- From LexisNexis® Mealey’s™ Daily Legal News.
GlaxoSmithKline PLC (GSK) has agreed to pay $ 90 million to 38 states to settle lawsuits that it promoted its Avandia anti-diabetes drug without supporting scientific evidence, the Oregon Attorney General’s Office announced Nov. 15.
The Attorney General’s Office said that the states filed individual state court lawsuits on Nov. 15 alleging that GSK misrepresented the cardiovascular risks of Avandia. The office said negotiated consent judgments were filed the same day.
The Oregon Attorney General’s Office said it launched its investigation two years ago and alleges that GSK made safety claims about Avandia that were not supported by scientific evidence. The states allege that GSK failed to disclose negative information about Avandia’s cardiovascular risks.
The Attorney General’s Office said that under the consent judgments with the states, GSK agrees to reform it marketing and promotion of diabetes drugs. It also agrees to:
* Refrain from making false, misleading or deceptive claims about any diabetes drug.
* Refrain from making comparative safety claims not supported by substantial evidence or substantial clinical experience.
* Refrain from presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information.
* Refrain from misusing statistics or otherwise misrepresenting the nature, applicability or significance of clinical trials.
For the next eight years, the consent judgment also requires that:
* GSK post summaries of all company-sponsored observational studies or meta-analyses conducted by the company that are designed to inform the effective, safe and/or appropriate use of its diabetes drugs.
* The company post summaries of company-sponsored clinical trials of diabetes products within eight months of the primary completion date.
* GlaxoSmithKline register and post all company-sponsored clinical trials as required by federal law.
Oregon and Illinois were co-leaders of the investigation and settlement negotiations.
The settling states are Oregon, Illinois, Washington, Arizona, Florida, Maryland, Pennsylvania, Tennessee, Texas, 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 and Wisconsin.