The Food and Drug Administration introduced on Thursday that it had formally ended the company’s wide-ranging prohibition on blood donations from homosexual and bisexual males, a longstanding coverage that had been denounced as discriminatory.
Instead, the FDA is finalizing steerage that features a questionnaire for all donors that’s aimed toward studying about their current sexual exercise. The extra focused questions will focus on whether or not somebody has had new or a number of intercourse companions or anal intercourse within the final three months.
Potential donors who had current intercourse beneath these screening standards can be turned away.
The revised coverage would additionally preclude blood donations from individuals taking oral PrEP to forestall HIV an infection, a restriction the company stated was designed to keep away from false-negative outcomes throughout blood screening.
In the revised coverage the FDA took its cues from Canada and the United Kingdom, which adopted related approaches. The US company has been working on the change for months and stated it additionally reviewed information from different nations and from a US examine inspecting this methodology.
Why It Matters: There is a blood scarcity
Blood donations are sorely wanted. They fell throughout and after the pandemic with the lower in school- and office-based blood drives.
The outdated guidelines have been much more restrictive in screening out homosexual or bisexual males. The replace permits blood donation corporations to make use of a extra evidence-based technique to scale back the chance of HIV transmission whereas additionally maximizing donations.
“This shift towards particular person donor assessments prioritizes the security of America’s blood provide whereas treating all donors with the equity and respect they deserve,” stated Kate Fry, the chief govt of America’s Blood Centers, which represents unbiased blood facilities that provide 60 p.c of the nation’s donations.
Background: PrEP standards have been criticized
GLAAD, an LGBTQ advocacy group, applauded the change as an finish to “a darkish and discriminatory previous rooted in concern and homophobia.” But the group criticized the FDA’s choice to show away donors taking PrEP medicines, saying the measure would add “pointless stigma.”
“The bias embedded into this coverage might, in actual fact, value lives,” GLAAD stated in a press release Thursday.
The company stated that PrEP medication have been efficient in lowering the unfold of HIV by way of sexual contact, however warned that blood transfusions may carry the next danger of an infection.
“Although HIV is just not transmitted sexually by people with undetectable viral ranges, this doesn’t apply to transfusion transmission of HIV as a result of a blood transfusion is run intravenously, and a transfusion entails a big quantity of blood in comparison with publicity with sexual contact,” the FDA stated in a information launch on Thursday.
What’s Next: Blood facilities will replace insurance policies
Vitalent, a blood donation firm, has stated that it could undertake the company’s revised screening guidelines by updating its donor historical past questionnaire and pc programs and by coaching workers.