- 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.
Monday, 19 November 2012
Washington State to receive $2.2 million in diabetes drug settlement !
SEATTLE — Washington State Attorney General Rob McKenna and 37 other attorneys general announced a $90 million settlement with GlaxoSmithKline LLC (GSK) to resolve allegations that the company illegally promoted its diabetes drug, Avandia.
“We believe that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting the health risks of taking Avandia,” said McKenna. “Those who suffer from diabetes already face a higher risk of heart disease. GlaxoSmithKline did not warn such patients that their cholesterol, and their chances of having a heart attack, might go up after taking the drug.”
A portion of Washington state’s $2.2 million share of the settlement will be used to cover attorneys’ fees and costs associated with the investigation of GSK. The rest will be made available as grants to organizations set up to help those who suffer from diabetes.
Approved in 1999, Avandia was marketed as superior to some other diabetes drugs. But an advisory committee convened by the FDA in 2007 discovered that GSK failed to submit data to federal regulators showing that Avandia increases patients’ total cholesterol level, an especially dangerous side effect in diabetics. The FDA stopped GSK’s ongoing clinical trials for the drug and restricted its availability. It now only allows its use by patients unable to achieve good results with other drugs.
As part of the settlement, GlaxoSmithKline agrees to reform how it markets and promotes diabetes drugs. Under a Consent Judgment filed today in King County Superior Court, GSK may not:
This is the second major settlement involving Avandia. In July, the drugmaker agreed to pay the states and the federal government a total of $2 billion in damages and civil penalties to compensate various healthcare programs, including Medicaid, for harm allegedly suffered as a result of its illegal marketing of the drug. It also paid a $1 billion criminal fine. Washington state’s share of that settlement was $8.7 million.