FDA Draft Guidance Seeks to Lift Historic Gender-Based Exclusions on Blood Donations After Years of Advocacy

The FDA published a draft guidance proposing revisions to its blood donation requirements, materials, questionnaires, and procedures to eliminate categorical exclusions against men who have had sex with men in the past three months, instead moving to gender-neutral individual assessments.

NPR reported on the history of this prohibition.  

The restrictions on donating blood date back to the early days of the AIDS epidemic and were designed to protect the blood supply from HIV. Originally, gay and bisexual men were completely prohibited from donating blood. Over time, the FDA relaxed the lifetime ban, but still kept in place some limits.

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The new proposed policy would eliminate the time-based restrictions on men who have sex with men (and their female partners) and instead screen potential donors' eligibility based on a series of questions that assess their HIV risk, regardless of gender. Anyone taking medications to treat or prevent HIV, including PrEP, would not be eligible.

The FDA stated the following: 

We, FDA, are issuing this draft guidance to receive comments on revised recommendations for evaluating donor eligibility using individual risk-based questions.  This draft guidance, when finalized will provide you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.  We are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures.  This guidance, when finalized, will supersede the guidance entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” dated April 2020, updated August 2020 (April 2020 guidance).  The recommendations contained in this draft guidance, when finalized, will apply to the collection of blood and blood components, including Source Plasma.

Comments may be submitted online regarding the draft guidance.