Gay, bisexual, and men who have sex with men (MSM) will soon be able to donate blood without restrictions for the first time since the AIDS crisis. The Food and Drug Administration (FDA) has released an updated set of recommendations for assessing blood donor eligibility to prevent transfusion-transmitted HIV. The new guidance is also expected to help address the nation’s blood supply shortage.
The FDA’s limitations on donations from gay, bisexual and MSM men have long been considered stigmatizing and discriminatory. Transportation Secretary Pete Buttigieg has even called out the restrictions. “ My blood’s not welcome in this country,” Buttigieg said. “And it’s not based on science; it’s based on prejudice.”
The FDA now recommends a series of “individual risk-based questions” for every blood donor, regardless of sexual orientation, gender or sex.
“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
Marks said, “The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products.”
Marks added, “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place.”
Under the new guidelines, all donors will answer a set of risk-based questions relating to their recent sexual activity and whether they take medications to treat or prevent HIV infection to determine whether they’re eligible to give blood. Those who have had anal sex with a new sexual partner or more than one sexual partner within the last three months would be restricted from donating blood.
The FDA states that this policy “eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility.”
According to the FDA, “all prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.”
Limitations against gay and bisexual blood donors date back to the HIV/AIDS crisis of the 1980s. In 1985, the FDA established a lifetime ban on donations by men who have sex with men (MSM) that remained in place until 2015, when the one-year deferral took effect. During the pandemic, the FDA amended their policy to allow MSM men to donate blood if they had abstained from sex for three months.
In January 2022, the American Medical Association (AMA) wrote, “The FDA must lift its discriminatory blood-donor policy. With the nation’s blood supply at its lowest point in a decade, and the American Red Cross declaring its first-ever national blood crisis earlier this month, it is time for the Food and Drug Administration (FDA) to do something the AMA and others have urged for years: remove its discriminatory ban that prevents many gay and bisexual men from becoming blood donors.”
The AMA explicated what many LGBTQ advocacy groups have argued for years: “The [FDA’s] current three-month deferral period singles out and bans blood donors based on their inherent attributes rather than the risk factors they present. For example, a man who has protected sex with another man in the three months prior to a blood donation cannot be a donor, but a man or woman who has unprotected sex with multiple partners of the opposite sex over the same time period remains eligible.”
That has now changed. One point still in contention from LGBTQ rights groups is another guidelines from FDA: People on medications that treat or prevent HIV, including pre-exposure prophylaxis (PrEP), will not be able to donate.
The FDA argues that “although the antiretroviral drugs are safe and effective,” they also have the propensity to impact the accuracy of blood screening tests that are used to detect HIV. The FDA stipulates that “though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results.”
While HIV cannot be transmitted sexually by anyone who has undetectable viral load levels, the FDA argues that there remains some risk of HIV transmission via transfusion. This is, according to the FDA, because transfusion intensifies the possibility of transmission.
The FDA statement says, “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.”
They added, “As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.”
The Red Cross says that blood banks already screen for HIV with qualitative HIV antigen and antibody assays and these have a near 100 percent accuracy rate.
GMHC, founded in 1982 as Gay Men’s Health Crisis, the world’s first HIV and AIDS services organization, issued a statement on the FDA changes.
In response to the new policy, Jason Cianciotto, GMHC’s Vice President of Communications and Policy, notes that the FDA changes are “an important step in the right direction” and that GMHC has been “calling on the FDA to implement a screening tool that assesses each prospective donor based on their risk for exposure to HIV within the window period that modern testing cannot detect it” since 2010.
Cianciotto adds, “This moves us closer to FDA policy based on science, not stigma, because HIV is not a ‘gay disease.’ There is nothing inherent to sex, gender identity, or sexual orientation that makes people more likely to contract HIV — or any other illness.”
GMHC also laid out more questions for the FDA on risk assessment and condom use, citing concerns that the new guidelines still unfairly target gay, bisexual and MSM men. GMHC also queries the “non-binding” status of the guidelines: “The FDA states that these recommendations are “nonbinding.” Does this mean that a blood donation center in one location could choose not to implement any of the guidance, while a center in a different location could implement some or all? If this is the case, then prospective blood donors who are MSM could still experience stigma and discrimination depending on where they live and/or what blood donation center they use.”
The FDA stated it will continue to evaluate data and technological developments to inform its eligibility recommendations.