The new approach eliminates rules that target men who have sex with men and instead focuses on sexual behaviors by people, regardless of gender, that pose a higher risk of contracting and transmitting HIV, according to an official with direct knowledge of the plan who spoke on the condition of anonymity because they were not authorized to comment. The FDA is expected to adopt the proposal after a period of public comment.
Other countries including Canada and the United Kingdom have made similar changes in recent years.
For decades, gay men said they were made to feel like pariahs as they were barred from performing a widely lauded act of community service, sidelined from joining friends and family giving blood after national disasters. The rigidity of the FDA rules — making no exceptions for those who are in monogamous relationships — made some feel as though they could not be trusted or are viewed as disease vectors, no matter what steps they take to protect their health.
“Keeping the blood supply safe is paramount, but it is also important to move forward so that we are not excluding a group of donors who could be perfectly safe,” Claudia Cohn, chief medical officer for the Association for the Advancement of Blood and Biotherapies , a nonprofit that oversees development of donor screening questionnaires.
When the country faced a dire blood shortage in the early months of the coronavirus pandemic in 2020, Cole Williams faced an awkward situation. Commercials soliciting blood donors constantly played on television. His family wanted to give blood together. But Williams, who is bisexual and now 22, had to explain he was ineligible because he had recently had sex with a man.
“We shouldn’t have to fight this hard to do something as selfless as giving blood,” said Williams, a nursing student who formed the advocacy group Pride and Plasma to advocate for changes to the FDA policy. “I could have as much unprotected sex with as many women as I wanted, and the FDA would have no problem with that.”
Technological advancements in blood screening and a new FDA-funded study backing the proposed approach rendered sweeping prohibitions on sexually active gay and bisexual men moot, some experts said. Newly eligible donors probably would not be able to give blood until the end of the year or early next year while the FDA finalizes changes and blood banks implement them.
Some activists say gay men would still be treated unfairly under the proposed guidelines, which would allow them to give blood if they had not had a new anal sexual partner in the prior three months.
There is no exception for people taking daily pills that drastically reduce the risk of contracting HIV, a landmark advancement that revolutionized prevention without relying on condoms or abstinence alone. There is no exception for those who consistently wear condoms. And there is no exception for those who can present a negative HIV test.
“Being monogamous with someone who is not living with HIV is not the only way to prevent transmission,” said Jason Cianciotto, vice president for communications and public policy at Gay Men’s Health Crisis, a group that has advocated to end the blood donation ban.
When the AIDS epidemic emerged in the 1980s, thousands of people who received blood transfusions became infected before scientists realized that the HIV virus that caused the disease could be transmitted by blood.
The FDA placed restrictions on blood donations by gay men, who had higher rates of HIV infection because the virus spreads more easily in smaller sexual networks and more efficiently during anal sex than vaginal sex. In 1985, the agency imposed an “indefinite deferral” — in effect, a lifetime ban — on blood donations from any man who had had sex with another man going back to 1977. As testing of the blood supply improved, the agency lifted the lifetime ban in 2015, requiring instead that men who donated blood needed to abstain from sex with other men for 12 months.
That deferral period was reduced to three months in April 2020, as blood shortages became increasingly severe because of the coronavirus pandemic.
The new risk assessment is expected to ask potential donors, regardless of gender and sexual orientation, if they have had any new sexual partners in the past three months, a person familiar with the FDA proposal said. They can give blood if they say no. Those who have had new sexual partners would be asked if they had engaged in anal intercourse in the past three months; those who have would be asked to wait three months to donate.
The FDA declined to comment on the contents of the new guidelines, first reported by the Wall Street Journal, but said they would be “gender-neutral and science-based.”
This will allow sexually active men in monogamous relationships with other men to give blood for the first time since 1985. It could also mean women will be barred from giving blood for the first time if they’ve had anal sex with a new partner, depending on the final details of the questionnaire, even though heterosexual anal intercourse has not been a major focus on public health efforts to contain HIV.
“For reducing stigma around queer identities, it’s worth it,” Benjamin Brooks, associate director of policy and education at Whitman-Walker, a DC-based LGBT health-care organization.
Bruce Walker, director of the Ragon Institute of Massachusetts General Hospital, MIT and Harvard, said the new policy should make the blood supply safer because it expands the donor questionnaire beyond one group and now focuses on identifying anyone who engaged in risky sexual practices during the three months before donating.
“We need to identify those people who are at high risk of being in that window period and prevent them from donating,” Walker said. “Up until now, it’s been very stigmatizing in that we’ve only delved deeply into risk factors for men who have sex with men.”
Canada’s federal health agency authorized a similar change last April.
Aditi Khandelwal, a hematologist and medical officer at Canadian Blood Services, a nonprofit based in Ottawa that provides blood products, said restriction based on sexual identity is “not ideal and does not get to the risk factors of how HIV is transmitted.”
Howard Forman, a 57-year-old Yale School of Medicine professor, started donating blood when he turned 18 in 1983, proudly carrying his donor card. But a few years after the FDA banned donations by men who have sex with men, Forman became ineligible and felt a sense of loss.
“They took away something that many people found meaningful,” Forman said.
Similar stories of disappointment and rejection would play out over the following decades.
Eric Kutscher, 32, wasn’t out to his classmates at Columbia University when he joined them to donate blood at the campus gym in 2011.
When he came to the question: “Have you ever had sexual contact with another man since 1977?” Kutscher answered “Yes.” And that’s when he was told he wouldn’t be allowed to donate.
Kutscher left the gym feeling ashamed and embarrassed. But after a few days, he started organizing a student effort to review the FDA’s policy on blood donors. That led to volunteer work as an HIV testing counselor, then medical school and a career in public health. Kutscher, an addiction medicine fellow at NYU Grossman School of Medicine, said he looks forward to being able to donate his O positive, the most common blood type.
“I understand how lifesaving this is and I’m excited to be a young, healthy adult man who is able to provide blood to the patients who need it,” he said. “As soon as I am eligible to donate blood, I will be the first in line.”
The FDA funded a study conducted between December 2020 and September 2022 by three of the nation’s largest nonprofit blood centers — Vitalant, OneBlood and the American Red Cross — to examine whether there are questions providers could ask sexually active gay and bisexual men to determine a person’s risk in donating blood.
Brian Custer, director of the Vitalant Research Institute and the study’s principal investigator, declined to share the results without FDA approval but characterized them as promising.
“Clearly, if there is a consideration of moving to an individual risk-based approach, then the FDA must believe they have sufficient data,” Custer said.
Some of the strongest advocacy for relaxing restrictions came from blood banks themselves.
Kate Fry, chief executive of America’s Blood Centers, an organization of independent blood banks that provide 60 percent of the nation’s supply, said lingering effects of the coronavirus pandemic continue to disrupt the supply. At least half of the blood centers have less than two days’ worth of blood rather than the recommended three to five days.
“We are in a very challenging time for the blood supply,” Fry said.
It’s unclear how much the new rules would expand the blood supply, which would require a concerted outreach campaign to inform gay and bisexual men accused of being banned that they might now be eligible to donate.
Some critics say a three-month waiting period, mirroring other Western countries, is still overly stringent because of advancements in testing that allow for HIV to be detected sooner.
Brad Hoylman-Sigal, an openly gay Democratic senator in the New York legislature, said any deferral “continues to foster stigma around men who have sex with men.”
“They need to completely get rid of any semblance of restrictions on gay men donating blood,” Hoylman-Sigal said.
The reason for the three-month deferral period, according to Khandelwal in Canada, is that testing for blood-borne viruses, which include hepatitis B and C as well as HIV, “is not perfect.” While viruses may be detected in a few weeks, the three-month period provides a generous “buffer” for detecting harmful viruses, she said.
Every unit of blood donated to a blood bank in the United States is tested for HIV using what’s called a nucleic acid test, which can detect the virus in a sample of blood “within 10 to 33 days of infection,” said Sean Cahill, director of health policy research at the Fenway Institute, a Boston-based group that serves the LGBT community. “The three-month deferral is taking that 33 days and tripling it to be extra sure, extra cautious about this period in the nucleic acid test.”
Stefan Baral, a professor in the department of epidemiology at Johns Hopkins University, said the problem with the US blood supply is not HIV-tainted blood but rather the dearth of donors.
“Nobody has been infected through blood transfusion for more than 20 years,” Baral said. “The US has a safe blood supply and the major issue with all of it is that there’s not enough of it.”