Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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8 Organization and Management
8 Organization and Management
Pages 196-214
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From page 196... ...
To accomplish this a strong central office for committee management is rewired To assure uniformity am1 adherence to established policies, this office should handle both drug:; arm b~olog6cs. The industry liaison panel feels that statutory differences between drugs and biologics on the one harm and medical devices on the other are such that it may be more appropriate for medical devices to be managed separately [emphasis added]
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From page 197... ...
Its purpose is to Claris the roles of these respective officials in advisory committee management. The Commissioner and His Office FDA advisory committees are formally chartered by the Commissioner of Food and Drugs lo advise him in the discharge of his responsibilities related to ensuring the safety and effectiveness of drugs, biologics, and medical devices for human use.
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From page 198... ...
What advisory committee system functions might be performed by the Office of the Commissioner? In the judgment of the IOM committee, a need exists for clear policy and management guidance to the FDA advisory committee system from the Commissioner regarding the role, importance, and general operations of advisory committees in the work of the agency.
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From page 199... ...
The IOM committee regards the specific organization of the Office of the Commissioner as the province of the Commissioner. However, given that all FDA centers, including the three of concern in this study, report to the Office of the Deputy Commissioner for Operations, it regards this office as the most likely location for a high-level advisory committee function.
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From page 200... ...
What functions might center directors be formally expected to carry out with respect to advisory committees? The following are important: · ensure implementation in their respective centers of agency-wide policy toward advisory committees developed in cooperation with the Office of the Commissioner; monitor the recruitment of advisory committee members for expertise, external endorsement, and special efforts to recruit women and minority members; · review all Custom tailoring" advisory committee meetings that involve matching the composition of the committee to the technical requirements of an agenda to avoid charges of Undue influence.; · help design an orientation and training program along the lines recommended below, examine issues that may arise in the work of one or several advisory committees that may cut across the work of the entire center and require consideration on a broader basis than a single committee (or division)
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From page 201... ...
Specific functions of executive secretaries include recruiting committee members and preparing nomination packages; administering conRict-of-interest reviews on initial appointment and processing waivers for specific meetings; arranging meeting logistics (whether on an internal or contract basis) ; distributing materials to advisory committee members; and following up committee meetings.
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From page 202... ...
Rather, it requires the diligence of center directors and policy oversight by the recommended highlevel official in the Ounce of the Commissioner. The TOM committee recommends that the executive secretaries report to a central unit in their respective centers for the purpose of providing administrative support to that centers advisory committees.
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From page 203... ...
COMPENSATION The authority lo set the daily rate of compensation for FDA advisory committees resides with the Commissioner of Food and Drugs. He is subject to four constrain~two legal, one budgetary, and one administrative.
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From page 204... ...
In general, the IOM committee Is concerned that these rates do not adequately reflect the value that FDA and the general public attach to the important work performed by advisory committee members. The IOM committee Commends that the Commissioner, with the Secretary of Health and lIuman Services, renew the adequacy of compensation for Public Health Service advisory committee members, including FDA advisory committee members, and take appropriate steps to maintain daily rates in relation to increases in the federal salary schedule.
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From page 205... ...
ORIENTATION AND llLAINING Insufficient orientation of advisory committee members is a recunnog complaint It was raised by the Industry Liaison Panel report and ~ the nteniews of current and former advisory committee members conducted by a working group of the IOM committee. Many~erhaps most-of these past and present advisory committee members felt that their training and orientation had been inadequate.
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From page 206... ...
The need for a systematic orientation program is generally recognize throughout the agency. Among advisory committee members, one encounters the belief that a more systematic orientation and Gaining program is needed, especially for new members, who reportedly often come to the initial committee meetings without knowing what is expected of them or how FDA exercises its regulatory responsibilities.
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From page 207... ...
Direct personal orientation of advisory committee members is also left to the discretion of the executive secretanes. (One CDER executive secretary expressed the view that the interests of the members of CDER's 17 advisory committees varied too much to hold one orientation session.)
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From page 208... ...
What questions deserve attention in considering a more systematic orientation and training program for advisory committee members? First, the rationale for such an effort is straightforward: systematic orientation and training of advisory committee members would fulfill a widely recognized need; it would promote the efficient use of committee members' talent; it would establish clear expectations for members about their roles and responsibilities; and it would permit agency officials to explicitly acknowledge the important public service contribution of advisory committee senace.
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From page 209... ...
for all advisory committee members. In addition, a videotape should be prepared to capture the views of the FDA Commissioner and relevant high-level FDA officials regarding the importance of the advisory committee function.
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From page 210... ...
In the course of the study, however, several suggestions have been made that the committee consider other types of advisory committees and these are reviewed briefly in this section. Policy Advisory Committee The first issue was whether the IOM committee should recommend that a policy advisory committee be established to advise the Commissioner on the broad policy issues related to drugs, biologics, and devices that come before the agency.
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From page 211... ...
No advisory committee exists for aggregating and considering such issues. Currently constituted technical advisory committees focus on product evaluation, broadly construed.
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From page 212... ...
Such clarification should include expanding the job descriptions of these officials as necessary. The IOM committee acknowledges the important role of FDA office and division directors in the work of advisory committees; it does not recommend circumventing these officials by proposing to locate operational responsibility for committees elsewhere, but urges clarification of their responsibilities for the effective performance of the system.
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From page 213... ...
It would be unnecessary to reiterate this basic distinction were it not that some agency critics regard advisory committees as independent adjudicatory bodies that should hear sponsors' views, on the one hand, and agency views, on the other, and decide in favor of one park or the other. Acknowledging this basic authorityadvisory distinction should facilitate advisory committees becoming even more effective and influential than they are at present, which the IOM committee endorses.
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From page 214... ...
As a result, the committee believes that its report, if widely disseminated, could serve to increase both internal agency accountability and external support for the advisory committee system. The IOM committee recommends that the Commissioner circulate this report widely within the ADA, to all advisory committee members, and to other interested parties.
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