GSK says there is no evidence that patients were harmed as a result of production issues at its manufacturing plant in Cidra, Puerto Rico.
The comments follow an episode of US TV programme 60 mintues in which former GSK employee Cheryl Eckard, whose “whistleblower” lawsuit uncovered a number of quality control issues, described conditions she observed at the facility in 2002 as the “worst thing I had run across in my career.”
She went on to say that: "All the systems were broken, the facility was broken, the equipment was broken, [and] the processes were broken,” citing problems with the water supply, potency variability in production runs and contamination as the major deficiencies.
Eckard also said she identified cases where products were mixed during the packaging process with, in one instance, the diabetes drug Avandia being boxed with the over-the-counter heartburn treatment Tagamet.
She also speculated that some bottles of the anti-depressant Paxil made at the facility may have contained two different dosages as both the 10mg standard and 25mg controlled release (CR) versions of the product were made on the same manufacturing line.
In its response GSK, which admitted it was guilty of quality control violations at the Cidra plant and the distribution of adulturated products as part of a $750m settlement in 2010, expressed regret about the state of operations at the now closed plant.
It also said that “GSK had been working with the US FDA 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.”
The UK drug major added that: “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.”
GSK also said that US Attorney Carmen Ortiz herself stated: “We did not uncover any evidence that patients were harmed from these adulterated batches.”
The firm also rejected the idea it engages in retaliation against employees who highlight quality control issues at any of its manufacturing facilities around the world.
“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.”