GSK fined $750m for old Puerto Rico plant violations
The case, which dates back to 2002, alleged that GSK failed to prevent contamination of Kytril, Bactroban, Paxil CR and Avandamet made at the plant between 2001 and 2005.
This, the lawsuit argued, meant that GSK was guilty of producing and distributing adulterated drugs, which is in breach of US Food and Drug Administration (FDA) rules.
GSK, whose SB Pharmco subsidiary operated the facility, admitted to the charges and said it regretted operating the site “in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements.”
PD Villarreal, GSK’s Head of Global Litigation said: “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.”
Tony West, Assistant Attorney General for the Civil Division of the Department of Justice (DoJ), welcomed the ruling, the size of the fine and its implications for the wider drug industry.
He explained that: "Adulterated drugs undermine the integrity of the FDA’s approval process, can introduce substandard or ineffective drugs on to the market and, in the worst cases, can potentially put patients’ health at risk."
The settlement is the fourth largest ever imposed on a pharmaceutical firm according to West, who added that the DoJ will continue to hold drug companies accountable for GMP violations.
B-MS moves to fix PR plant
The GSK settlement will attract the attention of drug manufacturers worldwide, particularly US firm Bristol-Myers Squibb whose anticontamination procedures at its plant in Manati, Puerto Rico are currently the subject of FDA criticism.
In a statement release a day ahead of the GSK ruling, B-MS CEO Lamberto Andreotti said his firm is working to address issues found at the facility, and predicted that it would be “inspection ready” by the end of the year.
