Last week, the U.S. Food and Drug Administration’s (FDA) Blood Products Advisory Committee (BPAC) met for two full days of sausage making—not always pretty, but the committee came up with a tasty product. Two topics were of particular interest to ABC member blood centers. Bacterial contamination of platelets was the subject of draft guidances from the agency in December 2014 and again in March 2016. ABC commented repeatedly on these, last in late winter of this year to urge FDA to make available an approach like that used in the United Kingdom, Héma-Québec and most recently Canadian Blood Services. It is delayed, high volume primary culture, in return for 7-day platelet dating without secondary bacterial testing on day 4 and later during storage. If the FDA accepts the recommendation of the BPAC (it is not required to do so), we can deliver to hospitals a safe, ready-to-use platelet that requires no further testing and/or relabeling there. Extended dating will be associated with lower outdates and offer operational advantages in collection facilities that will offset at least part of the increased cost of enhanced sensitivity. Consider this a victory for safety, customer service, and blood center operations—win-win-win. If pathogen reduction is the most effective approach to bacterial safety in platelets, then we now have a rest stop on the road to that approach while manufacturers make the process(es) more “user friendly.”
The urgent August 2016 guidance about the threat to recipients from Zika virus was not free of controversy. It was issued at a time of uncertainty about the importance of Zika to transfusion medicine, and the requirement for universal individual donor nucleic acid testing. Many of us asked if it was commensurate with what we estimated to be a low, but admittedly not zero, risk from the virus. I certainly questioned whether consuming the time and money required, without a more formal public assessment, was appropriately risk-based decision-making from a societal standpoint. At the time, and in part in response to our (the blood community’s) position, leadership at the FDA’s Center for Biologics Evaluation and Research and its Office of Blood Research and Review committed to timely reassessment of the guidance based on experience and new data. The discussion last week fulfilled that commitment and has resulted in what can be characterized as an evidence-based approach. The BPAC has recommended a strategy going forward that looks very much like that in use, with great success, for West Nile virus. Given that our vendors charge per donor tested, not per assay run, it will not save us much money, but it does simplify and rationalize our approach while we watch the progress of the Zika pandemic unfold. Explicit in BPAC discussions of Zika testing was the fact that no strategy will be perfect—there is no such thing as zero risk—but there was implicit and explicit recognition in the recommendation that there is such a thing as tolerable risk when it is managed appropriately. Development of ABC’s positions on these two subjects has been a bit like sausage-making too, but a messy, difficult process does not make it any less important. Members’ responsiveness to our request for thought, advice, criticism, and finally consensus is the core of our increased focus on advocacy—this makes your participation only more important. Stay tuned.
Louis Katz, MD; Chief Medical Officer & Interim CEO