Colorado Attorney General John Suthers banded with 44 other state attorneys general today to announce a $105 million consumer protection settlement with GlaxoSmithKline, LLC (NYSE: GSK) to resolve allegations that the company unlawfully promoted its asthma drug, Advair®, and antidepressant drugs, Paxil® and Wellbutrin®. The Complaint and Consent Judgment filed today in Denver District Court alleges that GlaxoSmithKline violated Colorado and other state consumer protection laws by misrepresenting the uses, qualities, and benefits of these drugs.
“Three prior settlements with GlaxoSmithKline regarding unfair and deceptive trade practices, substandard manufacturing techniques, and unlawful marketing activities resulted in settlements of more than $6.4 million as well as meaningful change in the companies’ behavior,” said Deputy Attorney General Jan Zavislan. “In addition to a requirement that GSK not misrepresent the uses and benefits of its products, this agreement also requires GSK to address how its sales representatives are compensated to ensure that its products are marketed accurately and appropriately. Because GSK is an industry leader, we believe this settlement will influence the sales practices of other pharmaceutical companies,” explained Zavislan. “Coloradans settlement share of $1,873,367 million will be used to educate consumers about fraud and to fund future enforcement actions.”
The Consent Judgment also requires GlaxoSmithKline to reform its marketing and promotional practices. Specifically, GSK shall not:
· Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product;
· Make any representation that any GSK product has any sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that it does not have;
· Make 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;
· Present favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions, when presenting information about a clinical study regarding GSK products in any promotional materials;
· Provide samples of GSK products to those healthcare professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled product for an off-label use; or
· Disseminate 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 Industry.
The Consent Judgment also requires GSK to continue its Patient First Program at least through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the Judgment requires scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for those responses to be unbiased and non-promotional.
Led by Oregon and Illinois, the settlement states are Alabama, Arizona Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, 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, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.