The Food and Drug Administration announced Thursday afternoon that it has finalized a rule that would establish a set of individual risk-based questions for every donor regardless of sexual orientation, sex or gender.
The revised policy is intended to reduce the risk of transfusion-transmitted HIV while also eliminating time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM.
These prior restrictions, in place since the HIV/AIDS epidemic of the 1980s, had long been challenged by healthcare stakeholders and LGBTQIA+ advocates as policies that were discriminatory and not backed by scientific evidence.
The rule was first proposed during National Blood Donor Month in January, where it was largely welcomed by industry stakeholders.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products,” said Peter Marks, MD., PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community.”
The finalized rule announcement received a positive response as the blood collection industry seeks to boost the nation’s blood supply amid a shortage that was intensified by the COVID-19 pandemic.
America’s Blood Centers issued a statement predicting that the rule will promote the safety of America’s blood supply and welcome new donors.
“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,” America’s Blood Centers CEO Kate Fry stated. “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. We are proud that America is now joining many nations around the world in changing our existing policies, which have historically stigmatized certain communities.”
Additionally, the American Medical Association, which has long pushed the FDA to eliminate time-based deferrals for certain populations at increased risk of HIV, also welcomed the news.
“We applaud the FDA for applying the latest scientific evidence to ensure that blood donation criteria are applied more equitably across all segments of our population, including the LGBTQ+ community,” Jack Resneck Jr., MD, president of the American Medical Association, said in a statement.
Resneck added that the FDA should also reevaluate its donation deferral policies for corneas, human cells and other cellular and tissue-based products.
The Congressional Equality Caucus, also tweeted its endorsement of the decision.
Still, despite the progress achieved by the FDA’s revised policies, there are restrictions that could affect potential donors from the LGBTQIA+ community.
People who have had a new sexual partner or more than one partner in the past 90 days or have had anal sex during that period would be deferred. The agency said that is intended to “reduce the likelihood of donations by individuals with new or recent HIV infection.”
The FDA added that potential donors taking medications to treat or prevent HIV infection, such as pre-exposure prophylaxis (PrEP), will also be deferred under the finalized recommendations.
To that end, while applauding the FDA for taking steps to broaden the donor eligibility guidelines, New York state senator Brad Hoylman-Sigal said he looks forward to “the day LGBTQ blood donation bans are lifted entirely.”
