FDA Limits Conflicts of Interest

March 2007

Criticism has swirled around the Food and Drug Administration (FDA) for allowing experts with monetary ties to medical companies to serve on their advisory panels. But the FDA has set new limits restricting advisors from evaluating companies and products with which they have connections.

The limits focus on two different tiers. If an expert has received direct payment, grants, or stock from a medical company totaling $50,000 or more in the last 12 months, they are not allowed to serve on any advisory panel related to that company. Those receiving less than $50,000 may sometimes serve on related panels, but they will not have voting rights.

This news comes as Congress has vocalized its displeasure with the FDA, and an Institute of Medicine report alleges conflicts of interest in the approval process. Some drugs, such as the antibiotic Ketek, have cause internal debate at the FDA whether they were approved before fully identifying the risks, or whether they should not have been approved at all.

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