Attorney General Pam Bondi and 37 Other Attorneys General Reach a $90 Million Settlement with GlaxoSmithKline Concerning the Diabetes Drug Avandia

Nov 15 • 83 Views • View Comments

Share Button

Contact:
John Lucas
Phone: 850.245.0150
john.lucas@myfloridalegal.com

Attorney General Pam Bondi and 37 Other Attorneys General Reach a $90 Million Settlement with GlaxoSmithKline Concerning the Diabetes Drug Avandia

TALLAHASSEE, Fla. –Attorney General Pam Bondi announced that she and 37
other attorneys general have reached a $90 million settlement with
GlaxoSmithKline, LLC (GSK) to resolve allegations that GSK unlawfully
promoted the diabetes drug Avandia. In a complaint filed today, Attorney
General Pam Bondi alleges that GSK engaged in unfair and deceptive
practices by misrepresenting Avandia’s cardiovascular risks and safety
profile. As part of the settlement, GSK agreed to reform how it markets and
promotes diabetes drugs.

“Misleading patients about a medication’s safety profile and cardiovascular
risks is dangerous,” stated Attorney General Pam Bondi. “GlaxoSmithKline is
now required to safely and properly promote its diabetes drug, Avandia.”

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 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 diabetic 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;

· GSK shall comply with the ICMJE Uniform Requirements for Manuscripts
submitted to Biomedical Journals.

The investigation’s executive committee consisted of the Attorneys General
from Florida, Arizona, Illinois, Maryland, Oregon, 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, and Wisconsin.

A copy of the consent judgment is available here:

http://myfloridalegal.com/webfiles.nsf/WF/MMFD-923MVZ/$file/ConsentSignedbyJudgeTuter.pdf

A copy of the complaint is available here:

http://myfloridalegal.com/webfiles.nsf/WF/MMFD-923MX5/$file/ComplaintsignedbyJudgeTuter.pdf

# # #

 

Leave a Comment