The Food and Drug Administration announced on Thursday that it had formally ended the agency’s wide-ranging prohibition on blood donations from gay and bisexual men, a longstanding policy that had been denounced as discriminatory.
Instead, the F.D.A. 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 or anal sex in the last three months.
Potential donors who had recent sex under those screening criteria would be turned away.
The revised policy would also preclude blood donations from people taking oral PrEP to prevent H.I.V. infection, a restriction the agency said was designed to avoid false-negative results during blood screening.
In the revised policy the F.D.A. 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.
Why It Matters: There is a blood shortage
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 H.I.V. 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 chief executive of America’s Blood Centers, which represents independent blood centers that supply 60 percent of the nation’s donations.
Background: PrEP criteria were criticized
GLAAD, an L.G.B.T.Q. advocacy group, applauded the change as an end to “a dark and discriminatory past rooted in fear and homophobia.” But the organization criticized the F.D.A.’s decision to turn away donors taking PrEP medications, saying the measure would add “unnecessary stigma.”
“The bias embedded into this policy may, in fact, cost lives,” GLAAD said in a statement Thursday.
The agency said that PrEP drugs were effective in reducing the spread of H.I.V. through sexual contact, but warned that blood transfusions could carry a higher risk of infection.
“Although H.I.V. is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of H.I.V. because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact,” the F.D.A. said in a news release on Thursday.
What’s Next: Blood centers will update policies
Vitalent, a blood donation company, has said that it would adopt the agency’s revised screening rules by updating its donor history questionnaire and computer systems and by training staff.