FDA proposes 'gender-inclusive' blood donor requirements with 'risk-based questions' for HIV

Current guidance requires "men who have sex with men" to abstain from relations for three months before donating blood.

Published: January 29, 2023 2:10pm

Updated: January 29, 2023 4:58pm

The U.S. Food and Drug Administration proposed using what it calls "gender-inclusive, individual risk-based questions" to reduce the risk of HIV transmission from blood donors to recipients by asking about new sexual partners and anal sex in a move that will allow more gay and bisexual men to donate blood.

Current FDA guidance requires "men who have sex with men" and women who have sex with men in this group to abstain from relations for three months before donating blood to reduce the risk of HIV transmission. 

The new donor history questionnaire proposed Friday would ask about new sexual partners within the past three months. If they answer affirmatively, the prospective donors would be asked about their history of anal sex over the past three months. 

"All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation," the FDA stated.

This means gay and bisexual men who have not had a new partner within the past three months will be able to donate blood.

The American Red Cross said it is "pleased" with the announcement and it "recognizes the hurt" that the donation deferral policy has caused.

Gay and bisexual men were banned from donating blood for life in the United States in a rule that lasted from 1985 until 2015, when the FDA said prospective male donors must have not had sex with another man in the past year, according to the Human Rights Campaign. In 2020, the FDA shortened the deferral period to three months. 

The Red Cross says it screens every unit of blood for multiple infectious diseases, but testing is still not 100% effective. "The per-unit risk of HIV-1 infection through blood transfusion is less than 1 per 2 million units screened," the agency stated.

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