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NEW: RI to Receive $1.2 Million from GlaxoSmithKline, LLC Suit

Thursday, November 15, 2012

 

Attorney General Peter F. Kilmartin announced today that he and 37 other Attorneys General reached a $90 million Consent Judgment with GlaxoSmithKline LLC (GSK) to resolve allegations that GlaxoSmithKline unlawfully promoted its diabetes drug, Avandia®. Rhode Island will receive approximately $1,243,000 from the settlement. Kilmartin alleges that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.

“Time and time again, pharmaceutical companies ignore consumer protection laws, make claims not supported by clinical experience, and misrepresent information, all in the name of racking up steep profits,” said Attorney General Kilmartin. “This year alone, the Office has secured more than $5 million from pharmaceutical companies who engaged in deceptive marketing practices, and we will continue to go after those companies who refuse to play by the rules.”

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

  • GSK must post summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;
  • GSK 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.
 

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