Proposed New Blood Donation Guidelines Focused on Individual Assessment an Important Step Toward Ending Discriminatory Policies, But More Progress Still Needed to Ensure Equitable Treatment of All Donors

by Delphine Luneau

Human Rights Campaign Calls for Expedited Development of Means to Inactivate Pathogens in Blood

WASHINGTON, D.C. — The Food and Drug Administration (FDA) today announced a long-awaited proposal today to update the guidelines surrounding blood donation by gay, bisexual, and other men who have sex with men (MSM). Most significantly, the proposal aims to move to a science-based, individualized assessment approach to determine who should be allowed to donate blood, rather than the existing guidelines that unfairly restrict gay, bisexual, and other men who have sex with men from donating.

The Human Rights Campaign (HRC), the nation’s largest lesbian, gay, bisexual, transgender and queer (LGBTQ+) civil rights organization, has for years advocated such a policy change. But other aspects of the proposed new policy still require refinement. Blood donation deferrals will remain in effect for people who rely on pre-exposure prophylaxis, or PrEP, to avoid blood recipients from contracting HIV. Existing research indicates that in some cases, PrEP can obscure HIV positivity. The FDA must finalize assessment of the ADVANCE Study to assess the actual risk. HRC encourages individuals utilizing PrEP to defer blood donations and to continue taking their PrEP regimen. Also, the number of partners of a potential donor should be less of a focus than new partners. The technology exists today to prevent transmission of certain pathogens such as HIV in plasma and platelets. This technology is currently in Phase III Clinical Trials for reduction of pathogens in red blood cells. Efforts should be expeditiously applied to advancing this technology.

“This proposed blood donation policy moves the country toward what LGBTQ+ advocates and medical experts have been saying for years – that a science-based, individualized risk assessment is the best, most equitable way to ensure safety of the blood supply while reducing unnecessary discrimination against gay, bisexual, and other men who have sex with men,” said Kelley Robinson, President of the Human Rights Campaign. “This new policy removes a decades-long barrier for many in our community – and there is more to do to ensure gay, bisexual and transgender people are no longer unfairly stigmatized when they try to donate blood. The assessment criteria have flaws, focusing excessively, for instance, on the number of partners a potential donor has instead of just on new partners.
“It is also unfortunate that the new policy continues to ban those on PrEP from donating blood. PrEP is the most powerful weapon we have to protect individuals from contracting HIV and to eventually wipe out the disease entirely. The fact that being on PrEP can conceal HIV positivity is accurate, but there is a solution on the horizon thanks to technologies being developed that would inactivate pathogens in the blood. In the meantime, it is absolutely essential that those who are currently receiving PrEP treatments continue to remain with their medication.
“We will soon be a step closer to ending the stigma that has existed for decades as a result of the harmful blood donation ban, and in the process, we will be able to ensure that the blood supply remains protected. Now the work must continue to refine this policy.”

The proposed policy will be subject to a 60-day public comment period, then subject to revision by the FDA. Blood centers will then need time to adopt the new assessment tools before the policy can go into effect. Currently, gay and bisexual men cannot donate blood unless they do not have sex of any kind for three months. For nearly 40 years, sexually active gay and bisexual men have not been allowed to donate blood.

The proposal follows the conclusion of the FDA’s ADVANCE Study, which examined whether a different donor deferral policy could be used at blood centers nationwide while maintaining the safety of the blood supply. The study concluded in September 2022, providing the agency with the data necessary to refine its blood donation policy.

Over 1.1 million people in the United States are living with HIV. Marginalized populations, including LGBTQ+ people, face both societal and economic barriers that prevent them from accessing healthcare and communities of color have been hit the hardest – 1 in 2 Black gay and bisexual cisgender men and 1 in 4 Latinx gay and bisexual cisgender men will be diagnosed with HIV in their lifetime.

According to the Centers for Disease Control and Prevention, a person living with HIV who is on treatment and has an undetectable viral load cannot transmit HIV during sex. Known as U=U, which stands for “Undetectable=Untransmissable,” this paradigm is 100% effective at preventing HIV transmission during sex. PrEP (Pre-Exposure Prophylaxis), has been found to be over 99% effective at preventing HIV during sex when taken as prescribed.

HRC has been at the forefront in the decades-long effort to update the policy, alongside other advocates. In 2020, HRC sent a letter to the FDA urging the agency to make swift changes to the policy in the face of the COVID-19 pandemic, which led to thousands of blood drives being canceled across the country. HRC has repeatedly asked for changes to the federal policy on blood donations, since the FDA adopted its initial, discriminatory policy in 1983. Nearly 15 years ago in 2010, HRC renewed its call to change the policy to be more fully inclusive of LGBTQ+ Americans. In 2015, following a new change to the policy that required gay, bisexual, and other men who have sex with men to be abstinent for a year, HRC again affirmed that this approach was unacceptable.

The Human Rights Campaign is America’s largest civil rights organization working to achieve equality for lesbian, gay, bisexual, transgender and queer people. HRC envisions a world where LGBTQ+ people are embraced as full members of society at home, at work and in every community.

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