30 Jan The American Academy of HIV Medicine Applauds Proposed Blood Donation Guidelines Focused on Individual, Science-Based Assessments
WASHINGTON – Friday the Food and Drug Administration (FDA) announced a proposal to update the guidelines on donating blood for men who are gay, bisexual, or who have sex with men. The Academy applauds this step forward in equity for blood donations and calls on the FDA to expedite research on technology that will also extend the ability to donate to groups who are still left out of this proposed change.
Under current FDA guidelines implemented in 2020, men who have had sex with men or are gay or bisexual and have been sexually active within three months prior to donating blood are barred from donating. The deferral period does not take into account other factors, including whether men are in monogamous relationships. The new proposed guidelines will remove the time-based deferral for gay, bisexual, and men who have sex with men and will instead use a donor history questionnaire that can more reliably assess HIV risk factors for all donors, regardless of gender or sexual orientation.
“For years, the Academy has strongly advocated for changes to the blood donation policy,” said Bruce J. Packett, executive director of the American Academy of HIV Medicine. “We are pleased that the FDA is finally turning to a science-based assessment system for each individual instead of a blanket ban that has unfairly stigmatized and discriminated against gay and bisexual men or men who have sex with men.”
The new proposed guidelines are a significant step in the right direction, though they still fall short in a couple of areas. First, blood donation deferrals will continue to be in use for people who are using HIV pre-exposure prophylaxis (PrEP). Research has shown that in some cases the use of PrEP may interfere with HIV tests, producing false negative results. However, new technologies are in development to prevent transmission of pathogens, such as HIV, in plasma and platelets. The FDA should make every effort to expedite the development of this technology, which is currently in phase III of clinical trials. As well, the new guidelines focus on the number of partners a potential donor has had in the past three months rather than simply focusing on whether donors have had a new partner.
“This move by the FDA puts public health first and ensures crucial health care needs are met, especially in light of the recent critical shortages in our country’s blood supply,” said Packett. A year ago, the American Red Cross announced a blood shortage crisis in the United States, and the country experienced a similar shortage in 2012. Allowing a wider eligibility of blood donors using science-based criteria grounded in updated HIV research will make sure that more people can donate much needed blood to secure the U.S. blood supply.
The FDA has a 60-day comment period that is now open for the proposed guidelines. Once the comment period closes, the FDA will finalize the guidelines. Afterward, blood collection centers in the U.S. will then implement the new individual assessment criteria.
To read the FDA’s announcement, visit: https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply
To review the full draft guidelines, visit: https://www.fda.gov/media/164829/download
To comment on the proposed guidelines, visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human
About the American Academy of HIV Medicine
The American Academy of HIV Medicine is the nation’s leading independent organization of health care professionals dedicated to providing excellence in HIV care and prevention. Our membership of practitioners and credentialed clinicians manage the health of the majority of people with and at risk of HIV in the United States.