GlaxoSmithKline has reached an agreement to pay a $3 billion fine (£1.9billion) after promoting drugs for unapproved uses and withholding safety data in the USA. This has been reported in the general media (BBC).
The settlement covers both civil and criminal liabilities for activities ranging from off-label promotion of anti-depressants, including promoting use in children and adolescents and direct payments to physicians, to withholding safety data and making unsupported safety claims for the now withdrawn diabetes drug rosiglitazone (Avandia®).
A statement issued by the company states that fundamental changes have been made throughout the American business to their procedures for compliance, selling and marketing. Government officials will continue to closely monitor the company for the next 5 years as part of the settlement.
A statement from the Deputy Attorney General in the US Department of Justice noted that this is the "largest health care fraud settlement in United States history".
Action: Clinicians should be aware of this fine and the resulting media reports. Such reports risk undermining public confidence in the pharmaceutical industry and, by proxy, healthcare organisations.
Thanks to Kevin Ashworth for spotting this article
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