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GlaxoMithKline Agrees to $105 Million Settlement

Filed June 5th, 2014 Eric

GlaxoSmithKline PLC has reached a series of settlements encompassing 44 states and the District of Columbia totaling $105 million. The settlement will resolve allegations that the pharmaceutical company improperly marketed and promoted its antidepressant drugs Paxil and Wellbutrin and asthma drug Advair.

In agreeing to the settlement, GSK did not admit to any wrongdoing or liability under the states’ laws in this settlement. GSK argued that the alleged violations of state trade practices laws are comparable to the matters settled with the federal government in 2012 that resulted in a settlement of $3 billion, Law360 reported.

The allegations against GSK were many.

New York Attorney General Eric Schneiderman claimed that the company engaged in deceptive and misleading practices in its marketing of Advair, Paxil and Wellbutrin for off-label uses. He also alleged that GSK concealed risks associated with Paxil. The attorney general’s complaint charged, 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,” according to Law360.

The complaint also alleged that GSK promoted Wellbutrin for treatment of sexual dysfunction and weight loss through its “happy, horny, skinny pill,” campaign, despite the fact that they were unapproved uses. The complaint further alleged that GSK hid and misrepresented multiple clinical studies that found Paxil’s ineffectiveness in treating children and adolescents with major depressive disorder, as compared to a placebo group, as well as a connection between the use of Paxil and an increased risk of suicidal thoughts and acts in adolescents, Law 360 reported.

The settlement outlaws GSK from making any false, misleading or deceptive claim about any of its products, while also banning it from making promotional claims not approved or permitted by the U.S. Food and Drug Administration (FDA) that a GSK product is better, more effective, or safer than an alternative drug.

The agreement also forbids GSK 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,” Law360 reported. Additionally, the settlement would ban GSK from broadcasting information about any off-label use of a GSK product, unless the information fell in line with applicable FDA regulations and guidelines.

According to Law360, the following states are involved: 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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