FDA Meeting to Address Transmissible Spongiform Encephalopathies

The Food and Drug Administration (FDA) has announced a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, which reviews and evaluates available scientific data concerning the safety of products that might transmit spongiform encephalopathies such as Creutzfeldt-Jakob disease and the bovine variant commonly known as mad cow disease. Agenda items for the October 28-29, 2010, meeting in Gaithersburg, Maryland, include (i) “FDA’s risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII” and (ii) “labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.” The committee will also discuss ways to reduce transmission risks and hear updates on the “development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.” FDA requests written comments by October 21, 2010. See Federal Register, September 14, 2010.