FDA relaxes ban on blood donations from gay and bisexual men
The news
The Food and Drug Administration announced this on Thursday formally ended the agency’s extensive ban on blood donations from gay and bisexual men, a long-standing policy that was labeled discriminatory.
Instead, the FDA is finalizing guidelines that include a questionnaire for all donors designed to learn about their recent sexual activity. The more focused questions will focus on whether someone has had new or multiple sex partners and anal sex in the past three months.
Potential donors who have had recent sex with new or multiple partners and anal sex below those screening criteria would still be rejected.
The revised policy would also exclude blood donations from people taking oral PrEP to prevent HIV infection, a restriction the agency says was designed to prevent false-negative results during blood tests.
In the revised policy, the FDA took its lead from Canada and the United Kingdom, which followed similar approaches. The US agency has been working on the change for months and said it also reviewed data from other countries and from a US study on this method.
Why it matters: There’s a blood shortage
Blood donations are desperately needed. They fell during and after the pandemic with the decrease in school and office blood drives.
The old rules were much more restrictive in excluding gay or bisexual men. The update enables blood donation companies to take a more evidence-based approach to reducing the risk of HIV transmission while maximizing donations.
“This shift to individual donor assessments prioritizes the safety of the U.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 serve 60 percent of the donations of the country.
Background: PrEP criteria received criticism
GLAAD, an LGBTQ advocacy group, hailed the change as an end to “a dark and discriminatory past rooted in fear and homophobia”. But the organization criticized the FDA’s decision to reject donors taking PrEP medications, saying the move would add “unnecessary stigma.”
“The bias embedded in these policies could actually cost lives,” GLAAD said in a statement Thursday.
The agency said PrEP drugs were effective in reducing the spread of HIV through sexual contact, but warned that blood transfusions may carry a higher risk of infection.
“While HIV is not sexually transmitted by individuals with undetectable viral levels, this does not apply to transfusional transmission of HIV because a blood transfusion is administered intravenously and a transfusion involves a large volume of blood compared to exposure through sexual contact” , the FDA said. said in a press release Thursday.
What’s Next: Blood centers will update the policy
Vitalent, a blood donation company, has said it would adopt the agency’s revised screening rules by updating its donor history questionnaire and computer systems and by training staff.