The U.S. Food and Drug Administration on Thursday finalized the elimination of certain restrictions that prevented healthy gay and bisexual men from donating blood.
Instead of requiring men who have sex with men or the women who have sex with them to abstain for sexual contact for three months, the FDA has created an individual risk assessment for all donors.
These questions are meant to reduce the risk of transfusion-transmitted HIV.
"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," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.
"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,"Marks added.
These policies are in alignment with what already happens in some other countries, including the United Kingdom and Canada, according to the FDA.
LGBTQ advocates said the decision was much needed.
"The FDA's decision to follow science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to help save lives, signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia," GLAAD President and CEO Sarah Kate Ellis posted on Twitter.
Under the new policy, all prospective donors who report having a new sexual partner, more than one sexual partner in the past three months or anal sex in the past three months will be deferred.
People taking medications to treat or prevent HIV infection, including antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), will also be deferred. These medications, though safe, may give false negative results on screening tests.
HIV isn't transmitted sexually by people with undetectable viral levels, but the same is not true of a blood transfusion because a large amount of blood is given intravenously, the FDA noted.
But Ellis took issue with the deferrals.
"While today's guidance is an important step in the right direction, the deferral period for individuals on PrEP, an FDA-approved drug proven to prevent HIV acquisition, continues to erect barriers to LGBTQ blood donors," Ellis said. "Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives."
More information
The U.S. Department of Health and Human Services has more on donating blood.
SOURCE: U.S. Food and Drug Administration, news release, May 11, 2023
