Settle Off-Label Suits. GlaxoSmithKline PLC announced on Wednesday that it would pay $105 million in settlements to resolve allegations from 44 states and the District of Columbia over the improper marketing of the asthma drug Advair and the antidepressants Paxil and Wellbutrin.
GSK did not admit to any wrongdoing or liability under state laws, and the company said the alleged violations are similar to matters in a $3 billion settlement with the federal government in 2012, according to Law360.
In the New York complaint, Attorney General Eric Schneiderman alleged that GSK engaged in deceptive and misleading practices in marketing Advair (fluticasone/salmeterol), Paxil (paroxetine), and Wellbutrin (buproprion) for off-label uses and concealed risks associated with Paxil, according to Law360.
The complaint charged that GSK promoted Advair for treatment of mild asthma although it was approved by the FDA only for treatment of more serious asthma. New York also alleged that GSK promoted Wellbutrin for use in weight loss and sexual dysfunction treatment through its “happy, horny, skinny pill” campaign, though these were unapproved uses.
The complaint alleged that GSK concealed and misrepresented clinical studies
Further, the complaint alleged that GSK concealed and misrepresented clinical studies demonstrating Paxil is ineffective in treating children and adolescents with major depressive disorder. The studies also demonstrated a connection between Paxil use and increased risk of suicidal thoughts and acts in adolescents.
“When pharmaceutical companies advertise drugs to consumers, their claims should be backed by the best available science, not just slick marketing,” Schneiderman said.
The settlement prohibits GSK from making any false, misleading or deceptive claim about any GSK product. The company may not claim that a GKS 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, Law360 reports.
According to the terms of the settlement, GSK’s promotional materials cannot present favorable information or conclusions from a study that is inadequate in scope, design, or conduct, nor may GSK provide samples of GSK products to health care professionals who are not expected to prescribe the product for an approved use.
GSK is barred from disseminating information about off-label use of a GSK product, unless the information is consistent with FDA regulations.
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