GlaxoSmithKline to pay $105M over improper drug marketing

RALEIGH, N.C. — GlaxoSmithKline allegedly lied about three popular drugs.  Now, the drug maker has to pay North Carolina and 44 other states $105 million to settle those allegations.  North Carolina gets $2.5 million of the settlement.
 
"We want to make sure that these companies abide by the rules," N.C. Attorney General Roy Cooper told Action 9.  "We think this is positive for patients across North Carolina and the country."
 
The states say GSK illegally marketed three drugs: Advair, Paxil and Wellbutrin.   They say, for 10 years, GSK promoted Advair as a "first line treatment for all asthma patients, when it was only approved for use in patients with long-term asthma or respiratory diseases."

The Food and Drug Administration approved Paxil to treat depression in adults, but the states say, for four years, GSK "deceptively promoted Paxil as safe and effective for children and adolescents, despite the lack of FDA approval. In addition, three GSK clinical trials failed to demonstrate Paxil's effectiveness in children and adolescents and raised concerns that Paxil may be associated with an increased risk of suicide in such patients."

The FDA also approved another anti-depressant, Wellbutrin, for adults. The states say, for four years, GSK "promoted Wellbutrin for various conditions for which GSK had never proven it to be safe and effective, including weight loss and the treatment of obesity; treatment of sexual dysfunction; treatment of Attention Deficit Hyperactivity Disorder; treatment of addictions; treatment of anxiety; treatment of bipolar disorder; and treatment of patients under the age of 18."

In addition to the $105 million, Cooper says GSK "must reform its marketing and promotional practices. GSK is also required to continue its Patient First Program, which reduces financial incentives for sales representatives to engage in deceptive marketing, at least through March 2019. In addition, the settlement requires scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional."

He says, "Besides North Carolina, the states that participated in the settlement are Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming."
 
In a statement to Action 9, GSK said, "[It] has reached settlements with 44 states and the District of Columbia for $105 million to resolve legal claims against the company regarding historic matters that relate to violations of state trade practices laws and are similar to the matters settled with the federal government in 2012.  The Company did not admit to any wrongdoing or liability under the states' laws in this settlement.  GSK is the first pharmaceutical company to commit to fundamental reforms to our business model in the US and around the world by stopping payments to doctors to speak about our products, stopping payments to doctors to attend medical conferences and cutting the tie linking the pay of our sales representatives who call on prescribers in the US to the number of prescriptions issued.  We are rolling out this innovative compensation model in the rest of the world."

WSOC