WASHINGTON — The Justice Department says GlaxoSmithKline will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to report important safety data about a diabetes drug to the Food and Drug Administration.
Government officials say it’s the largest health care fraud settlement in U.S. history.
Prosecutors say GSK encouraged use of Paxil for children although it was not approved for anyone under 18. The company also promoted Wellbutrin for uses besides major depressive disorder, its only approved use. They say that between 2001 and 2007 GSK failed to report on two studies of the cardiovascular safety of Avandia, a diabetes drug.
Of the penalties, $1 billion covers criminal fines and forfeitures and $2 billion is for civil settlements with the federal and state governments.