Nonautomatic Recalls

The question of what to do concerning the recall of AHF concentrate that might be contaminated with the pathogen that was the causative agent in AIDS seems to have come to a head in midsummer 1983. Virtually the entire meeting on July 19, 1983, of the FDA's Blood Products Advisory Committee (BPAC) was devoted to the question of what was known about AIDS and its transmission through the blood supply, and what BPAC should recommend to the FDA concerning recalls (FDA, BPAC 1983; see also Chapter 3).

The National Hemophilia Foundation seems to have been the only participant at the BPAC meeting that supported the automatic recall of any product that was found to have been manufactured with plasma taken from a person subsequently determined to have AIDS or to have had characteristics strongly suggestive of AIDS. Indeed, the BPAC recall agenda seems to have been set by an NHF Medical and Scientific Advisory Council (MASAC) position favoring automatic recall (FDA, BPAC 1983). However, that position had been formulated by the NHF prior to the BPAC meeting. At the meeting itself, NHF medical director, Louis Aledort, first stated the NHF position, then followed by stating his personal view that the NHF position had been formulated prior to the consideration of the Pharmaceutical Manufacturers Association assertions concerning the possible impact of automatic recalls on the availability of AHF concentrate (FDA, BPAC 1983).

The BPAC did not accept the automatic recall proposal. Instead, it recommended that product recall be handled on a "case-by-case" basis. The BPAC position was based on countervailing considerations. Distribution and use of "lots" of a product incorporating plasma from a donor with a definite diagnosis of AIDS was clearly undesirable. However, the BPAC was sufficiently concerned about the possibilities of misdiagnosis based on particular signs and symptoms, and about the effect of automatic recalls on the availability of AHF concentrate, that it was unwilling to recommend to the FDA that it demand automatic recall whenever a product was thought to contain plasma from an individual confirmed as or suspected of having AIDS.

The views presented to the BPAC were reviewed within the FDA (Donohue 1983). Based on that review it was decided that the "working policy" of the Office of Biologics would be to evaluate the desirability of a recall on a case-by-case basis whenever a batch of AHF concentrate was found to have been produced from a plasma pool that included material from a donor later found to have AIDS or strongly suspected to have AIDS (Novitch 1983). In each case the Office of Biologics was to take into account its judgment of the accuracy of the diagnosis, the timing of the occurrence of symptoms of AIDS in relation to the time of donation of the plasma, and the impact of a recall based on this



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