The Food and Drug Administration has announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.
The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. The FDA announced the availability of the guidance documents in today's Federal Register; copies of all of the guidances are available on FDA’s website. 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.
“The FDA’s regulatory decisions affect the health of millions of Americans, and we don’t make those decisions in a vacuum,” said Randall Lutter, Ph.D., deputy commissioner for policy. “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.”
FDA advisory committees are panels of independent, outside experts -- often the world’s leading authorities in their fields -- who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues. Last year 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. Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations. Today, FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting. 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 all be posted on the FDA’s web site in advance of the meeting. FDA intends to use new templates for waivers and financial interest disclosure that will make them clearer and more consistent.
Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. As detailed in the final guidance on advisory committee briefing materials, FDA intends to post briefing materials given to advisory committee members prior to a meeting on the FDA’s web site at least 48 hours before the meeting is scheduled to occur. The guidance document provides details on preparing and submitting documents to FDA for inclusion in the briefing materials, and also 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. Previously, advisory committees sometimes voted sequentially, with the committee chair calling on each member individually and asking them to announce their vote aloud. Simultaneous voting avoids “voting momentum” in which some voters may be influenced, even subconsciously, by the votes of those who precede them. The agency also recommends that the results of votes be announced immediately in the meeting, and FDA intends to post on the FDA website a list indicating how each member voted. Any posted list will be part of the permanent record of the meeting.
FDA also proposed new criteria to clarify when the agency should refer a matter to an advisory committee. In some instances FDA is required by law to refer a matter to an advisory committee. In other instances, FDA would consider these new criteria when deciding whether to refer a matter to an advisory committee. The draft guidance being published for public comment is designed to make FDA’s advisory committee process more predictable and transparent.
The agency also has made improvements to the advisory committee web site to make it easier for users to access news on advisory committee meeting dates, agendas, financial disclosures and briefing materials.
Source: U.S. Food and Drug Administration
The Food and Drug Administration has announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.
The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. The FDA announced the availability of the guidance documents in today's Federal Register; copies of all of the guidances are available on FDA’s website. 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.
To continue reading this article, sign up for FREE to
Membership is FREE and provides you with instant access to eNewsletters, digital publications, article archives, and more.
