Attorney General Kathleen G. Kane today announced a settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers. Attorney General Kane, along with 44 other Attorneys General, has reached a $105-million settlement with GlaxoSmithKline LLC. Pennsylvania will receive $4,125,815 as a result of the multi-state settlement.
The settlement seeks to resolve allegations that GlaxoSmithKline unlawfully promoted its asthma drug, Advair, and antidepressant drugs Paxil and Wellbutrin. The complaint and Consent Decree filed today allege that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs.
“Today’s settlement hopefully will result in a sea change of how pharmaceuticals are promoted and marketed to consumers,” Attorney General Kane said. “Consumers deserve clear and honest information about pharmaceuticals because they could hurt their health or well-being when misused or mixed with other medications.”
The Consent Decree 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 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 Guidance for Industry.
The Consent Decree also requires GSK to continue its Patient First Program at least through March of 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.
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