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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan. 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico.
GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutessegment that aired on Jan. 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico. The segment focused on an interview with former GSK employee Cheryl Eckard, who detailed the problems at the facility and which eventually resulted in a $750-million settlement between GSK and federal and state governments that was announced in October 2010.
In October 2010, GSK announced that it finalized a previously reported agreement in principle with the US Attorney’s Office for the District of Massachusetts and the US Department of Justice (DOJ) with respect to the investigation of the company’s former manufacturing facility in Cidra. GSK disclosed a $750-million charge to its second-quarter 2010 earnings on July 15 in connection with the agreement in principle. The settlement resolved issues at the manufacturing facility that took place in 2002. GSK closed the facility in 2009, citing declining demand for the medicines made at the facility, and no longer owns the facility.
“This settlement resolves a significant and long-standing legal issue facing the company,” said PD Villarreal, GSK’s senior vice-president and head of global litigation,” in an Oct. 26, 2010, statement in disclosing the settlement. "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (CGMP) requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009, and we are committed to continuous improvement in our manufacturing processes. Our commitment to compliance with CGMP is demonstrated by the fact that we have not received an FDA warning letter at any plant since the Cidra facility was cited in July 2002.”
GSK responded to the 60 Minutes segment over assertions made by Eckard in the interview that the quality-control issues resulted in problems with patient safety. In the interview with 60 Minutes correspondent Scott Pelley, she cited problems with sterility control and other quality-control problems in manufacturing that resulted in incorrect levels of active ingredients for certain drugs and mixed batches. An Oct. 26, 2010, DOJ press release detailed the manufacturing problems for certain products manufactured at the Cidra facility between 2001 and 2005. In its investigation, DOJ alleged that manufacturing problems at the Cidra facility failed to ensure that the finished products of Kytril, an antinausea medication, and Bactroban, a topical anti-infection ointment, were free of contamination from microorganisms. DOJ also alleged that the manufacturing process for a controlled-release version of the antidepressant Paxil caused the two-layer tablets to split. DOJ said the splitting caused the potential distribution of tablets that did not have any therapeutic effect and tablets that did not contain any controlled-release mechanism. The DOJ release also said that tablets of Avandament, an antidiabetes drug, did not always have an FDA-approved mix of active ingredients, and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect. Finally, DOJ asserted that the Cidra facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.
“GSK strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result of the Cidra issues,” said the company in its Jan. 2 statement. “The FDA, the US Department of Justice, and Neil Getnick, Cheryl Eckard’s attorney, all stated that 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 as a result of the adulterated batches.’”
GSK also rejected claims made by Eckard in the 60 Minutes interview that she was terminated for bringing the manufacturing problems to light. “GSK had been working with the US 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,” said GSK in its Jan. 2, statement. “…The company strongly rejects any claim of retaliation for whistle-blowing. In fact, employees are encouraged to report any concerns that they may have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees.”
Under the agreement reached with GSK in October 2010, GSK agreed to pay a criminal fine of $150 million and an additional $600 million to the federal government and states to resolve claims that it caused false claims to be submitted to government healthcare programs for certain quantities of adulterated Kytril, Bactroban, Paxil CR, and Avandamet. The civil settlement also resolved one lawsuit filed in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the federal False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. As part of the resolution, Eckard, was to receive approximately $96 million from the federal share of the settlement amount, according to the DOJ October 2010 press release.