The Food and Drug Administration today moved toward relaxing the country's widely criticized policy that bans gay men from ever donating blood. The federal department will recommend reforming the policy, limiting the ban to those who have had sex with men in the previous year.
"We would not recommend such a policy change if we didn't think the safety of the blood supply would be maintained," Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, said in a conference call with reporters.
The FDA will will submit the proposal to the Federal Register in 2015 to receive public comment, Marks said. He did not provide a timeline for codifying a final policy.
But the new recommendation has drawn criticism for not going far enough. Sen. Tammy Baldwin, while applauding the move as a step in the right direction, criticized the proposal as unscientific and singling out gay men. "Our goal is to replace this discriminatory, lifetime ban on blood donations by healthy gay and bisexual men with a policy based on individual risk," she said in a statement.
"While this announcement represents needed progress, I remain concerned that it does not achieve our goal of putting in place a policy that is based on sound science and allows all healthy individuals to donate," she added.
Gay Men's Health Crisis (GMHC) issued a statement calling the proposal "offensive and harmful."
"This new policy does not require heterosexual blood donors to be celibate for one year," the group said in a statement. "Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban. ... While the FDA is right to revisit the outdated lifetime ban, GMHC calls on the FDA and HHS Secretary [Sylvia Mathews ] Burwell to implement a risk-based blood donation policy, regardless of sexual orientation or gender identity, and to stop perpetuating the stigma and discrimination driving the HIV/AIDS epidemic."
Current policy bans all men who have had sex with men since 1977 from donating blood. Critics have described the 1983 policy, approved at the height of the AIDS epidemic, as an archaic and scientifically unjustified barrier to getting blood to those who need it.
"Half of the men who are unable to donate under the existing deferral would be able to donate under the revised policy," said FDA's Marks.
However, Ian Thompson, American Civil Liberties Union's legislative representative, said in a statement that a one-year deferral would still block many potential donors.
"The reality for most gay and bisexual men — including those in committed, monogamous relationships — is that this proposal will continue to function as a de facto lifetime ban," Thompson said.
The ACLU, he said, will keep advocating for a risk-based screening process, not an across-the-board deferral policy based on sexual orientation and today's proposal "must be seen as part of an ongoing process and not an end point."
The Human Rights Campaign (HRC) similarly argued that the recommended policy would still "stigmatize gay and bisexual men, preventing them from donating life-saving blood based solely on their sexual orientation, rather than a policy based on actual risk to the blood supply," according to a statement from David Stacy, HRC's government affairs director. "This new policy cannot be justified in light of current scientific research and updated blood screening technology. We will continue to work towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve."
On the call with reporters, Marks added that "compelling scientific evidence" does not support a deferral period less than one year for gay men "while still maintaining the safety of the blood supply." The FDA is implementing a national blood surveillance system, which may provide additional safeguards that prevent disease transmission. He said data collected under the system will allow the FDA to gauge whether the one-year deferral policy should be modified to include more potential blood donors.
Scott Schoettes, Lambda Legal senior attorney and director of the HIV Project, however criticized the policy change proposal as not being based on science.
"This is a step in the right direction, but blood donation policy should be based on current scientific knowledge and experience, not unfounded fear, generalizations and stereotypes," he said. "Within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV. Therefore, a deferral of more than two months — for anyone — is not necessary and does not noticeably enhance the safety of the blood supply."
The existing policy is also applied to transgender people. Mara Keisling, executive director of the National Center for Transgender Equality, told BuzzFeed News that while some transgender people donate without incident, that is the exception. "We think it is not supposed to hit transgender people, but, in practice, it has been a ban on transgender people donating blood," she said.
"We have transgender people who have tried to donate and been told transgender people are excluded, while other people are told you qualify as a gay man, and it doesn't matter if the person is a transgender man or a transgender woman," Keilsing explained. "It's just the usual ignorance we have to deal with."
Keisling said her group will ask the FDA to clarify its position on blood donations from transgender people under any new policy.
"For the purposes of determining donor eligibility, FDA believes that genetic males be considered males even after gender-altering surgery," an FDA spokesperson told Vox earlier this month.
The FDA has not yet supplied answers to a Tuesday inquiry from BuzzFeed News about how the current policy applies to transgender people — including transgender people who were born female — and how that would change under the new proposed policy.
An FDA panel convened on Dec 2. to hear from scientists and blood-donation groups, including the American Red Cross, but closed its meeting without voting on a recommendation.
Instead, the FDA's recommendation today reflects advice from a committee of the Health and Human Services Department, which suggested relaxing the ban in November. That committee said a national blood surveillance system should be required before changing the rules, a requirement that drew criticism this month from 80 members of Congress who said in a letter to Secretary Burwell that it would create an arbitrary delay.
Asked if the FDA would require the surveillance system be in place before the deferral could be shifted to one year, FDA spokesperson Jennifer Rodriguez told BuzzFeed News, "I can't speculate on the details of the draft guidance." But, she said, a blood surveillance system will be developed regardless of any changes to the donation deferral policy.
This article has been updated with statements from the ACLU and HRC, and additional comments from the FDA.
This article has been updated with information about how the blood deferral policy is applied to transgender people. BuzzFeed has asked the FDA to clarify how the current policy is intended to apply to transgender people and how that would change under the new recommendations.