The American Red Cross issued the following statement regarding the U.S. Food and Drug Administration’s guidance “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”:
“The American Red Cross is committed to achieving an inclusive blood donation process that treats all potential donors with equality and respect, and ensures a safe, sufficient blood supply is readily available for patients in need.
The U.S. Food and Drug Administration’s draft guidance which proposes new blood donor-eligibility criteria using a gender-inclusive, individual risk-based assessment - regardless of sexual orientation – to reduce the risk of transfusion transmitted HIV is a critical step forward toward that goal.
The Red Cross is committed to making these eligibility changes as quickly as possible however, development of a new industry health history questionnaire and implementation of the guidance requires coordination with multiple organizations including the FDA and the AABB. We will have more information on this timeline in the weeks ahead.
The Red Cross has worked for many years to change the deferral policy concerning men who have sex with men (MSM) – this work included decades of data collection and assessment on the impact to transfusion safety, ongoing advocacy to eliminate donor questions based on sexual orientation, and our recent role as a leading contributor in the FDA-funded ADVANCE Study. While the proposed eligibility change to an individual risk-based assessment marks significant progress, there is more work to be done and we will continue to provide data to the FDA in support of further progress.
The Red Cross also recognizes the hurt this policy has caused and that these are just the first steps in repairing relationships with the broader LGBTQ community.
The FDA process will allow 60 days for public comment on this draft guidance, and we encourage individuals to share their feedback during this period.”