On Nov. 17-18, the 114th meeting of the FDA Blood Products Advisory Committee (BPAC) was held. During BPAC's discussion of strategies to manage iron deficiency associated with blood donation in the morning of Nov. 17, PPTA presented results of the Association's study of ferritin levels in Source Plasma donors.
PPTA concluded that our data confirm that iron depletion and deficiency are not outcomes of frequent Source Plasma donation; thus, measures needed to protect whole blood and platelet donors are not needed for Source Plasma donors. BPAC agreed that the available scientific evidence confirm that iron supplementation in blood donors mitigates iron deficiency and improves hemoglobin recovery. BPAC also agreed that the available scientific evidence supports the need for routine monitoring of iron stores:
- Without effective iron supplementation: for all blood donors, frequent donors (male and female), and premenopausal female donors.
- With effective iron supplementation: for frequent donors (male and female) and premenopausal female donors, but not for all blood donors.
In the afternoon of Nov. 17, BPAC discussed proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0–12.4 g/dL. BPAC then discussed adverse reactions related to blood donation in teenage (16- to 18-year-olds) donors and the effectiveness of several mitigation measures. BPAC agreed unanimously that the available evidence: indicates that adverse reactions and injuries after blood donation in teenage donors are notable enough concern to require intervention; support applying the donor-specific criterion of estimated blood volume >3500 mL as a means to reduce donor reactions; and suggest that teenage blood donors are susceptible to developing iron deficiency. BPAC also agreed that the available data indicate that the specific measure of applied muscle tension is effective to minimize reactions.
In the morning of Nov. 18, BPAC heard an informational session on the Zika virus and blood safety in the U.S. BPAC then heard presentations on the Transfusion Transmissible Infections Monitoring System and the FDA workshop on preclinical evaluation of red blood cells for transfusion. PPTA thanks BPAC Industry Representative Toby Simon, M.D. (CSL Behring), whose term ended on November 18, for his service since 2012.
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115th meeting of the FDA Blood Products Advisory Committee +
On April 4, PPTA staff attended the 115th meeting of the FDA Blood Products Advisory Committee in Silver Spring, Md. In the morning, the Biologics License Application of Novo Nordisk's Recombinant Human Coagulation Factor IX, GlycoPEGylated, was discussed. Committee comments focused on the safety of the product, including risks in the intended population, particularly in the pediatric and elderly populations, and in the setting of life-time administration, and whether monitoring—particularly of neurologic function—should be provided for the safety of patients or study subjects.Read More
PPTA Presents at ACBTSA Meeting +
PPTA Standards Programs