PENNSYLVANIA RECORD

The commonwealth is poised to receive more than $4 million from a $90 million

national settlement that resolves allegations that drugmaker GlaxoSmithKline unlawfully promoted its diabetes drug Avandia, the Pennsylvania Attorney General’s Office announced late last week.

Attorney General Linda Kelly stated that the British-based pharmaceutical company has agreed to settle claims that it engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.

GlaxoSmithKline will reform the marketing and promotional protocols for its diabetes drugs, and as part of the settlement agrees not to make any false, misleading or deceptive claims about any diabetes drugs; make comparative safety claims not supported by substantial evidence or clinical experience; present favorable information previously thought of as valid but rendered invalid by more credible information; promote investigational drugs; or misuse statistics or otherwise misrepresent the nation, applicability, or significance of clinical trials, Kelly’s office announced.

Furthermore, for at least the next eight years, the drug manufacturer must promote summaries of all sponsored observational studies or meta-analyses conducted that are designed to inform the effective, safe and/or appropriate use of diabetes drugs; post summaries of GSK-sponsored clinical trials of diabetes products within eight months of the primary completion date; register and post all company-sponsored clinical trials as required by federal law; and comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals, the Attorney General’s Office stated.

Thirty-six other states and the District of Columbia joined Pennsylvania in the settlement. They are as follows: Arizona, Florida, Oregon, Illinois, Maryland, Tennessee, Texas, Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, 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.