GlaxoSmithKline has finalised a previously-reported agreement with the US government and is paying $750 million to resolve criminal and civil liability regarding manufacturing deficiencies at a former plant in Puerto Rico.
The settlement revolves around the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico facility. The products in question, manufactured at the plant between 2001and 2005, are the anti-nausea drug Kytril (granisetron), the anti-infective Bactroban (mupirocin), the antidepressant Paxil CR (paroxetine) and the type II diabetes combo Avandamet (metformin and rosiglitazone).
The civil settlement of $600 million resolves charges that GSK released to the market Bactroban and Kytril that was not sterile, Paxil CR tablets that lacked the active ingredient and Avandamet tablets that were "superpotent and subpotent". The other $150 million is a criminal fine.
PD Villarreal, GSK’s head of global litigation, said "we regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements". He added that the company "worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009", adding that "our commitment to compliance with cGMP is demonstrated by the fact that we have not received a US Food and Drug Administration warning letter at any plant since the Cidra facility was cited in July 2002".
Daniel Levinson, inspector general of the US Department of Health and Human Services., said that "if all pharmaceutical manufacturers complied with the law, there would be no need for such massive settlements and judgments. But until they stop stealing from taxpayers and threatening the health and lives of Americans", his office will continue to "vigorously pursue these corporations and their executives".
The settlement is the result of a whistleblower lawsuit filed in 2004 by Cheryl Eckard, a former quality assurance manager with GSK. She will receive $96 million, the largest reward for a single whistleblower in US history, and it is anticipated that Ms Eckard, who was fired by GSK in May 2003, will receive additional rewards from individual US states.