On Monday, the FDA updated several policies and procedures for advisory committees, including implementing stricter limits on financial conflicts of interest, new voting procedures and changes to the processes for disclosing information.
The agency said that disclosing information pertains to advisory committee members and specific matters considered at advisory committee meetings.
The FDA said its policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days, according to the agency.
“It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent. Today’s announcement strengthens our processes,” said Randall Lutter, PhD, deputy commissioner for policy.
The advisory committees are panels of independent, outside experts, who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues. In 2007, the FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children.
Two of the guidance documents address FDA's processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers, allowing participation in advisory committee meetings.
The FDA instituted a $50,000 cap as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting. For example:
- If an advisor’s personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting.
- If less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the advisor’s particular expertise.
- Waivers, which include a description of the advisor’s personal financial interest and why the need for the expertise was essential, will be posted on the FDA’s website in advance of the meeting. The FDA intends to use new templates for waivers and financial interest disclosure that will make them clearer.
Another change addresses the public availability of briefing materials: the background information provided to advisory committee members will be available in advance of a meeting. As detailed in the final guidance, the FDA intends to post briefing materials given to the committee prior to a meeting on the FDA’s website at least 48 hours before the meeting is scheduled to occur. The guidance provides details on preparing and submitting documents to the FDA for inclusion in the briefing materials, as well as recommends a timetable that sponsors should follow when submitting such documents.
The agency also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes. It is recommended that advisory committees use a process of simultaneous voting, in which all members vote at once.
The FDA also proposed new criteria to clarify when the agency should refer a matter to an advisory committee. In some instances, the FDA is required by law to refer a matter to an advisory committee. In other instances, the FDA would consider the new criteria when deciding whether to refer a matter to an advisory committee.