AG Gansler Reaches $105M Settlement with GlaxoSmithKline Over Unlawful
Promotion of Asthma Drug Advair, Other Medications
Drug manufacturer must also reform pharmaceutical sales incentives
Baltimore, MD (June 4, 2014) - Attorney General Douglas F. Gansler today announced a $105 million settlement with GlaxoSmithKline, LLC, (GSK) that promotes consumer health by changing the way pharmaceutical sales representatives are compensated. The settlement, which includes attorneys general from 45 states, resolves allegations that GSK unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin.
The Complaint and Consent Judgment filed today in Baltimore City Circuit Court allege that GSK violated state consumer protection laws by misrepresenting the uses and benefits of these drugs. Maryland was part of the 8-state Executive Committee that investigated the case and negotiated the settlement.
"This settlement is part of our ongoing vigilance against the deceptive marketing of prescription drugs," said Attorney General Gansler. "We will continue to fight to protect the health and wellbeing of consumers who take prescription drugs."
The settlement 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 Food and Drug Administration 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 health care professionals who are not expected to prescribe the sampled GSK products for an approved use.
The settlement also requires GSK to continue its Patient First Program, or a substantially equivalent program, through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing by prohibiting compensation based on volume of sales. In addition, the settlement requires scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for the data in these materials to be unbiased and non-promotional.