The news
The Food and Drug Administration announced on Thursday that it formally ended the agency’s broad ban on blood donations from gay and bisexual men, a longstanding policy that has been denounced as discriminatory.
Instead, the FDA is finalizing guidance that includes a questionnaire for all donors to learn 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 past three months.
Potential donors who have had recent sexual intercourse under these screening criteria would be rejected.
The revised policy would also bar blood donations from people taking oral PrEP to prevent HIV infection, a restriction the agency said was designed to prevent false-negative results during blood screening.
In the revised policy, the FDA followed suggestions from Canada and the United Kingdom, which took similar approaches. The US agency has been working on the change for months and said it has also reviewed data from other nations and from a US study examining this method.
Why it matters: There is a shortage of blood
Blood donations are sorely needed. They dropped during and after the pandemic with the decline in blood donations in schools and offices.
The old rules were much more restrictive in selecting 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 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, executive director of America’s Blood Centers, which represents centers independent blood donors who provide 60 percent of the nation’s donations.
Background: PrEP criteria have been criticized
GLAAD, an LGBTQ advocacy group, applauded the move as an end to “a dark and discriminatory past rooted in fear and homophobia”. But the organization criticized the FDA’s decision to deny donors taking PrEP drugs, saying the move would add “unnecessary stigma”.
“The bias built into this policy could, in fact, cost lives,” GLAAD said in a statement on Thursday.
The agency said PrEP medications were effective in reducing the spread of HIV through sexual contact, but warned that blood transfusions could carry a higher risk of infection.
“While HIV is not transmitted sexually 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 contact exposure. sexual activity,” the FDA said in a press release on Thursday.
What’s next: Blood centers will update policies
Vitalent, a blood donation company, said it would adopt the agency’s revised screening rules by updating its donor history questionnaire and computer systems and training staff.
