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FDA Committee Discusses Additional Blood Safety Measures for Donors

On April 1-2, 2009, the Blood Products Advisory Committee (BPAC) of the Food and Drug Administration (FDA) met in Gaithersburg, MD, to discuss issues on the safety of donated blood, cells and human tissues.

Part of the discussion centered on whether nucleic acid testing (NAT) should be mandated to screen blood donors for hepatitis B. NAT is believed to provide incremental improvements in detection compared to earlier testing methods. Although some blood collection centers already use this method voluntarily, it is not mandatory and not all have adopted it. FDA is now considering mandating the test based on several considerations, including recent data showing that some individuals who have been vaccinated against the virus can still acquire “breakthrough infections.” Also cited was the availability of newer “multiplex” NAT tests that can screen for multiple infections at the same time.

Speaking in favor of mandatory testing, Glenn Mones, NHF Vice President for Public Policy, urged the committee to “err on the side of safety,” even if the improvement is incremental. Mones cited a section of Recommendation #187 of NHF’s Medical and Scientific Advisory Council (MASAC), “MASAC Recommendations Concerning the Treatment of Hemophilia and Other Bleeding Disorders,” which advocates for the broad use of NAT testing because it “offers significant incremental sensitivity over the HIV antigen test and serologic tests for HIV, HCV, and HBV.”

The committee also discussed whether blood donors need to be tested for T. cruzi, the parasite that causes Chagas’ disease, prior to every donation. The agency is considering alternative testing strategies based on the very low incidence of infection in the United States. Again, NHF urged the committee to aim for the highest level of safety at all times, regardless of cost or convenience.

Finally, the committee discussed possible new standards for the use of plasma obtained from donors of whole blood in manufactured products. Currently, most manufactured plasma-derived products used to treat hemophilia and other conditions are derived from source plasma. Source plasma is obtained primarily from paid donors through a process called plasmapheresis and not from donors of whole blood.

NHF will continue to keep the community informed of these and other key blood safety issues as they develop. To view the full set of discussion materials from the recent FDA/BPAC meeting, please click here:

MASAC Recommendation # 187



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