FDA to propose altering ban on gay and bisexual men who want to donate blood – Washington Post

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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 on Tuesday.

Gay rights groups, which have long advocated for 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.

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 on Tuesday that the FDA would draft the new guidelines in early 2015, then revise them after a public comment period. He said he could not confirm whether the new rule would go into effect in 2015.

Marks also said that the FDA’s study of the issue led it to conclude that gay men should only be allowed to donate blood 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 on Tuesday afternoon. They said that tests can reliably detect HIV in the blood 45 days after infection, so imposing a longer ban on gay men 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. healthcare provider that caters to LGBT 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 he was glad to hear that the FDA would take public comments before drafting a final policy, and he said he planned to submit one.

“Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban,” the group Gay Men’s Health Crisis said in a statement.

The Human Rights Campaign and Lambda Legal also issued statements saying that the policy change is welcome but does not go far enough.

Currently, men and women of any sexual orientation are barred from donating blood for one year after having sex with someone with HIV, with a commercial sex worker or with an intravenous drug user.

In November, 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 blood.

Australia, Britain and Japan already use the one-year abstinence rule. South Africa asks all donors to wait six months after having sex with a new partner, of any gender.

Marks said that the FDA found “some of the most compelling data” in looking at the success of the policy in Australia.

Based on models that the FDA created, Marks said he expects about half of the would-be blood donors who are currently 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 UCLA, where researchers released a study on the topic in September. The study estimated that a one-year ban would lead to 185,800 additional men donating blood annually, and a complete end to all bans on gay men donating blood would lead to 360,600 new donors.

The study said that lifting the ban would increase the U.S. blood supply by 2 to 4 percent.

Bruner, at Whitman-Walker, said that 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 work on creating a new system to monitor 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.

Related: Health organizations and gay rights activists have called the ban outdated and discriminatory for years

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