GlaxoSmithKline fined $41m for manufacturing failings
pharmafile | June 28, 2011 | News story | Manufacturing and Production |Â Â GSK, pharma manufacturing newsÂ
GlaxoSmithKline has agreed to pay almost $41 million to dozens of US states in a lawsuit focusing on alleged substandard manufacturing processes.
Last year, GSK agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs at its now-closed facility in Cidra, Puerto Rico.
The federal action – brought by the US Department of Justice – resulted in a fine of $750 million, including a record $96 million ‘whistleblower’ payment to former employee Cheryl Eckard.
The latest settlement, which is still subject to approval by the US Superior Court, settles separate actions brought against the company by 37 individual state authorities and Washington DC.
In a statement, GSK said it had decided to settle the cases in order to avoid the expense and uncertainty of protected litigation, and was not admitting to any wrongdoing or liability under the states’ consumer protection laws.
GSK and subsidiary SB Pharmco Puerto Rico were accused of engaging in unfair and deceptive practices by manufacturing and distributing certain lots of drugs that were adulterated due to substandard manufacturing processes.
Products cited in the action included anti-nausea product Kytril (granisetron), antibiotic ointment Bactroban (mupirocin), antidepressant Paxil CR (paroxetine) and Avandamet (rosiglitazone and metformin) for type II diabetes, which were manufactured at the Cidra plant between 2001 and 2005.
GSK failed to ensure that the finished Kytril and Bactroban products were free of contamination from microorganisms, according to DoJ documents on the case, 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.
Phil Taylor
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