FDA to Restrict Conflicts of Interest in Advisory Committee Members

The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.

Only individuals with no potential conflicts of interest could fully participate and vote in advisory committee meetings without a waiver, the agency said. If the individual's interests total less than $50,000, he or she can be recommended to participate as a non-voting member, the guidance says.

The agency wants to simplify the process of determining who can serve on advisory committees and make it more transparent, FDA Deputy Commissioner for Policy Randall Lutter said.

Currently, the agency can grant a waiver allowing an outside expert to serve as an adviser, even when the expert discloses a potential financial conflict of interest. The draft guidance establishes more stringent standards for who should be excluded because of conflicts of interest, Lutter said.

The $50,000 limit would maintain the agency's access to experts while enhancing public confidence in advisory committees, Lutter said. The limit applies to funds and interest earned over the preceding 12 months, including stocks and consulting fees, he added. Other earnings could be decided on a case-by-case basis.

A "significant number" of current advisory committee members could be disqualified under the $50,000 limit, Lutter said, but he did not specify further. In some instances, an individual with a conflict of interest could get a waiver from the FDA commissioner to participate on committee, but this would be "relatively unusual," Lutter said.

The draft guidance will be open for public comment for 60 days. The guidance can be viewed at www.fda.gov/oc/advisory/conflictofinterest/guidance.html ( http://www.fda.gov/oc/advisory/conflictofinterest/guidance.html ).

( http://www.fdanews.com/did/6_58/ )