The Food and Drug Administration’s (FDA) Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC), met in Gaithersburg, MD, on Friday, June 12, 2009, to discuss risk assessment for the potential exposure to variant Creutzfeldt-Jakob Disease (vCJD) in US-licensed plasma-derived factor VIII products. People with von Willebrand disease and some patients with hemophilia A use plasma-derived products.
Speaking for the National Hemophilia Foundation, NHF CEO Val Bias submitted testimony for the record on donor deferral methods for vCJD in the US. The FDA sought the advice of TSEAC on whether additional risk-reduction measures were needed to maintain the safety of US plasma-derived products. This meeting was held in response to the discovery in February 2009 of a UK patient with hemophilia who likely contracted vCJD from a UK-manufactured plasma product.
In his testimony, Bias stated that the UK case is a reminder that vCJD remains an important safety issue for the bleeding disorders community. He went on to say that, “it is imperative that FDA keep abreast of emerging data on vCJD and adjust its risk assessments accordingly. While there are significant limitations in the data and modeling….we are reassured that the risk of exposure to vCJD remains extremely low.” He concluded by recommending that “government, industry, the medical and scientific community and patient organizations must all continue to work together to identify and respond to potential risks to the blood and plasma supply.”