Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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1 Introduction
1 Introduction
Pages 33-45
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From page 33... ...
In this report, we refer to these advisory committees and their administrative support as the FDA's advisory committee system. FDA technical advisory committees play an important, multifaceted role in the development and evaluation of new drugs, biologics, and medical dences.
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From page 34... ...
Three members of the IOM committee currently serve on FDA advisory committees, two others have served in the past, and three were previously involved as FDA officials in the design of the current system. In the early months of the study, two meetings were held between the committee chair, Dr.
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From page 35... ...
STUDY OBJECTIVES The purposes of the IOM study that arose out of the initial FDA request, the concerns of Commissioner Kessler, and the deliberations of the study committee are the following: · To understand the FDA's process of product development and evaluation so that the IOM committee could recommend how best to use advisory committees in the context of the FDA's overall mission, policies, and procedures. · To understand how FDA advisory committees are used in the three centers responsible for the evaluation of drugs, biologics, and medical devices.
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From page 36... ...
The contract ran from September 23, 1991, until October 22, 1992, during which the committee met only four times. As a result of this timetable, the IOM committee focused its attention on matters that it considered to be of greatest concern to the agency and to the advisory committees themselves, with two consequences worth noting here.
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From page 37... ...
Other means for obtaining such advice include workshops, symposia, consultants, and extensive, often informal, contacts among agency professionals and the scientific and medical communities. Although this report focuses on advisory committees, the IOM committee recognizes and endorses the appropriate use of these other means of obtaining independent expert advice.
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From page 38... ...
The IOM committee believes that the primary role of FDA advisory committees is and should be to provide independent expert scientific advice to the agency in its evaluation of specific drugs, biolo~cs, or medical devices at any stage of consideration by the agency. A related role is to advise the FDA on general cuteAa for evaluation and on broad regulatory issues that are not related to a specific product Several key terms warrant further comment.
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From page 39... ...
In Appendix A, we estimate the additional resources that the FDA will require to implement the recommendations of this report. The IOM committee recognizes that resources for advisory committees must be considered in the context of overall FDA budget priorities and that there is widespread concern about the adequacy of the agency budget to meet its growing statutory responsibilities.
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From page 40... ...
The FACA requires a formal nomination process for advisory committee members, including a Federal Register solicitation; that committee membership be "fairly balanced and that meetings be announced in the Federal Register 15 days in advance and be open and provide for public participation. The original FACA openness requirement was reinforced in 1977 by the Government in the Sunshine Act, which requires that deliberations of government collegial bodies, including advisory committees, occur in open session.
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From page 41... ...
· Five members of the IOM committee had served or were serving on FDA advisory committees in the areas of drug';, biologics, and medical devices and thus brought direct expenence to bear on the IOM committee's deliberations. · The IOM committee and its staff interacted with senior FDA professionals throughout the study.
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From page 42... ...
In January 1992, at a meeting that followed the IOM committee's first meeting, FDA senior staff advised the IOM staff of the necessity to conduct interviews with key FDA personnel. Although the amount of raw data on FDA advisory committees was enormous (e.g., lists of members, agendas, meeting transcripts, and other such matenals)
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From page 43... ...
, an advisory body serving the Department of Health and Social Services' Medicines Control Agency in the United Kingdom, are often held up as an alternative approach to that of the FDN The IOM committee, in support of this study, commissioned a very thoughtful paper on the use of advisory committees in drug and device approval in the United Kingdom, the Netherlands, Germany, France, and the European Communing. In all countries save the Netherlands, an official government agency makes the decision about approving drugs, biologics, and, in some cases, medical devices for introduction to the market.
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From page 44... ...
The IOM committee decided that the pursuit of cross-national comparisons in the use of advisory committees, however intnguing, would take it too far afield from its charge to provide the FDA with operational guidance on its use of technical advisory committees. APPENDIX For its purposes, the IOM committee has adopted operational rather than formal scientific or legal definitions of the three groups of products whose regulation and review are the subject of this report.
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From page 45... ...
Act, as amended, mainly by the criterion that they are "articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulate, or any supplement to any of them [which are] intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
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