DENVER —Attorney General John Suthers announced today that he and 37 other Attorneys General reached a $90 million settlement with GlaxoSmithKline LLC (NYSE: GSK) to resolve allegations that the drug manufacturer unlawfully promoted its diabetes drug, Avandia®. Under the consent judgment, of the total settlement, Colorado will receive $1.9 million in funds for failing to disclose all negative side effects.
The Attorneys General allege that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.
“GlaxoSmithKline must be straight with consumers about the known risks of its drug Avandia,” said Suthers. “After announcing a historic healthcare settlement in July, GSK is again paying a price for its bad behavior. This settlement should serve as a warning to all drug manufacturers.”
As part of the settlement, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. 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 Consent 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 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 the International Committee of Medical Journal Editors’ Uniform Requirements for Manuscripts submitted to Biomedical Journals.
The following states participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and the District of Columbia.
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