New FDA Activities for Minimising the TSE Risk

GMP News No. 816

GMP News
17 October 2006
 

New FDA Activities for Minimising the TSE Risk

 
As a reaction to recent developments, on 8 August 2006 the FDA published the draft for an amendment of the "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" dating back to 2002. The amendment includes the recommendation to refuse donators of blood and blood components who have received a blood transfusion in France since 1980. France is the first country on the European continent to which this procedure has been extended. Up till now, only the UK was listed. The draft document can be downloaded from the following address:
www.fda.gov/CBER/gdlns/cjdfrance.pdf

The reasons for this decision are the probability of exposure to BSE in France through the big number of cattle imports from Great Britain and the documented presumed cases of transfusion-related vCJD infections in Great Britain. On 1 August 2005, the definite or presumed vCJD cases in France itself added up to 14.

The measure described in this document is based on a resolution of FDA's TSE Advisory Committee taken during its meeting in February 2005. The transcript of this meeting is available at: http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4088t1.doc The discussions recorded in this transcript reflect all the complexity of the TSE problem.

A statement by Dr Donna DiMichele, Associate Professor, Cornell University, expresses it very well: "[...] this case is not like West Nile, which, you know, we were able to get control of very quickly, but, you know, I don't know what else to do, I mean, the population still has? I mean, this is a terrible disease."

Even though, in its recommendation, the expert group referred explicitly to France, some of its members pointed out that further European countries should also be kept under watch.

Dr Glenn Telling, Associate Professor, University of Kentucky: "[...] I'm concerned about the increased rise in cases in Switzerland, which has the second highest incidence of BSE in Europe, and the fact that new variant CJD may manifest in more than one molecular form."

One main argument against the recipients of French blood donations was that France itself excluded these persons from donating blood.

Author:
Dr Ulrich Herber
On behalf of ECA
 

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