FDA relaxes blood donation regulations for MSM
The US Food and Drug Administration (FDA) has released updated guidance for blood donation which relaxes the rules for donations from men who have sex with men (MSM). This follows decades in which MSM have been rejected or discouraged from donation blood due to a fear of HIV transmission.
The new guidance has removed the time-based deferrals and screening questions aimed specifically at MSM and women who have sex with MSM, instead utilising individual risk-based questions that will be asked to every potential donor as a means to reducing the risk of transmitting HIV.
This policy change means MSM will now be eligible to donate blood as long as they meet the new donor criteria, and all people who have had sex with a new sexual partner or more than one sexual partner in the last three months will have to defer. Also anyone taking medication to treat or prevent HIV infection, such as antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) will be deferred, despite the fact that these medications are safe and effective.
Peter Marks MD PhD, director of the FDA’s Center for Biologics Evaluation and Research, commented: “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. 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.”
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