Today (June 19th) In Public Health: News Updates You Need To Know
Hello readers! Today we have public health news update from the FDA, CDC, WHO and the NIH — enjoy!
FDA Launches Fast-Track Vouchers to Accelerate Drug Approvals Tied to National Priorities
The U.S. Food and Drug Administration (FDA) has announced a new pilot program designed to fast-track the review of certain drugs that align with critical U.S. public health and national security goals. The initiative is called the Commissioner’s National Priority Voucher (CNPV) and was unveiled by FDA Commissioner Dr. Marty Makary.
What Is the Program?
The CNPV is a non-transferable voucher given to select drug developers whose work directly supports national public health priorities. This includes medications or treatments aimed at:
Public health emergencies or emerging disease threats
Improving or accelerating cures for widespread diseases
Expanding domestic pharmaceutical manufacturing
Addressing long-standing unmet medical needs
Using the voucher, companies may reduce the FDA’s standard drug review timeline from 10–12 months to just 1–2 months.
How Will It Work?
To participate, companies must submit key components, such as product labeling, manufacturing data, and chemistry specifications, at least 60 days before filing their final application. The application will then be reviewed by a specialized FDA team using a collaborative “tumor-board” model, which is often used in hospitals for complex case reviews.
These vouchers are valid for two years and are not transferable or tradable, unlike some previous expedited approval incentives offered by the FDA.
What Are the Concerns?
While the FDA assures that no corners will be cut when it comes to patient safety or scientific rigor, some experts and consumer advocacy groups have voiced concerns:
Could the compressed timeline lead to oversight errors or missed safety signals?
How transparent will the FDA be about which companies or drugs qualify?
Will political or industry pressure influence decisions about what qualifies as a “national priority”?
There is also uncertainty about how the FDA will manage its workload if multiple companies begin using these vouchers at once, especially given the agency’s already stretched review resources.
Why This Matters for Public Health
This initiative could benefit patients by speeding access to life-saving or much-needed treatments, especially in areas where current options are limited or supply chains are vulnerable. It also signals a broader shift: the FDA is aiming to align its regulatory priorities with national preparedness and biomanufacturing resilience goals.
But the success of this program will depend heavily on:
Transparent criteria for awarding vouchers
Ongoing monitoring of safety outcomes post-approval
Balanced oversight that prevents favoritism or rushed science
Final Thoughts
The FDA’s new voucher program is a bold move that could reshape how quickly important drugs reach the public. It reflects a growing focus on national health preparedness, innovation, and faster access. But like any fast-track initiative, the details and safeguards will matter most.
FDA Suspends U.S. Clinical Trials Sending Americans’ Cells Abroad
What Happened
The FDA announced a halt on new clinical trials that involve sending American participants’ living cells including DNA samples to foreign laboratories in countries considered national security risks (e.g., China) for gene editing or manipulation, sometimes without participants' knowledge or informed consent.
This policy shift reverses a prior exemption which mistakenly allowed such transfers, including to companies partially owned by foreign adversaries, despite a 2024 U.S. export-control rule designed to protect sensitive biological data.
Why It Matters for Public Health & Security
Patient Consent & Trust
Many participants were unaware their cells might be exported abroad or genetically altered. Restoring transparency is essential to maintain trust in clinical research .Genetic & National Security Risk
There are concerns that manipulated cells and their genetic information could be misused by foreign labs, posing safety and biosecurity threats.Ethical Oversight
The FDA now requires trials to confirm domestic handling of biosamples and explicit informed consent before proceeding. Trials unable to comply will not be approved.Interagency Coordination
The agency is collaborating with NIH to audit existing federally funded clinical studies and enforce compliance with evolving biosecurity standards.
Action Taken
A review of all ongoing and planned trials involving cross-border cell manipulation has been initiated.
Trials must show complete transparency in consent procedures and domestic control of sensitive biological materials.
Clinical studies failing to meet these standards will no longer be allowed to proceed.
Public Health Takeaways
Researchers: Ensure your study designs now include clear consent about sample export and genetic engineering.
Ethics Boards & IRBs: Reassess informed consent protocols and sample-handling procedures to comply with new FDA requirements.
Participants: Ask clinical trial teams how and where your biological samples will be handled, especially when foreign labs are involved.
Public Health Leadership: Monitor this policy shift as it evolves. It's a telling example of how science, security, and ethics intersect in cutting-edge medicine.
WHO Urges Global Expansion of Midwifery Models to Save Lives
What’s the News
On June 18, 2025, the WHO released its Global Position Paper: Transitioning to Midwifery Models of Care, marking a key moment in efforts to transform maternal and newborn health worldwide.
Key Recommendations
The paper calls on all countries to:
Center maternity care around skilled midwives who guide women and newborns throughout pregnancy, childbirth, and postpartum
Promote continuity of care, where the same midwife or team supports a woman at each stage
Limit unnecessary medical interventions, opting for evidence-based, respectful care
In parallel, the Midwifery Accelerator, launched by UNFPA, UNICEF, WHO, ICM, and Jhpiego details a roadmap for action:
Commit & invest in midwife education, regulation, and leadership
Deploy & retain skilled midwives in underserved areas
Advocate & empower midwives and communities to support care models
Why It Matters
Life-Saving Impact: Universal midwifery coverage could prevent over 60% of maternal and newborn deaths, saving approximately 4.3 million lives annually by 2035.
Improved Birth Outcomes: Studies in high-income countries show midwifery-led care is linked to fewer cesareans, episiotomies, and forceps deliveries, and higher satisfaction.
Cost-Effective Solutions: Investing in midwives delivers a 16-to-1 economic return — every $1 spent brings $16 in health and social benefits.
Supporting Women-Centric Care: Midwifery models emphasize informed choice, emotional support, and empowering birthing people, which is a sharp contrast to highly medicalized, fragmented maternity systems.
Public Health Takeaways
Health Leaders & Policymakers: Prioritize midwifery models during Universal Health Coverage and maternal health policy rollouts.
Health Systems & Hospitals: Pilot continuity-of-care models and invest in midwife-led teams.
Funders & Donors: Support workforce training, regulation, and deployment initiatives in line with the “Accelerator” priorities.
Communities & Advocates: Educate families about midwifery care, integrate midwives into community health, and reduce barriers to access.
Final Thoughts
UN modeling and evidence show that midwifery-led continuity of care is one of the most impactful, cost-effective strategies for maternal and newborn health across low-, middle-, and high-income countries.
This is a public health opportunity requiring global commitment and local action to build safer, more equitable, and women-centered maternity systems.
WHO Issues Landmark Pregnancy Care Guidelines for Women with Sickle Cell Disease
What’s New
On June 19, 2025, the World Health Organization released its first global guideline specifically for managing sickle cell disease (SCD) during pregnancy, a major advancement in reducing maternal and newborn risks linked to this inherited blood disorder.
Why It Matters
SCD causes red blood cells to become sickle-shaped, impairing blood flow and leading to anemia, painful crises, infections, and organ damage. During pregnancy, these risks worsen: women with SCD are 4–11 times more likely to die, and their babies face higher risks of stillbirth, preterm birth, and low birth weight.
With 7.7 million people worldwide living with SCD, a 40% increase since 2000 — most of whom are in sub‑Saharan Africa, the Middle East, the Caribbean, and South Asia — this guideline addresses a critical, underserved global health issue.
The Guideline’s 4 Core Areas
Nutrition & Supplementation
Guidance includes improved protocols for folic acid and iron, with dosage adjusted for malaria-prone regions.Pain Crises & Infection Prevention
Recommends tailored pain management, infection control (e.g., vaccines, antibiotics), and prophylaxis against blood clots.Use of Blood Transfusions
Guidelines support prophylactic transfusions in high-risk pregnancies to reduce complications.Multidisciplinary, Respectful Care
Emphasizes continuity of care with a team approach, and the importance of informed, personalized, and stigma-free treatment from providers such as hematologists, midwives, obstetricians, and pediatricians.
Public Health Takeaways
Evidence-Based, Locally Adaptable: Unlike prior protocols from high-income countries, these guidelines are tailored for low‑ and middle‑income settings where over 80% of SCD and related maternal deaths occur.
Cost-Effective & High Impact: WHO models suggest implementing midwifery-led, multidisciplinary care could prevent thousands of maternal and infant deaths annually.
Addressing Treatment Gaps: Women with SCD, especially in resource-limited settings, which have been neglected by past research; the guideline urges more pregnancy-specific safety studies and investment.
Stigma Reduction: The document calls for proactive efforts to combat discrimination within healthcare facilities ensuring respectful, individual care plans.
Who Should Read This
Health Ministers & Program Managers: Integrate SCD pregnancy care into national policies and training.
Healthcare Providers: Adopt evidence-based protocols for supplements, transfusions, pain, and infection control.
Donors & NGOs: Support research, capacity-building, and public education campaigns.
Community Advocates: Spread awareness and encourage early prenatal care for women with SCD.
Final Word
This first-of-its-kind WHO guideline could transform outcomes for pregnant women with sickle cell disease and their babies, especially in the Global South. Through multidisciplinary, context-sensitive care and stronger investment in research, informed pregnancies can become safer and more equitable worldwide.
NIH Launches $10 Million Study to Track Long-Term Health Impact of East Palestine Train Disaster
What’s Happening
The National Institutes of Health (NIH), under HHS and led by Secretary RFK Jr., has allocated $10 million over five years to study the long-term health effects of the February 3, 2023, Norfolk Southern train derailment in East Palestine, Ohio. The formal Request for Applications was released today, with a July 21, 2025 deadline for grant proposals with research starting this fall.
Why It Matters
Chemical exposure risk: The derailment released vinyl chloride, benzene, butyl acrylate, and other hazards raising concerns about long-term health issues like respiratory damage, cancer risk, immune dysfunction, and effects on children’s health.
Community trust: Residents reported headaches, skin irritation, and respiratory symptoms shortly after the incident; however, transparency around contamination has been limited, and sparking distrust.
Coordinated research needed: The NIH initiative encourages collaboration between researchers, community members, local providers, and agencies like NIEHS and CDC to build trust and ensure scientific rigor.
What the Study Will Cover
Longitudinal epidemiological monitoring to track health trends and biomarker changes over time.
Public health surveillance systems to inform preventive actions.
Community-focused communication to keep residents informed and involved from design to reporting.
Leadership Praise
VP J.D. Vance, once a U.S. senator, pushed NIH to focus on East Palestine’s health impacts.
HHS Secretary Kennedy emphasized the importance of scientific answers for residents’ concerns.
Ohio Governor Mike DeWine called it essential for restoring the peace of mind of East Palestine’s ~4,700 people.
Public Health Takeaways
Trust through transparency: Early and ongoing involvement of residents and local clinicians in research design is essential for credibility.
Environmental-linked illness: Tracking exposures like cancer incidence, respiratory conditions, infant health, and mental wellbeing is key.
Scalable surveillance: This model could inform responses to future environmental disasters by integrating health tracking with local engagement.
CDC Warns: Listeria Outbreak Linked to Recalled Chicken Alfredo Meals
What’s happening:
The CDC, along with FDA and USDA’s Food Safety and Inspection Service (FSIS), is investigating a deadly Listeria outbreak tied to pre-made chicken fettuccine Alfredo meals sold at Walmart and Kroger under the Marketside and Home Chef brands. The meals were made by Texas-based FreshRealm and recalled on June 17, 2025.
Impact so far:
17 cases across 13 states, with 16 hospitalizations, 3 deaths (in Illinois, Michigan, and Texas), and one pregnancy loss.
Affected shoppers range widely in age (4 to 92), with a median of 79.
Products recalled:
32.8 oz Marketside Grilled Chicken Alfredo (best-by 6/27/25)
12.3 oz Marketside Chicken Alfredo with Broccoli (best-by 6/26/25)
12.5 oz Home Chef Chicken Alfredo (best-by 6/19/25)
Watch for establishment codes: EST. P‑50784, P‑47770, or P‑47718.
Why It Matters
Listeria risk: This bacterium thrives in cold, damp environments like refrigerators, and can cause severe illness, especially in pregnant individuals, infants, the elderly, and those with weakened immune systems. Symptoms include fever, muscle aches, headache, stiff neck, confusion, and loss of balance, sometimes appearing days to weeks after exposure.
Contamination timeline: The outbreak strain was identified in patient samples dating back to August 2024 and in a March 2025 product sample, though that batch never reached shelves.
Ongoing investigation: While FDA and FSIS have not pinpointed the contamination source, trace-back efforts and country-wide agency collaboration are still underway.
What You Can Do
Consumers
Don’t eat or serve these meals. Throw them away or return for a refund.
Thoroughly clean any fridge surfaces or utensils that touched the meals.
Watch for symptoms: contact a provider immediately if you experience fever, stiff neck, confusion, or muscle aches, especially if you’re pregnant, elderly, or immunocompromised.
Healthcare Providers
Be alert for Listeria in symptomatic patients with relevant exposure.
Treat confirmed cases promptly with IV antibiotics, and report cases to health authorities for investigation.
Retailers & Policy-makers
Ensure prompt removal and communication about recalled products.
Promote stronger food-safety protocols in refrigerated, ready-to-eat aisles to reduce future risks.
Public Health Takeaways
Silent threat: Listeria grows quietly in cool, moist environments—often unnoticed in refrigerated foods.
High-risk groups: Elderly, pregnant, and immune-compromised individuals are especially vulnerable.
Zero tolerance: Even a single contamination event demands swift public health response and clear consumer guidance.
Sources:
https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
https://www.who.int/news/item/18-06-2025-who-calls-for-global-expansion-of-midwifery-models-of-care
https://www.who.int/news/item/19-06-2025-who-issues-first-global-guideline-to-improve-pregnancy-care-for-women-with-sickle-cell-disease
https://www.fda.gov/news-events/press-announcements/fda-halts-new-clinical-trials-export-americans-cells-foreign-labs-hostile-countries-genetic
https://www.hhs.gov/press-room/nih-long-term-health-research-east-palestine-ohio-train-disaster.html
https://www.cdc.gov/media/releases/2025/2025-cdc-warns-of-listeria-outbreak-linked-to-recalled-chicken-fettuccine-alfredo-meals.html