FDA to Ease Blood Donation Restrictions for Men Who Have Sex With Men

Lucy Hicks

January 27, 2023

The US Food and Drug Administration (FDA) today revealed draft guidelines that would ease restrictions on blood donation for men who have sex with men (MSM). Previously, the FDA only allowed blood donations from MSM who had abstained from sex with another man for 3 months. Under the newly proposed guidance, the FDA recommends that all potential donors be screened with a questionnaire that assesses the risk for HIV on the basis of sexual behavior, recent sexual partners, and other relevant factors.

Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute, praised this "long overdue" change. "This marks a monumental shift and ends a long and painful era of blanket discrimination against gay men. No longer will eligibility to donate blood be based on sexual orientation. Instead, every person, no matter their sexuality, will be reviewed individually in order to determine their eligibility to donate," he said in an emailed statement.

The restrictions on MSM from donating blood began in response to the AIDS epidemic. In 1985, the FDA enacted a lifetime ban on blood donations from MSM. In 2015, the agency dropped this ban and instead required MSM to abstain from sex with other men for 1 year prior to donating blood. In 2020, this deferral period was shortened to 90 days. But LGBTQ rights groups and some medical societies, such as the American Medical Association (AMA), rebuked these requirements as discriminatory.

"The current three-month deferral period singles out and bans blood donors based on their inherent attributes rather than the risk factors they present," wrote previous AMA President Gerald Harmon, MD, in January 2022. "For example, a man who has protected sex with another man in the three months prior to a blood donation cannot be a donor, but a man or woman who has unprotected sex with multiple partners of the opposite sex over the same time period remains eligible."

The newly proposed guidelines drop the 3-month abstinence requirement for MSM. Instead, the current donor history questionnaire would be revised so as to ask all potential donors about new and multiple sexual partners in the past 3 months. Persons who report new or multiple sexual partner(s) over the past 3 months would then be asked whether they had engaged in anal sex over that period. Persons who report having new or multiple sexual partners as well as participating in anal sex in the past 3 months would not be allowed to donate until a later date.

Additionally, individuals taking preexposure prophylaxis (PrEP) would be deferred from donating. Those taking oral PrEP would be deferred for 3 months from their most recent dose, and those taking injectable PrEP would be deferred for 2 years from their most recent injection. Data suggest that these medications can delay detection of the HIV virus with licensed screening tests for blood donations and that their use can lead to false negative results, Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, explained during a press conference.

"We recognize that while these draft recommendations when finalized will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating. And that said, the FDA will continue to track the latest data relevant to PrEP and blood donation to inform these recommendations," he noted.

The recommendations would not make any changes to donation restrictions on the basis of other HIV risk factors. Individuals who have exchanged sex for money or drugs or have engaged in nonprescription injection drug use in the past 3 months would still be barred from donating. Anyone who has ever tested positive for HIV or has taken medication for HIV infection would continue to be barred indefinitely from donating blood.

The proposal is open for public comment for the next 60 days. The FDA will then review and finalize the guidance.

"Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies, thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients," Marks said. "We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible."

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