FDA Ends Ban on Blood Donations From Gay, Bisexual Men

The FDA has announced an end to the longstanding ban on gay and bisexual men donating blood, which had been denounced as discriminatory. Instead, a new policy would assess blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV.¹

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According to the announcement, the questions would be the same for every donor, regardless of sexual orientation, sex, or gender. Blood donation organizations can now implement these recommendations by revising their donor history questionnaires and procedures.¹

“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, MD, in a press release announcing the proposed changes. “Maintaining a safe and adequate supply of blood and blood products in the US is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”²

The updated policy is based on the best available scientific evidence and is in line with policies in place in countries such as the United Kingdom and Canada. Officials say it will potentially expand the number of people eligible to donate blood, while also maintaining safeguards to protect the safety of the blood supply.¹

“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.”¹

Previous FDA policy had involved time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance issued Thursday, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility. All prospective donors who report having a new sexual partner, or more than 1 sexual partner in the past 3 months, or anal sex in the past 3 months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for HIV detection by nucleic acid testing.¹

Additionally, those taking medications to treat or prevent HIV—including antiretroviral therapy, pre-exposure prophylaxis, and post-exposure prophylaxis—will also be deferred. Although officials noted that these antiretroviral drugs are safe, effective, and a vital public health tool, the available data suggest that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results.¹

Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously and involves a large volume of blood compared to exposure with sexual contact. The new guidance states that individuals should not stop taking their prescribed medications in order to donate blood.¹

FDA officials carefully reviewed numerous data sources before arriving at this decision, including data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility. They also evaluated findings from the ADVANCE study, which examined the rates of HIV risk factors as well as the use of medications to treat or prevent HIV infection among MSM study participants.¹

“The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place,” Marks said in the press release.¹

References

1. FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations. News release. FDA. May 11, 2023. Accessed May 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations
2. FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard US Blood Supply. News release. FDA. January 27, 2023. Accessed May 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply