America’s Blood Centers (ABC), The Association for the Advancement of Blood and Biotherapies (AABB), and the American Red Cross (ARC) submitted this joint comment letter to the FDA regarding its guidance on reducing Mycobacterium tuberculosis (Mtb) transmission risk in human cells, tissues, and cellular and tissue-based products (HCT/Ps).
This feedback addresses several crucial aspects of the guidance, including Mtb testing limitations, geographical risk factors, clinical evidence interpretation, physical evidence screening, and considerations for domino transplants. The organizations highlight the potential for false-positive results in TB testing and request clarification on donor eligibility determination algorithms. The blood community is seeking a more precise definition of “areas where TB is common” and request specific resources for identifying high-risk countries. The letter emphasizes the need for clearer differentiation between Mtb infection symptoms and other conditions, particularly for healthy donors of cellular starting materials. Clarification is also requested on the process of physical assessment for these donors. Additionally, the organizations propose an alternative approach for mitigating Mtb risk in domino partial heart transplants without requiring time-consuming mycobacterial cultures.
This expert feedback from leading blood and biotherapy organizations provides critical insights into the practical implications of the FDA’s guidance and highlights potential challenges in implementation, offering key suggestions for improvement.