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What You Need to Know about FDA’s Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions

What You Need to Know about the FDA’s Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations.

For Pride Month, we speak with Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research (CBER).

Health Equity Forum Podcast: Episode 12 - Transcript

RDML Richardae Araojo:  Hello and welcome to the Health Equity Forum Podcast hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA.  This June, the office is proud to join the FDA and HHS in celebrating Pride Month as we continue our work to support and advance the health of LGBTQI+ communities. In this episode, I will be speaking with Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research, or CBER, at FDA. The Center is responsible for assuring the safety and effectiveness of biological products including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies. Dr. Marks and I will discuss the recent FDA guidance on recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products. Dr. Marks, welcome to the Health Equity Foreign Podcast and thank you so much for being our guest today. 

Dr. Peter Marks:  Nice to be here today. Thank you. 

RDML Araojo:  We’ll talk more in depth about the recent changes later in this podcast, but I think it might be helpful for our listeners if we first take a step back and examine the history of blood donations. Can you speak about the history of blood donation eligibility requirements? 

Dr. Marks:  So, blood donation eligibility is based on a set of questions and it’s also, blood donations are also undergo tests to make sure that the blood is safe. And the tests are actually quite good. But the questions complement those tests to help us make sure that the blood supply is as safe as it possibly can be. And so, we’ve asked questions as part of blood donation for many, many years. And when HIV first came on the scene, we actually didn’t know what it was when it first came on the scene. And in 1983, we started to have deferrals based on questions that were asked. Those eventually, once we understood that HIV caused AIDS, turned into a set of questions around deferral for blood donation that focused on men who had sex with men, because those were the individuals who were most at risk for HIV. There were also some other groups that were deferred from donating because of the risk of HIV.  And over the course of time those questions were refined somewhat, and they evolved with time from what was an indefinite deferral for men who had sex with men to in 2015, it progressed to a 12-month deferral based on the available science at that time. And then in 2020, it evolved further to just a three-month deferral because the science had shown us that that deferral interval kept the blood safe. So that combination of questions asked plus a very, very good testing system is what has been used to keep the blood safe. 

RDML Araojo:  Thank you for that background, Dr. Marks. Of course, in May, the FDA finalized the new recommendations for assessing blood donor eligibility. Can you tell us about the announcement and provide a quick overview of what has changed? 

Dr. Marks: So, based on the emerging science, we have been able to move to what is now an individual risk assessment. Before we had to ask, essentially, men and women different questions. Now we can ask anyone, regardless of their sexual orientation, the same set of questions.  And so, we recommend eliminating the screening questions specific to men who have sex with men and to women who have sex with men who have sex with men. And instead, we recommend assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor, regardless of sexual orientation, sex, or gender. 

RDML Araojo:  After 2020, the FDA facilitated and funded ADVANCE, which stands for Assessing Donor Variability and New Concepts in Eligibility. Can you tell us about the purpose of that study and the results? 

Dr. Marks: Yes, thanks. It's a great question. That study was developed by a group of organizations, including community organizations, advocacy organizations, some academics, and actually the blood collectors to try to understand whether we could move from a deferral based on time and sexual orientation to one that was an individual risk assessment. And it involved examining behavioral and biomarkers of HIV risk in sexually active men who have sex with men to estimate the proportion of the study population who would not be deferred for higher risk sexual behaviors and who might be eligible to donate blood without any deferral. And so, the study intended to evaluate the individual risk assessment strategies as an alternative to the time-based deferrals which we had in place for men who have sex with men. And it examined a number of HIV risk factors, such as the number of people who had anal sex and the rates of HIV infection among men who had sex with men, who enrolled in the ADVANCE study.  And in addition, the study looked at the number of people that were using pre-exposure prophylaxis or post exposure prophylaxis who were having sex with other men. So, men who were using the routine things that we have now, PREP, to prevent transmission of HIV, that's a really good thing by the way. We're not - it's really important that people understand that even though PREP is currently a deferral from donating blood, that is, it's really important that people understand that it is a really good advance, and that people continue to take PREP if they're using it because as a public health intervention, it's a really important thing. And so, we expect that the results of the ADVANCE study will be published in scientific journals in the near future. 

RDML Araojo:  Thank you, Dr. Marks. Let's jump back to present day and dive a bit deeper into the new recommendations. The new FDA guidance uses individual risk-based questions. Can you describe these new risk-based questions? 

Dr. Marks: So, the intent of the individual risk assessment is to be able to ask everyone the same set of questions regardless of their sexual orientation, sex, gender.  And the idea is that all prospective donors who report having a new sexual partner or more than one sexual partner in the past three months and who have had anal sex in the past three 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, that is the period when the test can’t detect HIV, for detecting HIV by nucleic acid testing. So, there's a period during which our very sensitive tests can't actually pick up HIV. It's a very short period. But by asking these individual risk assessment questions, they help us make the blood supply even safer by having people who could have very recently been infected not donate blood. And additionally, under these recommendations, those taking medications to treat or prevent HIV infection, for example, antiretroviral therapy or Pre-Exposure Prophylaxis or PREP or Post Exposure Prophylaxis or PEP, will also be deferred. And it's again, as I've already said, these are really important public health interventions and although these antiretroviral drugs are safe, effective, and really important to prevent, help to prevent the spread of HIV, they also cause it to be harder to detect HIV in the blood that's donated. And because of that, we have to ask people who are taking those not to donate. Now, that doesn't mean that people should stop taking those medicines to donate. If you're taking those medicines, it's because you have a reason to be taking them, and so you should continue taking PREP, if you're taking it.  On the other hand, that's just a way that we can make sure by having people not taking PREP, that if there is HIV in the blood that's donated, we can detect it. 

RDML Araojo:  So, with the new recommendations, there’s still a three-month deferral in place for individuals who are considered at high risk for HIV transmission. Can you talk about the reasoning behind the three-month deferral? 

Dr. Marks: Yeah, thanks very much.  First of all, there were certain other conditions or situations, like people who exchange drugs for money or sex, or people who are commercial sex workers, where there still is a risk, and we don't have the data to move yet to an individual risk assessment for those people. Additionally, there are other infectious diseases besides HIV, like hepatitis, that we have to make sure that we help prevent the transmission of. So, that combination has led us to have that three-month deferral in place for certain other groups. That's not to say that we won't have progress in the future to move towards other deferral intervals or other individual risk assessments for those individuals. It's just that right now, we could only go so far with the science at hand. 

RDML Araojo:  Is there an example of a donor risk questionnaire that the FDA will provide to blood donation centers? 

Dr. Marks:  Yes, and in fact the, there is a, essentially, a standardized donor history questionnaire that's been something that we've had for many years. And as we posted our final guidance, moving to the individual risk assessment on May 11th, 2023, we also updated our guidance on that donor history questionnaire and that, that guidance is implementation of acceptable full length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components. And that recognizes as acceptable, the standard full length and abbreviated donor history questionnaires and accompanying materials that are prepared by the AABB Donor History Task Force. The AABB is a group of blood collectors that band together to work together towards issues around blood safety and blood supply. And if anyone's interested, those donor history questionnaire documents are accessible on FDA's website.

RDML Araojo:  Well, Dr. Marks, I think this is a good place to wrap up our discussion for today. Thank you so much for joining us for this very important discussion.

Dr. Marks: Thanks so much for speaking today. 

RDML Araojo:  I also want to let our listeners know, if they would like more information about blood donation, they can visit www.hhs.gov/givingequalsliving. For more information about the Health Equity Forum podcast series, visit our website at www.fda.gov/healthequity. While you're there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on Twitter @FDAHealthEquity. Remember, working together, we can create a world where Health Equity is a reality for all. 

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