FDA Proposes New Blood Donor Assessment Model
Most LGBTQ+ advocates welcome FDA’s proposed blood donor eligibility guidance, despite its flaws
Swathi Kodaikal, MSc, holds a master’s degree in biotechnology and has worked in places where actual science and research happen. Blending her love for writing with science, Swathi enjoys demystifying complex research findings for readers from all walks of life. On the days she doesn’t write, she learns and performs Kathak, sings, makes plans to travel, and obsesses over cleanliness.
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This past January, the U.S. Food and Drug Administration released an updated guidance to assess blood donor eligibility in an effort to make the guidance more gender-inclusive and safe.
Sometime in 1985, as the blood banks had limited abilities to test blood products, the FDA banned donations from several groups with higher rates of HIV infection—including men having sex with men (MSM). In 2015, the FDA lifted the ban and allowed gay and bisexual men who have not had sex within the last 12 months to donate. Then, amid the COVID-19 pandemic in April 2020, the FDA shortened the deferral period to three months. The updated model would now contain individual risk-based questions to reduce the risk of transfusion-transmitted HIV infection.
The new guidelines require screening all prospective donors for new or multiple sexual partners in the past three months. Those who have had both—a new sexual partner or more than one partner and who have had anal sex in the past three months—would be deferred from donation. Those taking oral medications to prevent HIV infection such as pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) would be deferred for three months from their most recent dose. And those taking injectable PrEP would be deferred for two years from their most recent injection.
Most LGBTQ+ advocates welcome this proposed blood donor eligibility guidance, despite its flaws. In a recent article in Them, Kelley Robinson, president, Human Rights Campaign, said it was “unfortunate” that the guidance continues to ban those on PrEP from donating blood: “The fact that being on PrEP can conceal HIV positivity is accurate, but there is a solution on the horizon, thanks to technologies being developed that would inactivate pathogens in the blood. In the meantime, it is absolutely essential that those who are currently receiving PrEP treatments continue to remain with their medication.”