Sunday, January 02, 2011

"60 Minutes" does Cidra/Paxil story on 2 Jan 2011

Back in October 2010, MarketWatch announced:

GlaxoSmithKline (GSK) has agreed to pay the government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans, the Department of Justice announced today. The settlement was the result of a whistleblower lawsuit filed in 2004 by the law firm of Getnick & Getnick LLP on behalf of Cheryl Eckard, a former Quality Assurance Manager with GSK.

The story was presented on CBS "60 Minutes" on January 2, 2011. Cheryl got about $96 million under the Federal Whistleblower Act, which goes back to the Civil War era.

Other details from MarketWatch:

In August 2002, Ms. Eckard, then a Global Quality Assurance Manager with GSK, was sent to the Cidra factory to lead a team of 100 scientists and quality experts brought from around the globe to fix manufacturing violations cited by the FDA. Cidra was then GSK's No. 1 factory in the world, making over 20 products worth $5.5 billion annually, including blockbuster drugs Avandia, Paxil and Coreg.

What she discovered went far beyond the manufacturing violations previously uncovered by the FDA. Her whistleblower lawsuit, filed by the Getnick firm in February 2004, included details about mixed-up products, super and subpotent diabetes drugs, an area of the factory used to make injectible drugs that was not sterile, air handling systems that misdirected the flow of product powders, a water system contaminated with microorganisms, and a host of other manufacturing and quality testing problems that led her to conclude that GSK could not assure that its product was free from contamination and made according to the drug formula registered with the FDA.

From August 2002 to her firing in May 2003, Ms. Eckard urged GSK managers to take swift and decisive action at Cidra, including shutting down the plant. She made a full report to the GSK Compliance Department, which treated her complaints as unsubstantiated. She then reported the fraud to the FDA in San Juan.

The FDA executed search warrants in October 2003 and in February 2005 seized all stocks of Avandamet and Paxil CR in the largest seizure in FDA history, estimated by the FDA to be worth $2 billion. The FDA also placed the Cidra plant under a Consent Decree, requiring that all products released to the market be approved by an independent monitor. The Cidra plant closed in 2009.

See also
GlaxoSmithKline whistleblower awarded $96m payout


Andy Rooney wished Happy New Year to everyone watching, and not watching. A little fun goes a long way. Andy includes sleeping as a way to enjoy himself. Andy bets a lot of people go to bed at 10:30pm on New Year's Eve and announced his intention to do so next year. Andy's birthday is coming up: January 14.


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