WASHINGTON – The US is working to further ease restrictions on blood donations from gay and bisexual men and other groups typically at higher risk of HIV.
The Food and Drug Administration on Friday announced draft guidelines that would remove the current three-month abstinence requirement for donations from men who have sex with men. Instead, all potential donors would be screened with a new questionnaire that assesses their individual HIV risks based on sexual behavior, recent partners and other factors.
If completed, many gay and bisexual men in monogamous relationships would be able to donate blood for the first time in decades. This is the FDA’s latest move to expand donor eligibility, with the potential to increase donations.
“We are confident that the safety of the blood supply will be maintained,” said Dr. FDA’s Peter Marks told reporters.
Gay rights groups have long opposed blanket restrictions on who can donate blood, saying they discriminate against the LGBTQ community. Medical societies, including the American Medical Association, have also stated that such exclusions are unnecessary given technological advances in testing blood for infectious diseases.
“Current and past blood donation guidelines have made unfounded assumptions about gay and bisexual men and really tangled people’s identities with their likelihood of having HIV,” said Sarah Warbelow of the Human Rights Campaign, an LGBTQ advocacy group.
The United States and many other countries began blocking blood donations from gay and bisexual men during the AIDS epidemic in the early 1980s to prevent the spread of HIV through the blood supply.
In 2015, the FDA lifted the lifetime ban and replaced by a one-year abstinence requirement. 2020 then the agency abstinence time shortened to three months after donations plummeted during the COVID-19 pandemic.
Regulators said there have been no negative impacts on the blood supply as a result of these changes.
The FDA establishes requirements and procedures for blood banks across the United States. All potential donors answer questions about their sexual history, use of injectable drugs, and recent tattoos or piercings, among other factors that may contribute to the spread of blood-borne infections. The donated blood is then tested for HIV, hepatitis C, syphilis and other infectious diseases.
Under the new proposal, men who have sex with men will be asked if they have had new or multiple partners in the past three months. Those who answered yes to both questions and also indicated having had anal sex would be barred from donating until a later date. The policy would also apply to women who have sex with gay or bisexual men.
Anyone who has ever tested positive for HIV would still be ineligible to donate blood. Those taking pills to prevent HIV would also be banned until three months after their last dose. The FDA noted that the drug known as PrEP can delay detection of the virus in screening tests.
Marks said the agency is ready to consider further easing restrictions “but we need to have the science to do it.”
FDA regulators will accept public comments on the proposal for 60 days before beginning finalization of the guidelines.
The proposed policy mirrors those used in Canada and the UK
The FDA partially backed its recent proposal to a current study by 1,600 gay and bisexual men. The FDA-funded study compared the effectiveness of a detailed, personalized sexual behavior questionnaire versus current time-based abstinence rules.
It will take several months for blood banks to make the changes, according to Cliff Numark, an executive at Vitalant, a blood center that participated in the study. The changes require new questionnaires, staff training and computer software updates.
The Red Cross said it supports the FDA’s changes, but added that it’s too early to know if they will lead to more blood donations.
Lukas Pietrzak, of Washington DC, said he volunteered for the FDA study. He credits emergency blood transfusions with saving his father’s life after a bicycle accident in 1991.
Pietrzak donated blood in high school but was not admitted after becoming sexually active as a gay man.
“Until I fully came out to my friends, I had to play around with why I never went to donate blood with them,” says Pietrzak, 26, who now works for the federal government.
If blood donations are called, “we can now participate,” said Pietrzak.
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