The FDA guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” states, “Defer for 3 months from the most recent sexual contact, a man who has had sex with another man during the past 3 months.” All U.S. blood collection organizations must follow this federal requirement.
The Red Cross recognizes the hurt this policy has caused to many in the LGBTQ+ community and believes blood donation eligibility should not be determined by methods that are based upon sexual orientation. We are committed to working with partners toward achieving this goal.
We continue to assist in evaluating alternative donor eligibility criteria and the expanded use of new technologies to work toward elimination of donor eligibility questions based on sexual orientation that would no longer be necessary. However, as a regulated organization, we cannot unilaterally enact changes concerning the MSM deferral policy.
In order to gather data related to the possibility of using an individual risk assessment behavior-based health history questionnaire in the U.S., the Red Cross, along with One Blood, Vitalant and partner LGBTQ+ community health centers, are participating in a pilot study funded by the FDA in select cities that could potentially lead to changes for blood donor eligibility criteria for gay and bisexual men. The study is focused on evaluating alternatives to determining donor eligibility.
This study is a first step in providing data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as a time-based MAM deferral in reducing the risk of HIV in the blood supply. If the study’s scientific evidence supports the use of the different eligibility questions, it could lead to further efforts to change the MSM eligibility criteria. More information about this study is available at ADVANCEStudy.org.
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