FDA Study Could End Gay, Bisexual Men Blood Donation Ban

The FDA has launched a study that could lead to removing blood donation restrictions by gay or bisexual men.

Gay and bisexual men were banned for life from donating blood in the U.S. at the height of the AIDS epidemic in 1985. The FDA amended those rules in 2015, allowing gay men who had been celibate for 12 months to donate blood, and shortened the time frame to three months in April during the COVID-19 pandemic due to blood shortages.

The purpose of the study, titled Assessing Donor Variability and New Concepts in Eligibility, or ADVANCE, is to ''determine whether a different donor deferral can be used at blood centers nationwide while maintaining the safety of the blood supply.''

''For this to be possible, a change would need to be made to the donor history questionnaire, and this study is the first step in assessing the safety of a change.''

A blood donation questionnaire ''to assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV'' could then potentially replace blanket restrictions.

The agency will evaluate 2,000 gay and bisexual men who have had sex with at least one other man in the three months before joining the study and who want to donate blood.

The FDA will partner with LGBTQ+ Centers in Washington, D.C., San Francisco, Orlando, New Orleans/Baton Rouge, Miami, Memphis, Los Angeles and Atlanta along with three of the nation's largest blood centers — Vitalant, OneBlood and the American Red Cross — to gather its data.

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