(Story updated at 3:45 p.m. ET.)
In the largest fraud settlement in U.S. history, 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.
The Justice Department on Monday announced a “global settlement” with the U.K.-based company that resolves three investigations related to the pharmaceutical giant and imposes an unusual corporate integrity agreement on Glaxo's worldwide operations.
The company 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 also agreed to pay a $243 million criminal fine for failing to report safety data to the Food and Drug Administration regarding its diabetes drug Avandia. The company will pay $657 million to resolve allegations about statements it made regarding Avandia's safety and efficacy.