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.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.