News & Insights

Dear Representative Neal Dunn and Representative Lori Trahan,  The Global Health Technologies Coalition (GHTC) is pleased to see a bipartisan endeavor to reauthorize the Protecting Americans from all-Hazards Preparedness Act (PAHPA). Since the reauthorization lapsed in 2023, it has been clear that successfully advancing this critical pandemic preparedness legislation requires a bipartisan, bicameral process.  While BARDA’s mission is to advance US national health security, the medical countermeasures (MCMs) developed routinely benefit people around the world. BARDA has advanced at least 93 innovations for antimicrobial resistance (AMR), at least 127 COVID-19 products, and 6 FDA-approved products for filoviruses like Ebola—many of which have been used around the world. As the leading advocacy coalition focused on global health research and development, GHTC wants to ensure the Biomedical Advanced Research and Development Authority (BARDA), through PAHPA, is equipped not only to respond effectively during public health emergencies, but also to make the proactive, forward-looking investments required to stay one step ahead of emerging pathogens.  GHTC Priorities for PAHPA Reauthorization  Require a new 5-year (2027-2031) Strategic Plan for BARDA  BARDA’s current strategic plan ends in 2026, and a new plan is needed to reflect lessons learned from COVID-19, the US mpox response, and the recent outbreaks of Ebola and Marburg in Africa. Requiring BARDA to articulate its goals for the next five years will help ensure strategic alignment with evolving threats. To strengthen the effectiveness and credibility of this plan and ensure it is informed by the best available science and aligned with real-world preparedness needs, we recommend that Congress direct BARDA to develop it through an open, consultative process that includes input from scientific experts, product developers, and other external stakeholders.  Establish dedicated funding for BARDA’s IEID Division  Although BARDA has created a dedicated Influenza and Emerging Infectious Disease (IEID) program, it lacks dedicated funding. Historically, investments in emerging infectious disease medical countermeasures have come primarily from emergency supplemental funding bills, like those for Ebola, Zika, and COVID-19— reinforcing a reactive, rather than proactive posture. This gap undermines preparedness.   We support the $10 million carve-out for Disease X in recent LHHS appropriations bills and appreciate prior report language that “supports robust funding for BARDA’s naturally occurring infectious disease programs, including emerging infectious diseases, AMR, and pandemic influenza;” however, this remains insufficient to meet preparedness needs. We encourage Congress to authorize $775 million annually for the IEID program, a figure validated by both the agency and external experts as the amount needed to successfully run an EID Division.   Prioritize deliverability in low-resource settings  Limited refrigeration, inconsistent electricity, insufficient sanitation, and constrained health workforce and laboratory capacity can hinder MCM deployment in low-resource settings, both globally and within the United States. For example, these constraints impeded the global and US uptake of first-generation COVID-19 vaccines and therapeutics. Operation Warp Speed was successful at quickly developing safe and effective vaccines, but its leadership told GHTC that deliverability for low-resource settings was not being considered in vaccine portfolio decisions.   To rectify this oversight in future preparedness planning, we recommend that PAHPA:  Require ASPR to conduct a study on factors limiting MCM deployment in low-resource settings in the United States and globally during public health emergencies Authorize BARDA to support national and global community engagement activities as part of MCM development, including support of clinical trial networks. Highlight the necessary capabilities mRNA vaccines provide to BARDA  mRNA is a critical platform technology for advancing the next generation of vaccines and therapeutics, particularly for rapidly mutating pathogens and to enable rapid development when a new disease X emerges. A retreat from mRNA research risks leaving the United States behind other countries, such as China, the United Kingdom, Australia, Germany, and South Korea, who are actively expanding investments in mRNA technologies. It also risks leaving us behind other investing countries in our ability to procure next-generation vaccines for the American people during future pandemics, and could have a reverberating impact if private investors follow suit, widening the innovation gap in our biotechnology ecosystem.  While there is opportunity to improve mRNA vaccines to enhance the durability of protection and reduce side effects, achieving these advancements will require continued investment.   To realize mRNA’s potential, we recommend that PAHPA:  Explicitly authorize BARDA to invest in mRNA platform technology development. Include report language directing BARDA to prioritize mRNA-based countermeasures in its portfolio decisions. Maintain BARDA’s authority to prioritize products for at-risk populations.  The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L. 116-22) and previous reauthorizations enable BARDA to prioritize “children, pregnant women, older adults, and other at-risk individuals” (42 USC § 247d-7e(c)(6)) in the development of MCMs. At a minimum, this language should be maintained to ensure that every American, regardless of age, health status, or circumstance, can access lifesaving medical countermeasures.  Strengthen transparency requirements  BARDA’s improved efforts in publicly reporting on its MCM research investments have been instrumental in supporting innovation, improving oversight, reducing duplication, and fostering collaboration with federal agencies and external partners in global health security. PAHPA should mandate and codify transparent reporting practices across all areas of BARDA investment, including chemical, biological, radiological, and nuclear (CBRN) threats, EIDs, and AMR. This will ensure consistent reporting, regardless of future BARDA leadership changes.  We recommend that PAHPA require BARDA to regularly and publicly report on its product-level investments to the greatest extent possible without compromising national security, and as part of that reporting, to detail the funding amount, threat area, product type, and phase of development for each MCM in its portfolio.  Eliminate the sunset for the Medical Countermeasure Innovation Partnership  The 21st Century Cures Act authorized BARDA to enter a partnership with a nonprofit entity to accelerate MCMs through venture capital practices. BARDA has since entered a successful partnership that has leveraged matched external funding to support at least eight promising innovations. This authority, however, expires on September 30, 2028 (42 USC § 247d-7e(c)(4)(E)(ix)). To ensure continued progress and impact, we urge Congress to eliminate the sunset clause for BARDA’s medical countermeasures innovation partnership authority.  Authorize loan authorities  To support our national preparedness, we urge Congress to establish a BARDA loan authority program modeled after the US Department of Energy's successful approach. This decisive action would better enable BARDA to finance large-scale projects, such as innovative biomanufacturing facilities like those for microneedle patch vaccines. BARDA should mandate a BARDA feasibility analysis to expedite implementation.  Maintain BARDA’s commitment to tackling AMR and advance complementary AMR legislation  AMR threatens the effectiveness of routine medical procedures and drugs critical for treating CBRN and infectious disease threats. Bacterial AMR was directly responsible for an estimated 1.14 million deaths in 2021 and was associated with a total 4.71 million deaths. Deaths attributable to AMR are projected to increase by almost 70 percent by 2050. Without action, annual deaths could reach 10 million globally by 2050, with significant deaths among children and newborns.   BARDA has provided critical support for development of AMR products at every stage of clinical development, but the pipeline of new antimicrobials and other products still remains insufficient to confront this rising threat.  To that end, we urge Congress to:  Reauthorize BARDA’s AMR programs. Leverage the “must-pass” nature of previous PAHPAs to attach and advance other complimentary legislation to spur and incentivize AMR R&D, including the PASTEUR Act and the SUPER BUGS Act if it is reintroduced in the 119th Congress. Conclusion  The next pandemic is not a question of if, but when. PAHPA reauthorization presents a critical opportunity to ensure BARDA has the authorities, resources, and strategic direction needed to keep America—and the world—safer from emerging biological threats. The investments and policy decisions made today will determine whether the United States responds to the next crisis from a position of strength or struggles to catch up while lives hang in the balance.  GHTC appreciates your bipartisan leadership on this essential legislation and stands ready to support your efforts to strengthen America's health security infrastructure. We urge you to incorporate these priorities into the PAHPA reauthorization to ensure BARDA can fulfill its mission of protecting Americans and advancing global health security for years to come.  We welcome the opportunity to discuss these recommendations further and to continue partnering with you on this essential work.  Sincerely,   Dr. Kristie Mikus, GHTC Executive Director 

The Global Health Technologies Coalition (GHTC) commends Congress for its bipartisan work to advance and approve a fiscal year 2026 spending package, which sustains and strengthens critical US investments in global health research and development (R&D)—including the creation of a first-of-its kind health R&D initiative at the Department of State. We applaud the Appropriations Committees for their steadfast leadership and bipartisan, bicameral collaboration in crafting legislation that reinforces a long-term, forward-looking vision for advancing high-impact global health innovation.  “This bipartisan minibus represents a meaningful reaffirmation of the United States’ commitment to advance lifesaving global health innovation,” said Dr. Kristie Mikus, Executive Director of GHTC. “These investments will help ensure the United States remains a global leader in developing the tools needed to prevent, detect, and respond to emerging health challenges, while also addressing long‑standing health challenges that continue to impact millions of people worldwide.” GHTC is particularly encouraged by the creation of a new “Prevention, Treatment, and Response Initiative” at the State Department. This initiative establishes and funds a disease-agnostic R&D mechanism within US global health programs—a concept GHTC has long championed through its Supporting Innovative Global Health Technologies (SIGHT) Fund proposal and one that has received broad support from the global health community. We look forward to working with congressional policymakers and the administration to ensure this new initiative accelerates the development and delivery of lifesaving innovations to the people and communities that need them most. GHTC also welcomes the bill’s funding increase for our nation’s biomedical innovation engine at the National Institutes of Health, including sustained investments in the National Institute of Allergy and Infectious Diseases and the Fogarty International Center. Continued support for basic research and scientific discovery is vital to maintaining US leadership in biomedical science and advancing innovation that benefits patients and public health and ensures the nation remains at the forefront of innovation and preparedness. These institutions form the indispensable backbone of our global health security apparatus and underpin the domestic biotechnology ecosystem. Finally, GHTC celebrates sustained investments in the Centers for Disease Control and Prevention’s Global Health Center and National Center for Emerging and Infectious Zoonotic Diseases, the Advanced Research Projects Agency for Health, the Biomedical Advanced Research and Development Authority, and other key offices driving R&D progress against the world’s most pressing health challenges. GHTC stands ready to support the effective implementation of these investments to advance a healthier, more secure future for all.