Up to date 12:55 p.m. ET
The U.S. Meals and Drug Administration issued proposed steerage Friday to ease restrictions on blood donations by males who’ve intercourse with males.
The change is predicted to take impact after a public remark interval.
The restrictions on donating blood date again to the early days of the AIDS epidemic and have been designed to guard the blood provide from HIV. Initially, homosexual and bisexual males have been utterly prohibited from donating blood. Over time, the FDA relaxed the lifetime ban, however nonetheless stored in place some limits.
Underneath the present coverage — final up to date in 2020 — males who’ve intercourse with males can donate blood in the event that they have not had sexual contact with different males for 3 months.
The brand new proposed coverage would get rid of the time-based restrictions on males who’ve intercourse with males (and their feminine companions) and as an alternative display screen potential donors’ eligibility primarily based on a sequence of questions that assess their HIV threat, no matter gender. Anybody taking medicines to deal with or forestall HIV, together with PrEP, wouldn’t be eligible.
The danger evaluation would come with questions on anal intercourse. Potential donors who’ve had anal intercourse within the final three months with a brand new sexual accomplice or a couple of sexual accomplice wouldn’t be eligible to offer blood.
The adjustments are geared toward addressing criticism that the present coverage is discriminatory and outdated, in addition to another barrier to bolstering the nation’s blood provide. Blood banks already routinely display screen donated blood for HIV.
“We’re transferring now to an inclusive coverage for blood donation,” mentioned Dr. Peter Marks, who leads the Heart for Biologics Analysis and Analysis on the FDA throughout a briefing Friday.
“We’ll proceed to work to be sure that we now have insurance policies that enable everybody who desires to donate blood to have the ability to donate blood inside what the science permits to be sure that the blood provide stays protected.”
In crafting the brand new steerage, the FDA has been trying to the outcomes of a research of about 1,600 homosexual and bisexual males to develop screening questions that may determine potential donors who’re almost certainly to be contaminated with HIV.
Response to the information from advocates, medical teams and blood banks has been constructive.
“The blood group may be very excited in regards to the proposed adjustments,” says Kate Fry, CEO of America’s Blood Facilities. “We now have advocated for a decade now for a transfer to a person threat evaluation mannequin. So that is very welcome by blood facilities throughout the nation.”
She confused that every one donated blood is rigorously screened for HIV and that testing has improved dramatically to make sure the security of the blood provide.
For a few years, the American Medical Affiliation, the American Purple Cross and LGBTQ+ advocacy teams have pushed for a change to the federal guidelines on blood donations.
“These adjustments are 40-plus years within the making they usually’re an amazing leap ahead in elevating science over stigma,” says Tony Morrison, a spokesperson for the advocacy group GLAAD.
However GLAAD and different teams say the adjustments nonetheless do not go far sufficient. They argue that a few of the remaining restrictions are nonetheless pointless and stigmatizing, such because the prohibition towards donations by individuals taking remedy PrEP to forestall HIV.
“After we restrict and defer people who find themselves being proactive of their sexual well being that stigmatizes them. The misperception is that individuals on PrEP are promiscuous or have a better threat of HIV an infection — that is categorically false,” says Morrison.
So his group will proceed to foyer the FDA to additional ease restrictions.
The proposed adjustments within the blood donation guidelines might be open for public remark for 60 days. The FDA will then assessment these feedback and subject a ultimate rule, in all probability later this 12 months. So monogamous homosexual males might begin donating blood once more someday in 2023.
Leave a Reply