The Food and Drug Administration (FDA) 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 finalising 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 HIV infection, a restriction the agency said was designed to avoid false-negative results during blood screening.
The Irish Blood Transfusion Service announced changes to blood donation rules in November 2022, with a move to individualised risk-based assessment for all potential donors. It followed years of advocacy from HIV Ireland among others which led to a reduction in the deferral period to four months for gay, bisexual and other men who have sex with men, announced in March 2022. The four-month deferral meant that a man, whose last sexual contact with another man was more than four months ago, was eligible to donate blood.
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In the revised policy, the FDA took its cues from Canada and the United Kingdom, which adopted similar approaches. The US agency has been working on the change for months and said it also reviewed data from other nations and from a US 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 maximising donations.
“This shift toward individual donor assessments prioritises 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 centres that supply 60 per cent of the nation’s donations.
GLAAD, a US LGBTQ+ advocacy group, applauded the change as an end to “a dark and discriminatory past rooted in fear and homophobia”. But the organisation criticised the FDA’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 HIV through sexual contact but warned that blood transfusions could carry a higher risk of infection.
“Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact,” the FDA said in a news release Thursday.
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. – This article originally appeared in The New York Times