GHTC responds to Senator Cassidy's RFI on modernizing NIH

GHTC responded to Senator Bill Cassidy's (R-LA) request for information (RFI) on modernizing the US Centers for Disease Control and Prevention (CDC).Dear Senator Bill Cassidy, We write to you today representing the Global Health Technologies Coalition (GHTC), a group of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. It is with this perspective that we intend to contribute input on opportunities to continue modernizing the US Centers for Disease Control and Prevention (CDC). After navigating the challenges and learning from the unprecedented impact of the recent pandemic, CDC has initiated a series of strategic policy changes and organizational realignments, as well as established new program areas to fortify its preparedness against future threats. These proactive measures directly address perceived gaps in CDC’s capabilities and warrant acknowledgment through robust intergovernmental support and adequate funding. One of CDC's notable strengths lies in the exemplary work of its global health-related program areas. Notable among these are the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Global Health Center (GHC), and the expansive efforts encompassed within the Global Health Security initiatives conducted by the organization. Regarding Fostering Innovation and Collaboration, the CDC should continue and expand its work through GHC. GHC provides expertise on immunizations, disease eradication, and public health capacity-building around the globe through its Global Divisions on HIV & TB, Public Health Protection, and Immunization. Among the far-reaching and high-impact work of GHC, one main priority is to “research, develop, and evaluate new tools and approaches to combat global health threats.” As a global hub for infectious disease research, GHC is uniquely equipped to develop and validate tools for disease surveillance and diagnosis. These tools are critical for both tracking events of public health importance, such as emerging infectious diseases, and monitoring the impact of US global health programs in settings that might otherwise have limited data collection capacity. CDC also provides vital scientific and technical support to interagency initiatives, including the US President’s Emergency Plan for AIDS Relief and the President’s Malaria Initiative. GHC is a great example of, from question 4 under the RFI’s Improving Upon What Works Well, “How can CDC improve linkages between in-country staff and program staff in CDC’s U.S. offices? What would be the benefit of improving these linkages?” Strengthening the global work of CDC would provide US citizens in lower-resourced, remote, and rural settings with health innovations that are fit for use, as well as provide early warning of disease threats that could reach US shores. Similarly, NCEZID and its newest sub-department, previously housed within GHC, the Department of Parasitic Disease and Malaria, uses its globally relevant research and collaborations to inform domestic responses to outbreaks and infections. This work has gained heightened significance in the wake of reports of locally transmitted malaria cases in Florida, Texas, and Maryland. The looming threat of various infectious diseases making their way to the United States underscores the need for continued vigilance. This is a challenge actively monitored by NCEZID, particularly through its Office of Advanced Molecular Detection. Leveraging cutting-edge technologies, such as DNA sequencing and advanced computing, the office delves into the intricate biology of infectious diseases to provide insights pivotal to the development of diagnostics, drugs, and vaccines. For instance, the office has played a vital role in determining the genetics of Ebola and Zika, as well as tracking COVID-19 variants. The agency’s wastewater surveillance programs have also provided pivotal insights into the scale of viral circulation in communities and the spread of COVID-19 variants; yet since this work was funded through emergency appropriations, these programs will run out of funding by fiscal year 2025 unless Congress appropriates sustainable yearly funding. As for Mechanisms to Modernize, the CDC is undergoing rapid and far-reaching improvements and modernization procedures that advocates are excited to see bear fruit. As it stands, the changes are too fresh to reap benefits, but the vision set forth by Dr. Rochelle Walensky and Dr. Mandy Cohen is coming into focus and addresses many of the questions posed in the RFI. One of the changes already mentioned—placing the Department of Parasitic Disease and Malaria under NCEZID – brings the global and domestic portfolios of parasitic diseases together, ensuring that tools and learnings mutually advance protection against parasitic diseases, both globally and in the United States. Other changes highlighted in the RFI like the Data Modernization Initiative and the moves to increase investments in the Epidemiology and Laboratory Capacity Program’s work on electronic laboratory reporting require a longer runway to get off the ground before further policy changes can be seriously considered. While the RFI is well-researched and tackles pertinent issues from multiple angles, the global health community observes the changes being made with optimism, largely predicated on frequent consultation and discussion with CDC officials. It is the advice of GHTC to take these overhauls of past data and lab practices as a clear acknowledgment of the early mistakes made during the COVID-19 response. In addition to the aforementioned changes, CDC is taking on a new approach to how it conducts internal business and presents itself to the public. The idea, dubbed “One CDC,” means to unify what was once a more decentralized organization. By striving to talk with one unified voice, CDC is helping to solve a persistent challenge that the whole of the US government struggled with during COVID-19—unclear and too many streams of communication. Instituting more whole-of-organization approaches to communications around public health emergencies should be considered throughout the government. Ultimately, the pathway for tangible improvements within CDC, as envisioned by GHTC, lies in affording the agency the necessary space and financial resources to attain the ambitious goals set for itself, the United States, and the global community. Recognizing that these investments in CDC's global initiatives directly benefit American global health security is paramount. At a time when global health systems are under immense strain and cumulative gains against persistent threats like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases risk erosion, safeguarding hard-won advancements demands substantial and sustained funding for all facets of CDC's global health activities. This comprehensive support is not only critical to mitigating potential setbacks but also ensures that Americans are shielded from a spectrum of both enduring and emerging health threats. We appreciate your attention to this matter and would be happy to collaborate further with the Senator’s office as action is taken to modernize CDC. Sincerely,  Alex Long  US Policy & Advocacy Officer  

The Honorable Xavier Becerra Secretary of the Department of Health and Human Services The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 RE: Support for an FDA Emerging Pathogens Preparedness Program Dear Secretary Becerra, We thank you for your leadership and contribution towards the United States’ pandemic preparedness strategy. In light of the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), we write to express our strong support for the FDA’s proposal to create an Emerging Pathogens Preparedness Program within the FDA's Center for Biologics Evaluation and Research (CBER). The FDA’s Summary of FY 2024 Legislative Proposals puts forward a plan for an Emerging Pathogens Preparedness Program that would “defend against emerging pathogens so the agency is better positioned to respond to identified threats of concern and focus experienced resources to work quickly on medical countermeasure development.” The increased regulatory capacity CBER provided to review COVID-19 vaccines was crucial to the success of Operation Warp Speed. According to Paul Mango’s Warp Speed memoir, CBER director Peter Marks “restructured his team and its internal processes to work around the clock to accelerate the evaluations.” A permanent office within CBER to handle preparedness and response would enhance this capacity for future pandemics. The reauthorization of PAHPA offers the perfect opportunity to do so, by embedding the regulatory successes of Operation Warp Speed in a more sustainable way. An IMF paper recently estimated that each day of the COVID-19 pandemic in 2020 and 2021 cost the U.S. economy $26 billion. 1 The massive value of preventing or shortening pandemics makes it critical to prepare for “Disease X” – a future catastrophic biological risk that could in theory be far worse than COVID. This has led to proposals by the G7 2 and the Coalition for Epidemic 2United Kingdom Cabinet Office. (2021). 100 Days Mission to Respond to Future Pandemic Threats. 1Baker, J., Chaudhuri, A., & Kremer, M. (2021). Accelerating Vaccinations. Finance & Development, 58(1). Preparedness Innovations 3 for a “100 Day Mission” to roll out vaccines and other countermeasures within a hundred days of the start of the next pandemic. To do this will require conducting early clinical trials on prototype vaccines against pathogen families with pandemic potential before an emergency occurs. These trials will need close supervision by the FDA and proactive guidance of how their data would be used in the event of a pandemic. Providing dedicated regulatory capacity at the FDA for this purpose is crucial to achieving these important goals. Finally, a dedicated CBER office could be used to facilitate future programs in the model of Operation Warp Speed. By ensuring rapid regulatory decision-making for target product categories whose social value greatly exceeds their market value, the proposed office could build a “warm base” of regulatory capacity that could be drawn on in the event of an emergency. We have been excited to see the announcement of President Biden’s “Project NextGen.” Creating an office like the one described can ensure that the next generation of coronavirus vaccines receive the same regulatory capacity and accelerated development that was so crucial to vaccines approved during Operation Warp Speed. The anticipated annual cost of an office to support the FDA’s proposed program is about $10-15 million, but its value in supporting preparation and response for the next pandemic is immense. Merely providing 1% of Project Next Gen’s $5 billion would ensure strong coronavirus vaccine review capacity for the next several years. Therefore the signatories below express our strong support for the program’s creation and funding. Sincerely, 1Day Sooner American Society for Microbiology BIO Coalition to Stop Flu Critical Path Institute Federation of American Scientists Global Health Technologies Coalition Infectious Diseases Society of America Institute for Progress International Vaccine Institute 3 Coalition for Epidemic Preparedness Innovations. (2022). CEPI 100 Days Report: Building a More Prepared World to Stop Pandemics. Medical Countermeasures Coalition National Foundation for Infectious Diseases Research!America Technologies for Pandemic Defense CC: Major General (ret) Paul Friedrichs Inaugural Director of the Office of Pandemic Preparedness and Response Policy (OPPR) and Principal Advisor on Pandemic Preparedness and Response. CC: Ms. Dawn O’Connell Assistant Secretary for Preparedness and Response (ASPR).