SFAF Statement on Proposed Blood Donation Policy Changes by FDA
SAN FRANCISCO, March 23, 2023 – San Francisco AIDS Foundation is glad to see a proposed policy change that moves away from identity-based criteria and time-based deferrals to assess ‘risk’ in blood donation, and instead implements donor history questionnaires that would more reliably assess HIV risk. This proposed change in policy would allow many more gay, bisexual, and other men who have sex with men to safely donate blood, and would remove blood donation requirements rooted in stigma and discrimination.
We do still have lingering concerns about the current version of the proposed policy, namely that people who are taking oral or injectable PrEP–a highly effective method of HIV prevention–are excluded from blood donations with a three month (oral) and two month (injectable) deferral. This counterintuitive policy would in practice prevent people who are the most engaged in HIV prevention from donating, and would even suggest to some that if they wished to donate blood, they would need to stop their PrEP medications for some number of months–effectively increasing their risk for infection.
Although some research has shown that use of PrEP may interfere with HIV testing, producing false negative results, new technologies are in development that may prevent transmission of HIV in plasma and platelets. We urge the FDA to follow recommendations by the American Academy of HIV Medicine and expedite development of these technologies.
We also have concerns about excluding people of any sexual orientation from donating based on sexual activity with one or more sex partners in the previous three months without assessing risk-reduction strategies employed during sex with new partners.
We look forward to working with others in the community and the FDA to further reduce stigmatizing and marginalizing policies that draw unreasonable distinctions between sexually active adults of all genders, identities and orientations.
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The FDA has a 60-day comment period that is now open for the proposed guidelines. Once the comment period closes, the FDA will finalize the guidelines. Afterward, blood collection centers in the U.S. will then implement the new individual assessment criteria.
To read the FDA’s announcement, visit: https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply
To review the full draft guidelines, visit: https://www.fda.gov/media/164829/download
To comment on the proposed guidelines, visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human