FDA's actions. These hypotheses focused consideration on (1) the reach of the agency's legal powers, (2) the information available at the time in relation to relevant public health considerations, (3) the FDA's resources, (4) the FDA's institutional culture, and (5) the economic costs of particular actions and the prevailing political climate.

A later section of the chapter includes a short discussion of other federal agencies and of private organizations involved in the regulatory process. The section immediately below introduces the framework of analysis: critical events, related regulatory policy questions, and explanatory hypotheses.

FRAMEWORK OF ANALYSIS

Critical Events

The history of the threat that HIV infection posed to the safety of blood and blood products, and the eventual suppression of that threat through the combination of private and public actions, can be told from numerous perspectives. Any one perspective will to some degree falsify and distort a multifaceted narrative. This chapter structures the story in terms of the Committee's interest in the appropriate development of FDA recall and lookback (recipient tracing) policies. The Committee highlights a series of "choice points" (either events or nonevents) that were presented to the FDA as increments of information about AIDS as a disease—and about possible means of preventing its spread through blood and blood products—became available. 1 In particular we consider the following critical events and questions discussed in the following sections.

Critical Event 1

On March 24, 1983, the FDA issued letters to all blood banks, plasma centers, and plasma fractionators requiring particular practices related to donor

1  

Unfortunately, "information" in this context is not entirely separable from the very regulatory process under investigation. The information the FDA required of plasma fractionators and blood banks, and the points in time when the agency took certain "facts" to be established are also regulatory decisions. Hence, the Committee has been interested not only in whether the FDA appears to have acted appropriately given the information available to it, but also the degree to which the agency set appropriate thresholds for the determination of scientific facts and made appropriate demands upon others to investigate important unknown variables that bore on it regulatory policies.



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