GSK fined $750m for selling contaminated drugs
Pharmaceutical giant GlaxoSmithKline (GSK) has been fined $750m after admitting that it knowingly sold adulterated drugs, including its popular Paxil antidepressant, for six years.
GSK allowed millions of its drugs onto the market between 2001 and 2005 that either were contaminated with microorganisms or had no therapeutic value. Aside from Paxil, the other contaminated drugs were Bactroban, an ointment for skin infections, and an anti-nausea drug, Kytril.
The drugs were manufactured at a plant in Puerto Rica, which was not observing standard health and safety protocols – although GSK management was aware of the deficiencies. The plant was closed in 2009.
Last week US federal prosecutors fined GSK $750m, made up of $150m criminal fines and $600m in civil penalties. In a statement, GSK said it regretted operating the plant in a manner that violated good manufacturing practices.
The production problems came to light only when a former GSK employee Cheryl Eckard informed the Food and Drug Administration, America’s drug regulator. Eckard had been sacked from her position as the company’s global quality-assurance manager after she had repeatedly reported her concerns to management. “This is not something I ever wanted to do, but because of patient safety issues, it was necessary,” she said after the settlement. As a whistle-blower, Eckard receives $96m of the settlement paid by GSK.
(Source; Los Angeles Times, October 26, 2010).