Therapeutic reports that while licensed to produce heat-treated Factor VIII in February 1984, it was already processing 45 percent of its total Factor VIII output with the heat treatment step in anticipation of licensing and requested voluntary withdrawal of its license for untreated AHF concentrate in July 1985 (McAuley pers. com. 1995). Miles, Inc. reports that 40 percent of its shipped product (Factor VIII) was heat-treated in 1984 and 99 percent was treated during 1985 (Hammes pers. com. 1995). (The timing was somewhat later concerning Factor IX.) Moreover, by 1985 the unit prices to intermediate consumers for heat-treated Factor VIII were only slightly higher than the unit price of untreated Factor VIII in 1983 and 1984 (Hammes pers. com. 1995; Persky pers. com. 1995). However, it was reported to the Committee that the price to the final consumer was higher and this was one of the reasons why some in the medical community did not recommend heat-treated AHF concentrate earlier (Dietrich, Lusher interviews). From these data it would appear that supplies of treated AHF concentrate were rapidly becoming available and that the costs of eliminating untreated AHF concentrate in inventory would have been limited essentially to its production costs and the costs of retrieval.

Had the FDA demanded recall of all untreated AHF concentrate—based perhaps on an assumption that the AIDS virus would turn out to be more like the general run of viruses in its susceptibility to pasteurization—there might have been no legal contest from the industry. Once a retrovirus had been isolated as the causative agent in AIDS, most virologists would have presumed that it would be susceptible to heat inactivation. Moreover, by 1985 the medical and scientific community agreed that heat-treated AHF concentrate was less likely to infect humans with HIV (McDougal, et al. 1985). Hence, even if the FDA doubted its legal authority to press for a recall of untreated AHF concentrate, it might well have achieved that goal without any test of its legal authority. And, if tested, it might well have prevailed on one of several theories.

Summary and Conclusions

On the positive side, this series of events demonstrates some of the strengths of industry self-regulation. The plasma fractionation industry seems to have perceived clear advantages to developing a workable heat treatment process and to have rapidly secured approval for different processes (Hammes pers. com. 1995; Leahy pers. com. 1995; McAuley pers. com. 1995; Persky pers. com. 1995. Also, the FDA licensed heat-treated AHF concentrate with commendable speed using relaxed testing requirements.

On the other hand, the weaknesses of this approach are also evident. The industry is responsive to the demands of physicians and therefore was not particularly interested in the pursuit of heat treatment when the threat was



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