The U.S. Food and Drug Administration said that scientific evidence shows the move will not create risks for the nation’s blood supply. It stopped short of removing the ban altogether, which some medical groups and advocates had recommended, saying it was not supported by science.
The policy change is expected to boost the supply of donated blood by hundreds of thousands of pints per year. Blood donations from gay men have been barred since the discovery that HIV, the virus that causes AIDS, was being transmitted through transfusions.
The FDA has carefully examined and considered the available scientific evidence relevant to its blood donor deferral policy for men who have sex with men, including the results of several recently completed scientific studies and recent epidemiologic data,” FDA Commissioner Margaret Hamburg said in a statement. The FDA said the move aligns the policy for gay men with that for other men and women who are at increased risk for HIV infection.
John Peller, President and Chief Executive Officer of the AIDS Foundation of Chicago, said that the new policy still holds heterosexual individuals and gay men to different standards. “We think that it’s a step in the right direction but it certainly doesn’t go far enough,” Peller said. “If the goal is to protect the blood supply while also increasing the pool of eligible donors we think that the FDA could go further and we encourage them to continue to review their policy.” Some infectious disease experts agreed that the one-year delay instituted under the relaxed standards was still overly stringent given the scientific evidence.
“Having gay men be abstinent for a year before they can donate is not based on any science. It does not take a year after contact to develop HIV,” Judith Aberg, Chief of the Division of Infectious Diseases at the Icahn School of Medicine at Mount Sinai said. The new HIV tests can detect acute HIV in weeks.”
But Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, said it was not possible to maintain the blood supply safety with a deferral of less than a year.
“At this time we simply do not have the scientific evidence to show that you can go to a shorter period,” Marks said during a press briefing.
The FDA said it will issue draft guidance on the policy, hopefully early in 2015. It would then review the comments and issue final guidance.
An FDA advisory committee met this month and discussed the effectiveness of new blood supply tests for HIV infections. In November, an advisory committee to the U.S. Department of Health and Human Services recommended a one-year deferral. The Williams Institute on Sexual Orientation and Gender Identity Law at the University of California, Los Angeles said in September in a study that eliminating the ban would bring in 615,300 pints of blood annually. Instituting a one-year deferral period would bring in 317,000 pints, the study found.