Avandia settlement worth $90M

by Bryan Cohen |
Nov. 19, 2012, 4:51pm

WASHINGTON, DC (Legal Newsline) - Thirty-eight state attorneys general announced a $90 million agreement on Thursday with GlaxoSmithKline to resolve allegations of unlawful drug promotion of Avandia.

GSK allegedly engaged in unlawful and deceptive practices by misrepresenting and understating Avandia's cardiovascular risks and misrepresenting that Avandia had a positive cholesterol profile.

"Protecting consumers is a priority of my administration, and this court action is a stark reminder that consumers deserve full accountability from any entity that engages in potentially deceptive practices," Arizona Attorney General Tom Horne said. "This consent judgment is tough, fair and it holds GlaxoSmithKline accountable for how the company marketed AVANDIA."

Under the terms of the agreement, GSK will make several changes related to its promotion of diabetes drugs, including that the company may no longer claim that its diabetes drugs are safer than other manufacturers' drugs unless it can support the claims with substantial clinical experience or evidence; present favorable information about its diabetes drugs using information the scientific community once thought was valid that became invalid because of more credible or newer contradictory information; promote investigational drugs; misuse statistics; or misrepresent the nature, significance or applicability of clinical trials.

The judgment also requires that GSK post summaries of all GSK-sponsored observational studies or meta-analyses that the company conducts that are meant to inform the public and the medical community that the diabetes drugs are safe, effective or appropriate for use in diabetic patients and must post accurate summaries of GSK-sponsored clinical trials of any diabetes products within eight months of the primary completion date.

The states included in the settlement include Wisconsin, Washington, Vermont, South Dakota, Rhode Island, Oklahoma, Ohio, North Dakota, North Carolina, New Jersey, Nevada, Nebraska, Montana, Missouri, Minnesota, Michigan, Massachusetts, Maine, Kansas, Iowa, Idaho, Hawaii, the District of Columbia, Delaware, Connecticut, Colorado, California, Arkansas, Alaska, Alabama, Texas, Tennessee, Oregon, Pennsylvania, Maryland, Illinois, Arizona and Florida.

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