The panel included experts in science and public health policy, adult and pediatric medicine, infectious diseases, rheumatology, immunology, transfusion medicine, epidemiology and statistics, and medical ethics. The Expert Panel reviewed information presented by medical experts, professional societies, patient advocacy organizations, and representatives of the U.S. Food and Drug Administration and the plasma products industry. In the absence of data to form evidence-based recommendations, the Expert Panel was asked to address the feasibility, design, and advisability of additional studies that could form the basis for such recommendations. The findings and recommendations of the Expert Panel are summarized in this report. This is particularly true of IVIG, the product with the broadest range of medical uses.
Recent recommendations concerning donor pool size deserve comment.
In the absence of scientific data to establish minimum donor pool sizes, the Expert Panel recommended that the FDA ensure that donor pool sizes do not exceed current manufacturing levels. It includes interpretive judgement in the presence of scientific uncertainty and disagreement about values. They must also develop and test public health and clinical care strategies, and communicate with the public about the risk and strategies for reducing it. First, uncertainty creates opportunities for advocates of self-interested and ideological viewpoints to advance plausible arguments that favor their desired outcome. Second, uncertainty intensifies bureaucratic cautiousness.