|November 15, 2012
Media Contact: Jenn Meale
Phone: (850) 245-0150
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TALLAHASSEE, Fla. –Attorney General Pam Bondi announced that she and 37 other attorneys general have reached a $90 million settlement with GlaxoSmithKline, LLC (GSK) to resolve allegations that GSK unlawfully promoted the diabetes drug Avandia. In a complaint filed today, Attorney General Pam Bondi alleges that GSK engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile. As part of the settlement, GSK agreed to reform how it markets and promotes diabetes drugs.
“Misleading patients about a medication's safety profile and cardiovascular risks is dangerous,” stated Attorney General Pam Bondi. “GlaxoSmithKline is now required to safely and properly promote its diabetes drug, Avandia.”
Under the consent judgment, 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 judgment 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 its diabetic 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;
· GSK shall comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals.
The investigation’s executive committee consisted of the Attorneys General from Florida, Arizona, Illinois, Maryland, Oregon, Pennsylvania, Tennessee, and Texas. Also participating in the settlement are: Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, Washington, and Wisconsin.
A copy of the consent judgment is available here: http://myfloridalegal.com/webfiles.nsf/WF/MMFD-923MVZ/$file/ConsentSignedbyJudgeTuter.pdf
A copy of the complaint is available here: http://myfloridalegal.com/webfiles.nsf/WF/MMFD-923MX5/$file/ComplaintsignedbyJudgeTuter.pdf