ay and bisexual men will soon be able to donate blood if they have not had sex with a man for at least one year, the Food and Drug Administration said Monday. The announcement ends a 32-year ban on any blood donations from men who have had sex with men.
Peter Marks, the deputy director of the FDA’s Center for Biologics Evaluation and Research, told reporters on a conference call that the agency picked the one-year abstinence policy because it didn’t have any data from other countries on the safety of shorter deferrals.
He said Australia, New Zealand, and the United Kingdom all have a one-year abstinence policy for gay men donating blood, and that Australia had 10 years of safety data — enough to show that there was “no significant increased risk” to the blood supply.
The prior ban had been condemned by gay rights organizations as discriminatory.
In a statement, the National Gay Blood Drive said the policy was still discriminatory. “While many gay and bisexual men will be eligible to donate their blood and help save lives under this 12-month deferral, countless more will continue to be banned solely on the basis of their sexual orientation and without medical or scientific reasoning,” the release said.
The Human Rights Campaign also criticized the rule.
“This new policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” David Stacy, the group’s government affairs director, said in a statement. “While it’s 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.”
People who receive a blood transfusion or are accidentally exposed to the blood of another person also have to wait a year before donating blood.
Testing still not perfect
Marks didn’t rule out the possibility that the FDA could let some individual blood banks accept blood from gay men who had abstained from sex for less than a year.
“It’s guidance, and not a rule,” Marks said. If a blood bank wanted to use a shorter deferral, he said, “we would generally want to see what evidence they were using, and we’d make an individual determination based on that.”
In another policy change that could be important to transgendered people, Marks said the policy will allow blood donors to identify their gender as whatever they want it to be.
Marks said the FDA also considered just relying on HIV tests to determine who can give blood, but decided that while current HIV tests are “highly accurate,” they’re “not perfect” because there is a period of eight to nine days in which an HIV infection might not show up in a test.
Relying only on HIV testing would lead to a fourfold increase in the risk of HIV contamination of the blood supply, Marks said, adding that “an increase of this magnitude is not acceptable.”
Marks left the door open to changing the policy in the future if the FDA develops evidence that gay men can safely donate blood after abstaining from sex for shorter periods.
“We fully expect that the policy put forward in this guidance will continue to evolve as new evidence is developed while we are carefully monitoring the blood supply,” Marks said.
Even with the final policy in place, it will take some time before gay men can head to blood banks and donate, said Debra Kessler of the New York Blood Center. First, blood banks need FDA approval for the changes they will be making to their donor forms, she said.
“It doesn’t happen tomorrow, it happens on government time,” she said. “But we’re really looking forward to making that change.”