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Vitalant Statement Regarding FDA’s Proposed Individual Risk Assessment for Blood Donations
Vitalant provides the following statement regarding the FDA’s draft guidance "Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products":
Jan. 27, 2023 – Vitalant is dedicated to welcoming as many people as possible to contribute to a safe and sufficient blood supply for patients in need. We believe that donor eligibility criteria should be based on the latest available scientific data, not sexual orientation, and support the FDA’s proposed guidance for an individual risk assessment for reducing the risk of HIV in the blood supply.
Vitalant served as the primary investigator and coordinator for the FDA-funded study called ADVANCE. During the study, Vitalant, OneBlood, the American Red Cross and partnering LGBTQ+ organizations enrolled participants and collected data to assist the FDA in evaluating alternatives to the current men who have sex with men (MSM) policy for gay and bisexual men. We are pleased that this data, along with data from the United Kingdom and Canada, was helpful in the FDA’s decision to recommend an individual-based risk assessment.
As the FDA indicated, today’s proposal will be open for public comment before it is finalized. We will continue to work with the FDA and industry partners as the guidance progresses. It’s important to note that this change cannot happen overnight. Once final, it will take time to update the donor history questionnaire and our computer systems, and train our staff, which we intend to complete as quickly as possible.
Vitalant (“Vye-TAL-ent”) is the nation’s largest independent, nonprofit blood services provider exclusively focused on providing lifesaving blood and comprehensive transfusion medicine services for about 900 hospitals and their patients across the U.S. Every day, Vitalant needs to collect nearly 5,000 blood, platelet and plasma donations to help save lives. For more information and to schedule a donation appointment, visit vitalant.org or call 877-25-VITAL (877-258-4825). Follow us on Facebook, Twitter and Instagram.
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