GlaxoSmithKline hit with £475m fine
(UKPA) – 4 hours ago
Drug company GlaxoSmithKline will pay $750 million (£475 million) to settle allegations that it knowingly manufactured and sold adulterated drugs, federal prosecutors in the US said.
US Attorney Carmen Ortiz said the London-based company will pay $150m (£95m) in criminal fines and $600m (£380m) in civil penalties related to faulty manufacturing processes at its plant in Cidra, Puerto Rico.
The company allowed several drugs to be adulterated between 2001 and 2005, including the widely used anti-depressant Paxil CR, a skin-infection ointment called Bactroban, an anti-nausea drug called Kytril, and a diabetes drug called Avandamet, Ortiz said.
GlaxoSmithKline said in a statement it regrets operating the plant in a manner that violated good manufacturing practices.
The company said the plant closed in 2009 due to declining demand for the medicines it made.
Executives revealed a $750m (£475m) charge to the company’s second-quarter 2010 earnings on July 15 in connection with the agreement.
Ortiz said no patients appeared to have been harmed by the quality problems, which included failing to ensure that Bactroban and Kytril were free of contamination from microorganisms and Paxil controlled release tablets that were split, meaning tablets were potentially distributed that did not have any therapeutic effect.
The investigation began after Cheryl Eckard, the global quality assurance manager, went to the plant in August 2002 to correct manufacturing violations cited by the US Food and Drug Administration (FDA).
She discovered numerous violations, including a contaminated water system and an air system that allowed for cross-contamination between different products. She reported the problems to her superiors and the compliance department, her lawyers said.
Ms Eckard, who worked at the company’s offices in North Carolina, eventually went to the FDA to report the problems and later filed a whistleblower lawsuit. She said she was fired in 2003 after repeatedly reporting the problems to the company. As a whistleblower under the federal False Claims Act, Eckard will receive $96m (£61m) of the settlement paid by the company.
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[...] Bactroban, an anti-nausea drug called Kytril, and a diabetes drug called Avandamet, Ortiz said. Read more of this post var addthis_product='wpp-250';var addthis_append_data='true';var addthis_language='en'; Share| [...]
Now that they have been sentenced, they can be legally referred to as “criminals” – which is exactly what they are. This was the case with Roche several years ago – see Dr. Mathias Rath.