The Food & Drug Administration recently announced plans to seek advice on deferral policies for blood donations, hinting that it might be open to lifting its ban on receiving donations from gay and bisexual men.
The FDA made the announcement in a notice published through the Federal Register Tuesday.
In it, the administration calls for “interested persons” to “submit comments, supported by scientific evidence…regarding potential blood donor deferral policy options to reduce the risk of HIV transmission…including the feasibility of moving from the existing time-based deferrals…to the use of individual risk assessments.”
Here, the “time-based deferrals” refer to the requirement that gay and bisexual men abstain from sex with other men for at least a year before donating blood.
This policy was implemented last year and replaced what was a lifetime prohibition on blood donations from gay men, originally conceived to control for HIV contamination in the blood supply before the advent of speedy and efficient HIV testing.
Now that it’s relatively simple to assess whether or not an individual has HIV, LGBT advocates believe its time for the FDA to lift its discriminatory abstinence requirement and replace it with individual risk assessments.
In the notice, the FDA asks respondents to answer the following six questions on just such a transition.
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?
U.S. Sen. Tammy Baldwin, the only out lesbian in Congress, said in a statement that the notice is an “encouraging” step forward in the fight to lift the ban.
“I have long fought to end discriminatory blood donation policies and improve them, including for healthy gay and bisexual men,” Baldwin remarked.
“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.”
The ban’s real life ramifications were felt this past June in the wake of the horrific mass shooting at Pulse nightclub in Orlando. Following the attack, dozens of LGBT individuals were turned away from local blood banks because of the FDA’s current policy.
In response to this, Baldwin, along with 24 other US Senators, penned a letter urging the Department of Health & Human Services to change its policy on blood donations. An additional letter was sent later with signatures from over 100 House lawmakers.
h/t: Washington Blade