GlaxoSmithKline will pay $3 billion to settle charges that it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.
The largest such settlement ever, it trumps Pfizer’s $2.3 billion 2009 settlement with the Department of Justice for misbranding Bextra and promoting off-label uses for Bextra, Geodon, Zyvox and Lyrica.
From 1998 to 2003, DOJ says that GSK promoted Paxil to treat depression in children by pushing a “misleading” journal article that selectively quoted clinical trials data purporting to show efficacy in treatment of patients under the age of 18, when the data showed the opposite.
From 1999 to 2003, DOJ says the company promoted Wellbutrin, then indicated only for Major Depressive Disorder, for such off-label uses as weight loss and sexual dysfunction.
Also, in 2001 and 2007, GSK failed to report safety data on Avandia to FDA, omitting post-marketing study data “regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia.”
GSK agreed to plead guilty to the charges and to pay criminal fines of $757 million for the Paxil and Wellbutrin abuses and $242 million for its Avandia actions, said DOJ. GSK will pay $2 billion to resolve False Claims Act liabilities on those and other drugs, and charges of pricing fraud.