With respect to nongovernmental organizations, it seems clear that there was a presumption that the blood bank industry, and perhaps to a lesser degree the commercial plasma and plasma fractionation industry, would be substantially self-regulating. Moreover, there was considerable concern throughout the critical period reviewed to take into account the desires and knowledge of affected producer, patient, and physician constituencies, particularly when they were highly organized and active. Moreover, these same parties were given a substantial role in providing technical advice to the FDA concerning the exercise of its regulatory responsibilities (Aledort, Bove, Rodell interviews).
In normal times these close working relationships between the FDA and the nongovernmental sector have major advantages, as we point out at the beginning of this chapter. Indeed, it would appear that self-regulation and advice-giving played important positive roles in mitigating and ultimately limiting the tragedy of blood-borne HIV virus. Certain blood banks acted early to institute screening programs. Alpha Therapeutic acted with great dispatch in eliminating unscreened components from its AHF concentrate (Gury 1982). And the plasma fractionation industry adopted a strong screening policy that was urged on all its members (ABRA 1983) well before the March 1983 FDA letters that recommended screening (Petricciani 1983a,b,c). Ironically and tragically, plasma fractionators were not encouraged by government to aggressively produce and market heat-treated AHF concentrate a year before scientific proof that heat treatment killed HIV, but they moved rapidly to provide that product once it became plausible to believe that heat treatment was effective against HIV. Although many may now think that its advice was myopic, the National Hemophilia Foundation was very active in attempting to balance the risks of HIV infection against the risks of uncontrolled bleeding and in informing its member units concerning what it believed to be the proper course of action [e.g., NHF Chapter Advisories #4-12; NHF Medical Bulletins #3-11].
Nevertheless, we have noted many worrisome aspects of the FDA's reliance on both self-regulation and information development and dissemination in the nongovernmental sector. Because the FDA did not demand information and monitor action, it had no way of knowing whether either self-regulation or implementation of its recommendations would be effectively carried out by regulated parties. The FDA and others may have been overly influenced by the concerns of the NHF and other treaters that AHF concentrates remain fully available (in some cases, in a non-heat-treated form) (FDA, BPAC 1983). Information about availability and the effects of regulation on availability seems to have come almost exclusively from the industry and to have had major impacts on FDA decisionmaking (FDA, BPAC 1983). Actions were not taken in the absence of consensus among nongovernmental parties, when stronger