The Justice Department announced today that GlaxoSmithKline will plead guilty in what will be the largest health care fraud settlement in U.S. history. According to USA TODAY, the company will pay a total of around $3 billion to resolve the federal criminal and civil reviews.
Under the terms of the settlement, GSK pleads guilty to three misdemeanor violations of the Federal Food, Drug, and Cosmetic Act. Two have to do with the unlawful promotion of depression drugs Paxil and Wellbutrin, and the third for failing to report certain safety information about Avandia to the FDA in periodic and annual reports (statement from GSK)
The criminal fine alone accounts for $956,814,400 of the settlement. GlaxoSmithKline will also pay $2 billion of the settlement to resolve civil claims under the federal government’s False Claims Act.
GSK (GlaxoSmithKline) earlier set aside $3 billion for legal costs to cover injuries caused by their drugs, including the blockbuster diabetes medication Avandia. They have already paid more than $700 million to resolve patient lawsuits for Avandia alone.
Now, it has been reported that GSK has set aside $3.5 billion to cover the fines and penalties arising from the government’s seven-year probe of the company’s failure to report safety data, alleged false price reporting, and illegal marketing practices.
GlaxoSmithKline has agreed to enter into a corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services as part of the settlement (GSK).
- GlaxoSmithKline ‘guilty of fraud’ (bbc.co.uk)
- GlaxoSmithKline Reaches Plea Agreement Over Drug Labeling – Bloomberg (bloomberg.com)
- GlaxoSmithKline to pay $3 billion for health fraud (seattletimes.nwsource.com)
- GlaxoSmithKline to pay $3 billion for health fraud (ktvb.com)
- GlaxoSmithKline to pay $3 billion for health fraud (mysanantonio.com)