The Justice Department announced on Monday, July 2, 2012 that GlaxoSmithKline has agreed to pay $3 billion in settlements and to plead guilty to criminal charges related to its branding, safety disclosures and price reporting of several drugs. This is the largest fraud settlement in U.S. history to date.
GlaxoSmithKline will pay $1.8 billion to resolve criminal and civil liabilities for off-label marketing, including $757 million in criminal fines for misbranding antidepressants Paxil and Wellbutrin, and more than $1 billion for alleged False Claims Act violations related to payments of kickbacks for those and other drugs.
The company will also pay a $243 million fine for failing to report safety data to the Food and Drug Administration regarding the diabetes drug Avandia. In addition, the company will pay $657 million to resolve allegations about statements it made regarding Avandia safety and efficacy and $300 million for allegedly failing to report its best prices for certain drugs to Medicaid, according to Stuart Delery, acting assistant attorney general.
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