Thursday, November 15, 2012
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.