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Editor: Robert J. Binstock
Profession: Avandia Attorney

Category: Other Avandia News

An FDA official has called for higher standards for new drugs in the wake of the Avandia controversy. Avandia has been linked to an increased risk of heart failure and heart attack by a New England Journal of Medicine article. The FDA responded to the alleged tie by placing the strongest warning available on Avandia, but allowed the drug to remain on the market.

Officials have now introduced the idea of testing new experimental drugs against drugs that are currently available on the market, instead of a placebo. This would hopefully make for a safer market, keeping less effective and possibly dangerous drugs from receiving FDA approval.

Dr. Robert Misbin, FDA medical officer, agrees that new drugs should offer something greater than what is already out there and stands behind the new proposed method of evaluation. Misbin also calls for safety trials to be preformed on all drugs before they approved.

While the FDA evaluates safety data as part of its clinical trials for approving a drug, Misbin is calling for a separate trial designed specifically to detect major safety problems. And that trial should not exclude patients at risk for serious adverse events, he said.

The effort here is protect the American public from risk of injury associated with many drugs and allow the FDA to better understand any risks that may be associated with a drug.