June 4, 2014
Las Vegas, NV – Nevada Attorney General Catherine Cortez Masto today announced a $105 million settlement with GlaxoSmithKline, LLC 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 alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs.
“Consumers have a right to know the truth about medications they take,” said Masto. “This settlement protects Nevada consumers and puts an end to unscrupulous marketing and promotional practices by this pharmaceutical company.”
The settlement also signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers. As its share of the settlement, Nevada will receive a total of $1,487,894, which will go to the state’s general fund.
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.
Chief Multistate Counsel JoAnn Gibbs represented Nevada in this matter. Oregon and Illinois led the Executive Committee, which also includes Attorneys General from Arizona, Florida, Maryland, Pennsylvania, Tennessee, and Texas.
Also participating in the settlement are Alabama, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
###