Faced with tremendous pressure during the coronavirus crisis to lift its policy barring gay men from donating blood, the Food & Drug Administration announced on Thursday it has eased the restrictions.
While the previous policy, established in 2015, barred men who have had sex with men in the past 12 months from making a donation, the new policy shortens the deferral period, requiring abstinence for only three months.
The FDA indicated it would make a change in a notice to stakeholders on Thursday, saying the decision was based on “evaluation of the totality of the scientific evidence available.”
“To help address this critical need and increase the number of donations, the FDA is announcing today that based on recently completed studies and epidemiologic data, we have concluded that the current policies regarding the eligibility of certain donors can be modified without compromising the safety of the blood supply,” the notice says.
In addition changing the recommended deferral period for men who have had sex with men from 12 months to 3 months, the FDA informs stakeholders of other changes.
Among them are easing ban on donations for women who have had sex with men who, in turn, previously have had sex with a man. For these women, the deferral period has similarly been changed from 12 months to 3 months.
Further, the new policy eases the 12 month deferral for individuals with recent tattoos and piercings to three months, and eases from an indefinite ban to a three month ban donations from people who have a past history of sex in exchange for money, or injection drug use.
Other changes are implemented easing policy related to blood donors who have travelled to malaria-endemic areas, such as countries in Africa, or to European countries where the donor faced potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.
White House Deputy Secretary Judd Deere said via email to the Washington Blade the new policy is safe and consistent with President Trump’s vision for blood donations.
“President Trump wants those who wish to donate blood and for those who accept the donations to be able to do so safely,” Deere said. “Today’s decision is driven by health and science. The White House supports the Commissioner on this action.”
The FDA issued the notice to stakeholders at the same time it published on its website a 17-page official memo outlining the changes, declaring they were made to address the shortage in the blood supply amid the COVID-19 crisis and therefore would not wait for a public comment period.
“As a result of this public health emergency, there is a significant shortage in the supply of blood in the United States, which early implementation of the recommendations in this guidance may help to address (even though the recommendations in this guidance are broadly applicable beyond the COVID-19 public health emergency),” the memo says.
The three month deferral period is consistent with recommendations from the American Red Cross, which before the coronavirus had called on the FDA to shorten the deferral period.
The American Red Cross, in an organizational statement, said the new policy changes, including the three-month deferral period for gay men, will “potentially allow more individuals to donate and help ensure blood collection organizations across the country continue to meet patient needs throughout this pandemic and beyond.”
“Consistent with our Red Cross position, this is the first and important step toward a greater goal of an equitable blood donation process that treats all potential donors with equality and respect, and ensures a safe, sufficient blood supply is readily available for patients in need,” the statement says.
In 1983, the FDA implemented a lifetime ban on blood donations from gay and bisexual men amid fears in the early days of the HIV/AIDS epidemic. During the Obama administration in 2015, that policy was eased to a ban on donations from men who’ve had sex with men in the past year — but restrictions nonetheless remained in place.
The 2015 deferral policy had angered LGBTQ advocates for some time, but indignation became piqued during the blood supply during the coronavirus as U.S. Surgeon General Jerome Adams made an urgent plea for donations.
Among the reasons critics called the previous outdated is the belief testing procedures would catch any HIV in the blood supply regardless of the donor.
Scott Schoettes, counsel and the HIV Project Director at Lambda Legal, said in a conference call hosted by the Human Rights Campaign, however, that isn’t true.
“People believe that it catches all new cases of HIV or new cases of Hepatitis B, Hepatitis C, other blood borne infections,” Schoettes said. “That is not the case. There are still a window period during which that testing would not uncover a newly acquired infection.”
Schoettes said Lambda believes the deferral period could be shortened more than three months based on current science, but for the time being “it is important that people continue to abide by the rules that are place until we can convince the people determining these policies to change the policies so that is really risk based and/or to shorten that deferral period.”
Prior to the FDA’s change, the LGBTQ media watchdog GLAAD was engaged in a weeks long campaign calling on the agency to lift the gay blood ban. A petition launched by GLAAD as of Thursday had more than 20,000 signatures.
Sarah Kate Ellis, CEO of GLAAD, said in a statement the FDA changes are good progress and worth celebrating, but more needs to change.
“This is a victory for all of us who raised our collective voices against the discriminatory ban on gay and bisexual men donating blood,” Ellis said. “The FDA’s decision to lower the deferral period on men who have sex with men from 12 months to 3 months is a step towards being more in line with science, but remains imperfect. We will keep fighting until the deferral period is lifted and gay and bi men, and all LGBTQ people, are treated equal to others.”
In recent weeks, numerous members of Congress had called on FDA to change the policy in several letters to the agency. Among them were Sen. Tammy Baldwin (D-Wis.), who led 17 senators in renewing the call for an end to the policy. Reps. Carolyn Maloney (D-N.Y.) and Alexandria Ocasio-Cortez (D-N.Y.) also signed a joint letter to the FDA this week.
In the conference call with reporters Thursday, Baldwin said the change is “progress,” but isn’t enough and shouldn’t have required a pandemic to happen.
“We know that the blanket deferrals are not based in science and are not based on the best expertise on these topics,” Baldwin said. “And so we’ve got to push further into important step to addressing an immediate dire blood supply shortage.”
In a joint statement, Maloney and Ocasio-Cortez echoed the sense the new FDA policy is a good first step, but more is needed.
“While shortening the deferral period for gay and bisexual men is a good first step, it is critical that FDA move toward assessing potential donors by individual risk, rather than blanket deferral,” the lawmakers said. “A policy that fails to do this perpetuates stigma and falls short of ensuring that every person who can safely donate blood in the United States has the opportunity to do so.”
But victory has a thousand fathers. Just about an hour before FDA announced the change, a White House official said the Blade via email, “The White House has been working with FDA to study the issue.” The White House had previously not responded to requests to comment on gay blood ban.
Also in the morning just before the FDA announced the change, the Human Rights Campaign publicized an April 2 letter from HRC President Alphonso David to the FDA calling for new policy “based on science” for gay blood donations. (The letter stops short of outright calling for an end to the ban.)
“While deferral is necessary for some donors, the current 12 month deferral period is not in line with evidence-based science,” the letter says. “To ensure the blood supply is the safest it can possibly be, risk should be evaluated based on the individual risk behaviors of every donor, rather than on community-wide prevalence.”
Having had receptive anal sex without a condom is an example of a factor that would “present an unacceptable degree of risk” for blood donations, the Human Rights Campaign letter says.
Shortly after the FDA announced its policy change, David in the conference call with reporters was more fiery and said easing a broadly encompassing deferral period for blood donations from gay men is inadequate.
“A gay man or a bisexual man who has sex with another man within three months of the date of donation — despite using condoms, despite taking HIV prevention medication like PrEP — they cannot donate blood,” David said. “This difference is unfair, and it’s based on bias deferral should be based on information that is within the personal knowledge, and control of the prospective donor.”
David Stacy, government affairs director for the Human Rights Campaign, said the organization opted to work with the FDA quietly and behind the scenes in the days leading up to the change in the policy.
“We think this is a science issue, and a health issue,” Stacy said. “And so we’ve been trying to have more of the quiet advocacy versus the beat them over the head with it, because we don’t want them to feel like they’re being jammed into it. We want them to get there based on the science.”