Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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2 Historical Evolution of FDA Advisory Committees
2 Historical Evolution of FDA Advisory Committees
Pages 46-69
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From page 46... ...
Its responsibilities encompass investigational drugs, biologics, and devices; the evaluation and regulation of new products; postmarketing surveillance of some products; licensing of establishments; oversight of manufacturing processes; product labeling and advertising of prescription drugs and restricted devices; and other functions. Public advisory committees are used widely throughout the federal government for a wide array of purposes.
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From page 47... ...
This chapter recounts the history of FDA advisory committees as it has evolved along somewhat different pathways for drugs, biologics, and medical devices Vanations are due partly to the differences in regulatory responsibilities in these areas and partly to the administrative entities and their cultures. At the end of the chapter, a brief section contrasts FDA advisory committees with the study sections of the National Institutes of Health.
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From page 48... ...
on previously marketed prescription drugs, establishing its own review committees for over-the counter drugs, and extending such committees to new prescription drugs. The evolution of this use of outside scientific experts, recounted by Cooper for the 1960s, is briefly summarized here and then discussed at greater length below for the NAS-NRC Drug E~capy Study and for the OTC review.
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From page 49... ...
Importantly, not one of these efforts was required by the Food, Drug, and Cosmetic Act; each was initiated by the FDA as a way to implement key portions of the statute. Drug Efficacy Study The Drug Efficacy Study, conducted by the NAS-NRC at the request of the FDA, began in mid-1966 and concluded in 1969.
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From page 50... ...
Goddard saw no conflict between the NAS-NRC effort and existing FDA advisory groups. The latter, he wrote, "are not equipped to undertake a task of this magnitude and cannot be expected to alter their other activities to the extent that would be required.nS What is also interesting in retrospect is that Goddard also wrote that no problems were anticipated with conflict of interest: The Food and Drug Administration is prepared to accept the principle of professional integrity whereby panelists with personal interest in a therapeutic entity will not personally participate in deliberations where their personal interest is involved.
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From page 51... ...
Although the reports of the Drug Efficacy Study were only advisory, in the sense that FDA retained both the authority to disagree and the responsibility for all implementing decisions, they were often decisive in the agents decision making. Implementation, however, required that the FDA formally accept the study's recommendations; if it decided to withdraw approval for a drug, it was obliged to announce its plan to do so and afford the sponsor an opportunity to respond.
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From page 52... ...
Many decisions were made by split vote and compromise.) Over-the-Counter Drags Although the Drug Efficacy Study dealt primarily with prescription drugs, the NAS-NRC panels also considered 420 over-the-counter drugs (out of a total of 3,500 drugs reviewed)
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From page 53... ...
Baumgartner's history of the OTC review concluded that the FDA grossly underestimated the size and complexity of the panel phase, which lasted 10 years. The panels reviewed, by therapeutic category, 722 individual active ingredients that had 1,454 active uses in the hundreds of thousands of marketed OTC drug products; in the process, they evaluated more than 14,000 volumes of submitted data and other scientific materials.
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From page 54... ...
This environment of openness and public scrutiny was very different from that of the Drug Efficacy Study and much more characteristic of our present period. Prescription Drug Review In the early 1970s, following the episodic efforts of the prior decade, an advisory committee system evolved for prescription drugs.
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From page 55... ...
In the late 1970s, the FDA added consumer representatives to its prescription drug advisory committees. This arrangement did not work well, because such representatives were frequently at a scientific disadvantage in discussions with other committee members.
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From page 56... ...
The Drug Efficacy Study suggested a model, and the OTC renew moved advisory committees under the direct management of the FDA Prescription drug review activities incorporated advisory committees into the continuing operations of the agency in its review of new drugs. BIOLOGICS The federal government regulated biological products intended for human use even before it began to regulate drugs and medical devices.
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From page 57... ...
Thus, Section 351 of the Public Health Service Act, as currently amended, defines biological products as Any virus, therapeutic serum, town, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound) , applicable to the prevention, treatment, or cure of diseases or injuries of man.
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From page 58... ...
Although these conferences did not pronde advice on specific regulatory decisions, they contributed data and discussions that often influenced the development of requirements for the product and, in the process, generated international consensus about standards. During the years in which the biologics regulatory program was a component of the NIH, ad hoc advisory committees were sometimes formed to deal with matters of high public v~sibilin~r, such as a major new product that was being considered for approval or an important problem that occurred with an existing marketed product.
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From page 59... ...
Dunng this time, both the committee and the agencies scientific staff had formed close working relationships with the research personnel of the potential manufacturers of the vaccine, as well as with other scientists in the national and international public health communities involved in poliovirus vaccine research. In this same penod, licensing applications for lesser biological products usually received no outside attention and were reviewed and acted on solely by the staff of the biologics regulatory organization.
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From page 60... ...
At that time, there were no standing committees for biologics regulatory decisions, and the ad hoc committees that were involved had a narrow focus. To carry out its regulatory functions, the bureau created a process similar to the comprehensive OTC drug review and formed six standing committees to review the principal categories of biological products: major vaccines, bacterial vaccines, blood products, and products for which the science base was substantially less, such as allergenic extracts.
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From page 61... ...
The Study Group on Medical Devices of the Department of HEW issued its report, Medical Devices: A Legislative Plan, in September 1970.2i This committee and its report were known as the Cooper Committee and Cooper report, respectively, after the chairman, Dr. Theodore Cooper, then Director of the National Heart and Lung Institute of the NIH.
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From page 62... ...
However, the approaches favored by the consultants ranged from self-regulation to insistence on Good Manufacturing Practices to Remarketing notification to Remarketing approval, and did not reflect consensus. The report noted That a system of 'peer group' review of scientific data would induce confidence within the medical device community that decisions related to devices and standards were soundly based." The basic logic regarding the use of outside experts, whether for classification, standard setting, or premarket~ng review, was spelled out as follows: The variety of medical devices already in use are produced from an equally wide variety of materials.
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From page 63... ...
The report also recommended that a Medical Devices Advisory Council should be available to the Secretary for policy issues related to medical devices and should include experts in device development and representatives of manufacturers, users, and patients. On the basis of the Cooper report's recommendation, the FDA initiated an inventory of medical devices and began classifying medical devices that were already on the market.24 Two pilot panels-one for orthopedics and another for cardiovascular devices-met in November 1971 to develop a system for classifying devices, and by late 1972, the FDA had indicated its intention to classifier all devices over the next 12 to 18 months with the aid of outside expert panels.25 lye agency also announced that it was initiating efforts to develop device standards.
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From page 64... ...
The Medical Device Amendments, which were enacted in late 1976, were heavily influenced by the Cooper report. They required the creation of advisory panels or committees for two purposes.
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From page 65... ...
NIH STUDY SECTIONS It is worth contrasting FDA advisory committees with the study sections of the National Institutes of Health, if only bemuse academic medical scientists are very familiar with the latter and often extrapolate these experiences to the operations of the former. The functions of the two sorts of committees, and the contexts in which they operate, are quite different.
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From page 66... ...
. Thus, as will be clear throughout this report, FDA advisory committees differ in important policy, administrative, and operational respects from the more familiar NIH study sections.
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From page 67... ...
The device amendments, which do require such committees for evaluation of medical devices, constitute congressional recognition of their importance for the agency. · In the case of the Drug Efficacy Study, the OTC drug review, and the biologics review, these committees fulfilled major workload functions clearing a backlog of work for which the agency lacked adequate personnel-and provided independent expertise.
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From page 68... ...
R Keith Cannan, Status of the Drug Efficacy Study of the National Academy of SciencesNational Research Council." Food, Drug; Cosmenc Law Joumal (January 19683:32-35.
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From page 69... ...
Link, scooper Committee Report and Its Effect on Current FDA Medical Device Activities, Food, Druid Cosmetic Law Joumal (October 1972~:624~28.
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