News Release: States Reach $105 Million Settlement With Glaxosmithkline Concerning Asthma Drug AdvairPosted on Jun 4, 2014 in News Releases
DEPARTMENT OF COMMERCE AND CONSUMER AFFAIRS
Office of Consumer Protection
KEALII S. LOPEZ
OCP EXECUTIVE DIRECTOR
NEWS RELEASE FOR IMMEDIATE RELEASE
STATES REACH $105 MILLION SETTLEMENT WITH GLAXOSMITHKLINE CONCERNING ASTHMA DRUG ADVAIR
Hawaii to Receive $1.2 Million in Agreement
HONOLULU —The Department of Commerce and Consumer Affairs (DCCA) Office of Consumer Protection (OCP) today announced an industry-changing agreement with drug manufacturer GlaxoSmithKline, LLC (GSK) in conjunction with 43 other states and the District of Columbia.
The case signals a major change in the way pharmaceutical sales teams are paid in the future. The combined settlement by the states for $105 million resolves allegations that GSK unlawfully promoted its asthma drug, Advair®, and antidepressant drugs, Paxil® and Wellbutrin®. Today’s filing of a state court complaint and stipulated judgment in Hawaii alleges that GSK violated Hawaii’s consumer protection laws by misrepresenting the uses and qualities of these drugs.
“While we are certain this will put a stop to the off-label use of these drugs, we will be keeping a close eye on how the company proceeds forward in its business practices,” said OCP’s Executive Director Bruce Kim. “Patients need to feel safe in the way their health is being treated. Profit cannot be the motivation for these decisions.”
The state courtjudgment also requires 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 guidance for industry.
GSK is also required 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 state 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.
“Patients’ interests must come first,” Kim added. “Making unsubstantiated claims to increase sales of these drugs for unapproved, off-label uses is strictly forbidden under the terms of today’s judgment.”
The Office of Consumer Protection was represented in the case by its Senior Staff Attorney Lisa Tong.
The State of Hawaii’s DCCA Office of Consumer Protection educates and protects consumers from unlawful acts or practices by companies, which may cause harm to consumers. For more information, contact the Office of Consumer Protection at (808) 586-2636.
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DCCA Communications Officer