FDA to Ease Restrictions on Blood Donations From Gay Men

By: Ranier Simons, ADAP Blog Guest Contributor

About 6.8 million people in the United States donate blood annually, and about 13.6 million units of whole blood and red blood cells are collected.[1] Not only are whole blood and red blood cells used to treat people, but blood components such as plasma and platelets are also used for treatment. Because blood and platelets cannot be manufactured, ensuring the safety and efficacy of the blood supply is paramount. Security includes protocols to keep the blood supply free from disease, primarily focusing on reducing the risk of HIV transmission through blood and blood products. Historically, these protocols included permanently barring or discouraging men who have sex with men (MSM) from donating blood. As a result of scientific data domestically and globally, in January, the U.S. Food & Drug Administration (FDA) released guidance planning to ease those previous rules that had been in place for decades.[2] 

Photo Source: The Boston Globe

The emergence of HIV/AIDS in the early 1980s irrefutably changed the blood system landscape. Initially, the disease was identified in MSM, associated with people who used intravenous drugs and people who exchanged sex for money. Before screening tests were created to test donor blood, the FDA was tasked with figuring out how to reduce the risk of HIV transmission through blood and blood products. In 1983, the FDA created official guidance and recommendations for educating donors about risk factors for AIDS. Blood collection agencies started using risk questions and rejecting blood from specific donors based on those factors. These measures helped reduce disease transmission, yet thousands of people still contracted HIV from blood transfusions before testing was available.[3]

HIV was identified as the cause of AIDS in 1984, which spurred research into the creation of donor blood screening tests. The first FDA-approved screening tests for antibodies against HIV occurred in 1985.[3] In September 1985, it was first recommended by the FDA that no male donors who had ever had sex with another man from 1977 onward would be allowed to donate blood.[3] In 2010, an Interagency Blood, Organ & Tissue Safety Working Group (BOTS Working Group) consisting of representatives from the Center for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), HHS Office for Civil Rights (OCR), Office of the Assistant Secretary for Health (OASH), and FDA, was put together to investigate scientific evidence-based ways to change the policy.[3] Many different studies were conducted. The results from those studies, in combination with data from countries that had already shortened the indefinite deferral period for blood donation by MSM, resulted in the FDA recommending a 12-month deferral instead of a permanent ban in December 2015.[3]

The evolution continued. In 2014, FDA launched the Transfusion Transmissible Infections Monitoring System (TTIMS). It was to monitor the rates of relevant transfusion-transmitted infections (RTTIs) detected among blood donors before and after policy changes.[3] Two years after the 12-month referral was initiated, data showed there was no increased risk to the U.S. blood supply for HIV. Over time, other countries, including the United Kingdom and Canada, moved to a 3-month deferral recommendation with no reports of adverse outcomes from the change. Using the results from continued surveillance, the evidence from other countries, and the ongoing usage of testing that can detect HIV, HBV, and HCV within three months of initial infection, the FDA updated the recommendation to a 3-month deferral period for MSM in April 2020.[3] In addition to MSM, the proposal to move the indefinite ban to 3-month referral for people who exchanged sex for money and those who used non-prescription intravenous drugs was also instituted.[3]

Photo Source: Medical Express / Health Day

January 2023 has brought a new proposed policy change that is not wholly focused on MSM. As a result of ongoing U.S. research, in addition to epidemiological data from other countries that have already changed, the FDA is proposing to move to a gender-inclusive risk-based, individual behavioral assessment for blood donor referral. The new guidance suggests asking all donors the same questions regardless of gender. 

Donors, regardless of gender, would be asked if they have had a new partner or multiple partners in the past three months. If yes, they will be asked if any sex was anal. If the answer is yes, that person would be deferred from donation for three months. If the sex were vaginal only, they would be allowed. Donors are also to be asked about PrEP usage. If donors use oral PrEP, they will be deferred from donation for three months from their last dose. If they use a long-acting injectable form of PrEP, they will be postponed for two years following the most recent injection. Data shows that the usage of PrEP may delay the detection of HIV by currently licensed screening tests for blood donations, potentially resulting in false negative results in infected individuals.[3] Individuals living with HIV who have reached undetectable status with antiretroviral treatment are permanently denied blood donation. While undetectable status means untransmissible through sexual contact, antiretroviral drugs do not entirely eliminate HIV from the body; thus, transfused blood could still potentially transmit HIV infection.[3] The above questions highlight the newly proposed questions and deferral recommendations. To view a more exhaustive explanatory list, please view the FDA guidance document here.

Changing the guidance to ease restrictions on MSM and other risk-identified groups will potentially help with the nation's blood supply shortage. Most importantly, the move to gender-inclusive individual risk assessment will change the future research paradigm to be scientific and evidence-based to consider the fluidity and intersections of all genders and sexual preferences.

[1] American Red Cross. 2023. U.S. Blood Supply Facts. Retrieved from https://www.redcrossblood.org/donate-blood/how-to-donate/how-blood-donations-help/blood-needs-blood-supply.html

[2] Firth, S. (2023, January 27). FDA to ease restrictions on blood donations from gay men. Retrieved from https://www.medpagetoday.com/washington-watch/fdageneral/102863

[3] FDA. (2023, January). Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Coronavirus-Related Blood Shortages Lead to Blood Donor Reforms, But Discrimination Remains

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Since the outbreak of Coronavirus, decisions have been made within the government on many topics including financial relief for students, unemployment and others. One of these decisions involves blood donations. On April 2, the U.S. Food and Drug Administration ("FDA") revised their guidelines which previously banned gay men from donating blood for a year after sexual intercourse with another man.

In these new guidelines, the FDA has instead recommended a three month wait period for these men. This will remain in place throughout the course of COVID-19 or within 60 days of the emergency being lifted, according to The Hill.

The national blood supply has been critically low, according to The Red Cross. Pleas for donations from healthy donors have been made within the past years, but with the recent outbreak of COVID-19, the need is much greater now.

According to their website, the American Red Cross provides roughly 40% of the nation’s blood and blood components, all volunteer based. Group O- blood is the most highly sought-after blood group, because it is universally accepted by other blood types.

The recent change in FDA guidelines to allow men who have sex with men to donate blood after 3 months may seem as better than the previous guidelines, which it is. However, this recent guideline change has revealed many issues with the blood donation program in America.

It was only in December of 2015 that the FDA moved their lifetime ban on gay and bisexual men donating blood to a one year wait period.

“Blood centers nationwide screen potential donors by asking a set of questions written to determine risk factors that could indicate possible infection with a transmissible disease, such as HIV or hepatitis. According to the FDA, this pre-screening eliminates up to 90% of donors who may be carrying a blood-borne disease,” the Human Rights Campaign said.

This raises the question: if screening donors is already a universal concept in blood donation, why should gay men have to wait a period of time to donate blood? Even if a gay man had sexual encounter with an HIV positive person, if they went through the pre-screening process for blood donation and reported either they had sex with another man who they were unsure of their sexual history and/or they had sex with a man who they are sure is HIV positive, wouldn’t that eliminate the risk there?

The American Red Cross tests all donated blood after donations for infectious diseases, but it may not be 100% effective in donors who may have been infected with a blood-borne pathogen recently.

However, if a gay man has taken the necessary precautions to protect against transmission of blood-borne diseases such as HIV or hepatitis, I see no reason as to why they cannot safely donate blood- especially in a time of crisis and a national shortage.

In an article written for USA Today, David Oliver spoke on issues he’s faced as a gay man attempting to donate blood amid Coronavirus.

“The first and only time I donated blood; I hadn't had sexual contact with another man. Heck, I hadn’t yet come out. I was 21 years old and passed out shortly after doing it. Over the six years since then, it has been too easy for me to throw my hands up and say: "Well, I can't even donate anyway." But during this time of crisis, I would give anything to help,” Oliver said.

This narrative is all too common among LGBTQ+ men. The need for blood is greater than ever, and if screening processes are taken and donors are open about their past possible exposure to pathogens, I see no reason as to why this blood shortage could not be addressed by all Americans.

Photo Source: Change.org

“The American Red Cross believes blood donation eligibility should not be determined by methods that are based upon sexual orientation. We are committed to working toward achieving this goal,” The American Red Cross said.

The goal of blood donation eligibility not being based upon sexual orientation is an achievable one. Americans must look past their ignorance and outdated ideas of LGBTQ+ men and blood donation to help the greater good.

References:

• Blood Needs & Blood Supply. (n.d.). Retrieved from https://www.redcrossblood.org/donate-blood/how-to-donate/how-blood-donations-help/blood-needs-blood-supply.html
• Human Rights Campaign. (n.d.). Blood Donations and the LGBTQ Community. Retrieved from https://www.hrc.org/resources/blood-donations
• LGBTQ Donors. (n.d.). Retrieved from https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements/lgbtq-donors.html
• Oliver, D. (2020, March 30). Red Cross is asking for blood donations amid coronavirus. Because I'm gay, I'm excluded. Retrieved from https://www.usatoday.com/story/opinion/voices/2020/03/20/coronavirus-let-lgbtq-men-donate-blood-amid-shortage-column/2876677001/
• Weixel, N. (2020, April 2). FDA loosens restrictions on gay men donating blood amid pandemic. Retrieved from https://thehill.com/homenews/administration/490824-fda-loosens-restrictions-on-gay-men-donating-blood-amid-coronavirus#.XoYgEQB4AkA.twitter

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.