Ohio Attorney General Mike DeWine has announced that he and 44 other attorneys general have reached a $105 million settlement with pharmaceutical company GlaxoSmithKline LLC. Ohio’s share of the settlement will be $2,882,287.91.
The settlement resolves allegations that the company unlawfully promoted its asthma drug Advair and its antidepressant drugs Paxil and Wellbutrin.
“Pharmaceutical sales teams were promoting these drugs for off-label uses,” Attorney General DeWine said. “This is not only illegal but also dangerous to consumers. The settlement changes the way sales teams are motivated and paid in order to protect consumers from unnecessary risk. Financial gain should never take priority over the health and safety of consumers.”
The complaint and consent judgment, submitted today before the Lucas County Court of Common Pleas, allege that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of Advair, Paxil, and Wellbutrin.
The consent judgment requires GlaxoSmithKline (GSK) 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 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 health care 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 these responses to be unbiased and non-promotional.
Participating in the settlement are the attorneys general of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, 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.