Today, Attorney General Madigan announced that Illinois will receive $5.1 million from a resolved settlement with GlaxoSmithKline LLC (GSK). Madigan and 44 other state attorney generals alleged that GSK unlawfully promoted its asthma drug Advair and antidepressants Paxil and Wellbutrin, which in turn, violated state consumer protection laws. The total amount of the settlement came to $105 million plus GSK must reform its marketing and promotional practices.
Although GlaxoSmithKline did not acknowledge any wrong doing; the state attorneys alleged that GlaxoSmithKline promoted Advair for the initial treatment for mild asthma sufferers, this off label use was not approved by the FDA. It was alleged that they illegally marketed their antidepressant drug, Paxil, as safe and effective for children and teens, in spite of the fact that clinical trials raise concern that the drug was associated with an increased risk of suicide, and that it was not approved for this use by the FDA. They also illegally marketed their antidepressant drug, Wellbutrin, to children without FDA approval. Wellbutrin was also promoted as a “off-label” drug for weight loss and to treat attention deficit disorder, anxiety, bipolar disorder and as a treatment for addiction.
“GlaxoSmithKline put its business interests ahead of what was best for vulnerable patients,” Madigan said. “This settlement will put a stop to the illegal marketing practices the company used to boost its sales.”
As part of the settlement, GSK is required to continue it's so-called “Patient First Program,” for five years, which reduces the level of financial incentives by the company to drug sales representatives in order to reduce deceptive marketing tactics. They are required to provide scientifically trained personnel to develop and approve responses to health care providers questions that does not promote specific drugs.
GlaxoSmithKline is prohibited to make any false, misleading and/or deceptive claims about their products, cannot provide any sample products to health care professionals who are not expected to use the sample product for a FDA approved use, present favorable information or conclusions from a study that is inadequate when presenting information about of clinical study regarding their product in any promotional materials, and they are disallowed to disseminate information describing any off label use of a GSK product.