GlaxoSmithKline PLC (GSK) has agreed in another settlement to pay $105 million to 44 states and the District of Columbia. This settlement resolves allegations that the company improperly marketed and promoted the asthma drug Advair and the antidepressant drugs Paxil and Wellbutrin. The violations of state trade practices laws are similar to the matters settled with the federal government in 2012, which resulted in a $3 billion settlement.
New York Attorney General Eric Schneiderman alleged in the suit that GSK engaged in deceptive and misleading practices when it marketed Advair, Paxil and Wellbutrin for off-label uses and concealed risks associated with Paxil. It was alleged, among other things, that GSK promoted Advair for treatment of mild and intermittent asthma even though it was approved by the FDA only for treatment of more serious asthma conditions.
It also alleged that GSK promoted Wellbutrin for treatment of weight loss and sexual dysfunction through its “happy, horny, skinny pill” campaign, even though these were unapproved uses. GSK was said to have concealed and misrepresented clinical studies that demonstrated Paxil’s ineffectiveness in treating children and adolescents with major depressive disorder, as compared to a placebo group, and that demonstrated a connection between Paxil’s use and an increased risk of suicidal thoughts and acts in adolescents. Attorney General Schneiderman made this observation in a statement:
When pharmaceutical companies advertise drugs to consumers, their claims should be backed by the best available science, not just slick marketing.
The Attorney General’s office, in a statement, had more to say about the settlement. The statement said the agreement does the following:
• It prohibits GSK from making any claim that is false, misleading or deceptive about any GSK product.
• The drug manufacturer was also prohibited from making promotional claims not approved or permitted by the FDA that a GSK product is better, more effective, safer or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience.
• It prohibits the company from presenting favorable information or conclusions from a study that is inadequate in design, scope or conduct in any promotional materials, and from providing samples of GSK products to health care professionals who are not expected to prescribe the sampled GSK products for an approved use.
• It bars GSK from disseminating information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA guidances for the industry.
• It requires GSK to continue its Patient First Program through March 2019, which reduces financial incentives for sales representatives to engage in deceptive marketing by removing individual sales targets and begins the process of ending direct payments to health care professionals for speaking engagements and attendance at medical conferences.
GSK now says it’s the first pharmaceutical company to commit to stopping payments to doctors to speak about its products, stopping payments to doctors to attend medical conferences and cutting the tie linking the pay of its sales representatives who call on prescribers in the U.S. to the number of prescriptions issued. That is most significant and hopefully GSK has started a trend in the industry. The company said in a statement that it was “rolling out this innovative compensation model in the rest of the world.”
The states involved in the settlement are: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, 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 Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming, plus the District of Columbia.
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