GlaxoSmithKline pays out £63m to settle US marketing allegations

http://www.theguardian.com/world/2014/jun/04/glaxosmithkline-settle-lawsuit

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GlaxoSmithKline (GSK) has agreed to pay $105m (£63m) to settle allegations by 44 US states and the District of Columbia that it promoted its medicines for unapproved uses.

The company was accused of illegally marketing its big-selling asthma drug Advair for use by mild asthma sufferers and the antidepressants Paxil and Wellbutrin for use by children and teenagers without approval from the US regulator the Food and Drug Administration (FDA). Several antidepressants have been associated with increased risk of suicide in younger patients.

Illinois attorney general, Lisa Madigan, said in a statement: "GlaxoSmithKline put its business interests ahead of what was best for vulnerable patients."

While doctors are allowed to prescribe medicines as they see fit – including so called off-label uses – pharmaceutical companies are allowed to promote their products only for conditions specifically approved by the FDA.

Michigan's attorney general, Bill Schuette, said in a statement announcing his state's $2.6m portion of the settlement: "Consumers shouldn't have to wonder whether financial incentives are negatively influencing their medical care."

Under the settlement, GSK is banned from disseminating information describing any off-label use of a product, unless such information and materials are consistent with applicable FDA regulations and FDA guidance.

The settlement also requires GSK to continue its "Patient First Programme" that reduces the level of financial incentives by the company to sales representatives in order to reduce deceptive marketing tactics for five years.