Medicaid for their approximate losses, and forfeit nearly $1.8 million to the United States.

Under the Food, Drug and Cosmetic Act, a drug manufacturer must thoroughly investigate why a drug fails to meet specifications, whether or not the drug has been distributed into interstate commerce. Moreover, when a manufacturer receives information concerning a significant chemical change in a distributed drug or a failure of a distributed drug batch to meet specifications, it is required to promptly file a field alert report with the FDA. A manufacturer's failure to file such a report, if done with the intent to defraud or mislead, is punishable by a term of up to five years' probation and a fine of $500,000 or twice the gross amount gained from the offense.

The government had alleged that in May 2008, KV and Ethex received complaints from a pharmacy in California and a distributor in Canada of oversized morphine sulfate pills, a pain-relief medication which had been manufactured by KV and distributed by Ethex. In response to the complaints, KV recalled specific lots of morphine sulfate in June 2008 and filed a field alert report regarding the oversized tablets with the FDA.

According to the charges, a KV internal investigation that began in May 2008 discovered sporadic instances of various oversized KV-manufactured drugs, including morphine sulfate, propafenone and dextroamphetamine sulfate. Propafenone is an anti-arrhythmia drug that is used to treat some kinds of heart disease. Dextroamphetamine sulfate is used to treat attention deficit disorder in children. The charges alleged that despite the fact that KV's internal investigation uncovered evidence of various oversized propafenone and dextroamphetamine sulfate tablets, Ethex did not file the required field alert reports with the FDA.

"Even though they were aware of serious manufacturing problems concerning their oversized drugs, Ethex failed to notify the FDA as required by law," said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. "The Justice Department will vigorously prosecute those who pursue profits at the expense of consumer safety."

The case was investigated by the FDA's Office of Criminal Investigations and is being prosecuted by the U.S. Attorney's Office for the Eastern District of Missouri and the Civil Division's Office of Consumer Litigation at the Justice Department. Additional assistance is being provided by the FDA's Office of Chief Counsel.

SOURCE U.S. Department of Justice

Back to top

RELATED LINKS
http://www.justice.gov

'/>"/>

SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. MAP Pharmaceuticals Reports 2009 Fourth Quarter and Year End Financial Results
2. Alexza Pharmaceuticals to Present at the Cowen and Company 30th Annual Health Care Conference
3. DUSA Pharmaceuticals, Inc.(R) to Host Fourth Quarter and Full Year 2009 Financial Results and Corporate Highlights Conference Call
4. Awards Strengthen Stonhard's Reputation for High-Performing Floors in the World's Most Prominent Pharmaceutical Facilities
5. Thomas Pharmaceuticals, Ltd to Merge with Global Medical Equipment of AZ
6. Abbott Completes Acquisition of Solvay Pharmaceuticals
7. Vestara and EXP Pharmaceutical Services Corp. Announce Partnership Making Available Industry's Only Automated Pharmaceutical Waste Management Solution to over 5,000 U.S. Hospitals
8. Huifeng Bio-Pharmaceutical Provides Preliminary 2009 Financial Results and 2010 Guidance
9. Six Key Areas of Learning for Pharmaceutical and Healthcare Marketing in 2010
10. Frost & Sullivan Ghanaian Pharmaceutical Industry Innovation & Advancement Award Conferred on LaGray Chemical Company
11. Viscira Expands Interactive Solutions to Reduce Marketing Expenses for Pharmaceutical Companies in Challenging Economic Times
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , ... February 24, 2017 , ... With ProGlass Prism ... Pro X . Users have total control over position, rotation, distortion, edge softness, edge ... within Final Cut Pro X. , With ProGlass Prism users are given the tools ...
(Date:2/24/2017)... ... 24, 2017 , ... The Radiology Business Management Association will select ... the annual Building Better Radiology Marketing Programs conference, held this year from ... Texas. Nine awards are given out in five categories. They are:, ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... jointly issued a letter to withdraw previous guidance issued by the ... identity. The guidance issued in May 2016 by the Obama Administration came in ...
(Date:2/23/2017)... CA (PRWEB) , ... February 23, 2017 , ... Los ... two episodes of WE TV’s “Mama June: From Not to Hot,” which will begin ... notable, “Mama” June Shannon, known to millions from the 2012 reality television series, “Here ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Dr. David ... in Henderson, NV 89052. Dr. Mahon was named a 2017 Top Patient Rated ... is an online directory that recognizes local physicians and dentists who have earned ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... China , 23. Februar 2017 Im ... , eine nationale Wirtschaftszone in der südwestlichen chinesischen Provinz Guizhou, ... der Errichtung einer Innovationsplattform aktiv an der Entwicklung einer eingebetteten ... Continue Reading ... ...
(Date:2/23/2017)... 23, 2017 AcelRx Pharmaceuticals, Inc. (Nasdaq: ... development and commercialization of innovative therapies for the ... will release fourth quarter and yearly financial results ... AcelRx management will host an investment-community conference call ... Time) on March 2 nd 2017 to ...
(Date:2/23/2017)... , February 23, 2017 According ... by Product (X-ray Imaging Digital, Analog), MRI (Closed, Open), ... MSK, Cardiology, Oncology), End User (Hospitals, Imaging Centers) - ... studies the global market over the forecast period of ... ~USD 36.43 Billion by 2021, at a CAGR of ...
Breaking Medicine Technology: