(The following press release from Missouri Attorney General's Office was
received by e-mail. The sender verified the statement.)
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
"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 www.clinical<http://www.clinical>trials.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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