FDA to Restrict Conflicts of Interest in Advisory Committee Members

The FDA is proposing in a draft guidance to bar any person with more than $50,000 in ties to device and drug companies from participating in an agency advisory committee.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 $50,000 limit would maintain the agency's access to experts while enhancing public confidence in advisory committees, FDA Deputy Commissioner for Policy Randall 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.