Attorney General Bob Cooper And 44 Attorneys General Reach $105 Million Settlement With GlaxoSmithKline Concerning Asthma Drug Advair

Wednesday, June 4, 2014

Attorney General Bob Cooper 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 45 Attorneys General led by a bipartisan leadership committee 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. Tennessee will receive $3 million for the Attorney General’s work on the leadership committee of this multistate consumer protection investigation.

The complaint and agreed final judgment filed today in Davidson County Circuit Court alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. In particular, the complaint alleges that GSK used false and misleading representations to promote Advair as a first line treatment for all asthma patients, including mild asthma patients who only occasionally needed a rescue inhaler. Furthermore, GSK allegedly provided financial incentives to GSK sales representatives to deceptively promote Advair for mild asthma patients.

“We appreciate the cooperative work of all the states participating in this consumer protection investigation,” Attorney General Cooper said. “My office remains vigilant in its efforts to stop deceptive marketing practices by some drug companies which may lead to unnecessary, expensive drugs and risk the health of Tennesseans.”

The agreed final 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 products 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 agreed final 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.

The State’s Complaint and Agreed Final Judgment may be viewed by going online to www.tn.gov/attorneygeneral and clicking on “Filings of Interest.”

Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at (615) 741-4737 or toll-free in Tennessee at 1-800-342-8385.





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