In December 2015, the Food and Drug Administration (FDA) moved from a lifetime ban on gay and bisexual men donating blood to a deferral of one year for any man who has had sex with another man during the past 12 months. According to the Food and Drug Administration, this pre-screening eliminates up to 90 percent of donors who may be carrying a blood-borne disease.
On April 2, 2020, the Food and Drug Administration (FDA) announced that it was updating its policy regarding blood donations from men who have sex with men (MSM), reducing the deferral period from 12 months to three months. Blood centers nationwide screen potential donors by asking a set of questions written to determine risk factors that could indicate possible infection with a transmissible disease, such as HIV or hepatitis. According to the Food and Drug Administration, this pre-screening eliminates up to 90 percent of donors who may be carrying a blood-borne disease.
On June 8, the American Red Cross implemented the changes to donor eligibility criteria announced earlier this spring by the FDA. They encourage individuals who believe they may now be eligible to give under the new guidelines to visit RedCrossBlood.org to learn more about donor eligibility requirements that help ensure the safety of both blood donors and blood recipients.
The FDA’s Center for Biologics Evaluation and Research regulates and establishes standards for the collection of blood and blood products. The center receives advise on this issue by the Blood Products Advisory Council, which meets regularly to consider issues such as altering the pool of potential blood donors.
Every donated unit of blood undergoes a rigorous series of tests to determine any possible presence of HIV, hepatitis, syphilis and other blood-borne disease. None of these tests, however, are 100 percent accurate, and they can produce faulty results. For instance, despite current restrictions and testing of approximately 12 million units donated each year, 10 HIV-infected units have slipped through. To ensure the safety of blood and other tissues for donation, the FDA uses scientific data to automatically defer certain populations. Because gay and bisexual men have higher incidence of disease, they are eliminated from the donor pool immediately.
Human Rights Campaign believes that the updated policy, like its precursors, does not treat persons with like risks in a similar way. It also believes that donors are deferred based on their membership in a group — in this case, all men who have sex with men — rather than engagement in risky behavior, such as unprotected sex. For example, a man who has had protected oral sex with another man once in the 3 months currently barred from donating blood. Yet a woman who has had unprotected sex with multiple partners over the same time frame with no knowledge of their personal histories remains in the donor pool.
HRC believes that the integrity and safety of the blood supply in this country should be preserved, strengthened and maintained. Any change or alteration in the regulations governing donor suitability must be based in science. The federal government must invest in new research to study risk behavior. HRC has strongly encouraged FDA to revise the donor questionnaire based on an individual risk assessment of sexual behaviors upon which all donors are evaluated equally, without regard to sexual orientation or gender identity.
As part of its announcement of the revised deferral policy, the FDA indicated was undertaking the research necessary to modernize the donor questionnaire.