Health
FDA proposes new rules for participation on advisory committees
NEWS IN BRIEF — Posted April 9, 2007
The Food and Drug Administration released March 21 new proposals intended to govern more strictly who serves on its advisory committees.
Among the changes is one that committee members with $50,000 or more in financial interests, whether in stocks or consulting fees in a particular company, generally not be allowed to participate in a meeting involving that company. Those with less than $50,000 might be allowed to participate in discussions but not vote.
Currently, waivers often are granted to members who have some financial ties to companies, and this practice has given rise to questions about members' impartiality.
The advisory committees are panels of outside experts who evaluate such matters as drug approvals and warning labels. Although the FDA doesn't have to accept a committee's advice, it generally does.
The agency believes that many current members no longer would be allowed to serve under the new rules, but it had no exact count, said Randall Lutter, PhD, FDA's acting deputy commissioner for policy. He acknowledged that it was likely to be a "significant number."
In an effort to attract new and appropriate expertise, the agency last month made available on its Web site a list of all committee vacancies (link).
The guidance was issued as a draft and was to be available soon in the Federal Register for a 60-day public comment period.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/04/09/hlbf0409.htm.
