Topline
The U.S. Food and Drug Administration finalized recommendations Thursday to loosen its blood-giving guidelines by now using risk-based questions rather than time-based questions to determine if someone is eligible, making the process more inclusive for gay men, who have been prevented from donating in the past over concerns about spreading HIV.
Brian Nolan of the American Red Cross sorts blood in Rutland, Vermont. What started as a documentary … [+]
Key Facts
The FDA will now determine if someone is eligible to donate blood using a set of “individual risk-based questions” aimed at reducing the risk of transfusion-transmitted HIV, but, in a shift from previous methods, these questions will be the same for all people regardless of sexual orientation.
The policy moves the U.S. into alignment with the United Kingdom and Canada around who is eligible to donate, and the FDA said the decision was based on “the best available scientific evidence” that included data from these countries and information from the Transfusion Transmissible Infections Monitoring System.
Under the new guidelines, any prospective donor who reports a new sexual partner, or more than one sexual partner, in the last three months and has had anal sex in the last three months will be deferred for three months.
A donor who doesn’t report having any new sexual partners but who has had anal sex in the last three months may be eligible to donate if all other criteria are met, the FDA says.
The decision—which blood-collecting establishments are now able to implement by updating their donor questionnaire—may expand the number of people eligible to donate blood, which will help address the country’s blood shortage; according to America’s Blood Centers, as of Thursday just 14% of centers reported having enough blood to last one day and 31% had enough blood to last one to two days.
Key Background
Prior to this change, the most recent change in guidelines for blood donation came in 2020 when the FDA enacted a 3-month deferral period rather than the 12-month deferral period that had been in place. Even though there are some major changes in the updated guidance, there is no change in the donor deferral time periods for those who have exchanged sex for money or drugs or have a history of non-prescription injection drug use, the FDA said. Also, any person who has ever tested positive for HIV or has taken medication to treat HIV infection will continue to be deferred permanently.
Crucial Quote
“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, director of the FDA’s 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.”
Further Reading
FDA updates blood donation policy to include gay, bisexual men (The Hill)