Pharmaceutical and health care company GlaxoSmithKline LLC has agreed to plead guilty and pay $3 billion "to resolve its criminal and civil liability arising from the company's unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices," the U.S. Department of Justice said today.
The charges involved misbranding of the drugs Paxil and Wellbutrin from 1998-2003 and failing to report safety data about the drug Avandia from 2001-07.
The government said Glaxo unlawfully promoted Paxil for treating depression in patients under 18, although the U.S. Food and Drug Administration never approved its use for pediatric patients; that it promoted the anti-depressant Wellbutrin for weight loss, substance addictions and other off-label uses; and that it failed to include safety data about the diabetes drug Avandia about possible cardiovascular risks associated with the drug.
The civil settlement also includes claims of Glaxo promoting off-label use of other drugs as well.
In a statement on the Glaxo website, chief operating officer Sir Andrew Witty said the pleading "brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."
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