June 10, 2014
FRANKFORT– Attorney General Jack Conway last week announced Kentucky’s participation in a multistate settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid. Kentucky joined 43 other states and the District of Columbia in reaching a $105 million settlement with GlaxoSmithKline (GSK) to resolve allegations that the pharmaceutical manufacturer unlawfully promoted its asthma drug, Advair, and its antidepressant drugs, Paxil and Wellbutrin. The complaint and consent judgment filed today alleges that GSK violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. Kentucky’s share of the settlement is approximately $1.75 million.
“My office will not tolerate misleading marketing by pharmaceutical companies,” Attorney General Conway said. “I will continue to investigate and vigorously pursue cases against drug companies that put profits ahead of public safety and health.”
The consent judgment also requires GSK to reform its marketing and promotional practices. Specifically, the company 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 Food and Drug Administration (FDA), that a GSK product is better, more effective, safer, or has less serious side effects 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.
· Disseminate information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations.
The consent judgment also requires GlaxoSmithKline to continue its “Patient First” program at least through March of 2019. “Patient First” reduces financial incentives for sales representatives who 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.
In addition to Kentucky and the District of Columbia, the states participating in the settlement were Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, 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.