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FDA to propose altering ban on gay and bisexual men who want to donate blood FDA to propose altering ban on gay and bisexual men who want to donate blood
(34 minutes later)
The Food and Drug Administration will propose lifting its ban on blood donation for men who have had sex with other men, and will replace it with a one-year deferral period after homosexual conduct, the agency announced on Tuesday. 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.
Since 1983, the FDA has banned any man who has had sex with another man, from 1977 to the present, from donating blood. The policy was instituted in the early days of the AIDS crisis, when little was known about HIV, but fears were rising of a virus transmitted among gay and bisexual men.Since 1983, the FDA has banned any man who has had sex with another man, from 1977 to the present, from donating blood. The policy was instituted in the early days of the AIDS crisis, when little was known about HIV, but 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.”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.
Currently, men and women of any sexual orientation are barred for 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.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.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.
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