problems the Committee found indicated a failure of leadership and inadequate institutional decisionmaking processes in 1983 and 1984. No person or agency was able to coordinate all of the organizations sharing the public health responsibility for achieving a safe blood supply.
Federal agencies had the primary responsibility for dealing with the national emergency posed by the AIDS epidemic. The Committee scrutinized bureaucratic function closely and came to the following conclusions about the management of potential crises.
First, unless someone from the top exerts strong leadership, legal and competitive concerns may inhibit effective action by agencies of the federal government. Similarly, when policymaking occurs against a backdrop of a great deal of scientific uncertainty, bureaucratic standard operating procedures designed for routine circumstances seem to take over unless there is a clear-cut decision-making hierarchy. An effective leader will insist upon coordinated planning and execution. Focusing efforts and responsibilities, setting timetables and agendas, and assuming accountability for expeditious action cannot be left to ordinary standard operating procedures. These actions are the responsibilities of the highest levels of the public health establishment.
Second, the FDA and other agencies in the early 1980s lacked a systematic approach to conducting advisory committee processes. These agencies should tell their advisory committees what it expects from them, keep attention focused on high-priority topics, and independently evaluate their advice. Because mistakes will always be made and opportunities missed, regulatory structures must organize and manage their advisory boards to assure both the reality and the continuous appearance of propriety.
Third, agencies should not rely upon the entities they regulate for analysis of data and modeling of decision problems.
Fourth, agencies need to think far ahead. They must monitor more systematically the long-term outcomes of blood transfusion and blood product infusion to anticipate both new technologies and new threats to the safety of the blood supply. The Committee believes that the Public Health Service should plan what it will do if there is a threat to the blood supply. It should specify actions that will occur once the level of concern passes a specified threshold. The Committee favors a series of criteria or triggers for taking regulatory or other public health actions in which the response is proportional to the magnitude of the risk and the quality of the information on which the risk estimate is based. Taking on small steps allows for careful reconsideration of options, particularly as information about uncertain risks unfolds. Not all triggering events need lead