GlaxoSmithKline will pay $105 million to settle charges that it unlawfully promoted its asthma drug Advair and antidepressants Paxil and Wellbutrin. The payment settles charges brought by 45 state attorneys general.
The attorneys general alleged GSK violated state consumer protection laws by misrepresenting the proper use and qualities of Advair, Paxil and Wellbutrin and by marketing the drugs for “off-label uses,” or uses that were not approved by the U.S. Food and Drug Administration (FDA).
“GlaxoSmithKline put its business interests ahead of what was best for vulnerable patients,” said Illinois Attorney General Lisa Madigan. “This settlement will put a stop to the illegal marketing practices the company used to boost its sales.”
The case is the most recent in a long list of lawsuits and prosecutions that accused GlaxoSmithKline of unlawful conduct.
The attorneys general alleged GSK promoted Advair for off-label use to mild asthma sufferers. Mild asthmatics were steered to the drug for initial treatment, which was not a use approved by the FDA, even when substantially cheaper alternative medications were a better treatment option for these patients.
GSK also illegally marketed its antidepressant drug, Paxil, as safe and effective for children and teens, which the FDA had not approved, in spite of clinical trials that raised concerns the drug was associated with an increased risk of suicide.
The attorneys general alleged GSK also illegally marketed a second antidepressant drug, Wellbutrin, to children without FDA approval. GSK also unlawfully marketed Wellbutrin as an “off-label” drug for weight loss and to treat attention deficit disorder, addiction, anxiety and bi-polar disorder.
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.