States reach settlement over drugs Advair, Paxil and Wellbutrin
Raleigh: Drug manufacturer GlaxoSmithKline will pay North Carolina and 44 other states $105 million to settle allegations that the company unlawfully marketed drugs, Attorney General Roy Cooper said Wednesday.
“Drug companies have an obligation to market drugs only for purposes that are safe and effective,” Cooper said. “The drug approval process is designed to protect the health of consumers, and it’s important that process be followed.”
Cooper’s Consumer Protection Division filed a complaint and consent judgment in Wake County Superior Court against GlaxoSmithKline, LLC (GSK) this morning. North Carolina will receive $2.5 million as its share of the judgment.
The settlement resolves allegations that GSK illegally marketed three drugs, Advair, Paxil, and Wellbutrin, for purposes that had not been approved by the FDA. Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote that drug for an unapproved use, a practice called off-label marketing.
North Carolina and the other states allege that from the year 2000, when Advair was approved by the FDA, until 2010, GSK used false and misleading representations to promote 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 states contend that GSK provided financial incentives to sales representatives to promote Advair for mild asthma patients and that the company also distributed clinical trials that had been determined by the FDA to be insufficient evidence for the first line treatment for mild asthma patients to health care professionals, without disclosing that the FDA rejected that evidence as insufficient.
In 1992, the FDA approved Paxil to treat depression in adults, and it was subsequently approved for other uses in adults. The FDA has never approved Paxil for patients under the age of 18.
Based on the states’ investigation, between 1999 and 2003 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.
In 1985, the FDA approved Wellbutrin to treat major depressive disorder in adults. The states allege that between 1999 and 2003, 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.
The states claim GSK engaged in the off-label promotion of Wellbutrin by encouraging sales representatives to steer health care professionals directly to the off-label uses. It is alleged that sales representatives hosted speaker programs, continuing medical education programs and lavish dinners to promote Wellbutrin for unapproved uses. The states also discovered GSK was paying health care professionals to be consultants on advisory boards where they were presented with information about off-label uses.
Consent judgment requires reforms
In addition to paying $105 million including $2.5 million to North Carolina, as conditions of today’s settlement, 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.
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.