US Attorney Carmen Ortiz announced yesterday that the London-based company will pay USD 150 million in criminal fines and USD 600 million in civil penalties related to faulty manufacturing processes at its plant in Cidra, Puerto Rico.
The company allowed several drugs to be adulterated between 2001 and 2005, including Paxil CR, a skin-infection ointment called Bactroban, and an anti-nausea drug called Kytril.
GlaxoSmithKline said in a statement that it regrets operating the plant in a manner that violated good manufacturing practices. The company said the plant closed in 2009 due to declining demand for the medicines made there.
Ortiz said that no patients appeared to have been harmed by the quality problems at the plant, which included failing to ensure that Bactroban and Kytril were free of contamination from microorganisms and causing Paxil controlled release tablets to split, causing the potential distribution of tablets that did not have any therapeutic effect.
The investigation began after Cheryl Eckard, the company's global quality assurance manager, went to the Food and Drug Administration to report problems at the Puerto Rico plant.
Eckard, who worked at the company's offices in North Carolina, said she was fired in 2003 after repeatedly reporting the problems to her superiors and the company's compliance department.
"This is not something I ever wanted to do, but because of patient safety issues, it was necessary," Eckard told reporters after the settlement was announced yesterday.
As a whistleblower, Eckard will receive USD 96 million of the settlement paid by the company.