November 15, 2012

Pennsylvania joins 37 other states in $90 million settlement with GlaxoSmithKline

HARRISBURG ? Attorney General Linda Kelly today announced that Pennsylvania will receive more than $4 million as part of a national settlement with GlaxoSmithKline that resolves allegations that the company unlawfully promoted its diabetes drug, Avandia.

Kelly said that GlaxoSmithKline, a British based pharmaceutical company that operates worldwide, has agreed to pay $90 million to resolve allegations that the company engaged in unfair and deceptive practices by misrepresenting Avandia?s cardiovascular risks and safety profile.

As part of the Consent Judgment, GlaxoSmithKline agrees to reform how it markets and promotes diabetes drugs and agrees to 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 agreement also has the following terms that are effective for at least eight years:

• GlasoSmithKline (GSK) must post summaries of all sponsored observational studies or meta-analyses conducted that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;
• GlaxoSmithKline 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 ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals.

The 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. Also participating in the settlement are Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, 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, Wisconsin.

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