May 25, 2023
Peter Marks, MD, PhD, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, joined an AABB Hot Topic Discussion this afternoon to provide more information to the blood community on the FDA’s final guidance on individual donor assessments (IDA) to determine blood donor eligibility and to answer questions from the audience. The session was moderated by Sharon Carayiannis, MT(ASCP)HP, AABB’s vice president, science and practice.
During the session, Marks reiterated that FDA assessed findings from several sources – including the Transfusion Transmitted Infection Monitoring System (TTIMS), results from the United Kingdom and Canada, and data from the ADVANCE study – to confirm that moving to an IDA policy for donor eligibility would continue to ensure the highest levels of quality, safety and availability for the blood supply. Marks also applauded the collaboration among various members of the blood community who worked together to confirm the data and ensure policy changes could be made safely and effectively.
Marks pointed out key findings from the ADVANCE study and noted the role this research played in advancing policy change. In particular, he said the results showed that among people not taking PrEP, there were a reasonable number that had only one sexual partner – and not a new partner – in the previous three months. Any HIV infections among these donors would have been longstanding and, therefore, detected by current testing methods. The conclusion was that such donors should be eligible to donate without adding concerns to the safety of the blood supply.
Marks also discussed the implementation timeline for blood centers throughout the country. “We expect some blood collectors to be able to begin accepting donations under the new criteria as early as June 2023,” he said. “Some blood collection systems may require a few months to implement and will need additional time to enable computer reprogramming and training.”
Marks acknowledged that many blood centers are currently constrained by various challenges and must continue to collect blood while implementing new protocols. “We understand the challenges here,” he said. “However, we expect all centers to be making a good faith effort to move in the right direction.”
Additional information on IDA – including preparatory and training materials – is available in AABB’s IDA Resource Library. AABB’s “Toolkit for Implementation of Individual Donor Assessment and the Donor History Questionnaire Version 4.0 and Accompanying Materials” is also available for operational assistance and considerations.