Saturday is the Fourth of July – a day when we celebrate our country and our freedom. So it’s a particularly appropriate time to consider the relationship between the blood world and our government. (Okay, the declaration of independence was signed on July 4, establishing the anti-government; the government we have now was not really established until several years and a failed try later. But we will celebrate this government anyway.)
Our most transparent relationship with our nation is with the military. We of course are pleased to be able to supplement blood supplies whenever the armed forces needs assistance, and our donors line up in droves to meet those needs. Similarly, military personnel and veterans are an important part of our donor base in many areas. Research conducted or funded by the military over the years has also contributed mightily to our knowledge of transfusion in trauma and other extreme circumstances.
The other most obvious relationship between the government and blood is that with the Food and Drug Administration, which can regulate some of the tiniest details of our operations. Much like a marriage, our relationship with FDA not infrequently has conflict. While both pursue maintaining a safe and sufficient blood supply for each person who needs a transfusion, we do not always see eye to eye.
Often times when considering blood safety interventions, we neither see the same sources of risk, nor do we evaluate and approach risk the same way. One of the advantages of a risk-based decision-making model is that our assumptions and evidence will be more transparent to each other, probably leading to better and earlier consensus. The participation of the Department of Health and Human Services’ Advisory Committee on Blood and Tissue Safety and Availability in this process offers another governmental channel for input. Unlike FDA, that Committee can, by design, evaluate in a broader sense issues like supply and economic considerations.
For years we have complained that the government in general moved too slowly in our field. There have been some recent signs that the regulators are moving more quickly. The draft guidance regarding the deferral for men who have had sex with men (MSM) was issued shortly after all the studies they deemed necessary were completed; the final guidance will probably be issued this year. Blood centers and research organizations have provided important information and data for this project. We hope this cooperation bodes well for future endeavors. As July 4 approaches, we celebrate the cooperation between blood centers and the nation’s government, to provide the best and safest blood for all our people.
Susan Rossmann, MD, PhD, Board President; email@example.com