Ken Paxton

Thursday, November 15, 2012

Texas AG Abbott, States Reach $90 Million Settlement with Drug Maker

AUSTIN Texas Attorney General Greg Abbott today announced that the State of Texas and a coalition of 37 states resolved their enforcement action against drug maker GlaxoSmithKline LLC. Under a consent judgment entered today, GlaxoSmithKline must pay a total of $90 million to resolve allegations that it unlawfully promoted its diabetes drug, Avandia. The State of Texas will receive $6.2 million under the agreement approved by the court today.

According to the states’ enforcement action, GlaxoSmithKline unlawfully misrepresented Avandia’s cardiovascular risks and safety profile.

As part of the consent judgment, GlaxoSmithKline is required to reform the manner in which it markets and promotes diabetes drugs. Under the 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 requires the company to post summaries of its observational studies that are designed to inform providers of safe and appropriate uses of its diabetes drugs, as well as summaries of clinical trials of diabetes products within eight months of trial completion. These and other requirements are in effect for a minimum of eight years.