The Food and Drug Administration has officially begun reconsidering its ban on blood donations from gay and bisexual men amid pressure from Democrats in Congress. The agency posted a request Tuesday seeking public comment on what alternative blood donor deferral policies could look like, suggesting the possibility that the longstanding prohibition on gay blood donations may soon be lifted.
In recent years, activists and even many national medical and health associations have argued that it’s unfair and discriminatory because HIV is not only transmitted by men who have sex with men. It can be transmitted through anal and vaginal sex, as well as through intravenous drug use, and is indiscriminate of whether the person transmitting the disease is straight, bisexual, gay, female, or male.
While the lifetime ban on blood donations was relaxed last December after years of protest, the ban continues to restrict men who have had sex with other men in the past year from giving blood.
The ban was originally implemented in 1983 during the HIV/AIDS crisis and was intended to limit the risk of the HIV/AIDS virus infecting blood supplies. Before there was screening for HIV in blood donations, thousands of people caught HIV that way. By the end of 2001, more than 14,000 people became infected with HIV through blood transfusions, many of them children.
That was before the age of tests with the ability to detect HIV in blood. These days all blood donations are required by the FDA to be screened for hepatitis B, hepatitis C, HIV, a virus called HTLV, the bacteria that causes syphilis, West Nile virus and the parasite that causes Chagas disease. Currently only about one in 2 million blood donations might carry and transmit HIV if given to a patient, according to the National Heart, Lung, and Blood Institute.
FDA policies also exclude other people at risk of transmitting disease from giving blood, including injecting drug users, people with travel to certain areas and people who’ve recently gotten tattoos.
The issue came to light again last month in the aftermath of the nation’s largest mass shooting at a gay nightclub in Orlando Florida which claimed the lives of 49 people and wounded 53 others. LGBT groups argued that many friends and loved ones couldn’t donate blood because of the ban.
Shortly thereafter, a group of 24 U.S. senators signed a letter urging the Department of Health & Human Services to change the policy. Several days later, 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.
In the seven-page notice published in the Federal Register on Thursday, the FDA indicates it is 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.”
Acknowledging opponents suggestions for moving to a system that evaluates individual risk, the FDA asks commenters to address the following six questions and encourages stakeholders to provide scientific data to back up their comments:
- What questions would most effectively identify individuals at risk of transmitting HIV through blood donation?
- 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?
- 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?
- 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.
- What changes might be necessary within blood collection establishments to assure that accurate, individual HIV risk assessments are performed?
- How best to design a potential study to evaluate the feasibility and effectiveness of alternative deferral options such as individual risk assessment?
Several lawmakers have spoken out in the wake of today’s news. Among them, U.S. Representative Mike Quigley, Vice-Chair of the Congressional LGBT Equality Caucus said “I am encouraged by today’s announcement that the FDA will look into policy solutions in order to move away from the discriminatory time-based deferrals and move closer to individual risk assessment as it relates to blood donor safety screenings… The tragedy at Pulse nightclub in Orlando highlighted the discrimination gay and bisexual men face when attempting to donate blood to those in need.
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.”
According to a 2014 research brief published by the Williams Institute, if the FDA lifted its previous lifetime ban of gay and bisexual men donating blood, it could have increased the nation’s annual blood supply by 4%.
The White House has continued to defend the one-year deferral requirement on blood donations from gay and bisexual men as a policy based on “scientific advice.” There’s been no statement yet from the Obama administration about whether or not the President supports further relaxing the ban on blood donations.