Corporate Compliance

Drug, device ties capped at $50K for docs on FDA ad boards

Compliance Monitor, April 4, 2007

The FDA has proposed stricter conflict of interest rules that set a grant or fee cap of $50,000 for experts who serve on the FDA's advisory committees. Outsides experts with more than $50,000 in ties to drug and device companies regulated by the FDA would be barred from advising the agency under draft guidelines issued last week.

The guidelines also would limit the participation of experts if they had held a generally disqualifying financial interest within the preceding year. The FDA has provided a flowchart for agency employees to follow when seeking potential advisers.

The new policy would affect a "significant number" of present board members, FDA Acting Commissioner Randall W. Lutter told The New York Times. Last month, former FDA Commissioner Lester Crawford pleaded guilty to lying about owning stock in FDA-regulated companies. He received three years' supervised probation and was fined about $90,000.

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