Major prescription drug company GlaxoSmithKline (GSK) is expected to plead guilty and pay upwards of $3 billion as part of the largest healthcare fraud settlement in United States history, according to an official statement released by the Justice Department Monday.
According to the statement, the settlement comes from the company’s illegal promotion of its products and failure to report safety-related data to the Food and Drug Administration. The company also allegedly engaged in false price reporting in the scandal.
GSK is charged with two counts of introducing misbranded drugs, identified as Paxil and Wellbutrin, and one count of failing to report safety data about another drug, Avandia, to the FDA. The plea agreement includes a $1 billion fine for GSK, over $956 million of which is a criminal fine. The remaining $2 billion of the agreement will be used to resolve civil claims under the federal government’s False Claims Act (FCA).
Paxil and Wellbutrin have come under fire in recent months after researchers found that the drugs were linked to adverse events for babies during pregnancy. Charges of failing to report safety data stems from GSK’s Avandia drug, users of which have an increased risk of heart failure and heart attack.
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