MEDIA ADVISORY:
WHAT: Officials from the U.S. Food and Drug Administration Blood Products Advisory Committee (BPAC) will meet with government institutions and top experts from academia and private industry on September 10, 11 and 12 in two separate meetings to address issues related to safety of the blood supply including: -- Bacterial contamination of donated blood products for transfusion which can lead to sepsis (Sept. 10) -- Risk of infectious disease such as malaria from blood donors traveling abroad, and impact on donor pool and blood shortages (Sept. 11) -- Emerging concerns of U.S. diseases spread by ticks like babesiosis and lyme disease (Sept. 12) WHY: All of these organizations are committed to ensuring the safety of the nation's blood supply. Recent fines against the American Red Cross have shed public light on concerns around contaminants in the blood supply and areas for improving blood product safety. For example: -- 125 blood transfusion related fatalities were reported to the FDA in 2005 and 2006(1) -- 1 in 3,000 units of platelet blood components are believed to be bacterially contaminated at time of transfusion(2) putting 1 in 500 patients at risk for sepsis (based on an average of 6 units of platelets per transfusion) -- West Nile Virus took four years to identify and arguably more than 3,200 people were infected through blood transfusion(3) -- FDA reported a total of five deaths related to transfusion- transmitted babesiosis in 2006 and 2007(4) The FDA BPAC and Department of Health and Human Services Advisory Committee on Blood Safety and Availability (ACBSA) have previously met to discuss strategies to improve blood safety, including pathogen inactivation, a proactive approach to eradicate bacteria, viruses and pathogens from the blood supply. HOW: Pathogen inactivation technologies have the ability to inactivate bacteria, viruses and parasites from donated blood that may not be detected by current diagnostic tests. Many European countries are currently using pathogen inactivation to safeguard their blood supply. WHO: Speakers will include representatives from the American Red Cross, Centers for Disease Control, academic and industry experts. Learn more about areas for improvement of blood safety or to speak to an expert about pathogen inactivation and its anticipated benefits to the U.S. blood supply by speaking with: -- Dr. Jeff McCullough, M.D., American Red Cross Professor, Transfusion Medicine, Professor, Laboratory Medicine & Pathology, University of Minnesota -- Dr. Larry Corash, M.D., Chief Medical Officer, Cerus Corporation WHEN / WHERE: FDA Meeting: Blood Products Advisory Committee Sept. 10, 2008, 8:00 a.m. to 5:45 p.m. Sept. 11, 2008, 8:00 a.m. to 3:00 p.m. Hilton Hotel, Washington, D.C./Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852 Complete BPAC Meeting Agenda: http://www.fda.gov/CbER/advisory/bp/bp0908.htm FDA Workshop: Risk of Transfusion-Transmitted Babesiosis in the United States Sept. 12, 2008, 7:30 a.m. - 5:30 p.m. Lister Hill Center Auditorium, Building 38A, National Institutes of Health, 8800 Rockville Pike Bethesda, MD 20894 FDA Workshop Announcement: http://www.fda.gov/Cber/meetings/ttb091208.htm FDA Workshop Agenda: http://www.fda.gov/Cber/meetings/ttb091208ag.htm
(1) FDA Web site http://www.fda.gov/cber/blood/fatal0506.htm as of Sept. 3, 2008
(2) CDC Web site at Fatal Bacterial Infections Associated with Platelet Transfusions found at this link http://www.cdc.gov/mmwR/preview/mmwrhtml/mm5407a2.htm as of May 9, 2008
(3) HJ Alter. Pathogen Reduction: A precautionary principle paradigm. Transfusion Medicine Reviews. Vol. 22, 2 April 2008
(4) FDA Web site announcing FDA Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States at http://www.fda.gov/cber/meetings/ttb091208.htm as of August 27, 2008
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