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.