The Food and Drug Administration announced Thursday that it has officially ended the agency’s blanket ban on blood donations from gay and bisexual men, a longstanding policy denounced as discriminatory.
Instead, the FDA is finalizing guidelines that include a questionnaire for all donors to find out about their recent sexual activity. More focused questions will focus on whether someone has had new sex partners 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 under these screening criteria would still be turned away.
The revised policy would also prevent blood donations from people taking oral PrEP to prevent HIV infection, a restriction the agency says was designed to prevent false negative blood screening results.
In the revised policy, the FDA has taken inspiration from Canada and the United Kingdom, which have taken similar approaches. The American agency is working on the change for months and said it also looked at data from other countries and from a US study looking at this method.
Why it matters: There is a shortage of blood
Blood donations are sorely needed. They dropped during and after the pandemic as school and office blood drives decreased.
The old rules were much more restrictive in weeding 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 maximizing donations.
“This shift to 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, director General of America’s Blood Centers, which represents independent blood centers that supply 60% of the nation’s donations.
Background: PrEP criteria have been criticized
GLAAD, an LGBTQ advocacy group, applauded the change as the end of a “dark and discriminatory past rooted in fear and homophobia”. But the organization criticized the FDA’s decision to refuse donors taking PrEP drugs, saying the measure would add “unnecessary stigma”.
“The bias built into this policy may, in fact, 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 could carry a higher risk of infection.
“Although HIV is not sexually transmitted by people with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is given intravenously and a transfusion involves a large volume of blood through to exposure through sexual contact,” the FDA said. said Thursday in a press release.
What’s Next: Blood Centers Will Update Their Policies
Vitalent, a blood donation company, said it would adopt the agency’s revised screening rules by updating its donor background questionnaire and computer systems and training staff.