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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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Profilate had always been produced from US-only plasma.

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The Abbott/Alpha product, Profilate, was licensed in 1975 initially with the following warning: "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present".

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Abbott/Alpha stated that tests had been negative for the presence of hepatitis, but not "all units" of "potentially" infectious plasma could be detected so the risk (the inference is, only a little) was "still present" (their later data sheets did however advise the use of single-donor products where possible).

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The licencing authority invited the Minister to make it a requirement of the licence that plasma should be obtained only from donor centres in the US or other specified countries that satisfied the licensing authorities.

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The requirement that plasma should be obtained only from donor centres in the US or other specified countries that satisfied the licensing authorities was followed in the product licence.

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Armour had undertaken that plasma "will be only from donor centres in the USA, and from USA sources."

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Armour stated in correspondence to the DHSS that "the number of donations is approximately 1,540 per batch to give a pooled plasma of approximately 1,000 litres."

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Robert Christie stated that he understood "that Armour US purchased small amounts of plasma necessary to address shortages. I do not know the details of any such purchases."

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Armour did not use prison plasma in 1982 and showed no interest in suggestions made in April 1985 that the use of screening tests and heat treatment might permit a return to the use of prison plasma in factor concentrates.

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When Armour applied for a product licence for a high potency variant of Factorate, the company stated that all plasma was collected from establishments licensed by the FDA "and transferred to Armour under conditions defined" in the Code of Federal Regulations.

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Armour, in common with Immuno and Alpha, began by emphasising the precautions taken to render the product safe before saying that despite these the product "may contain causative agents of viral hepatitis."

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