CDC, and the NIH, and the person serving as the Assistant Secretary for Health all changed between 1982 and 1984.

Advisory Mechanisms

In the early 1980s, the FDA and other agencies did not have a systematic approach to conducting advisory committee proceedings. Such an approach requires that agencies tell their advisory committees what is expected of them, keep attention focused on high-priority topics, and independently evaluate the advice offered. No regulatory process should have its information base effectively controlled by an advisory panel. Public agencies must be able to generate and analyze the information that they need to assure that decisions serve the needs of the public. The FDA failed to observe this principle when it allowed statements and recommendations of the BPAC to go unchallenged, apparently because it could not independently analyze the information (Chapter 6).

Because mistakes will always be made and opportunities sometimes missed, regulatory structures must be organized and managed to assure both the reality and the continuous appearance of propriety. The prominence of representatives from blood banks and blood product manufacturers on the BPAC, with no balancing influence from consumers and no process within the FDA to evaluate its recommendations (Chapter 6), is a failure of advisory committee management. Perhaps advisory committees should contain fewer topical experts and more members with expertise in principles of good decisionmaking and the evaluation of evidence. A committee so constituted might run a reduced risk of standing accused of having conflicts of interest.

Analytic Capability and Long-Range Vision

Leadership passes to the organization that has access to information and the ability to analyze it. Federal agencies should avoid exclusive reliance upon the entities which they regulate for analysis of data and modeling of decision problems. The FDA should have had some independent capacity to analyze the information presented at the July 1983 BPAC meeting that suggested that with only three or four suspect donors, an automatic recall policy would completely deplete the nation's supply of AHF concentrate (Chapter 6). In addition, there did not seem to be any focus within the Public Health Service prepared to, or charged to, analyze the options, costs, and benefits of the options for protecting the blood supply that were discussed at the January 4, 1983, meeting convened by CDC.

In addition, agencies need to monitor more systematically the long-term outcomes of blood transfusion and blood product infusion and to think far ahead



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