This joint comment from the Association for the Advancement of Blood and Biotherapies (AABB), America’s Blood Centers (ABC), and the American Red Cross (ARC) to the U.S. Food and Drug Administration (FDA), offers feedback on the draft guidance concerning the mitigation of Hepatitis B Virus (HBV) transmission through human cells, tissues, and cellular and tissue-based products (HCT/Ps).
In the submission, the organizations express their support for the FDA’s commitment to continuously updating policies based on new evidence to ensure the safety and availability of life-saving products for patients in need. They particularly support the FDA’s revised guidance format, which encompasses separate documents addressing the risk reduction of specific communicable diseases, acknowledging the value of such tailored recommendations.
The submission also highlights concerns regarding the lack of a specified timeframe for assessing the risk of secondary sexual partners, pointing out potential discrepancies in eligibility determinations for donors based on their sexual associations. The organizations urge the FDA to provide clear, time-bound guidelines for such assessments, drawing parallels with the clarity observed in blood donor eligibility criteria.
The submission also advocates for the alignment of HCT/P recommendations with existing blood donor guidelines, emphasizing the importance of maintaining consistency in screening guidelines. Additionally, it requests an extended implementation period of at least one year to allow facilities ample time to effectively integrate and validate the proposed changes within their complex systems, ensuring a smooth transition with minimal disruptions.