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Attorney General's News Release

November 15, 2012

Missouri to receive more than $2 million as part of settlement with pharmaceutical company over drug marketing

Jefferson City, Mo. – Attorney General Chris Koster today announced that Missouri will receive more than $2 million as part of a $90 million consent judgment with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline unlawfully marketed its diabetes drug, Avandia.

Koster and 36 other Attorneys General allege that GlaxoSmithKline misrepresented Avandia’s cardiovascular risks and safety profile. Koster said GSK marketed its drug by touting certain safety benefits when GSK did not have competent and reliable scientific evidence to substantiate these representations.

“My office will continue to hold pharmaceutical companies accountable for misleading consumers and doctors,” Koster said.

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 make available summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the public about effective, safe, and/or appropriate use of its diabetes drugs;
  • GSK shall make available 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 summaries are to be posted in publicly available registries at either NIH’s registry at http://www.clinicaltrials.gov or on GSK’s clinical study registry.

The consent judgment requires GSK to pay $2,075,691.24 to the Missouri Merchandising Practices Fund.



 
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