The Food & Drug Administration has announced it is seeking comment on deferral policies for blood donations, suggesting it’s reconsidering the prohibition of blood donations from gay and bisexual men.
In a seven-page notice set for official publication in the Federal Register on Thursday, the agency indicates it’s opening a public comment period on policies intended to keep HIV out of the blood supply.
“As part of the effort to continue to assess its donor deferral policies, FDA is opening this docket to provide a mechanism for the public to submit additional information regarding potential blood donor deferral policy options,” the notice says. “Specifically, we invite interested persons to submit to the docket comments supported by scientific evidence regarding possible revisions to FDA’s blood donor deferral policies to reduce the risk of HIV transmission by blood and blood products.”
Currently, the Food & Drug Administration requires gay and bisexual men to abstain from sex with other men for one year before donating blood. That policy, implemented last year, replaced the lifetime ban on blood donations from men who have had sex with men, although LGBT advocates have said the new deferral requirement is still essentially a ban.
Observing that opponents of the current policy of deferral have sought to replace it with one that evaluates individual risk, the FDA poses six questions to potential commenters and encourages stakeholders to provide scientific date to back up their comments:
1. What questions would most effectively identify individuals at risk of transmitting HIV through blood donation?
2. Are there specific questions that could be asked that might best capture the recent risk of a donor acquiring HIV infection, such as within the 2 to 4 weeks immediately preceding blood donation?
3. How specific can the questions be regarding sexual practices while remaining understandable and acceptable to all blood donors? For example, could questions about specific sexual behaviors be asked if they helped to identify which donors should be at least temporarily deferred because of risk factors? To the extent the questions are explicit about sexual practices, how willing will donors be to answer such questions accurately?
4. Under what circumstances would a short deferral period for high risk behavior be appropriate? For each short deferral period identified, please specify the duration of the deferral and provide the scientific rationale.
5. What changes might be necessary within blood collection establishments to assure that accurate, individual HIV risk assessments are performed?
6. How best to design a potential study to evaluate the feasibility and effectiveness of alternative deferral options such as individual risk assessment?
Tara Goodin, an FDA spokesperson, said the notice establishes a “formal process” by which the agency solicits comment on the idea of moving from current policy “to alternate deferral options including the use of individual risk assessment.”
“The recommendations revised in December 2015, which are based on risk behaviors and not sexual orientation, are founded upon the best scientific information currently available, and included a rigorous examination of several alternative options, including individual risk assessment,” Goodin said. “Opening of the public document means that we’re seeking information and data on the feasibility of potentially moving toward individual risk assessments, if scientific evidence supports such a change.”
U.S. Sen. Tammy Baldwin (D-Wis.), the only out lesbian in Congress, said in a statement the notice is an “encouraging” step in an effort to lift the gay and bisexual blood ban.
“I have long fought to end discriminatory blood donation policies and improve them, including for healthy gay and bisexual men,” Baldwin said. “It is encouraging that the FDA is taking another step forward to develop better blood donor policies that are grounded in science, don’t unfairly single out one group of individuals, and allow all healthy Americans to donate. I will continue to push for policies that secure our nation’s blood supply in a scientifically sound manner based on individual risk.”
In the aftermath of the mass shooting at a gay nightclub in Orlando, Fla., last month, which claimed the lives of 49 people and wounded 53 others, lawmakers had called on the Obama administration to lift the ban in favor of a policy based on individual risk.
In June, Baldwin was among 24 U.S. senators to sign a letter urging the Department of Health & Human Services to change the policy. In a separate letter, U.S. Reps. Barbara Lee (D-Calif.), Mike Quigley (D-Ill.) and Debbie Wasserman Schultz (D-Fla.) were among more than 100 House lawmakers who signed a separate letter calling for an end to gay and bisexual blood ban.
White House Press Secretary Josh Earnest defended the one-year deferral requirement on blood donations from gay and bisexual men in the aftermath of the Orlando shooting as a policy based on “scientific advice.” On Tuesday, the White House didn’t respond to the Washington Blade’s request to comment on the notice.
Brandon Lorenz, a spokesperson for the Human Rights Campaign, said his organization is hopeful the FDA’s request for comment indicates an upcoming change in policy.
“The FDA’s current policy cannot be justified in light of current scientific research and updated blood screening technology,” Lorenz said. “We are committed to working towards an outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve. We’re hopeful this call for comments represents the next step toward changing an outdated and short-sided policy.”