FDA Finalizes Blood Donor Eligibility Guidance

blood donation

On May 11, 2023, the U.S. Food and Drug Administration released final guidance providing recommendations for evaluating blood and plasma donor eligibility using individual risk-based questions. Consistent with FDA’s January 2023 proposed guidance, the final guidance eliminates time-based donation deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Instead, FDA recommends that donor history questionnaires ask all donors, regardless of sex or gender, to answer individual risk-based questions designed to reduce the risk of transfusion-transmitted HIV. 

The FDA recommends that people taking medications to treat or prevent HIV infection be deferred from donating. FDA notes that, “though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV,” thereby potentially yielding false negative results.  

FDA notes that its revised donor eligibility guidance aligns with policies in place in countries such as Canada and the United Kingdom. FDA also reports that the revised guidance is supported by national and international blood safety data, including information collected through FDA’s ongoing surveillance of the U.S. blood supply and the FDA-funded ADVANCE study.  

Publication of FDA’s final guidance does not automatically trigger an immediate change in blood donation policies. Blood collection establishments will have to revise their blood donor history questionnaires, obtain FDA review and sign-off, and publish the questionnaires, before newly-eligible donors will be able to donate. 

HFA, on our own and as a member of the American Plasma Users Coalition (APLUS), has consistently advocated that blood safety policies must be based on science and must protect the health and safety of the end user. In advance comments on the revised guidance, APLUS commended FDA’s transition to an individual risk-based assessment; advocated for ongoing surveillance and data collection activities around donor eligibility; and urged continued efforts to develop and implement effective pathogen inactivation methods. HFA will continue to champion these principles as we monitor the implementation of the revised guidance.