GSK agreed to plead guilty and pay $3 billion: $1 billion criminal and $2 billion civil. The Paxil count concerned pediatric promotion from April 1998 through August 2003 despite no FDA pediatric-depression approval; the government alleged use of a misleading journal article and non-disclosure of two other negative studies.
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA).
GSK agreed to plead guilty and pay $3 billion: $1 billion criminal and $2 billion civil. The Paxil count concerned pediatric promotion from April 1998 through August 2003 despite no FDA pediatric-depression approval; the government alleged use of a misleading journal article and non-disclosure of two other negative studies. The criminal plea is distinct from civil allegations. Except for the three-count plea, settled civil claims were allegations only with no determination of liability.