The U.S. Food and Drug Administration (FDA) has finalized historic changes to discriminatory recommendations for assessing the eligibility of potential blood donors that originated in 1985.
The new recommendations for assessing donors replace outdated “time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM,” according to the FDA news release. Blood donor eligibility assessment will instead be based on “individual risk-based questions… for every donor, regardless of sexual orientation, sex or gender.” The U.S. FDA follows in the footsteps of and with the consideration of data from updates made to the United Kingdom and Canada’s own eligibility criteria. The United Kingdom adopted gender-inclusive assessments based on individual risk factors in 2021 followed by Canada in 2022.
Some donor deferrals that are recommended are for those who have tested positive for HIV, those who have taken medication to either treat or prevent HIV, those who have had a new sexual partner or more than one sexual partner in the last three months and engaged in anal sex in the last three months, and both sex workers and those injecting non-prescription drugs.
These updated FDA recommendations were initially proposed and published in January per the FDA’s process of allowing public comment for 60 days before reviewing and finalizing changes. The FDA’s Final Guidance Document as well as the Federal Register Notice can be found in full here. Public comment can still be submitted on any guidance at the aforementioned link as well.
Included with the guidance update is a history of previous FDA policies and recommendations beginning in the early 1980s with the AIDS crisis as well as an explanation of research and scientific data used. Prior updates to the FDA’s guidance came in April of 2020 in response “to the COVID-19 public health emergency and reported shortages in the U.S. blood supply” and featured an update from a 12-month deferral period for MSM (December 2015) to a three-month donor deferral period. The guidance also encourages the updating of all blood center educational materials as well as donor questionnaires.
This change in FDA policy has been supported by organizations such as America’s Blood Centers, the national organization for independent blood collection centers, and GLAAD, a well known LGBTQIA+ media advocacy organization.
Chief Executive Officer at America’s Blood Centers Kate Fry said: “This shift toward individual donor assessments prioritizes the safety of America’s blood supply while treating all donors with the fairness and respect they deserve. The FDA’s final guidance is based on data showing the best protection against diseases like HIV is through strong testing of all blood donations and a uniform screening process for all donors.”
President and CEO of GLAAD Sarah Kate Ellis also tweeted in support of the update:
The FDA’s decision to follow science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to help save lives, signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia. https://t.co/GZ1QU7QOtC
— Sarah Kate Ellis (@sarahkateellis) May 11, 2023
Image: Gage Skidmore/ Creative Commons