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GlaxoSmithKline Healthcare Fraud Settlement Approved by Judge

Filed July 6th, 2012 Laurie

On Thursday, a federal judge approved an agreement between drugmaker GlaxoSmithKline to pay $3 billion to settle allegations that it committed criminal and civil violations involving 10 drugs, making it the largest healthcare fraud settlement in U.S. history.

The company pleaded guilty to marketing the popular antidepressant drugs Paxil and Wellbutrin for unapproved uses. According to the original complaint, government officials alleged that GSK promoted Paxil as safe and effective for children and adolescents. The U.S. Food and Drug Administration, however, never approved the drug for youths and the company’s clinical trials actually raised concerns about an increased suicide risk.

Prosecutors also alleged the company promoted Wellbutrin for a variety of unapproved purposes, including bipolar disorder, obesity, attention deficit disorder, and sexual dysfunction.

GSK admitted it had failed to report to the government some safety concerns with the drug Avandia. The U.S. government restricted use of the diabetes drug in 2010 and it was banned in Europe after it was found to significantly increase the risks of heart attacks and heart failure.

U.S. Deputy Attorney General James M. Cole called the ruling “historic” and said it would serve as a warning to other companies that choose to break the law.

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