US Food and Drug Administration on Thursday paved the way for more gay and bisexual men to donate blood by finalizing new risk-based rules for blood donation. Going forward, prospective donors will be asked the same set of questions regardless of their sex or sexual orientation.
Before the FDA began taking a second look at its policies several years ago, gay and bisexual men had faced a lifetime ban on blood donation, a move many said was discriminatory. The most recent policy required men who have sex with men to wait three months after sexual contact with other men before they can donate blood.
The policy changes eliminate deferrals and screening questions specific to men who have sex with men and women who have sex with MSM. It brings the United States in line with other countries such as the UK and Canada, which have also implemented risk-based rules.
The new questions are designed to reduce the risk of transmission of HIV, or human immunodeficiency virus, through blood donation. The FDA says it made the changes after reviewing data from other countries that have similar rates of HIV and have already implemented risk-based eligibility for blood donations, information on the accuracy of tests to detect HIV, surveillance information from a system that monitors infections passed by transfusions, and information on individual risk factors gleaned from a government-funded study.
Under the new rules, anyone reporting a new sexual partner, more than one sexual partner, or recent anal sex will be told to wait at least three months to donate blood. This reduces the likelihood that someone with a new or recent infection could donate during a window of time when their infection would not be picked up by lab tests.
Anyone taking medications to treat or prevent HIV, such as PrEP, would also be deferred from donation. The FDA says that while HIV is not transmitted during sex in people whose viral levels are are undetectable, the same does not apply to blood donation. Blood is transfused directly into a vein, and involves a larger volume of fluid, making it inherently riskier than sexual contact.
The FDA advises against stopping HIV medication or PrEP to donate blood.
“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. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Marks said the agency would continue to closely monitor the safety of the US blood supply after the rules are implemented.
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