F.D.A. Considering New Approach to Blood Donation by Gay and Bisexual Men
The Food and Drug Administration is considering a more individualized strategy for screening gay and bisexual men for blood donation amid an ongoing national blood shortage, according to an agency official briefed on the proposal.
The F.D.A. has long discouraged men who have sex with men from donating blood. A complete prohibition was put in place in the 1980s, amid fears of H.I.V. transmission. In 2015, the agency allowed gay and bisexual men to donate if they had not had sexual contact with other men for the previous year.
The period was reduced to three months after severe blood shortages during the Covid-19 pandemic.
The new plan would require men who have sex with men to fill out a questionnaire about condom use and recent sexual activity. The idea, still under debate, would be to allow those with no new partners in the last three months to donate.
The F.D.A. has not publicly discussed the strategy, which was first reported by The Wall Street Journal. The broad outlines are controversial among L.G.B.T.Q. advocates, who say that past blood donation policies were discriminatory and that unequal treatment remains a concern.
“I think it is a nominal step in the right direction,” said Sarah Kate Ellis, the president and chief executive of GLAAD, an L.G.B.T.Q. advocacy organization that has been pushing to end the ban for years.
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“It’s not where it should be, though. Our community and leading medical experts have been saying now for years that these decisions that the F.D.A. is making on blood bans for the L.G.B.T.Q. community are based in stigma and not science. And we’re seeing that pattern continue here.”
The new approach is meant to strike a balance between activists who want no restrictions that single out gay and bisexual men and blood banks that want to eliminate the risk of a recipient acquiring H.I.V., according to the F.D.A. official, who requested anonymity to describe the internal discussions.
Several large blood centers are wrapping up an F.D.A.-funded study designed to assess the safety of replacing the current three-month waiting period with a more individualized assessment.
The researchers, who enrolled about 1,600 gay and bisexual men in eight metropolitan areas, are hoping to identify a set of screening questions that can differentiate men who are more likely to have recently acquired H.I.V. from those who are less likely to have recently contracted the virus.
Participants in the project, known as the ADVANCE study, answered a variety of questions about their recent, risk-related behaviors, such as whether they had any new sexual partners or were taking pre-exposure prophylactic drugs, known as PrEP, that reduce the risk of H.I.V. infection, said Brian Custer, director of Vitalant Research Institute and principal investigator of the study.
The participants’ blood was also tested for H.I.V. and the antiretroviral drugs used in PrEP.
The researchers have already shared an interim analysis with the F.D.A. and should have the final results ready before the end of the year, Dr. Custer said. He declined to provide more information about the preliminary findings, citing a confidentiality agreement with the F.D.A., but said that he expected the results to be informative for the agency.
“I really am confident that we have important information for the F.D.A. to be able to consider what an individual, risk-based approach to donor selection might look like,” he said.
Susan Stramer, vice president for scientific affairs for the American Red Cross, said in a statement that the study was meant “to make blood donation a more inclusive process while maintaining the safety of the blood supply.”
“While we have not been notified by the F.D.A. concerning policy changes at this time, the Red Cross looks forward to a future in which donation eligibility is not based on sexual orientation, and more healthy individuals can give blood to help patients in need,” she said.
The current blood shortage is tracked daily by America’s Blood Centers, the trade association for 59 community facilities. On Wednesday, about a quarter of the centers, or 16, had less than a day’s supply on hand.
“In this post-pandemic environment, blood drives hosted by businesses — in particular — have not returned to pre-pandemic levels as the way people work has changed,” Nick Gehrig, the senior director for communications at Vitalant, said in an email.
