FDA must articulate its requests or requirements in forms that are understandable and implementable by regulated entities. In particular, when issuing instructions to regulated entities, the FDA should specify clearly whether it is demanding specific compliance with legal requirements or is merely providing advice for careful consideration.
In the early 1980s, the FDA appeared too reliant upon analyses provided by industry-based members of the Blood Products Advisory Committee (BPAC). Thus the Committee arrived at
Recommendation 9: The FDA should ensure that the composition of the Blood Products Advisory Committee reflects a proper balance between members who are connected with the blood and blood products industry and members who are independent of industry.
An agency that is well-practiced in orderly decisionmaking procedures will be able to respond to the much greater requirements of a crisis. This consideration leads to
Recommendation 10: The FDA should tell its advisory committees what it expects from them and should independently evaluate their agendas and their performance.
Advisory committees provide scientific advice to the FDA, but they do not make regulatory decisions for the agency. The FDA's lack of independent information and an analytic capability of its own meant that it had little choice but to incorporate the advice of BPAC into its policy recommendations. To ensure the proper degree of independence between the FDA and the BPAC, the Committee makes
Recommendation 11: The FDA should develop reliable sources of the information that it needs to make decisions about the blood supply. The FDA should have its own capacity to analyze this information and to predict the effects of regulatory decisions.
One of the crucial elements of the system for collecting blood and distributing blood products to patients is the means to convey concern about the