Were Quality Issues at GSK Cidra an Outlier or Another Point in a Trend…

by Daniel R. Matlis

60 Minutes aired a one-on-one interview with Cheryl Eckard, the whistle-blower in the GSK Cidra case.
During her poignant interview Eckard describes her experiences and findings starting in 2002, when she lead the quality assurance team which evaluated GSK’s Cidra, Puerto Rico Plant.

 As a result of legal action triggered by Eckard’s revelations, GSK pleaded guilty to a felony relating to the distribution of “adulterated drugs Paxil CR, Avandamet (a diabetes drug), Kytril (a drug given to cancer patients), and Bactroban.” The company paid $750 million to settle the criminal conviction and Eckard’s suit. Under the whistleblower law, Eckard received $96 million, as a percentage of the millions that the government recovered in the fraud suit.

The plant at Cidra is now closed.

GSK issued a statement in response to the 60 Minutes piece. According to the statement, “GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK’s commitment to manufacturing quality.” “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.”

In light of the Pharma quality issues making headlines in recent years, I wonder if Cidra was an outlier or another point in a trend…

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