SUMMARY

A number of themes can be identified in the historical development of the use of advisory committees by the FDA. Among the most prominent are the following:

  • FDA leadership took the initiative in introducing advisory committees for the review of drugs and biologics; these committees were not imposed on the agency by the Congress. 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. Over time, they came to play a central role in the assessment of new products and technologies.

  • The use of advisory committees in the biologics program involved the review of intramural research programs and personnel, in addition to product evaluation. In addition, in vaccine development, the committees were used throughout the product development cycle and participation included scientists from other units of the Public Health Service as well.

  • For medical devices, the anticipated uses of advisory committees were product classification, standard setting, and review of new products. The initial classification panels did their work and were not continued; the function is now fulfilled by product review panels. The standard-setting function did not develop as anticipated and committees, save the Technical Electronic Product Radiation Safety Standards Committee, were not used for this purpose. The primary purpose of device advisory committees today is the review of new products.

  • In the FDA setting, advisory committees play a supportive role to agency professionals. They do exercise great influence in agency decisions, but their role as advisers is more literally so than is the case for NIH study sections.

NOTES

1.  

Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, Mass.: Harvard University Press, 1990).

2.  

Bruce L. R. Smith, The Advisers. Scientist in the Policy Process (Washington, D.C.: The Brookings Institution, 1992).



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