Howard Brown Health Response to the FDA’s New Proposed Guidance on Blood Donation

(Chicago, IL, January 27, 2023) – Today, the FDA announced draft guidance to relax restrictions on blood donation for gay, bisexual, and other men who have sex with men (MSM). This is a critical step forward toward a more equitable blood donation policy based on current science and individual risk behaviors.

Howard Brown Health commends the FDA for taking steps to lift these discriminatory restrictions. Its proposal to shift from identity-based blanket bans to a system of individual risk assessment would allow sexually active gay and bisexual men to donate for the first time since the lifetime ban was enacted.

In the 1980s, the FDA enacted a lifetime ban on blood donations from MSM. It was not until 2015 that the lifetime ban was eased somewhat to allow gay and bisexual men to donate after a 12-month abstinence period. These restrictions were first enacted when very little was known about HIV and very few options existed for treatment and prevention. Since then, the field of HIV prevention and treatment has advanced rapidly, and the technology used to screen blood donations for HIV has become far more sophisticated and accurate. Despite this, blood donation policies have not been updated accordingly. The restrictions on gay and bisexual men are not supported by current medical science, and they reinforce stigma about HIV and the LGBTQ+ community.

Under the new proposed guidance, all prospective donors would complete a questionnaire to assess for various HIV risk behaviors. Prospective donors who report new sex partners or multiple sex partners in the past three months would then be asked if they engaged in anal sex during that time period. If so, they would be deferred from donation, regardless of gender or sexual orientation. This means that monogamous gay and bisexual men, monogamous trans women and their partners, monogamous individuals who have sex with MSM, and anyone with new or multiple partners who does not report anal sex would be able to donate without deferral.

However, there is still room for improvement: the proposed guidance still includes deferrals for individuals who are on PrEP, have used PEP, or have engaged in sex work, and continues the lifetime ban on donation for anyone with a history of non-prescription injection drug use.

We urge the FDA to continue ongoing research to refine the individual risk assessment, especially for those with multiple partners and for people using PrEP who remain at low-risk for HIV acquisition. The need for a robust blood supply is paramount and we should not be turning away any qualified donors.

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Read the FDA’s statement:
https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply

Submit a public comment regarding this proposal (open until 03.28.23):
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human

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Media Inquiries:
Wren O’Kelley, Associate Director of Communications and Marketing
mediainquiries@howardbrown.org
872.269.3411