Governor's Office of Consumer Protection and Attorney General Sam Olens, along with 44 Other Attorneys General, Reach a $105 Million Consumer Settlement with GlaxoSmithKline Concerning the Asthma Drug Advair
Atlanta, GA - John Sours, Administrator of the Governor’s Office of Consumer Protection and Georgia Attorney General Sam Olens 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. The Attorneys General have reached a $105 million settlement with GlaxoSmithKline, LLC 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.
“We are committed to stopping illegal marketing practices by businesses that put their own interests before what is best for their customers,” says Administrator John Sours. “This conduct is especially pernicious because it involves the long-term and widespread distribution of powerful drugs, which were repeatedly and carelessly disseminated for many years.”
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.
“GlaxoSmithKline put Georgia consumers at risk by inappropriately promoting drugs for uses which were not approved by the Food and Drug Administration,” says Attorney General Sam Olens. “My office worked closely with the Governor’s Office of Consumer Protection to ensure that the company is held accountable for its misleading marketing practices. We will continue to collaborate in order to protect Georgia consumers from unfair business conduct.”
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.
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, 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.