The Food and Drug Administration plans to lift its lifetime ban on blood donation for men who have had sex with other men, and will propose replacing it with a one-year ban after homosexual activity, the agency announced Tuesday.
Gay rights groups, which have long advocated a change to the ban, largely decried the announcement, saying that expecting gay blood donors to remain celibate for a year is not reasonable or medically necessary.
Others were heartened by the relaxation of a long-criticized ban. “This is a very good next step in a process that began in the early 1980s,” said Jay Menitove, who chaired a federal advisory committee that recommended the change.
Anthony Fauci, director of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, said, “There’s no doubt about it, that any way that you can safely add to the pool of donors to counter this chronic shortage of blood is a good thing.”
The recommended change could increase the U.S. blood supply by 2 percent, researchers said.
Since 1983, the FDA has banned any man from donating blood if he has had sex with another man, even one time, since 1977. The policy was instituted in the early days of the AIDS crisis, when little was known about HIV and fears were rising of a virus transmitted among gay and bisexual men.
As tests for HIV in donated blood became standard, calls for the FDA to lift the ban increased. Last year, the American Medical Association called for a change; one board member called the ban “discriminatory.”
Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, said in a telephone call with reporters Tuesday that the FDA would draft the new guidelines early next year and then revise them after a public comment period. He said he could not confirm whether the new rules would go into effect next year.
Marks also said the FDA’s study of the issue led it to conclude that gay men should be allowed to donate blood only if they have been abstinent for one year.
“At this time, the scientific evidence is not compelling that we can change to anything less than a one-year deferral and still maintain the current level of safety of the blood supply,” he said.
Gay rights groups challenged that statement Tuesday. They said tests can reliably detect HIV in the blood within much less than a year of infection, so imposing a longer ban is unnecessary.
“A ban of one year doesn’t really make sense, from a scientific or a medical perspective,” said Daniel Bruner, director of legal services at Whitman-Walker Health, a D.C. health-care provider that caters to lesbian, gay, bisexual and transgender patients. “It’s overly broad, in that you sweep in a lot of people who pose no risk whatsoever to the blood supply. And you are stigmatizing an entire population by telling people that they need to remain celibate for an entire year — whether they are monogamous, whether they practice safe sex, whether they are on medication like the prophylactic that makes the chance that they become infected almost zero.”
Bruner said that he was glad to hear that the FDA would take public comments before drafting a final policy and that he planned to submit one.
In a statement, the group Gay Men’s Health Crisis said, “Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban.”
The Human Rights Campaign and Lambda Legal, among other gay rights groups, also issued statements saying the policy change is welcome but does not go far enough.
Fauci described the proposed one-year rule as “an abundance of caution.”
He said anyone who contracts HIV would test positive sometime from six weeks to six months after infection. A year-long ban, therefore, serves to set people at ease rather than to give time for infections to turn up in tests.
“With the tests that one has that screen the blood, it makes it extremely unlikely — even under other circumstances less than a year — it makes it extremely unlikely that there would be transmission through blood,” Fauci said.
This month, the FDA convened a two-day meeting on the issue to consider reform proposals. An advisory group for the Department of Health and Human Services recommended replacing the lifetime ban with a 12-month period after same-sex conduct during which men could not donate.
Menitove, the Kansas City doctor who chaired that advisory committee, said the committee decided to recommend a one-year ban despite hearing evidence that HIV infections would be detected in a shorter period.
“One of the things that I think was in the background was that when you look at the demographics, men who have sex with men are at higher risk for certain infectious diseases, including those that are emerging,” he said. He said he thought a one-year wait would allow the FDA to respond to any new diseases that may arise among gay men.
“We want to be fair. We want to be socially contemporary. On the other hand, we have a responsibility to blood recipients,” Menitove said.
Men and women of any sexual orientation are barred from donating blood for a year after having sex with someone with HIV, with a commercial sex worker or with an intravenous drug user.
Australia, Britain and Japan already use the one-year abstinence rule for gay men. South Africa asks all donors to wait six months after having sex with a new partner of any gender.
Marks said the FDA found “some of the most compelling data” in looking at the success of the policy in Australia. The country changed to the one-year rule in 2000 and found in a 2010 study that the risk of contracting HIV through blood transfusion had not significantly increased.
Based on models that the FDA created, Marks said he expects about half of the would-be blood donors who are kept away because they have had sex with other men would become eligible to donate. He said he could not provide a number of men he expected would become eligible donors.
A similar estimate came from the Williams Institute at the University of California at Los Angeles, where researchers released a study on the topic in September. It estimated that a one-year ban would lead to 185,800 additional men donating blood annually, and that a complete end to all bans on gay men donating blood would lead to 360,600 new donors.
The UCLA study said that lifting the ban would increase the U.S. blood supply by 2 to 4 percent.
Bruner, at Whitman-Walker, said the one-year requirement would still keep many safe donors away from blood drives.
“I would imagine that there might be a fair number of people who had sex on one or a few occasions decades ago or many years ago with another man who really hadn’t since. But in terms of people who identify as gay men or bisexuals, I assume it wouldn’t really be much different than asking heterosexuals, ‘You can donate blood if you haven’t had sex in the last year,’ ” Bruner said. “I imagine there are people who would qualify, but there are an awful lot of people who wouldn’t.”
Marks said the FDA will also monitor whether the policy change influences the safety of the blood supply. Currently, he said, the American Red Cross detects and discards hundreds of units of donated blood which contain the HIV virus each year. The chance of finding an HIV-contaminated unit in the blood supply, he said, is 1 in 1.5 million.
“We wouldn’t recommend such a policy change if we didn’t believe the scientific evidence supported that the safety of the blood supply would be maintained,” he said.