South Dakota Joins $90 Million Settlement with GlaxoSmithKline

  
South Dakota Joins $90 Million Settlement with GlaxoSmithKline

 

FOR IMMEDIATE RELEASE :  Friday, November 16, 2012
CONTACT:  Sara Rabern (605)773-3215

 

South Dakota Joins $90 Million Settlement with GlaxoSmithKline 

 

PIERRE, S.D.- Attorney General Marty Jackley announced that he and 37 other Attorneys General reached a $90 million Consent Judgment with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its diabetes drug, Avandia®. Under the agreement South Dakota will receive approximately $1.2 million dollars.

“We are pleased to join this multistate agreement to ensure that consumers are better protected from unacceptable marketing practices. This settlement sends a clear message that these types of allegations will be taken very seriously,” said Jackley.

The Attorneys General allege that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.

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 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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