GlaxoSmithKline settles for $105 million

GlaxoSmithKline settles for $105 million over label dispute with 45 states.

GlaxoSmithKline has agreed to pay $105 million to 45 states to settle charges it improperly marketed the asthma drug Advair and the antidepressants Paxil and Wellbutrin.

The states alleged that, to boost drug sales, GlaxoSmithKline invited doctors to lavish meetings and planted speakers at medical conferences to encourage docs to prescribe the drugs for off-label, or unapproved, uses.

The drug Wellbutrin, for example, had been only been approved for treating depression in adults, but the company promoted it as a treatment for teens, as well as a treatment for conditions that included weight-loss and sexual dysfunction.

Paxil had been approved for adults, the suit said, but GlaxoSmithKline promoted it for treating depression in minors, even though the Food and Drug Aministration hadn’t approved that use and three clinical trials showed the drug increased the risk of suicide in young patients.

The company, the suit said, rewarded its sales reps to mislead healthcare professionals about how Advair could be used as an asthma treatment, without disclosing the Food and Drug Administration had rejected some of its claims because they lacked sufficient documentation.

The attorneys general alleged GSK promoted Advair for off-label use to mild asthma sufferers, which was not a use approved by the FDA.. It was also accused of illegally marketing its antidepressant drugs, Paxil and Wellburtin, as safe and effective for children and teens, which the FDA had not approved. Wellbutrin was also marketed as an “off-label” drug for weight loss and to treat attention deficit disorder, addiction, anxiety and bi-polar disorder.

Under the settlement, GlaxoSmithKline must reform its marketing and promotional practices.

The settlement will require GSK to continue its so-called “Patient First Program” for five years. The Patient First Program reduces the level of financial incentives by the company to drug sales representatives in order to reduce deceptive marketing tactics.

The settlement also requires scientifically trained personnel to develop and approve responses to health care provider questions to ensure their responses are unbiased and do not promote specific drugs.

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