The federal government regulates blood banking, monitors the safety and efficacy of blood products, and promotes research on blood diseases (OTA 1985). In late 1972, the U.S. Department of Health, Education and Welfare reported several problems within the blood supply system, including an inadequacy in the quantity of blood supplied, an unreliability in the quality of blood owing to the high rates of transfusion-related hepatitis, an inefficiency in the system itself owing to waste in some areas and shortages in others, and excessive costs of blood and blood services. On July 10, 1973, the Assistant Secretary for Health announced the National Blood Policy, which became "the focal point around which blood banking policy has evolved over the past decade" (OTA 1985). The National Blood Policy recognized that reliance on "commercial sources of blood and blood components for transfusion therapy has contributed to a significantly disproportionate incidence of hepatitis, since such blood is often collected from sectors of society in which transmissible hepatitis is more prevalent." For this reason, the National Blood Policy encouraged efforts to establish an all-volunteer blood donation system and to eliminate commercialism in the acquisition of whole blood and whole-blood components [Federal Register 1975] (Hutt and Merrill 1991).
The National Blood Policy listed four primary goals: to provide an adequate supply of blood; to ensure a higher quality of blood; to facilitate maximum accessibility to services; and to achieve total efficiency (U.S. Senate 1979). The first actions taken to meet these goals included the adoption of an all-volunteer blood collection system (for whole blood); coordination of all costs and charges; regionalization of blood collection and distribution; and an examination of the standards of care for hemophiliacs and other special groups. The policy did not address the commercial acquisition of plasma, the preparation and marketing of plasma derivatives, and the commercial acquisition of blood for diagnostic reagents (Hagen 1982).
In 1975, the American Blood Commission (ABC) was established and funded by the National Heart, Lung, and Blood Institute and was charged with implementing the "lion's share" of the objectives set forth in the National Blood Policy (OTA 1985). The progress of the ABC was hindered by lack of funds, disagreement between the two largest blood suppliers, resistance to regionalization of blood collection and distribution, problems in obtaining data from blood banks, and a lack of knowledge of blood banking by lay members of the commission (U.S. General Accounting Office 1978). In 1985 the ABC was formally disbanded.