ABC member blood centers are dedicated to ensuring patient access to safe and available blood products. Over the past several years, this work has required significant investment in the opening of new donation locations, with ABC members now operating nearly 700 donation locations across the United States. Despite utilizing the same operating procedures, machines, and often staff used at existing locations, blood centers must often wait over a year to receive licensure for these new sites to ship blood across state lines. This disruption in operations impacts the ability of blood centers to serve patients in need and threatens emergency preparedness for the nation’s blood supply.
In response, ABC has conducted extensive work to propose commonsense solutions to streamline and modernize the product licensure process for blood centers. This work has included convening thought leaders from throughout the blood community, industry-wide data collection, and multiple meetings with our partners at the Food and Drug Administration (FDA).
From the outset, we knew that it was critical to create a consistent and reliable licensure process that accelerates the timeline for licensure while not impacting the safety of the nation’s blood supply. We strongly believe this can be accomplished through existing measures like blood center Annual Reports and accelerated approvals, comparability protocols, and standard operating procedures (SOPs). If blood is safe to use in one state, it should certainly be safe to use across a state line without needing to wait a year or more.
While licensure delays are certainly impacted by regulation, it also became clear during our work that some of the delays facing blood centers were the result of inconsistencies that needed clarification by FDA. As such, over the past six months, ABC has engaged FDA in a series of in-depth conversations and communications on licensure, validation, and testing requirements, presenting real-world data to the agency. In response, FDA provided a number of clarifications that will hopefully significantly reduce some wait times. The specific clarifications are available to ABC Member Centers here. Additionally, ABC has developed resources to assist ABC member blood centers in synthesizing the ABC questions to FDA, and FDA’s corresponding responses.
It is important to remember that advocacy is often a marathon, not a sprint, and our work is far from over. However, it is also important that we celebrate intermediate victories, especially those that make more blood available to patients. We thank ABC members for their continued support of our work related to this important advocacy issue. We also commend the FDA for listening to our concerns and proposals, clarifying inconsistencies that led to unnecessary delays in inspections, and committing to work with ABC and the blood community to continue to examine this important issue.
Please contact us with any questions, comments, or suggestions at jcoffey@americasblood.org.