Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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7 Committee Operations
7 Committee Operations
Pages 173-195
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From page 173... ...
Although some explicit policies guide FDA advisory committee operations, relatively few current policies are documented. One question that confronted the IOM committee, therefore, was to determine how much written policy guidance was needed to ensure effective performance.
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From page 174... ...
(NIH schedules grant proposal cycles and study section meetings one or two years in advance and consults with the major professional societies in particular fields before doing so.) Second, in informal discussions industry representatives responded favorably to advance scheduling provided the particular advisory committee met at least three times per year and on a regular basis.
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From page 175... ...
Modification of current practice would require that the agency issue an explicit policy on advance scheduling, plan for an appropriate transition period, and carefully monitor the implementation of scheduling in the transition Venom The IOM committee believes that advance scheduling would be justified as a means for making better use of advisory committees. The IOM committee recommends that FDA adopt a policy of annual advance scheduling of advisory committee meetings and of meeting agendas, with renew cycles having deadlines for sponsor submission of data, Fl)
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From page 176... ...
Program Management at CDER Product evaluation issues, broadly construed, receive the greatest attention in the CDER document on advisory committee agenda items. However, the document also suggests several subjects for advisory committee agendas that relate to the management of the NDE program.
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From page 177... ...
formally scheduling a meeting and publishing an announcement of that meeting in the Federal Register, and (2) a few days before the meeting, sending committee members a detailed agenda with specific questions on which advice is sought.
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From page 178... ...
The second stage-setting the detailed agenda of committee meetings~nvolves establishing the specific meeting topics and time allocations and preparing the specific questions that the advisory committee will consider. Of these steps, preparing the questions is the most important.
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From page 179... ...
The TOM committee recommends that in the formulation of meeting agendas and of questions, the advisor committee chair be routinely consulted as a standard procedure. It further recommends that committee members be routinely informed that they may modify FDA prepared questions, based on their review of the data, and introduce questions of their own before or at an advisory committee meeting.
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From page 180... ...
The TOM committee concurs with Temple regarding the "distinction without a difference." The IOM committee believes that FDA reviewing units should be free to ask advice on both scientific questions and related regulatory implications, as they deem important. A related issue is the charge that the FDA sometimes asks ~loaded" or leading questions.
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From page 181... ...
The specific questions for the meeting should be delivered no later than 10 days before a meeting. The IOM committee believes that the responsibility for fulfilling this recommendation rests not only with committee executive secretaries, but also with the directors and the application reviewers of the appropriate division.
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From page 182... ...
However, when asked by the IOM committee about the ground rules for communications from FDA personnel to committee members, the Chief Counsel to the FDA responded in this way: In our view, FDA staff could legally discuss such preliminary issues as agenda topics, materials, and questions with a part of an advisory
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From page 183... ...
Indeed, the National Hunger Coalition case suggests that a combination of agency staff and committee members may even hold substantive discussions outside of announced committee meetings, if the discussions are preliminary, are of a staff nature, and do not involve giving advice to an agency, and so long as any preliminary advice arrived at Is rendered to the agency by the full committee.3 The practices of some FDA centers, she suggested, may be stricter than necessary to reduce any legal risk One caveat suggested by the Chief Counsel was that the Office of Government Ethics (OGE) may hold the opinion that review of materials by an advisory committee member before a committee meeting may constitute participation in "a particular matter" and thus require screening for conflict of interest and, if necessary, the issuance of a waiver before it takes place.
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From page 184... ...
The rationale for such a prohibition stems from a desire to preclude a minority of any advisory committee from establishing a position before a meeting and exerting influence favoring that position in committee discussions. The presumed limitation unnecessarily restricts discussion among committee members and is not required by the FACA Again, the FDA Chief Counsel has written that That preliminary discussions among committee members do not Violate FACED In short, staff instructions against such consultations may seem overly cautious.
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From page 185... ...
Communication Between the FDA and the Public Regarding the public release of the questions prepared for the advisory committe, the general practice of the FDA has been to make them available to the public on the morning of a meeting. The IOM committee agrees with this practice and does not recommend earlier release to the public.
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From page 186... ...
The role of the advisory committee chair is critical to the effective performance of a committee. The chair should control agenda time efficiently; protect committee discussion time; ensure, in consultation with agency staff, that the meeting arrangements facilitate committee deliberations; regulate, as necessary, media coverage of meetings; and ensure that
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From page 187... ...
The IOM committee recommends that the FDA routinely consult committee chairs in the allocation of time to agenda items and that this allocation try to anticipate points throughout the meeting at which committee questioning will be likely It further recommends that
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From page 188... ...
and that they must work to protect committee discussion time, including exercising strict control on the presentations of sponsors and the FI) A before the committee and attendant questions and discussions by committee members.
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From page 189... ...
First, safety, effectiveness, and other factors considered in advisory committee recommendations are continuous variables. Second, given that there are no definitive empirical bases for deciding issues before an advisory committee, the FDA should seek to determine both the range and strength of the experts' opinions.
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From page 190... ...
These include agency presentations, agency committee interactions, and seating arrangements. Agency Presentations The Industry Liaison Panel emphasized the importance it attaches to neutrality of presentation by the agency.
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From page 191... ...
Indeed, failure to do so might be construed as manipulation by not apprising the committee of factors that will be important in the agency's official decision. On the other hand, the IOM committee strongly believes that agency presentations about a sponsor's application should be professional in tone, and thorough, fair, and scientifically objective in their critiques.
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From page 192... ...
The division director should not sit next to the committee chair. Other agency personnel should be placed so that a demarcation between committee members and FDA staff is apparent.
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From page 193... ...
On the one hand, the Industry Liaison Panel recommended the creation of a large pool of experts on whom FDA could draw for advisory committee members as a means to ensure a match between expertise and agenda item. This proposal reflects the view that the competencies sought on an advisory committee are often specific to a given agenda.
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From page 194... ...
It also notes that the progress of an NDA approval is closely followed by the financial investment community, and simple prudence argues against informing committee members of a forthcoming approval in advance of notifying a sponsor. The IOM committee recommends that the FDA follow up each advisory committee meeting as follows: routinely and immediately provide committee members with a copy of all press releases issued after a committee meeting; inform members by FAX at the time of decision about the approval or disapproval of any application that the committee has considered; routinely report on the status of matters previously considered by the committee at the beginning of each meeting; and report annually the disposition of committee-related matters.
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From page 195... ...
Williams, Ph.D., to Richard A Rettig, Better Use of FDA Advisory Committees Through Voting Rules," March 10, 1992 6.
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