Glaxo's Response to 60 Minutes Segment on Puerto Rico Plant
When 60 Minutes aired an interview with the whistleblower in the GlaxoSmithKline class action lawsuit that alleged bad practices in the manufacturing procedures at the company's Puerto Rico plant, company officials had a lot to say in Glaxo’s defense.
The plant's former quality control manager, Cheryl Eckard, appeared on the news show to talk about what she saw at the plant that led to a plague of problems for Glaxo afterward. She stated that while she conducted a survey of the Puerto Rico plant, she saw that they were using tainted water in the making of drugs like Paxil and Avandia. In addition, she saw that the pills were getting mixed up together in the packages and that the dosages were wrong. She also stated during her interview that she warned Glaxo officials of these problems but that they shipped the drugs anyway, and that one 8-year-old boy may have gotten one of the packages that contained 2.5 times the dose of Paxil that he was supposed to get.
In a press release that was issued, Glaxo responded to Eckard’s comments.
"GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality,” Glaxo officials wrote. “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."
The press release also stated that Glaxo disagreed with the statements made that anyone that may have been taking Paxil or Avandia suffered injury because of the problems at the Cidra plant. They cited a statement that was issued by Massachusetts U.S. Attorney Carmen Ortiz who said that her office did not uncover any evidence that patients were harmed from the adulterated batches.
Glaxo also focused on the company’s good track record with Good Manufacturing Practice requirements and noted that they fixed the manufacturing problems at the Cidra plant to ensure that the plant procedures met with both Glaxo's and the FDA standards before closing it down due to a lack of demand for the drugs sold at that plant in 2009.
