Phoenix (Wednesday, June 4, 2014) – Attorney General Tom Horne is today announcing a settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers. Arizona, along with 44 other states, reached a $105 million settlement with GlaxoSmithKline, LLC to resolve allegations that the company unlawfully promoted its asthma drug, Advair®, and antidepressant drugs, Paxil® and Wellbutrin®. For example, GSK encouraged false and misleading marketing tactics to promote Advair as a drug that should be prescribed to anyone with asthma, when in actuality it was meant for those with severe asthma only. Financial incentives were given to sales representatives who sold these drugs to physicians, using these misleading tactics.
Arizona’s portion of the settlement is $3.1 million, which will be deposited into the Consumer Fraud Revolving Fund. The Complaint and Consent Judgment filed today alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs.
“The use of deceptive acts or practices, or misrepresentations in connection with the sale or advertisement of goods or services, is unlawful under the Consumer Fraud Act,” Attorney General Tom Horne stated. “Our Office will continue to take action against anyone who engages in such unlawful acts.”
The Consent Judgment also requires GlaxoSmithKline to reform its marketing and promotional practices. Specifically, the company 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.