FDA Relaxes Blood Donation Rules for Gay and Bisexual Men

After decades of rejecting or discouraging men who have sex with men (MSM) from donating blood for fear of HIV transmission, the FDA issued final guidance on Thursday relaxing donor eligibility rules.

Under the new recommendations, the FDA scrapped time-based deferrals and screening questions targeting MSM and instead call for individual risk-based questions to be asked of every potential donor as a means of minimizing the risk of transfusion-transmitted HIV.

The changes mean that MSM would be eligible to donate blood if they met new donor criteria, such as being in a monogamous relationship.

"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 press release. "The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community."

Under past guidance from 2015, the FDA allowed blood donations by MSM if they abstained from sex for 12 months first, which was later reduced to 3 months starting in April 2020.

With these new recommendations, consistent with the draft rule issued in January, any potential donor who reports having a new sexual partner or more than one sexual partner in the preceding 3 months and anal sex in the preceding 3 months will be deferred to reduce the chances of donation by an individual with a new or recent HIV infection whose status may not be detectable by HIV nucleic acid testing.

In addition, individuals taking medications used to prevent HIV infection, such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), will also be deferred.

The guidance calls for a 3-month deferral following the most recent dose of an oral medication for preventing HIV infection and a 2-year deferral from the most recent dose of an injectable medication to prevent HIV, due to the pharmacokinetic properties of each.

"Though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false-negative results," the FDA noted.

While HIV is not transmitted by those who have undetectable viral levels during sex, blood transfusion transmission of HIV is different, because it happens intravenously and involves a larger volume of blood than exposure through sexual contact, the agency explained.

The FDA also warned individuals not to quit their prescribed treatments, such as PrEP or PEP, in order to be allowed to donate blood.

Any individual who has ever tested positive for an HIV infection or taken any medication to treat an HIV infection will continue to be deferred permanently.

The new recommendations apply to the collection of blood and blood components, including source plasma.

The agency said it "strongly believes" that instituting this new individual risk-based approach "will not adversely affect the safety or availability of the U.S. blood supply."

In developing its guidance, the FDA reviewed data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility, surveillance information from the Transfusion Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV, and data from the FDA-funded Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study.

The agency said it will work with the blood collection industry to implement the new recommendations in a timely way, and will continue to monitor the blood supply once the changes have taken effect. In addition, it will continue to review "additional data and new technological developments" as they emerge to shape future recommendations.

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