FDA To Ease MSM Blood Donations; Ban Lifted on HIV Organ Donation
On Tuesday, FDA released draft guidelines that would ease a decades-old measure that prohibits men who have sex with men from donating blood, the Washington Post reports (Zauzmer, Washington Post, 5/12).
Current FDA regulations prohibit MSM from donating blood because they are at increased risk for HIV. The government's blood donation ban -- which began in the 1980s -- applies to all men who have had sex with another man since 1977 (Washington Post, 5/12). The ban has not been updated since 1992 (Ferris, The Hill, 5/12).
In November 2014, an HHS advisory panel voted 16-2 in favor of allowing MSM to donate blood if they have not had sex with another man for one year (Nathan, Reuters, 5/12).
Under the proposed guidelines, a man who has sex with men would be eligible to donate blood if one year has passed since he last had sex with another man. The FDA task force considered a shorter deferral period -- as it takes less than one year for HIV to be detected in blood -- but opted for the one-year time period that is in place in other countries. The proposed guidelines noted that studies have shown the one-year ban is effective at protecting the blood supply in Australia.
An FDA task force noted in the proposed guidelines that some MSM in a survey reported that they have donated blood, despite the current ban. Researchers contacted 83 MSM who said they had donated blood, and half said they would follow the one-year deferral, according to the proposed guidelines.
The task force did not believe that MSM in monogamous relationships should be exempt from a one-year ban. The report noted that condoms fail in one to two of 100 instances of anal sex, with a higher failure rate among individuals using them in monogamous relationships. In addition, it noted both same-sex and heterosexual couples have about a 25% rate of infidelity (Washington Post, 5/12).
The draft guidance will be finalized after a period for public comment and hearings, according to Reuters. FDA might also seek recommendations from experts (Reuters, 5/12).
The American Medical Association spoke in favor of the revision, calling it "a step in the right direction to end the lifetime ban that prohibits men who have had sex with men from ever donating blood" (The Hill, 5/12).
Meanwhile, civil rights groups have said the measure would still work as a de facto ban on MSM who have sex regularly, according to the Post.
Human Rights Campaign Government Affairs Director David Stacy in a statement said, "While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men" (Washington Post, 5/12). He also noted that the policy "prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply" and "simply cannot be justified in light of current scientific research and updated blood screening technology" (Ross Johnson, Modern Healthcare, 5/12).
The American Red Cross and AABB in a joint statement expressed support for revising the ban to a one-year deferral. They said their centers would adhere to the revisions once they have had time to update their systems (Washington Post, 5/12).
HIV Organ Donor Ban Lifted
Existing regulations have prohibited using organs from individuals with HIV in research since 1988. The new policy will take effect on June 8.
CDC estimates that about 1.2 million U.S. residents have HIV. As many as 30% of U.S. residents with HIV have abnormal kidney function, which means they eventually could need a transplant, according to HHS.
The HHS rule meets a mandate in the HIV Organ Policy Equity Act, a 2013 law that permitted research into organ transplants between individuals who have HIV (Rice, Modern Healthcare, 5/12).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.