GlaxoSmithKline has hit back at attacks made by a 60 Minutes television whistle-blower report in the USA over its former issue-ridden Puerto Rico manufacturing plant.
On 2 January, the 60 Minutes report reviewed the quality control at the Cidra, Puerto Rico facility through interviews with Cheryl Eckard, former GSK manager of global quality assurance, who was sent in 2002 by the firm as part of a team to address issues that had been cited by the US Food and Drug Administration. The report implied that patients suffered harm as a result of the production issues.
“All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career,” Eckard told 60 Minutes.
She claimed water contaminated with bacteria was used to make drugs, the active pharmaceutical ingredients were not measured accurately, there were production line failures, medication mix-ups and incorrect packaging, and even employees were seen to be actively contaminating products.
“I contacted the vice-president of quality for North America and I told him that he needed to shut down the factory and call the FDA,” she said. “I urged him to stop the trucks that were leaving the dock that day. I went back to work and waited for the news that they had called the FDA or that they had stopped shipments, and it didn’t happen.”
GSK has already paid out $750 million in settlement for a whistle-blower case brought by Eckard back in October over claims the company sold mislabelled and defective drugs that had been produced at the Cidra facility. GSK agreed to plead guilty to a criminal felony for “releasing into interstate commerce” versions of drugs that did not have FDA approval for the mix of active ingredients involved in the batches. The facility was closed in 2009.
Despite the company acknowledging the manufacturing issues at the plant, described as “inconsistent with GSK’s commitment to manufacturing quality”, it said in a statement it “strongly disagrees with 60 minutes’ implication that patients suffered harm as a result of the Cidra issues”, adding that “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 US Attorney Carmen Ortiz herself stated: ‘We did not uncover any evidence that patients were harmed from these adulterated batches’”.
GSK also said in the statement 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, it said.
“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,” GSK added.