November 15, 2012, #12-29
Attorney General Bob Cooper announced today that he and 37 other Attorneys General reached a $90 million agreement with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its diabetes drug, Avandia. As a result, Tennessee will receive $3 million for the Attorney General’s work on the leadership committee of this multistate consumer protection investigation.
The Attorneys General allege that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.
“We appreciate the cooperative work of all the states participating in this investigation,” Attorney General Cooper said. “We remain vigilant in our efforts to stop marketing practices by some drug companies which may risk the health of Tennesseans.”
As part of the agreement, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. Going forward, GSK may not:
- Make any false, misleading, or deceptive claims about any diabetes drug;
- Make comparative safety claims not supported by substantial evidence or substantial clinical experience;
- Present favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;
- Promote investigational drugs; or
- Misuse statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials.
The agreement also has the following terms that are effective for at least eight years:
- GSK must post summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the effective, safe, and/or appropriate use of of its diabetes drugs;
- GSK shall post summaries of GSK-sponsored clinical trials of diabetes products within eight months of the primary completion date;
- GSK shall register and post all GSK-sponsored clinical trials as required by federal law; and
- GSK shall comply with industry requirements for papers submitted to biomedical journals for publication.
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.
