The Food & Drug Administration announced on Monday it has made final its change to the U.S. prohibition on gay and bisexual men donating blood, eliminating the lifetime ban in favor of a policy requiring one-year of abstinence before accepting donations.
Stephen Ostroff, the FDA’s acting commissioner, said in a statement the change reflects scientific evidence and continued safety to reduce the risk of HIV transmission via blood donation.
“The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” Ostroff said. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”
According to the statement, the FDA reviewed policies on HIV transmission through blood products to determine the best change based on the most recent scientific evidence. Other countries, including the United Kingdom and Australia, currently have 12-month deferrals on blood donations from men who have sex with men.
In the future, the FDA will continue to evaluate its blood donor deferral policies as new scientific information becomes available, the statement says.
Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation & Research, said the FDA reviewed alternative options, including individual risk assessment, but the requirement for one-year of abstinence was the best policy.
“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population,” Marks said. “We will continue to actively conduct research in this area and further revise our policies as new data emerge.”
The FDA instituted the blood donor ban in 1983 in response to the AIDS crisis. The policy prohibits any man who’s had sex even once with another man since 1977 from donating blood. At the time, the policy was deemed necessary because gay and bisexual men have a higher rate of HIV/AIDS infection.
Amid calls from LGBT advocates to eliminate the gay blood ban, the FDA first proposed the change to the one-year deferral period in December 2014. Although many opponents of the ban said the change was a step in the right direction, they maintained any kind of deferral period was discriminatory and not based on current science given current testing procedures.
Lawmakers who had led calls on the FDA to lift the gay blood ban, including Rep. Mike Quigley (D-Ill.), gay Rep. Jared Polis (D-Colo.) and lesbian Sen. Tammy Baldwin (D-Wis.), said during the comment period on the proposed rule the agency should make clear the new policy is a temporary one that will yield to complete elimination of the prohibition.
Polis said in a statement the new rule continues “the government’s troubling precedent of allowing stigma to trump science” for blood donations.
“There is no scientific reason to impose a celibacy requirement on gay men before they can donate blood,” Polis said. “The FDA should implement a process that screens potential donors relying on a science-based risk assessment rather than outdated stereotypes.”
Quigley said in a statement the LGBT community has enjoyed significant advancements in recent years, but the change in blood donation policy “does not keep up with that same progress.”
“A time-based deferral focusing solely on men who have sex with men is still discriminatory and fails to exclude donors based on actual risk factors,” Quigley said. “However, I remain encouraged by the ongoing conversation to change this outdated policy. As the leader of the bipartisan, bicameral effort to reverse the FDA’s discriminatory policy, I will continue to fight for a deferral policy based on behavioral risks, commensurate with the rest of the population and based on sound science, bringing equality for the LGBT community while still protecting the U.S. blood supply.”
Baldwin said in a statement to the Washington Blade she’s encouraged the FDA acted swiftly on the proposed rule change, but it should only be the first step in changing an outdated policy.
“This revision doesn’t go far enough – and I expect the FDA to maintain its commitment to work with stakeholders to develop better blood donor policies based on science,” Baldwin said. “I will continue to push the administration to move forward to achieve our ultimate goal of blood donation policies that are based on individual risk factors, that don’t unfairly single out one group of individuals, and that allow all healthy Americans to donate.”
A White House spokesperson deferred comment on the change to the gay blood ban to the FDA. In May, White House Press Secretary Josh Earnest said the administration is “guided by science” in its policy on blood donations.
Earnest maintained the president has “a very strong record” on LGBT rights, but said other factors are a consideration.
“He also feels strongly about making sure that we have an effective system that manages the reserve blood supply of the country, and we’re mindful of that, and that’s why we have some of the best scientists in the world at the FDA that are looking at this issue and making sure that we can reach a policy that is in the best interest of the country,” Earnest said.
Ryan James Yeszak, director of the National Gay Blood Drive, said the finalization of the rule marks the time advocates begin “the final push to eliminate discrimination based on sexual orientation from the blood donation process altogether.”
“We strongly encourage the FDA to move toward a deferral based upon individual risk assessment,” Yeszak said. “We will commence organizing the National Gay Blood Drive immediately in conjunction with the implementation of the revised MSM blood donor policy.”