The U.S. Food and Drug Administration (FDA) published the final guidance titled “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.” The FDA guidance officially shifts the U.S. to individual donor assessments for blood donor screening rather than sexual orientation, eliminating time-based deferrals for sexually active gay and bisexual men and women who have sex with them. FDA did not state a specific timeframe for guidance implementation.
The final guidance is in part based on scientific findings and data from the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study, which will be published in peer-reviewed medical journals. While the final guidance did not materially change from the draft guidance, it does include several clarifications such as:
- in line with America’s Blood Centers’ (ABC) joint comments to FDA, the agency included a recommendation that donor educational materials indicate that individuals should not discontinue their prescribed medications, including pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), in order to donate blood.
- As requested in ABC’s comments to FDA, the guidance provides clarification on the definition of a “new partner” by including examples of what would be considered having sex with a new partner, including having sex with someone for the first time, or having had sex with someone in a relationship that ended in the past and having sex again with that person in the last three months. Additionally, if a donor has questions about whether, for the purposes of blood donation, they are considered to have had sex with a new partner, the blood establishment’s responsible physician must evaluate the donor’s responses and determine the eligibility of the donor (21 CFR 630.5 and 630.10(a)).
Additionally, the final guidance continues the deferral for PrEP/PEP. Donor deferral for use of PrEP and PEP drugs, regardless of gender or sexual orientation, remains in place with an individual deferral of three months after the last oral dose or two years after the last injection of a medication to prevent HIV infection. The reason for this deferral is the available data demonstrate that the use of PrEP and PEP may delay detection of HIV by currently licensed screening tests for blood donations, potentially resulting in false negative results. The guidance also maintains the recommendations for deferral of individuals for HIV risk from April 2020 FDA guidance, including a three-month deferral for individuals who have exchanged sex for money or drugs, or have a history of non-prescription injection drug use, as well as individuals with other HIV risk factors, including contact with another person’s blood, receipt of a blood transfusion, or a recent tattoo or piercing. Finally, the guidance continues the permanent deferral for any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection. It also maintains the requirements that blood establishments test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
The FDA also published Guidance for Industry titled “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.” This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the Association for the Advancement of Blood & Biotherapies (AABB) Donor History Task Force.
ABC issued a news release supporting the FDA’s policy change. “This shift toward individual donor assessments prioritizes the safety of America’s blood supply while treating all donors with the fairness and respect they deserve,” said ABC Chief Executive Officer Kate Fry, MBA, CAE. “The FDA’s final guidance is based on data showing the best protection against diseases like HIV is through strong testing of all blood donations and a uniform screening process for all donors…It is important to note that these changes cannot be implemented overnight. We will continue working with our member blood centers to welcome impacted donors as quickly as possible.”
The blood community also issued a statement in support of the final guidance. “ABC, AABB, and the American Red Cross “applaud the important, science-driven step forward in blood donation criteria that will base eligibility on an individual donor assessment using the same set of questions for all donors, regardless of sexual orientation…The blood community is united in its commitment to maintain the safety and availability of the nation’s blood supply. Evidence from the Transfusion Transmitted Infections Monitoring System (TTIMS), other countries, and from the recent ADVANCE study support evaluating donor eligibility using individual donor assessment and other existing safeguards.”
ABC will continue to provide updates on the FDA guidance and implementation of the shift to individual donor assessments.