FDA on Monday released a final rule that eases a decades-old policy that prohibited men who have sex with men (MSM) from donating blood.
Past FDA regulations stipulated that MSM were "deferred as blood donors ... because MSM are, as a group, at increased risk for HIV, hepatitis B, and certain other infections that can be transmitted by transfusion."
The ban, which began in the 1980s, applied to all men who had sex with another man since 1977. The ban had not been updated since 1992.
The new policy allows MSM to donate blood if they have abstained from sex with another man for at least one year. While tests can detect HIV in blood in as few as nine days after transmission, FDA says it implemented the one-year restriction because of the period of time during which an individual can be HIV positive but still test negative for the virus.
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FDA had considered a shorter deferral period but opted for the one-year delay that is in place in other countries. In the final rule, FDA noted that research in Australia found the safety of the country's blood supply was unchanged after the country replaced a lifetime ban on MSM blood donations with a one-year deferral. Studies have not evaluated the safety of shorter deferral periods, according to FDA.
Peter Marks, deputy director of FDA's Center for Biologics Evaluation and Research, says the new policy is "supported by the best available research." Marks says the newest blood tests for the disease are "highly accurate but not perfect ... that is why the elimination of all deferrals is not feasible at this time."
FDA said in a release that it "will continue to reevaluate its blood donor deferral policies as new scientific information becomes available."
AIDS advocates react
Nathan Svoboda, president of the not-for-profit Project More Foundation, says the change "is definitely progressive and more inclusive," adding, "We hope this will only be the beginning of a multistep revision process. We're hoping at one point we'll be able to include everybody." According to Svoboda, a "huge percentage" of MSM still will not be eligible to donate blood under the new policy.
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Kelsey Louie, CEO of AIDS organization Gay Men's Health Crisis, says the new policy "ignores the modern science of HIV-testing technology while perpetuating the stereotype that all gay and bisexual men are inherently dangerous" (Ferris, The Hill, 12/21; Ross Johnson, Modern Healthcare, 12/21; McNeil, New York Times, 12/21; Kaplan, "Science Now," Los Angeles Times, 12/21; Allday, San Francisco Chronicle, 12/21).
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