New FDA Final Rule Eases Blood Donation Ban for Gay, Bisexual Men
Previous 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 (California Healthline, 5/13).
The rate of HIV transmission from blood transfusions has dropped from one in 2,500 to one in 1.47 million, according to FDA (Ross Johnson, Modern Healthcare, 12/21).
In November 2014, an HHS advisory panel voted 16-2 in favor of allowing MSM to donate blood if they had not had sex with another man for one year. FDA in May released draft guidelines to ease the restriction (California Healthline, 5/13).
New Policy Details
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, the one-year restriction was implemented because of the period of time during which an individual can be HIV positive but still test negative for the virus (McNeil, New York Times, 12/21).
FDA had considered a shorter deferral period but opted for the one-year delay that is in place in other countries (California Healthline, 5/13). 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. According to FDA, studies have not evaluated the safety of shorter deferral periods (Kaplan, "Science Now," Los Angeles Times, 12/21).
Peter Marks, deputy director of FDA's Center for Biologics Evaluation and Research, said the new policy is "supported by the best available research." Marks noted that the newest blood tests for the disease are "highly accurate but not perfect," adding, "That is why the elimination of all deferrals is not feasible at this time" (New York Times, 12/21).
Advocates Note Progress But Call for Further Action
Nathan Svoboda, president of the Project More Foundation, said the change "is definitely progressive and more inclusive." He added, "But 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 (Allday, San Francisco Chronicle, 12/21).
Kelsey Louie, CEO of GMHC, said the new policy "ignores the modern science of HIV-testing technology while perpetuating the stereotype that all gay and bisexual men are inherently dangerous" (New York Times, 12/21).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.