F.D.A. Considering a new approach to blood donation by gay and bisexual men

The agency may introduce a personalized risk assessment to replace the current ban for men who have had sex with men in the past last three months.

The Food and Drug Administration is considering a more individualized strategy for screening gay and bisexual men for blood donation amid national blood shortages , according to an agency official briefed on the proposal.< /p>

The F.D.A. has long discouraged men who have sex with men from donating blood. A complete ban 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 in the previous year.

The time frame was reduced to three months after severe blood shortages during the Covid-19 pandemic.

The new plan would require men with sex with men to complete a questionnaire on condom use and recent sexual activity, among other risk factors. The idea, still under debate, would be to allow those who have not had new partners in the past three months to donate.

The strategy has was first reported by the Wall Street Journal. In a statement released Wednesday, the F.D.A. said new data "will likely support a policy shift to individual risk-based donor screening questions to reduce HIV risk." transmission."

The outline of the plan is controversial among L.G.B.T.Q. advocates, who say past policies on blood donation were discriminatory and the inequality of treatment remains a concern.Kate Ellis, President and CEO of GLAAD, an L.G.B.T.Q. advocacy organization that has been lobbying to end the ban for years.

"It's not where it should be, though. Our community and leading medical experts have been saying for years now that these decisions that the F.D.A. fact about blood bans for L.G.B.T.Q. community are based on stigma, not science. And we see that trend continuing here.

The new approach seeks to strike a balance between activists who want no restrictions on gay and bisexual men and blood male banks who want to eliminate the risk that a recipient contracts H.I.V., according to the F.D.A. official, who requested anonymity to describe internal discussions.

Several Major Blood Centers Conclude F.D.A. aimed at evaluating the safety of replacing the current treatment's three-month waiting period with a more individualized assessment.

The researchers, who recruited approximately 1,600 men gay and bisexual men in eight metropolitan areas, hope to identify a set of screening questions that can differentiate between men who are more likely to have recently acquired HIV. of 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 new sexual partners or whether they took pre-exposure prophylactic drugs, known as PrEP, which reduce the risk of contracting H.I.V. infection, said Brian Custer, director of the Vitalant Research Institute and the study's principal investigator.

Participants' blood was also tested for HIV. and 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 on the preliminary findings, citing a confidentiality agreement with the FDA, but said he expected the results to be informative for the agency.

"I am truly convinced that we have important information for the F.D.A. to be able to consider what a...