FDA ends prohibition of blood donations by gay, bisexual men

The Food and Drug Administration announced Thursday that it had formally ended the agency's wide-ranging prohibition on blood donations from gay and bisexual men, a long-standing policy that had been denounced as discriminatory.

Instead, the FDA is finalizing guidance that includes a questionnaire for all donors that is aimed at learning about their recent sexual activity. The more targeted questions will focus on whether someone has had new or multiple sex partners and anal sex in the last three months.

Potential donors who had recent sex with new or multiple partners and anal sex under those screening criteria still would be turned away.

The revised policy would also preclude blood donations from people taking oral PrEP to prevent HIV infection, a restriction the agency said was designed to avoid false-negative results during blood screening.

In the revised policy, the FDA took its cues from Canada and the United Kingdom, which adopted similar approaches. The U.S. agency has been working on the change for months and said it also reviewed data from other nations and from a U.S. study examining this method.

Blood donations are sorely needed. They fell during and after the pandemic with the decrease in school- and office-based blood drives.

The old rules were far more restrictive in screening out gay or bisexual men. The update allows blood donation companies to use a more evidence-based way to reduce the risk of HIV transmission while also maximizing donations.

“This shift toward individual donor assessments prioritizes the safety of America's blood supply while treating all donors with the fairness and respect they deserve,” said Kate Fry, the CEO of America's Blood Centers, which represents independent blood centers that supply 60% of the nation's donations.

GLAAD, an LGBTQ+ advocacy group, applauded the change but criticized the FDA's decision to turn away donors taking PrEP medications, saying the measure would add “unnecessary stigma.”

The agency said PrEP drugs were effective in reducing the spread of HIV through sexual contact but warned that blood transfusions could carry a higher risk of infection.