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December 2, 2022

FDA is reevaluating its blood donation guidelines amid a national shortage

Daily Briefing

    FDA is currently evaluating a new set of guidelines that would allow more sexually active men who have sex with men (MSM) to donate blood, according to people familiar with the proposal.

    FDA reevaluates blood donation guidelines

    Historically, FDA has discouraged men who have sex with men from donating blood. According to CDC, unprotected anal sex presents a higher risk of HIV transmission than other forms of sex.

    In the 1980s, the agency implemented a complete ban, citing fears of HIV transmission. In 2015, FDA started allowing MSM to donate blood if they had abstained from sexual activity with other men for one year before donating.

    Under FDA's current guidelines, which were put in place amid severe blood shortages during the Covid-19 pandemic, all MSM are still required to abstain from sex for three months before donating blood.

    FDA's new plan would require MSM to complete a questionnaire about several risk factors, including their recent sexual activity. Under the new guidelines, MSM who have not had any new partners within three months would be allowed to donate.

    Blood centers such as the American Red Cross (ARC) test donations for HIV, hepatitis B and C, and other viruses, but tests can't detect HIV immediately after infection. However, "With the latest HIV tests, that window is probably no greater than 10 days from the time of exposure," said Bruce Walker, an infectious-diseases specialist and director of the Ragon Institute of MGH, MIT and Harvard.

    The agency's proposed guidelines come amidst blood shortages in certain parts of the country. The change would also follow a study of around 1,600 MSM that evaluated whether an individualized-risk assessment would serve as an effective method to screen for blood donation. The study was conducted earlier this year by Vitalant, OneBlood, and the ARC—three of the largest nonprofit blood centers in the county.

    For the study, participants were asked a series of questions, including whether they had more than one sexual partner during a specific time, the type of sexual activity they engaged in, and whether they used condoms.

    "We have a strong data set," said Brian Custer, director of Vitalant Research Institute and principal investigator of the study. "We have highly relevant information to envision what an individual risk-based approach would look like."

    On Wednesday, FDA said that new data "will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of H.I.V. transmission." While the new guidelines have not yet been finalized, FDA said it plans to implement them in the coming months.

    Experts remain conflicted about FDA's new guidelines

    For years, LGBTQ advocacy groups have maintained that MSM should be allowed to donate blood, calling FDA's blood donation policy discriminatory. Other groups, including the American Medical Association and the ARC have also called for the policy to be changed.

    According to the New York Times, the new policy will aims to find a position that balances the concerns of both activists against blood donation restrictions for out gay and bisexual men and blood banks that want to eliminate the risk of a recipient acquiring HIV, said an anonymous FDA official.

    "I'm thrilled to see this step forward," said North Carolina Department of Health and Human Services Secretary Kody Kinsley, who led an initiative with 12 other state health leaders to push for an updated blood donation policy. "It's long past time for us to protect the blood supply based off what people do and not who people are."

    Still, many experts have voiced concern about unequal treatment. "I think it is a nominal step in the right direction," said Sarah Kate Ellis, the president and chief executive of GLAAD, an LGBTQ advocacy organization.

    "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," Ellis added.

    Sarah Warbelow, legal director for Human Rights Campaign, encouraged FDA to allow more MSM to donate blood. "Any policy that singles out gay and bisexual men perpetuates stigma while failing to further the goal of a safe blood supply," she said.

    Separately, Susan Stramer, VP for scientific affairs for the ARC, said 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. (Jewett/Anthes, New York Times, 12/1; Whyte/Marcus, Wall Street Journal, 11/30)

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