Health
FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply
Last Updated on February 2, 2023 by Daily News Staff
The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.
These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply.
“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, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. 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.”
Under the new proposed guidance:
- The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
- The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
- All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
- Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Other considerations in the guidance include:
- No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
- Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.
- Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
- Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.
- Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.
- Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections.
- The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
The agency recognizes that, while these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood. However, this does not mean that individuals taking PrEP should stop taking these medications to donate blood. The FDA will continue to track the latest data relevant to PrEP and blood donation.
“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
To inform these draft recommendations, the FDA carefully reviewed numerous data sources, including data from the United Kingdom and Canada, countries with similar HIV epidemiology that have implemented this gender-inclusive, individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, and the performance characteristics of nucleic acid testing for HIV. Additionally, the agency funded the Assessing Donor Variability And New Concepts in Eligibility (ADVANCEExternal Link Disclaimer) study. This study examined several HIV risk factors, such as anal sex, rates of HIV infection and rates of PrEP and PEP use among MSM study participants.
As part of the FDA’s established process, today’s proposal will be open for public comment for 60 days. The agency will then review and consider all comments before finalizing this guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.
Related Information
- Keeping Blood Transfusions Safe: FDA’s Multi-layered Protections for Donated Blood
- Blood & Blood Products
Child Health
Changing the Landscape of Childhood Cancer Survivorship
Childhood Cancer: hile “cancer” is a term no family wants to hear, especially when it comes to their children, there is reason for hope. Today, 85% of children diagnosed with cancer survive at least five years. Survival is only part of the journey, however.
Changing the Landscape of Childhood Cancer Survivorship
(Feature Impact) While “cancer” is a term no family wants to hear, especially when it comes to their children, there is reason for hope. Today, 85% of children diagnosed with cancer survive at least five years, according to the National Cancer Institute, up from 75% three decades ago.
Watch this video to learn more
“This progress is driven in large part by dedicated research,” Hyundai Hope on Wheels Board Member Kevin Reilly said. “Over the last 28 years, Hyundai Hope on Wheels has committed over $300 million in pediatric cancer research and program grants, awarding more than 1,600 grants to 210 medical institutions nationwide, impacting thousands of young lives each year.”
Survival is only part of the journey, however. Nearly half (46%) of U.S. adults believe a child ringing the hospital bell after cancer treatment means the child is cancer-free and their medical journey is largely over, according to a survey conducted by Atomik Research on behalf of Hyundai Hope on Wheels. For the children and families living through a diagnosis, the reality is far more complex.
“The reality is that healing continues long after treatment, which is why sustained investment in survivorship care is a priority for us,” said John Guastaferro, executive director of Hyundai Hope on Wheels.
Isabella Franco-Capps, 11, understands that journey firsthand. Diagnosed with B-cell acute lymphoblastic leukemia at age 5, her journey took two years before she could say she’s “a cancer survivor.”
“I was diagnosed with b-cell acute lymphoblastic leukemia,” she said. “This began my two-year-long journey of scans, pokes, chemotherapy and hospital stays. And now I’m a cancer survivor.”
Fellow Hyundai Hope on Wheels National Youth Ambassador, Jackson Trihn, 12, is using his voice to call for continued research and to bring hope to others.
“The role … is being able to share my story,” he said. “Not just to spread awareness but to spread hope to kids that need it. And awareness is so important because people don’t understand how hard pediatric cancer can be.”
Continued progress can help ensure more children ring the bell and receive the care and support they need long after they’ve had the opportunity to do so. To learn more about these efforts and how you can help, visit HyundaiHopeOnWheels.org.
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(Feature Impact) Driven by rising rates of obesity, diabetes, high blood pressure and other risk factors,cardiovascular disease has surpassed cancer as the leading cause of death among Hispanic adults in the United States.
Hispanic people represent nearly 1 in 5 of the U.S. population and are the nation’s largest ethnic minority group, yet many continue to face barriers to achieving heart health and accessing high-quality healthcare. A new scientific statement published in the American Heart Association’s flagship journal, “Circulation,” revealed how social, economic, cultural and environmental factors contribute to persistent disparities in cardiovascular health, calling for culturally tailored prevention strategies, equitable access to care and greater representation of Hispanic populations in cardiovascular research.
“Hispanic populations in the U.S. are incredibly diverse even within their own communities with differences in genetic ancestry, language, cultural traditions and social experiences that can significantly influence cardiovascular health,” said Johanna Contreras, M.D., M.Sc., FAHA, director of the Division of Heart Failure and medical director of the Hispanic Heart Center within the Mount Sinai Health System. “Yet Hispanic people remain underrepresented overall in the research that guides prevention and treatment strategies… Without better representation and more detailed data, we risk overlooking important differences that can help us improve care and save lives.”
Hispanic Cardiovascular Health by the Numbers
Cardiovascular risk factors – obesity (nearly 46%), type 2 diabetes (15.5%) and high blood pressure (approximately 44%) – are prevalent among Hispanic adults and often emerge at younger ages and occur more frequently among Hispanic adults compared with white adults.
According to the report, only about 1 in 5 Hispanic adults achieves ideal cardiovascular health as defined by the American Heart Association’s original Life’s Simple 7 metrics. Updated analyses using the Life’s Essential 8 framework demonstrated persistent disparities for heart and brain health, as well as suboptimal dietary quality, sleep patterns and levels of physical activity.
Social and Economic Barriers Matter
Biology alone does not explain cardiovascular health disparities. The environments where people live, work and age, along with social and economic challenges, impact heart health. In fact, approximately 17% of Hispanics live below the federal poverty threshold, compared with 8.2% of white adults.
“Many Hispanic adults face obstacles that extend far beyond the doctor’s office,” Contreras said. “Limited health insurance coverage, language differences, food insecurity, environmental exposures and concerns related to immigration status can make it more difficult to prevent disease, manage chronic conditions and receive timely treatment.”
Contreras emphasized the cultural values and practices of Hispanic people also influence how they perceive their health and healthcare options.
“Family plays a central role in many Hispanic communities and can be an extraordinary source of strength, support and resilience,” Contreras said. “At the same time, family members are often called upon to translate medical information, navigate health systems and help make healthcare decisions for loved ones. Those responsibilities can shape how health information is understood and acted upon.”
An Action Plan for Improving Hispanic Health
There are practical opportunities to achieve equitable cardiovascular health and reduce disparities through community engagement, culturally responsive care, inclusive research and policies that address the underlying drivers of health.
“Reducing cardiovascular disease among Hispanic populations demands action at every level,” Contreras said, “from improving access to culturally responsive care and expanding research participation to addressing the social and environmental conditions that shape health.”
By addressing both medical risk factors and the social conditions that shape health, experts believe there is an important opportunity to reduce disparities and help more people live longer, healthier lives. Learn more at Heart.org.
Photo courtesy of Shutterstock
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Food and Beverage
Beyond Protein: 2 Nutrients Your Plate Might Be Missing
Nutrients: Everyone is talking about protein these days whether watching their weight or managing a disease like type 2 diabetes. However, fiber and healthy fats are nutrients many people are overlooking. One food that makes it easier to invest in your health, according to nutrition experts: avocados.
Beyond Protein: 2 Nutrients Your Plate Might Be Missing
(Feature Impact) Everyone is talking about protein these days whether watching their weight or managing a disease like type 2 diabetes. However, fiber and healthy fats are nutrients many people are overlooking. The latest reports show most Americans already meet or exceed recommendations for protein while nearly all (about 95%) do not eat enough fiber, and many people consume too much saturated fat versus unsaturated fat, according to the 2025 Dietary Guidelines Advisory Committee. Prioritizing ways to get more fiber and healthy fats on your plate could be key to managing weight and type 2 diabetes goals this summer.
One food that makes it easier to invest in your health, according to nutrition experts: avocados.
A growing body of research and materials from Avocados – Love One Today, a science-based resource, suggests fresh avocados offer weight management benefits, help with type 2 diabetes management and are good for blood sugar management.
According to a study* of more than 27,000 adults published in the journal “Internal Medicine Review,” people who ate just over half of an avocado per day weighed 7.5 pounds less, had smaller waist sizes and tended to have healthier overall eating habits, including higher intakes of fiber and healthy fats, compared to people who didn’t eat avocados. Among the list of benefits, this delicious and healthy fruit uniquely contains fiber and healthy fats in each nutrient-dense bite which slows digestion, helping you feel satisfied and fuller longer which can help you consume fewer calories overall. In fact, if you’re using a GLP-1, avocados are one of the foods to add to your menu to make small meals feel more filling and satisfying while supporting nutrient needs.
Scientists also recently took a second look at the largest study* about avocado consumption to-date involving close to 1,000 adults, per the journal “Current Developments in Nutrition,” and found that consistently eating one avocado every day for six months (no other diet changes required) significantly reduced dietary glycemic load (GL) by nearly 14 points, a metric that evaluates how what you are eating is affecting your blood sugar levels. GL may be an important consideration in the management of chronic diseases like type 2 diabetes. By slowing digestion, fiber and healthy fats also support stable blood sugar levels.
There are many ways to enjoy avocados, including chopped, sliced, mashed, blended, in baked goods or even frozen. Avocados add flavor, variety and nutrition across the day.
Try these recipes for Avocado and Blueberry Chia Pudding, Avocado Breakfast Bowl with Leafy Greens for your next breakfast or snack.
*Remember: Small, consistent food choices can add up over time. Research suggests regularly eating avocados may support weight management and blood sugar targets while providing the fiber and healthy fats that many Americans are overlooking. These studies were supported by the Avocado Nutrition Center. While these findings are encouraging, the studies highlighted show an association, not cause and effect, and thus more research is needed to confirm these findings in other populations.
To explore evidence-based avocado nutrition information, along with practical tips and easy recipes, visit Avocados – Love One Today, a leading resource for avocado nutrition information.
Avocado and Blueberry Chia Pudding
- 1 1/2 cups plain, unsweetened soy milk (or milk of choice)
- 1 ripe, fresh avocado, halved, pitted and peeled
- 3/4 cup frozen blueberries
- 1/2 cup unsweetened vanilla Greek yogurt
- 1 tablespoon maple syrup
- 1/3 cup chia seeds
To Serve:
- 1/3 cup granola
- 1/3 cup fresh blueberries
- 1 kiwi, chopped
- 1/2 fresh, ripe avocado, halved, pitted, peeled and chopped
- In blender, puree soy milk, avocado, blueberries, yogurt and maple syrup until smooth. Pour mixture into storage container or bowl and add chia seeds. Whisk well to combine. Cover with lid or plastic wrap and refrigerate 4 hours or overnight, until thickened.
- To serve, divide into bowls and top with granola, fresh blueberries, kiwi and avocado.
- Notes: Use any milk (dairy or non-dairy) that you prefer in pudding. Use fresh blueberries or conventional frozen blueberries. Other topping options include: nuts, seeds, hemp hearts, sliced banana or strawberries, or nut butter.
Avocado Breakfast Bowl with Leafy Greens
Bowl:
- 1 medium sweet potato, chopped (about 1 3/4 cup)
- nonstick cooking spray
- 1/4 teaspoon smoked paprika
- 1/4 teaspoon garlic powder
- 1/4 teaspoon salt
- 1/2 cup quinoa
- 1 cup water, plus additional for boiling eggs, divided
- 2 eggs
- 2 cups arugula
- 1 ripe, fresh avocado, halved, pitted, peeled and chopped
- 1/4 cup pickled red onions
Avocado Tahini Dressing:
- 1/2 large avocado
- 1/4 cup tahini
- 1 lemon, juice only (2 tablespoons)
- 3/4 cup water
- 1 tablespoon fresh chives
- salt, to taste
- pepper, to taste
- Preheat oven to 400 F. Add chopped sweet potato to baking sheet. Spray with cooking oil then add smoked paprika, garlic powder and salt. Toss to coat in spices. Bake 22-25 minutes, or until tender.
- In medium saucepan, add quinoa and water. Bring to simmer and cover, cooking 12-15 minutes, or until quinoa is tender and fluffy.
- Fill small saucepan with water and bring to boil. Use slotted spoon to lower eggs into water. Cook 8 minutes then transfer eggs to bowl of ice water to cool before peeling.
- To make dressing: In small blender, puree avocado, tahini, lemon juice, water and fresh chives until smooth. Add more water, 1 tablespoon at a time, if needed, to thin until pourable. Season with salt and pepper, to taste.
- Assemble bowls, each with 1/2 sweet potato, 1/2 cup quinoa, 1 egg, 1 cup arugula, 1/2 avocado, 2 tablespoons pickled red onion and 3 tablespoons dressing. Reserve remaining dressing in refrigerator.
Heart-Healthy Frozen Avocado Banana Paleta
- 1 ripe, fresh avocado, halved, pitted, peeled and diced
- 4 cups orange juice
- 2 medium bananas, peeled and sliced
- 1 tablespoon lime juice
- 8 paper cups (5 ounces)
- 8 wooden craft sticks
- In blender, blend avocado, orange juice, bananas and lime juice on high until smooth. Divide into paper cups. Cover cups with aluminum foil. Insert one stick through center of each foil. Freeze 4 hours until firm.
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