American Red Cross Statement on FDA MSM Deferral Policy

April 1, 2021 — The American Red Cross issued the following statement regarding the U.S. Food and Drug Administration’s guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” which outlines the deferral criteria for men who have had sex with men (MSM):

The American Red Cross seeks to build an inclusive environment that embraces diversity for all those who engage with our lifesaving mission. As such the Red Cross believes blood donation eligibility should not be determined by methods that are based upon sexual orientation and is committed to working with partners toward achieving this goal.

In April 2020, the U.S. Food and Drug Administration reduced the deferral time for men who have sex with men (MSM) from 12 to three months. The Red Cross is encouraged by this action, which we view as an interim step to achieving our greater goal. But the Red Cross also recognizes that further progress is needed, and we continue to strongly support the expanded use of new research and technologies to work toward elimination of donor eligibility questions that would no longer be necessary. 

In December 2020, the Red Cross, along with One Blood, Vitalant and partner LGBTQ+ community health organizations, launched 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 ADVANCE Study is focused on evaluating alternatives to the FDA’s MSM policy. 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 deferral related to MSM 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.

The Red Cross, like all blood collectors in the U.S., is required to follow the eligibility guidelines issued by the FDA. While the Red Cross cannot unilaterally enact further changes to the MSM deferral policy, we will continue to work with other U.S. blood collection organizations to gather and provide data to the FDA for additional research and evaluation.

We remain steadfast in our commitment to ensure that every blood recipient receives safe, lifesaving blood when needed. We ask advocates and stakeholders to join us in this important dialogue and pathways toward achieving our goal, while recognizing the need to always maintain patient safety. Together, we will work toward an inclusive and equitable 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.

Review information about blood donation eligibility and the LGBTQ+ community.