Getting Ahead of the Game

The Food and Drug Administration (FDA) does not have any blood donors, much less millions of them. But ABC does. Advocacy is a key value of ABC, an activity highly prized by our members. One reason for an association to exist is that members share common goals in approaching the rule-makers and budget-makers, especially in a field as regulated as blood banking. But there are many types of advocacy, with different time horizons and probabilities of success. We have an opportunity now to work on “preventive advocacy”- that is, doing something ourselves to prevent or inform future regulations. 

The FDA is, of course, interested in donor safety, and especially now in donor hemoglobin. This is mainly about donor safety, but also to ensure a minimum hemoglobin content (and hence oxygen-carrying capacity) in a bag of red cells. It is now clear that the standard pre-donation hemoglobin does not detect depleted iron stores in our donors. This occurs in first-time donors, but most often in those who donate intensively. Our frequent donor programs are excellent in many ways, but may have the unintended consequence of leaving some repeat donors with low iron stores. 

Is this important? Is this dangerous for donors? The evidence is not clear. The Retrovirus Epidemiology Donor Studies  (REDS) studies documented iron depletion in many donors and did not seek evidence of harm to those with low levels. In other clinical contexts, NOT dealing with otherwise healthy donors, there have been suggestions of neurocognitive issues, restless leg syndrome, fatigue, and anemia in those with low iron stores. Low iron stores may be especially common in the teenage years.  

The FDA is not waiting indefinitely for more studies. At the Blood Products Advisory Committee meeting in November 2016, the Committee was asked to comment on various strategies for mitigation of the low iron risk, including measurement of iron stores, provision of education and/or iron replacement medication, and lengthening the interdonation interval. The Committee was essentially unanimous in favor of taking action. So, the FDA is considering regulatory action. We are not sure of the time frame for the FDA, but if we act now, we may prevent guidance that we don’t like. 

The studies to date are on a fairly small scale. We need better operational data, from blood centers of all sizes, to be able to offer strategies that work in the real world. As we work together and gather real world information, we will be able to see what is best for our donors and for us. It will not be simple, and will involve costs-both direct and in loss of donations. Nevertheless, it is incumbent upon us to do this BEFORE others feel the need to impose regulation. In this, we can be our own best advocates.

Susan Rossmann, MD, PhD; Board President; srossman@giveblood.org