GSK makes record whistleblower payout
pharmafile | October 28, 2010 | News story | Manufacturing and Production | Cheryl Eckard, FDA, GSK, GlaxoSmithKline, manufacturing compliance, whistle blower
GlaxoSmithKline has officially agreed to plead guilty to distributing adulterated drugs made at its now-closed facility in Cidra, Puerto Rico, and pay a $750 million fine, according to the US Department of Justice.
The size of the fine had earlier been disclosed by the company, but new details have emerged including a record whistleblower payment to Cheryl Eckard, a former quality assurance manager at GSK who will receive $96 million from the settlement.
According to the lawfirm representing Eckard this is the first time that the US False Claims Act has been used to “hold drugmakers accountable for violations of government manufacturing standards”, and could set a precedent for other similar actions.
Eckard was dismissed in 2003 after raising concerns with the company’s management about manufacturing violations at the Cidra facility. She notified the FDA of the situation and filed a lawsuit in 2004.
GSK will pay $150 million to settle the criminal charges and $600 million for the civil claims, which relate to a number of cases of adulterated drugs manufactured at the Cidra plant between 2001 and 2005, according to a DoJ statement.
Brands cited in the case included anti-nausea medication Kytril (granisetron), the topical antibiotic Bactroban (mupirocin), Paxil CR (paroxetine) for depression and diabetes treatment Avandamet (rosiglitazone and metformin).
GSK failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms, it is alleged, while Paxil CR tablets made at the facility split and may not have had any therapeutic effect. In addition, Avandamet tablets may have had too little or too much active ingredient, says the DoJ.
Commenting on the case, US Attorney Carmen Ortiz, said: “As this investigation demonstrates, we will not tolerate corporate attempts to profit at the expense of the ill and needy in our society – or those who cut corners that result in potentially dangerous consequences to consumers.”
GSK senior vice president and head of global litigation, Perre Villareal, said the company “regrets that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements”.
“GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes,” he added.
Phil Taylor
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