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TSE Removal Claims for Plasma Derivative Labeling To Be Addressed By Cmte.
FDA is asking the Transmissible Spongiform Encephalopathies Advisory Committee
at a Feb. 20 meeting whether the agency should consider labeling claims for the
clearance of TSE agents in plasma derivatives, based upon specific demonstration
of TSE removal during manufacturing.
Current plasma derivative labeling includes a warning that "because (this
product) is made from human blood, it carries a risk of transmitting infectious
agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD)
agent."
FDA’s proposed draft labeling would add the statement: "It has been demonstrated
that (the manufacturer’s) manufacturing process provides substantial clearance
of agents similar to those causing CJD and variant CJD. Thus the theoretical
risk of transmission of CJD or vCJD is considered extremely remote."
FDA noted that "the most feasible strategy for significantly reducing risk at
this time is removal of potential TSE infectivity by manufacturing procedures."
The agency added that "no single manufacturing step can be considered
‘generically’ effective in removing" such agents.
Clearance of TSE agents is also complicated by "uncertainties regarding the
nature of this pathogen," FDA said. "The physico-chemical characteristics of TSE
agents in human blood, if present there, remain unknown."
A science-based labeling claim of "specific TSE agent clearance might…provide an
incentive for industry to study and to pursue reduction of TSE risk via
manufacturing processes," FDA suggested.
Such an incentive is especially important because "validated and licensed blood
screening tests for detecting donors incubating TSEs seem unlikely to be
available in the near future."
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