FDA Relaxes 'Blood Ban' For Gay Men, But LGBTQ Advocates Want Bigger Change

The Food and Drug Administration recommended a change in policy due to “unprecedented challenges to the U.S. blood supply” amid the coronavirus crisis.

The federal government’s surprise decision on Thursday to relax restrictions on blood donations by gay and bisexual men is a positive step as the U.S. faces shortages during the coronavirus pandemic, LGBTQ advocates said. But this isn’t the last time the nation will need blood ― and advocates hope that the policy change will lead to further moves to let gay, bisexual and queer men donate freely.

“It is progress to know this is expected to last beyond the pandemic,” Sen. Tammy Baldwin (D-Wis.) said on a call with reporters. “However, we know that the blanket deferrals are not based in science. … We’ve got to push further.”

The Food and Drug Administration announced that it was recommending a three-month deferral for men who have sex with men, rather than its previous one-year deferral period, which required that potential donors had abstained from sex for a year. The move, which was accompanied by the lessening of a suite of other donation restrictions, was made to address what it called “unprecedented challenges to the U.S. blood supply” during the pandemic.

The move to relax the so-called blood ban came amid national calls from the LGBTQ community, which has long sought a change to the policy. Given the need for blood donations, they argued that a blanket ban on donations from a subset of the public is both discriminatory and dangerous. The COVID-19 outbreak has only strengthened calls to end the ban: The pandemic has strained U.S. blood supplies as normal collection centers closed (the Red Cross said in March it had canceled 2,700 blood drives resulting in 86,000 fewer donations) and the donor pool became more limited due to new restrictions based on potential coronavirus exposure.

GLAAD, the national LGBTQ nonprofit, had collected more than 20,000 signatures on a petition calling on the FDA to remove the restrictions during the COVID-19 pandemic. In a statement, GLAAD President and CEO Sarah Kate Ellis said that the FDA decision was a “victory” 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,” Ellis said.

The FDA first established restrictions on gay and bisexual men (officially men who have sex with men, or MSM) in 1983 amid the HIV/AIDS epidemic, since MSM were the most likely group to show infections. That was revised in 2015 to be a one-year deferral, but national groups said even that was discriminatory and effectively barred even men in monogamous relationships from donating.

Though it was good to see the FDA change its policy based on “science and facts over fear and bias,” Human Rights Campaign President Alphonso David said the decision “is only a step forward.” He advocated for the FDA to replace its “virtual ban” with an assessment that would “evaluate donors based on individual risk rather than on their identity.”

“Modernization of this policy is essential to ensure that the blood supply remains as safe as possible while maximizing the donor pool,” David said on a call with reporters.

Rep. Chris Pappas (D-N.H.), who had written to the FDA in February seeking a permanent change to what he called an “outdated, discriminatory” policy, said in a statement that “more must be done to follow science and allow healthy individuals to give blood ― especially during a crisis where donations are needed.”

Advocates say the FDA’s decision could clear the way for it to replace its broad deferral with a behavioral assessment that would evaluate donors based on certain risk factors, like being in a monogamous relationship, practicing safe sex or taking medication, such as PrEP, that can prevent HIV exposure. The FDA has announced a pilot to test the HIV Risk Questionnaire, which backers said would be a more fair screening tool; the pilot has not yet begun.

Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said in a statement that the changes “are expected to remain in place after the COVID-19 pandemic ends, with any appropriate changes based on comments we receive and our experience implementing the guidances.”

In recent years, countries including the United Kingdom and Canada revised their own MSM policies to a three-month deferral. That, as well as improved testing that can screen for potential infections in donated blood, helped give the FDA confidence there would be no additional risk, according to the agency.

The FDA also relaxed rules that restricted commercial sex workers, intravenous drug users, people who had recently traveled to malaria hot spots, people who had spent significant time in the United Kingdom and European countries that may have been exposed to mad cow disease, and people with recent tattoos or piercings. Those changes are also to remain in place, subject to a public comment period.

The revised deferral will also allow gay and bisexual men who have recovered from a COVID-19 infection to donate antibody-rich plasma if they meet the deferral requirements. That plasma could prove useful for future coronavirus treatment.

AABB, formerly the American Association of Blood Banks, applauded the decision to support “a safe and adequate blood supply during the COVID-19 pandemic.”

“The agency’s evidence-based approach, long requested by AABB, will expand the donor base, and help ensure that blood centers across the nation are better able to address the impact of the COVID-19 pandemic,” the organization said in a statement.

However, the changes will not be instantaneous, as blood banks will have to update questionnaires and software to accommodate the recommended changes (donation centers are also not required to make the changes). Brian Custer, vice president of research and scientific programs at the blood donation nonprofit Vitalant, said the sweeping new recommendations could be “a lot to take on” for blood centers already dealing with new steps to minimize coronavirus transmission risks.

Still, said Custer, the widespread change was a signal that “new scientific data can come along and can help FDA change policy.”

“I’m quite impressed by the scope of it,” Custer said. “It’s a signal from the FDA of the need we have right now. It’s the right decision given all the challenges.”

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