The federal government is moving to ease a 31-year-old prohibition on blood donations from gay and bisexual men, the Food and Drug Administration announced Tuesday.
The policy change would allow gay and bisexual men to donate blood if they have been celibate for one year, partially rolling back a 1983 ban that has since been described as medically unwarranted.
The FDA plans to issue a draft guidance in 2015, which will set off the months-long regulatory process.
“The policy change will take time to implement so this won’t be an immediate change,” Dr. Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, said.
The FDA’s announcement is the biggest step in a decades-old debate on whether gay and bisexual men, who are at a higher risk for HIV/AIDS, can safely donate blood. But a large group of advocates – including members of Congress, the LGBT community and medical associations – believe the change should go further.
A leading HIV/AIDS advocacy group, the Gay Men’s Health Crisis, said the government’s decision to keep the one-year ban remains “offensive and harmful.”
“Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban,” the group wrote in a statement.
Sen. Tammy BaldwinTammy Suzanne BaldwinWarren, Daines introduce bill honoring 13 killed in Kabul attack This week: Democrats kick off chaotic fall with Biden's agenda at stake Bottom line MORE (D-Wis.), a longtime advocate for a policy change, said it was not enough.
“The Administration must continue to work towards implementing blood donation policies based on individual risk factors instead of singling out one group of people and turning away healthy, willing donors, even when we face serious blood shortages,” she wrote in a statement.
The policy has faced mounting criticism for more than four years. Groups including the American Red Cross and America’s Blood Centers have called the ban “medically and scientifically unwarranted.” The American Medical Association voted to end the ban last summer.
After the new policy goes in place, Marks said the FDA will begin new studies to determine whether the ban could be reversed entirely.
“As we gather data, we will visit the policy in the future, but I can’t state when we’ll be able to do that, at this time,” he said.
Marks said the FDA has not yet seen scientific evidence that supports a total elimination.
“At this time, we simply don’t have the evidence that we can go to a shorter period,” he said. “We’ve come to the conclusion that the recommended one-year deferral is reasonable.”
The FDA had been widely expected to endorse the one-year deferral period after a group of advisers to the Department of Health and Human Services voiced support earlier this fall.
But a panel of FDA advisers earlier this month said it would be risky to lift the ban.
“There’s too many questions in science that aren’t answerable,” Corey Dubin, a member of the committee and founder of an HIV/AIDS advocacy organization called Committee of Ten Thousand, said then.
The advisory panel, which includes 16 top scientists and industry executives, recommended more research before revising the policy.
This story was updated at 2:00 p.m.