Alan Williams, PhD
Associate Director for Regulatory Affairs (HFM-300)
Food and Drug Administration
Center for Biologics Research and Review
Woodmont Office Center, Suite 400N
1401 Rockville Pike
Rockville, MD 20852
Dear Dr. Williams:
The AABB Interorganizational Task Force on Influenza Pandemics and the Blood Supply appreciates the Food and Drug Administration’s (FDA) assistance in working to ensure that patients’ blood needs can be met in the event of a severe influenza pandemic. As we have discussed, there is widespread concern that a severe pandemic will severely impact the availability of blood products as individuals who are sick or caring for sick loved ones will not be able to donate.
In an effort to prevent critical blood shortages, the Task Force has developed a template to request an exception for a shorter inter-donation interval for Whole Blood and Red Blood Cell donations in the event of a pandemic. Experience with donors with hemochromatosis has shown that donors can tolerate phlebotomy much more frequently than the standard eight-week requirement, so long as they have acceptable hemoglobin levels. The Task Force believes that allowance for a shorter inter-donation interval is the most significant step that FDA can take to alleviate shortages during a pandemic. We are asking FDA to acknowledge that the language proposed in the attached draft template is appropriate so that the Task Force can distribute it to blood collection facilities working to prepare for a severe pandemic.
In addition, during the last meeting of the Task Force, the concept of a “walking donor” pool – i.e., allowing blood collected from individuals who had successfully donated in the previous six months to be distributed prior to infectious disease testing, which would be completed subsequently – was introduced. The Task Force would welcome your expansion on how you see such an approach being applied. Would the donor examination or history be amended or truncated? Would testing requirements be relaxed? Please let us know your thoughts.
Thank you for your efforts to address blood supply issues relating to a possible influenza pandemic. The Task Force looks forward to your response to the above requests.
Louis Katz, MD
Cc: Elizabeth Callaghan