FDA has long sought advice from advisory committees, groups of independent outside experts who assist agency officials in evaluating a range of scientific, technical, and policy issues. While it values the input of these committees, FDA has always made the final decisions. On August 4, 2008, FDA issued Guidance to strengthen its management of advisory committees. Two of these documents address FDA’s processes for dealing with potential conflicts of interest and waivers allowing individuals to participate in advisory committee meetings. The other two concern when the Agency is to refer a matter to an advisory committee and how committees will vote.
Conflicts of Interest
Meetings within the scope of the Guidance are those involving “particular matters”: those involving deliberations, decisions, or actions focused upon the interests of specific persons, or of a discrete, identifiable class of persons. Those invited to participate in such meetings must report to FDA any financial interest related to the subject matter. “Financial interest” means the potential for gain or loss to the candidate (or to a person/organization whose interests are imputed to him) resulting from governmental action on the matter. A financial interest does not necessarily require disqualification. If an interested expert’s advice is essential, FDA may grant a waiver. Under the new Guidance, $50,000 is the maximum personal financial interest an advisor may have in all companies that the meeting could affect. To calculate this sum, FDA considers grants, stockholdings and contracts. Before the meeting, FDA will post waivers including a description of the advisor’s personal financial interest and why his expertise is needed.
“Preparation and Public Availability of Information Given to Advisory Committee Members”
Under this new Guidance, a committee’s briefing materials, subject to restrictions under the Freedom of Information Act (FOIA), 5 U.S.C. § 552, will be made publicly available. Where information may be exempt from disclosure, FDA will post a publicly available version of the briefing materials on its Web site no later than two business days before the advisory committee meeting. Where there are no FOIA-protected materials, FDA will post the materials more than two days before the meeting.
The Guidance provides an extended discussion of information and briefing materials that typically will and will not be disclosable under FOIA. Long though they are, the lists of materials disclosable and not are “neither exhaustive nor absolute.” In general, exempt documents are concerned with proprietary information, trade secrets, and information whose release would invade personal privacy.
The Agency expects those claiming exemption for specified information to explain in detail why they have so concluded. FDA does not deem itself bound by the sponsor’s conclusions, and after review will notify the sponsor of its decision. The Agency will go through a similar process for its own FDA-prepared briefing materials.
FDA believes that expert opinion should be clearly understood and identified with that expert. Hence, the current practice is for the committee chair to call on each member individually and ask him to announce his vote out loud. Advisory committees are now to use simultaneous voting: all members will vote at once. While voting is underway, there should be no further discussion or clarification; such comments are now permissible only after the vote. The theory is that this new approach will avoid “voting momentum,” so that voters are not subconsciously influenced by the votes of those preceding them. On its web site, FDA will post how each member voted.
Non-voting members are to be encouraged to participate in vigorous pre-vote debate. Questioners should ask clear and non-leading questions.
Referrals to Advisory Committees
In some cases, FDA refers matters to advisory committees because doing so is statutorily required. In most instances, however, FDA has discretion to refer or not. FDA has also issued a draft Guidance identifying factors it will consider in deciding whether to refer a matter to an advisory committee: 1) Is the matter at issue of such significant public interest that as part of the Agency’s regulatory decision-making process it would be highly beneficial to obtain an advisory committee’s advice? 2) Is the matter so controversial that it would be highly beneficial to obtain such a committee’s advice? 3) Could an advisory committee provide special expertise the Agency needs to consider the matter fully? If one or more of these tests are met, then the matter should generally be referred. Otherwise, it should not. The Guidance also proposes that for all first-of-a-kind or first-in-class products for human use, FDA either refer the product to an advisory committee or summarize, in the action letter for that product, the reasons why, before approval, it did not do so.
Independent outside experts provide FDA valuable assistance. Potential committee members should acquaint themselves with these new Guidance documents so they can continue to contribute their time and talents. Sponsors should be aware of committee processes that may impact product approvals or other activities.