Background Analysis: US FDA Advisory Committee to Review Ways To Reduce the Transmission Risk of Variant Creutzfeldt-Jakob Disease (vCJD) and Bovine Spongiform Encephalopathy – JUN 1, 2015 (TSEAC)
The US FDA has scheduled a Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) Meeting for Monday, June 1, 2015. The Committee will hear update presentations on the following topics: 1) The variant Creutzfeldt-Jakob Disease (vCJD) situation worldwide and an update on the United Kingdom's Transfusion Medicine Epidemiological Review; 2) vCJD in the United States; and 3) the bovine spongiform encephalopathy (BSE) situation worldwide and the United States Department of Agriculture's (USDA’s) regulatory approaches to reduce the risk of food-borne exposure of BSE. Following the update presentations, the Committee will hear presentations from FDA on current measures to reduce risk of vCJD from transfusion in the U.S., and a mathematical model of the risk reduction achievable under the current and alternative geographically-based donor deferral policies when implemented in conjunction with the use of leukocyte reduction of blood components. The Committee will then discuss FDA's geographically-based donor deferral policies and other strategies, including leukocyte reduction of blood components, to reduce the risk of transfusion-transmitted vCJD. FDA will seek advice from the Committee in developing future recommendations to reduce this risk.