FDA Updates Recommendations for Assessing Blood Donor Eligibility

Credit: Getty Images.
The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM have been eliminated.

To reduce the risk of transfusion-transmitted HIV, the Food and Drug Administration (FDA) has finalized a set of individual risk-based questions to assess blood donor eligibility.

Under the updated policy, all prospective blood donors would be asked the same risk-based questions, regardless of sexual orientation, sex or gender, in order to determine eligibility. The time-based deferrals and screening questions for men who have sex with men (MSM) and women who have sex with MSM have been eliminated.

To reduce the likelihood of donations from individuals with new or recent HIV infection, potential donors who report having a new sexual partner, or more than 1 sexual partner in the past 3 months, and anal sex in the past 3 months, would be deferred. Individuals taking antiretroviral therapy to treat or prevent HIV, preexposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) would also be deferred. Use of these medications may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results.

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community.”

Both the United Kingdom and Canada have similar blood donation policies in place.

“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,” added Marks.


FDA finalizes move to recommend individual risk assessment to determine eligibility for blood donations. News release. May 11, 2023. https://www.prnewswire.com/news-releases/fda-finalizes-move-to-recommend-individual-risk-assessment-to-determine-eligibility-for-blood-donations-301822266.html.