FDA updates deferral guidance for blood and plasma donation

Regulatory NewsRegulatory News | 31 August 2020 |  By 

An update to guidance for industry on reducing the risk of transmission of Creutzfeldt-Jacob disease (CJD) through blood and blood components clarifies terminology and recommendations for patients who have received cadaveric pituitary human growth hormone. Some previous travel-based deferrals have also been revised or eliminated.
The revised guidance from the US Food and Drug Administration (FDA) addresses screening for variant CJD (vCJD) as well as other transmissible spongiform encephalopathies for donors of blood and blood products. The update from the 2016 guidance now recommends that donors be indefinitely deferred if they have been diagnosed with vCJD, CJD or any other transmissible spongiform encephalopathy, or if they have a blood relative who has been diagnosed with a familial prion diseases.
Donors should not be questioned about these conditions, though, according to the revisions, because these diseases are rare and it is not possible to identify those who might have one of these conditions but is asymptomatic. “However, individuals that volunteer such information should be indefinitely deferred,” according to the guidance.
Donors no longer need be indefinitely deferred if they have received injected bovine insulin, or if they have spent 5 or more years in Europe since 1980.
Previously, donors who were US military or civilian personnel and their dependents residing on bases in Europe for 6 or more months during certain time periods from 1980 onward were indefinitely deferred. This recommendation for deferral has been removed.
Donors who have received an allogeneic human cadaveric dura mater transplant should also be indefinitely deferred, a recommendation that clarifies the less-specific wording of the 2016 guidance.
The new guidance recommends indefinite deferral of a donor who volunteers information that he or she has received cadaveric pituitary human growth hormone. However, the rarity of this procedure together with the lack of clinical evidence for CJD transmission from blood components has led FDA to recommend that human growth hormone be removed from medical deferral lists.
The guidance continues to recommend indefinite deferral of individuals who spent 3 or more months in the United Kingdom during the period of 1980-1996. As before, donors should also be deferred if they have spent a cumulative 5 or more years in France, but the period of concern is now adjusted to begin in 1980 and end in 2001. Those spending 5 or more years in Ireland during this period should also be indefinitely deferred.
Individuals who received a transfusion in the United Kingdom or France from 1980 to the present continue to be recommended for indefinite deferral; Ireland was added as an additional transfusion site in this list.


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Tags: biologics, FDA, US

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