TRENTON – New Jersey will receive approximately $2.54 million as a result of its participation in a multi-state settlement with GlaxoSmithKline (GSK) that resolves allegations the company misrepresented the cardiovascular safety of its diabetes drug Avandia, Attorney General Jeffrey S. Chiesa announced today.
Under terms of the settlement, GSK has agreed to pay a total of $90 million to 38 states, including New Jersey, to resolve allegations it violated consumer protection laws by misrepresenting both the risk of heart attack associated with Avandia, as well as the safety of using Avandia alone, and in conjunction with other diabetes drugs.
In addition to the monetary terms, the settlement includes a number of conditions designed to prevent future misleading or deceptive communications related to Avandia, as well as any other GSK products marketed for glycemic control for patients with Type 2 diabetes.
“This settlement is important to protecting New Jersey consumers because it calls for the use of only clear, objective, scientifically-supported information in the promotion of GlaxoSmithKline’s Type 2 diabetes products,” said Chiesa. “In addition, the settlement contains certain accountability and transparency provisions that will ensure that health care providers have timely access to the results of observational studies and clinical trials focused on these drugs.”
A Consent Judgment memorializing the settlement was filed today in New Jersey Superior Court. The Consent Judgment provides that GSK:
- Will not make comparative safety claims unsupported by substantial evidence or substantial clinical experience;
- Will not present favorable information previously thought of as valid but rendered invalid by contrary, and more credible, recent information;
- Will not promote investigational drugs;
- Will not misuse statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials.
The settlement requires that GSK post summaries of all GSK-sponsored observational studies or meta-analyses conducted by the company that are designed to inform the effective, safe, and/or appropriate use of any GSK diabetes product.
It also requires that summaries of all GSK–sponsored clinical trials of diabetes products must be posted within eight months of the trial’s primary completion date.
Under the settlement, GSK must also register and post all GSK-sponsored clinical trials as required by Public Law No. 110-85, and must comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals.
Deputy Attorney General Alina Wells, assigned to the Division of Law’s Consumer Fraud Prosecution Section, handled the Avandia matter on behalf of the State.
The Avandia investigation was led by the Attorneys General of Oregon and Illinois, with an Executive Committee consisting of the Attorneys General of Arizona, Florida, Maryland, Pennsylvania, Tennessee, and Texas. Along with New Jersey, other participants in the settlement include: Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, Washington, and Wisconsin.