America’s Blood Centers (ABC), the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross submitted joint comments to the U.S. Food and Drug Administration’s (FDA) guidance titled “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry” supporting a shift to more inclusive donor eligibility criteria. In the comments, the blood community expressed their support for “evidence-based decision-making to update donor eligibility requirements” also requesting that the agency replace individual risk assessment with individual donor assessment in the final guidance “to remove the negative connotation perceived by donors and the public.”
The comments urged the agency to address donor use of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and antiretroviral therapies (ART) by requesting that “federal government partners join FDA in protecting the safety of the blood supply by actively promoting consistent messaging at every opportunity to the public.” The blood community also advocated for timely evaluation of evidence-based decisions to update requirements for blood products to determine where similar updates can be appropriately applied to requirements for biotherapy products.”
Additionally, the blood community asked the agency to assist with messaging on implementation timelines by “establish[ing] public messaging noting FDA’s landmark decision and emphasizing our collective commitment to sustaining the high level of safety for our blood supply.” In particular, communicating landmark changes, such as those proposed by FDA, must “be implemented with a commitment to safety over speed to maintain the public’s trust in the blood supply [and] require extensive staff training and education, [along with] patience and public support for blood donor centers supplying transfusion services to meet the needs of patients across the country.”
The blood community also requested that implementation “recognize the challenges and extended implementation timelines based on the collection of plasma for further manufacture.”
The comments also provided:
- recommendations on “clarification [of the] reference to ‘positive test’ verses ‘confirmed positive test;’”
- recommendations on clarification of “sexual contact with a person who has ‘ever had a positive test for HIV’ versus a ‘confirmed positive test for HIV;’”
- recommendations on the “definition of a ‘new partner;’” and
- recommendations on “calculating the donor deferral period.”
The blood community concluded the comments by recognizing the FDA’s “commitment to evidence-based donor eligibility recommendations to support the safety and availability of the blood supply” and expressing gratitude for the agency’s willingness to “work with us as we review the published data supporting the recommendations in the final guidance and prepare for the complex implementation process which will follow.”