November 16, 2012 — GlaxoSmithKline (GSK), the manufacturer of Avandia, will pay $90 million to settle lawsuits filed by 38 state attorney generals’ offices. One condition of the settlement is that GSK does not have to admit guilt regarding allegations that the company intentionally minimized the risk of heart attacks linked to Avandia, a diabetes medication.
After years of receiving reports of strokes and heart attacks linked to Avandia, the U.S. Food and Drug Administration (FDA) finally withdrew it from the market in 2011. In July 2012, the company pled guilty and paid $3 billion to settle federal charges that the company defrauded the U.S. healthcare system by misrepresenting data about the safety of Avandia. It was the largest-ever healthcare fraud settlement against a drug company.
As a condition of the state settlement, GSK agreed to change the way they market and promote diabetes drugs. The company is prohibited from:
- Making false, misleading, or deceptive claims about any diabetes drug.
- Making comparative claims that are not supported by clinical evidence
- Presenting favorable evidence for their drug that has been proven to be invalid by more recent research
- Promoting investigational drugs
- Misusing statistics or misrepresenting the nature, applicability, or significance of clinical trials
In the future, GSK will also be required to improve transparency of its clinical trial data for new diabetes drugs. This will include registering all GSK-sponsored studies with the federal government, posting summaries of the studies, and complying with international requirements for studies submitted to medical journals.
The following states will be receiving settlements from GSK: Oregon, Illinois, 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, Washington and Wisconsin.