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FDA finalizes new rules on blood donations

A ‘significant milestone for the agency and the LGBTQI+ community,’ official says

The American Red Cross brought a bloodmobile to Adams Rite Aerospace in Fullerton, Calif. on Jan. 20, 2022.
The American Red Cross brought a bloodmobile to Adams Rite Aerospace in Fullerton, Calif. on Jan. 20, 2022. (Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

The Food and Drug Administration on Thursday finalized new rules eliminating blanket restrictions on blood donations from LGBT men, responding to long-standing pressure from advocates, blood banks and public health groups.

The new guidelines are instead focused on individual risk behaviors, rather than sexual orientation. The rules block anyone from donating blood if they have had new or multiple sexual partners and have also had anal sex in the previous three months. Anal sex carries a much higher risk of HIV transmission than vaginal sex.

“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, director of the Center for Biologics Evaluation and Research. 

“The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations, and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place.”

The FDA first proposed the rule in January to cheers from advocates, academics and blood banks. 

Previously, the FDA maintained a blanket ban on blood donor eligibility for men who have sex with men if they had a sexual encounter within the previous three months. 

Anyone living with HIV would still be barred from donating, along with anyone who has had engaged in sex work or intravenous drug use in the previous three months.

LGBT advocates urged the FDA to go further, saying the guidelines still risked discrimination against LGBT people. 

Donated blood is tested for HIV and other viruses prior to entering the blood supply. But people who take preventive HIV medication would also be deferred for either three months or two years from their most recent dose — depending on whether they’re taking oral medications or receiving injections — because of the risk of false negatives on an HIV test.  

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