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GlaxoSmithKline pays $105 million to settle accusations of ‘off-label’ marketing

GlaxoSmithKline (GSK) has agreed to pay $105 million to settle accusations that it promoted three of its top drugs for non-approved uses.

The settlement with 44 states and the District of Columbia, announced on Wednesday, ends claims that the drug maker marketed its Advair, Paxil, and Wellbutrin products for uses not approved by the Food and Drug Administration, in what is commonly known as “off-label” marketing.

In one case, GlaxoSmithKline promoted its Wellbutrin drug as a treatment for sexual dysfunction, anxiety, and obesity, using the slogan “happy, horny, skinny drug.” The push dramatically increased sales for the drug that is otherwise only approved for treating depression.

Sales representatives were encouraged to advocate off-label uses to health care professionals, and, in some cases, the drugmaker paid health care professionals to be “consultants” on advisory boards where they were presented with information about the drugs’ unapproved uses.

GlaxoSmithKline, which did not admit wrongdoing in the settlement, has agreed to adjust its marketing for the three drugs and stop promoting the off-label uses. The company will also no longer provide monetary incentives to its sales force to push non-FDA approved uses.