Gansler: Company misrepresented profile of diabetes drug Avandia
BALTIMORE—Attorney General Douglas F. Gansler announced Nov. 16 that his Consumer Protection Division, along with Attorneys General from 36 other states and the District of Columbia, reached a $90 million settlement with GlaxoSmithKline, LLC to resolve allegations that the pharmaceutical manufacturer unlawfully promoted its diabetes drug, Avandia.
“Diabetics, who already face heightened cardiovascular risks, should not be put at additional risk because of misleading claims about the drugs they take,” said Attorney General Gansler. “This settlement puts drug companies on notice that they need to take responsibility for their claims or face consequences.”
The settlement stems from allegations that GlaxoSmithKline engaged in unfair and deceptive trade practices by misrepresenting Avandia’s cholesterol profile, its cardiovascular risks and benefits and its overall safety profile.
Under the settlement agreement, GlaxoSmithKline will reform its marketing and promotion of diabetes drugs, and may not make any false, misleading or deceptive claims about any of its diabetes drugs.
Additionally, for at least eight years, GlaxoSmithKline may not:
-- In promoting its diabetes drugs, make comparative safety claims that are not supported by substantial evidence or substantial clinical experience;
-- Use promotional materials for its diabetes products that present favorable information that has been rendered invalid by contrary and more credible, recent information;
-- Promote investigational diabetes drugs; or
-- Misuse statistics or otherwise misrepresent the nature, applicability or significance of clinical trials.
Also for at least eight years, GlaxoSmithKline must:
-- Post on its clinical study registry all observational studies or meta-analyses they conduct that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;
-- Post summaries of GSK-sponsored interventional clinical trials of Type 2 diabetes products within eight months of the study’s primary completion date;
-- Register and submit results of all GSK-sponsored clinical trials as required by federal law; and
-- Comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals when submitting a manuscript on clinical study results regarding any of its diabetes drugs.
An eight-member Executive Committee, which included Maryland, investigated the case and negotiated the settlement. The following Attorneys General participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, 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 and Wisconsin.
Source: Office of Attorney General Douglas F. Gansler