In a long overdue, the FDA proposes barring outside experts with more than $50,000 in ties to drug and medical device makers from advising the agency under draft guidelines issued Wednesday.

The newly proposed conflict of interest guidelines would allow scientific experts who accept less than $50,000 in corporate grants, contracts and consulting fees - or hold less than that amount in company stock - to still serve on advisory committees. But that could happen only if the need for their services outweighs a potential conflict. However, they would be barred from voting, according to a draft copy of the guidelines posted on the FDA Web site.

The move comes amid growing scrutiny over the potential for conflicts of interest on advisory panels. The FDA routinely grants waivers for outside experts that allow them to serve as agency advisers, even when they report financial ties that create a potential for a conflict of interest. A recent study found more than one-fourth of experts relied on by the FDA for advice on drugs, including whether to approve new pharmaceuticals, reported a financial conflict.

The FDA has long maintained that it would be impossible to exclude all advisers with industry ties since it would effectively deny the agency access to people with the expertise and experience it seeks. But members of Congress, consumer advocates and some academics argue such claims are untrue.

The guidelines also would limit the participation of experts if they had held a generally disqualifying financial interest within the preceding year. As part of the guidelines, the FDA laid out a six-step flowchart that agency employees are to follow in vetting potential advisers.

FDA statement;
FDA Guidance Document;
JAMA study on FDA committee conflicts.

Hat tip to the Associated Press[tags]Advisory Committees, Conflicts Of Interest, FDA[/tags]