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GSK responds to suggestions of patient harm

GSK has issued a response to the 60 Minutes TV programme aired in the US that focused on a former manufacturing facility in Puerto Rico

GlaxoSmithKline (GSK) has issued a response to the 60 Minutes television programme aired in the US that focused on one of its former manufacturing facilities in Puerto Rico.

The programme focused on the quality issues at the Cidra facility and implied patients suffered harm as a result of them.

In 2010, Cheryl Eckard, a former manager of quality assurance at Cidra brought a case against GSK for issues relating to quality. It was settled for $750m. She described the problems identified during an inspection in 2002 in the television programme. These included product contamination, incorrect packaging and inconsistent dose strengths.

During the programme, GSK vice president Ian McCubbin said all of its 80 production plants operated to the "same standard" and "same quality system".

The difference between Cidra and the rest of the plants "is the effectiveness with which the quality system was implemented; it was much weaker and that resulted in compliance issues that occurred."

In response to the programme, GSK issued a statement saying it "regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality." It also "strongly disagrees with 60 Minutes' implication that patients suffered harm as a result of the Cidra issues."

The company added that it "worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA." The plant was closed in 2009 due to a declining demand for the medicines made there, GSK said.

4th January 2011

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