The Food and Drug Administration (FDA) recently announced a new proposal to conduct individual risk assessments for blood donations, marking an important shift from its blood donation policies for the past few decades. The FDA’s individual risk assessments intend to promote a more LGBTQ-inclusive environment for blood donations, reversing long-standing cultural stigmas and discriminatory associations between sexuality and the risk of contracting HIV. With a reported 6,600 gay couples in Puerto Rico alone, the FDA’s decision on whether to implement its proposal will impact a significant number of LGBTQ individuals in the territories.
This potential reform builds upon previous steps to expand eligibility, as gay and bisexual men received lifetime bans from donating blood until 2015. That year, the FDA required twelve-month abstinence to be eligible to donate; later, in 2020, that prerequisite was reduced to three months. Now, rather than prohibiting blood donations on a broad, group basis, donation sites will assess each individual donor’s eligibility after screening for HIV and other transmittable diseases.
Extending donor eligibility to more LGBTQ individuals will be particularly important in the US territories. While Puerto Rico bans healthcare discrimination on the basis of sexuality or gender identity, LGBTQ medical freedoms remain bleak across the territories. Notably, there are no anti-discrimination laws for LGBTQ healthcare in Guam, American Samoa, the US Virgin Islands, or the Northern Mariana Islands. Ultimately, the FDA’s blood policy will shape the future of LGBTQ equality in both the mainland and territorial US.
This expansion of blood donor eligibility also comes at a critical time for the US territories, many of which have reported blood supply shortages with the advent of the COVID-19 pandemic. Notably, the Blood Bank of Puerto Rico made a plea for improved blood reserves in 2020 as COVID-related restrictions limited blood donations in the territory. However, US blood donation agencies previously struggled to adequately address these shortages. The Red Cross, a significant facilitator of blood donations in the territories, reported a 10% decline in the number of donors since the pandemic began. In addition, 50% of blood centers are at risk of closure with aging donor pools. Thus, this FDA policy is crucial to resolve blood supply issues in the territories. Kari Lundeen of the Nebraska Community Blood Bank expects a 3% increase in the national blood supply.
The Zika virus outbreak in Puerto Rico in 2016 further accentuates the importance of alleviating territorial blood supply issues. With 40,000 infected from the mosquito-borne illness, Puerto Ricans needed blood product shipments from the mainland US to counter the contamination of the blood supply. Although the worst of the Zika epidemic is now over, the US Centers for Disease Control and Prevention warned of further cases after the first death from the disease in February last year. Therefore, the FDA’s new individual screening guidelines are critical in expanding blood access in the territories and addressing blood-related health problems.
Importantly, this reform is a final culmination of input and research from the US territories. The US Department of Health and Human Services proposed this change after recommendations from the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA), which includes Eric Santiago-Justiniano. Santiago-Justiniano of the pharmaceutical company Fresenius Kabi focuses his healthcare operations in Puerto Rico, advocating for better inclusion of the US territories in his input to the ACBTSA. In addition to Santiago-Justiniano’s valuable involvement in crafting federal blood supply policies, the Association of State and Territorial Health Officials (ASTHO) praised the FDA proposal last week. The ASTHO represents viewpoints from medical experts from across the US, including the territories; therefore, it is an essential forum for advancing blood supply-related healthcare equity in the US territories. ASTHO CEO Michael Fraser commented on the FDA proposal: “Assessing eligibility based on individual risk will safely expand the pool of eligible blood donors, and the FDA’s policy is a step in the right direction.”