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Dr Kingdon recorded that:"All importation stopped following the FDA direction that source plasma and the centres producing source plasma be licensed; the FDA would not inspect offshore sites which meant that imported plasma would not be approved plasma and therefore could no longer be used in the manufacture of blood products. As a result, since approximately 1978, all plasma used for the production of concentrates in the United States has been obtained from donors in the United States."

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There was a single centre in Belize, which was also licensed for fractionation (and hence should have been inspected) by the FDA.

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A meeting was held at the National Institute for Biological Standards and Control ("NIBSC") between civil servants, American and British fractionators, clinicians and scientists. Among the issues discussed was the size of donor pools.

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At an NIBSC meeting the National Hemophilia Foundation's position that products should be automatically recalled where a donor was diagnosed with AIDS or characteristics strongly suggestive of AIDS was explained.

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The WHO Resolution urged Member States to promote national self-sufficiency on the basis of voluntary donations and to "enact effective legislation governing the operation of blood services and to take other actions necessary to protect and promote the health of blood donors and of recipients of blood and blood products."

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A letter sent by the US Assistant Secretary for Health to the UK Chief Medical Officer, confirmed that "Source plasma used in manufacturing licensed plasma derivatives, in the US or overseas, must be collected in facilities with US licenses."

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Dr Cooper indicated that he would be interested in the views of Dr Yellowlees both on the labelling of the products and the "benefit-to-risk considerations".

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Dr Cooper stated stated that "Source plasma collected outside the U.S. and shipped to overseas consignees manufacturing products not licensed by us are not subject to any U.S. regulations."

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The Krever Report notes that by March 1982, 257 cases of PCP or Kaposi's sarcoma (including 25 of both) had been linked to immunosuppression (demonstrated by a reversal of the usual T-helper/suppressor ratio) and identified to the CDC task force.

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The Krever Report recorded that "In the autumn of 1983 and early 1984, U.S. fractionators added warnings about the risk of AIDS to the information in the product inserts - Armour, for its factor VIII concentrate, in October 1983; Cutter, for its commercial factor VIII concentrate, in January 1984; and Hyland, for its factor VIII concentrate, in March 1984."

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A committee on opportunistic infections in patients with haemophilia in the US met to exchange information about the cases and to conduct surveillance. At its second meeting in Washington DC it was agreed that the possibility must be explored and that techniques should be developed immediately to reduce or eliminate the risk of infection from Factor 8 concentrates.

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A formal compliance program for the plasma fractionation industry was established in 1977. The US Institute of Medicine committee noted that source identification for plasma (ie whether from a paid or voluntary donor) did not apply, though it did for whole blood for transfusion from 1978.

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The FDA had a Blood Products Advisory Committee ("BPAC") which, though it contained members drawn from a variety of scientific disciplines, in the 1980s had a substantial membership drawn from those involved in blood banks and fractionators.

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Material which would be excluded from any production of concentrate in the UK because of the high risk it posed was included in the concentrates Alpha exported to the UK. The FDA knew this was happening but sought to persuade rather than enforce.

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It was agreed that the possibility of people with haemophilia contracting AIDS from blood products must be explored and that techniques should be developed immediately to reduce or eliminate the risk of infection from Factor 8 concentrates.

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The Institute of Medicine Committee's report was critical of the CDC.

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A senior official at the American Red Cross wrote in a memorandum that: "it has long been noted that CDC increasingly needs [a] major epidemic to justify its existence ... In short, we can not depend on CDC to provide scientific, objective, unbias[ed] leadership".

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When Dr Francis suggested at the meeting that Hepatitis B core testing should be introduced, as a surrogate test for the presence of the putative virus, he was not supported by any of his superiors.

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Hyland stated that no products fractionated from plasma pools containing the donor's plasma had been shipped to customers in Europe. Hyland explained that it had taken this action unilaterally and not at the request of the FDA.

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A ministerial submission from January 1976, relating to the product licence application for Factorate, set out what was known at that time about the sources of plasma for Factor 8 concentrates that were used in the UK, including whether the Medicines Inspectorate had visited facilities.

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