The long-awaited change is near! Gulf Coast Regional Blood Center is reviewing the new proposal from the Food and Drug Administration (FDA) that could ease restrictions on gay and bisexual men as blood donors. The FDA’s proposal to move to an assessment of sexual behavior of individuals, regardless of gender, will maintain the safety of our nation’s blood supply while treating all donors with the fairness, equality, and respect they deserve.
The proposed draft guidance is only the first step in a lengthy process of welcoming some new individuals as blood donors. The entire process will take time, including the public comment period, publication of the final guidance, and blood center implementation of the changes. Gulf Coast Regional Blood Center is committed to moving this change along as quickly as the process allows. We understand many people have waited a very long time for this change, and we look forward to welcoming new donors in as soon as possible!
The Food and Drug Administration (FDA) and Blood Banks
Blood banks across the United States are regulated by the Food and Drug Administration (FDA). The FDA is the agency responsible for enforcing the standards for blood collection and the production of blood products. This includes transfusable components of whole blood, red blood cells, platelets or plasma, and pharmaceuticals that are created from blood. The agency also inspects blood banks and monitors reports of errors, accidents, and adverse clinical events. Gulf Coast Regional Blood Center follows all guidelines implemented by the FDA.
Eligibility and Health Screening
The Food and Drug Administration (FDA) uses scientific data to determine which donors should be deferred based on the health history and tests performed on donated blood. All donors are required to complete pre-donation health screening to determine eligibility before being allowed to give blood. This includes a questionnaire where questions are asked about health history based on past and current behavior risks. All donors must meet the Food and Drug Administration’s (FDA) eligibility to donate. The questions on the health questionnaire follow FDA guidelines.
FAQs
The Food and Drug Administration (FDA) states that men who have sex with men (MSM) can donate blood. However, the FDA’s latest 2020 Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products states MSM can’t donate blood for three months from their most recent sexual contact with another man. This will continue to be the policy for all blood centers until changes from the recent new guidance by the FDA becomes official.
Some parts of the world have lifted restrictions for gay and bisexual men who donate blood. In the United States, a study was conducted in 2022 to determine if different eligibility can be used at blood centers nationwide for gay and bisexual men. Those results were given to the FDA at the end of 2022. Updated guidance on gay and bisexual blood donors from the FDA was released in January 2023.
There are no Food and Drug Administration (FDA) guidelines prohibiting women who have sex with women from donating blood. However, women who have sex with men who have sex with men (MSM) can’t donate blood for three months from their most recent sexual contact with MSM.
The Food and Drug Administration (FDA) recommends blood establishments allow donors to self-identify and self-report for the purpose of blood donation. Deferrals to donate do not exist for transgender donors. However, men who have sex with men (MSM) can’t donate for three months from their most recent sexual contact with another man. Women who have sex with MSM can’t donate for three months from their most recent sexual contact with MSM.
The Food and Drug Administration (FDA) recommends blood establishments allow donors to self-identify and self-report for the purpose of blood donation. Men who have sex with men (MSM) can’t donate for three months from their most recent sexual contact with another man. Women who have sex with MSM can’t donate for three months from their most recent sexual contact with MSM.
All donated blood is tested by the Food and Drug Administration’s (FDA) approved testing kits to detect infectious diseases. Gulf Coast Regional Blood Center is required to test for the following: HIV (human immunodeficiency virus) type 1 and 2, Hepatitis B and C, Syphilis, Human T-Lymphotropic Virus (HTLV) type I and II, West Nile Virus and Chagas disease. Donated blood must be quarantined until it is tested and shown to be free of infectious disease before going to hospitals.
During the Acquired Immune Deficiency Syndrome (AIDS) epidemic in the 1980’s, the FDA implemented the first blood donor deferral policy in 1983 based on the little information the agency had about the disease. In 1984, it was discovered that the bloodborne pathogen HIV was the cause of AIDS, and that there were high rates of cases in men who have sex with men (MSM). In 1985, the FDA restricted MSM and people engaging in sex work and intravenous drug use from donating blood indefinitely.
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Gulf Coast Regional Blood Center would like to thank you for taking the time and exploring these topics!