In July 2012, GlaxoSmithKline ("GSK") agreed to pay $3 billion to resolve criminal and civil issues relating to its promotional and reporting practices. GSK pleaded guilty to two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about Avandia to the Food and Drug Administration ("FDA"). GSK will pay a criminal fine of $956 million and forfeit $43 million. In addition, the company will pay $2 billion to resolve allegations related to civil liability under the False Claims Act ("FCA").
The FCA allegations include: promoting various drugs for off-label use, making false statements concerning the safety of Avandia, and reporting false prices. According to the Department of Justice ("DOJ"), the $3 billion in total penalties represents the largest health care fraud settlement in U.S. history. GSK also entered into a five-year corporate integrity agreement ("CIA") with the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG"). For more, see here.