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In January 2023, the Biden administration and the U.S. Food and Drug Administration (FDA) took a significant step toward dismantling antiquated and discriminatory policy preventing gay and bisexual men from donating blood. The new policy moves away from discriminatory policy based on identity and toward a science-based, individualized risk assessment approach.
Click here to learn more about the progress made in Blood Donation policies and follow HRC’s efforts to drive change.
The updated guidance abandons the discriminatory deferral policy based on one’s identity within a group (i.e., gay, and bisexual men, and same gender loving men).
The updated guidance now requires all persons to be evaluated based on an individual donor assessment. All prospective donors will be asked the same questions, and if deemed eligible, can donate blood.
Prospective donors will not be asked if they are monogamous, or in a monogamous relationship.
Under the new guidance, all prospective donors will be asked the same set of questions about new or multiple sexual partners.
Those who do not report having new or multiple sexual partners and did not have anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Under the updated guidance, persons taking oral PrEP will be deferred for 3 months, while those taking injectable PrEP, will be deferred for 2 years.
While undetectable still equals non transmissible for sexual transmission, the same does not apply to transfusion transmission of HIV.
The basis for this deferral is grounded in current science. If a prospective donor using PrEP acquires HIV, it is possible that the medication could cause a false-negative test result because the virus has dropped to an undetectable level. That means a person taking PrEP/PEP could unknowingly transmit the virus to our nation’s blood supply.
The FDA guidance is very clear, that individuals should not stop taking their prescribed medications, including PrEP or PEP, in order to donate blood.
All prospective donors will be asked the same questions and complete the same Donor History Questionnaire.
With the new guidance, individuals will not be deferred simply because they had male-to-male sexual contact.
According to the Red Cross, as of August 7th, all of its blood centers are accepting newly eligible donors. The America’s Blood Centers are also in the process of accepting newly eligible donors.
All blood centers must update their computer systems and have them approved by FDA. As a result, each blood center will have their own timeframe for implementing the revised guidance.
Prospective donors are encouraged to contact their local blood center directly to learn if they, too, are now accepting newly eligible donors.
Yes. In fact, transgender women have been eligible to donate blood since December 2015.
Under the updated guidance, transgender men and other prospective donors will be evaluated based on the same eligibility criteria, and if they meet those criteria, will be able to donate blood.
According to America’s Blood Centers, approximately 3% of the U.S. population donates blood each year.
Modernizing the eligibility guidelines will expand the pool of eligible donors and has the potential to increase the blood supply and, in turn, help respond to blood shortages.
We have called on HHS and FDA to advance implementation of pathogen reduction technology that can inactivate pathogens like HIV, Zika, and many, many more.
Blood centers across the country have currently have this technology in place for use on plasma and platelets.
Similar technology for red blood cells is currently in Phase III clinical trials.
Individuals may be deferred from donating for a variety of reasons: recently traveling in a country where malaria is prevalent, taking a range of medications that could result in an adverse reaction if the blood were passed through transfusion.
We ask that all individuals who show up to donate be honest in response to the questions as they are the first line of defense in keeping the blood supply safe.
The FDA, HHS, blood centers, and patient advocates share the same goal -- ensuring the safety of the blood supply. These changes could not have been made without rigorous scientific review, and confidence that the blood supply would continue to be safe for all recipients.
HRC has been at the forefront in the decades-long effort to update the policy, alongside other advocates.
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 and bisexual to be abstinent for a year, HRC again affirmed that this approach was unacceptable. HRC believes further investment in technologies and research – such as technology to reduce pathogens in red blood cells currently in Phase III Clinical Trials – is needed to enable even more individuals to donate whole blood.
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.
In August 2023, the American Red Cross implemented the FDA’s updated final guidance regarding an individual donor assessment for all blood donors regardless of gender or sexual orientation. This change eliminated previous FDA eligibility criteria based on sexual orientation.
They encourage individuals who believe they may now be eligible to give under the new guidelines to visit RedCrossBlood.org to learn more about donor eligibility requirements that help ensure the safety of both blood donors and blood recipients.
The FDA’s Center for Biologics Evaluation and Research regulates and establishes standards for the collection of blood and blood products. The center receives advice on this issue from the Blood Products Advisory Council, which meets regularly to consider issues such as altering the pool of potential blood donors.
In a 2023 HRC survey, nearly 90 percent of respondents believe the federal government needs to “prioritize investing in more technologies and research to allow more people to donate blood.” The technology exists today to prevent transmission of certain pathogens such as HIV in plasma and platelets.
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