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FDA advisors must abide by new financial limits

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Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines released Monday. The Food and Drug Administration's guidance formalizes draft policy issued in March 2007. If an adviser's financial interest falls below $50,000, the FDA may grant them a waiver that allows them to participate, but will do so only if they find there is an essential need for the adviser's particular expertise.

"It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent," Randall Lutter, a deputy FDA commissioner said Monday.

Advisory committee members often represent the world's leading authorities on a particular disease or condition. Drug and device makers often pay them lucrative consulting and speaking fees, but such financial arrangements also can lead to the appearance of a conflict of interest.

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