GlaxoSmithKline Agrees to $105 Million Settlement of Off-Label Use Cases

GlaxoSmithKline_Agrees_to_$105 Million_SettlementDrug maker GlaxoSmithKline has agreed to pay $105 million to 44 states and the District of Columbia to resolve allegations about improper marketing of the asthma drug Advair and the antidepressants Paxil and Wellbutrin.

GSK did not admit to any wrongdoing or liability under the states’ laws, Law360 reports, and the company said the alleged violations are similar to those resolved with the federal government in a $3 billion settlement.

In the New York complaint, Attorney General Eric Schneiderman alleged that GSK engaged in deceptive and misleading practices, marketing Advair (fluticasone/salmeterol), Paxil (paroxetine), and Wellbutrin (buproprion) for off-label uses and concealing risks associated with Paxil. The complaint charged GSK with promoting Advair for treatment of mild asthma although the Food and Drug Administration (FDA) had approved it only for treatment of more serious asthma. The complaint also claimed that through its “happy, horny, skinny pill” campaign, the company promoted Wellbutrin as a weight loss and sexual dysfunction treatment, both of which are unapproved uses. The complaint claimed the company concealed and misrepresented studies showing Paxil’s ineffectiveness in treating major depressive disorder in children and adolescents, and the demonstrated link between adolescents’ Paxil and their increased risk of suicidal thoughts and acts. Schneiderman said that pharmaceutical companies’ advertising claims “should be backed by the best available science, not just slick marketing,” according to Law360.

Under the settlement, GSK may not make false, misleading, or deceptive claims about its products. Any claim that a product is safer, more effective, or has less serious side effects must be backed by substantial evidence or substantial clinical experience, Law360 reports. Promotional materials cannot present favorable information or conclusions from a study deemed inadequate in scope, design, or conduct. GSK may not give drug samples to health care professionals who are not expected to prescribe the drug for an approved use. Information about off-label use  may not be disseminated unless it is consistent with FDA regulations.



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