The FDA has gradually loosened restrictions on blood donations from homosexual men in the last decade after a lifetime ban was put in place in 1985 in response to the AIDS crisis. But now, following pressure from gay rights groups and medical organizations, draft guidelines propose that gay and bisexual men no longer have to abstain from sex for three months in order to donate blood.
The proposed guidelines would revise the questionnaire to ask potential donors about their sexual activity.
[T]he current donor history questionnaire would be revised so as to ask all potential donors about new and multiple sexual partners in the past 3 months. Persons who report new or multiple sexual partner(s) over the past 3 months would then be asked whether they had engaged in anal sex over that period. Persons who report having new or multiple sexual partners as well as participating in anal sex in the past 3 months would not be allowed to donate until a later date.
Additionally, individuals taking preexposure prophylaxis (PrEP) would be deferred from donating. Those taking oral PrEP would be deferred for 3 months from their most recent dose, and those taking injectable PrEP would be deferred for 2 years from their most recent injection. Data suggest that these medications can delay detection of the HIV virus with licensed screening tests for blood donations and that their use can lead to false negative results, Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, explained during a press conference. […]
The recommendations would not make any changes to donation restrictions on the basis of other HIV risk factors. Individuals who have exchanged sex for money or drugs or have engaged in nonprescription injection drug use in the past 3 months would still be barred from donating. Anyone who has ever tested positive for HIV or has taken medication for HIV infection would continue to be barred indefinitely from donating blood. (Medscape)
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Today, FDA announced we are proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. https://t.co/Ucrp6a8Hy0
— U.S. FDA (@US_FDA) January 27, 2023
“Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so," said FDA Commissioner Robert M. Califf.
The public comment period is open for 60 days, after which the FDA will review and finalize the new measures.
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