Ind. To Receive $2.1 Million in Settlement with GSK
June 4, 2014—Indiana Attorney General’s Office Press Release—
GSK will pay $105 million to 45 states concerning the asthma drug Advair
INDIANAPOLIS – Indiana is set to receive nearly $2.1 million as a result of a multi-state settlement Attorney General Greg Zoeller entered into with drugmaker GlaxoSmithKline, LLC. The terms of the settlement require that the funds be used for consumer education related purposes.
The monies stem from a $105 million consumer settlement Zoeller joined with 44 other attorneys general and GSK today to resolve allegations that GlaxoSmithKline 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.
“Pharmaceutical companies are required to only promote a prescription drug for uses that have been approved by the FDA,” Zoeller said. “Off-label marketing can put patients unnecessarily at risk, which is why those decisions are best left to the treating physician and not the pharmaceutical companies.”
The Consent Judgment 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 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.
Other states participating in the settlement are Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, 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.