GlaxoSmithKline disputes report on '60 Minutes'
Posted January 3, 2011 11:18 a.m. EST
GlaxoSmithKline (NYSE: GSK) said in a statement issued Monday that patients were not harmed as a result of production problems at a plant it once operated in Puerto Rico.
The drug giant responded after aired Sunday night in which a former Triangle-based GSK quality inspector Cheryl Eckard spoke at length publicly about the case. Eckard was the whistle blower in the case, which GSK settled last fall for $750 million.
"GSK strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result of the Cidra issues," said the company, which operates its U.S. headquarters in RTP.
In the television report, Eckard described the contamination and packaging problems she found.
"All the systems were broken, the facility was broken, the equipment was broken, the processes were broken," she said.
GSK operates its U.S. headquarters in RTP.
The GSK statement in its entirety follows:
"GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company.
"GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality. It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past -- between 2001 and early 2005 -- and related to one manufacturing facility. GSK had been working with the U.S. Food and Drug Administration to improve the plant’s performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address the issues cited by the FDA.
"GSK strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result of the Cidra issues. The FDA, the US Department of Justice, and Neil Getnick, Cheryl Eckard’s attorney, all stated there was no indication that patients were harmed as a result of the production issues at Cidra. Massachusetts U.S. Attorney Carmen Ortiz herself stated: 'We did not uncover any evidence that patients were harmed from these adulterated batches.'
"GSK’s manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies – including the FDA – conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. GSK is committed to continuous improvement in our manufacturing processes. Patients should have a high level of confidence about GSK’s manufacturing and the quality of our medicines.
"GSK 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. The company strongly rejects any claim of retaliation for whistle-blowing. In fact, employees are encouraged to report any concerns they might have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees."