°®¶¹´«Ã½

The Honorable Larry Bucshon 2313 Rayburn House Office Building Washington, D.C. 20515

The Honorable Diana DeGette 2111 Rayburn House Office Building Washington, D.C. 20515

Dear Representatives Bucshon and DeGette:

On behalf of the American Society for °®¶¹´«Ã½ (ASM), we appreciate the opportunity to submit this response to the next step in the 21st Century Cures initiative. We commend you for your steadfast commitment to supporting science, medical research and public health. ASM is one of the largest life science societies in the world, with a membership of over 32,000 researchers, educators and health professionals across 114 countries. Our mission is to promote and advance the microbial sciences by deploying our resources and expertise to laboratories and health care settings around the world, advocating for robust funding and collaborative multi-disciplinary scientific research and fostering a deeper public understanding of microbiology and its role in daily life. 

As supplemental funding for the coronavirus response expires, pressing public health needs identified in Cures 2.0 continue, including preparedness for the next pandemic and strategies for addressing major public health challenges, such as vaccine uptake and antimicrobial resistance. The COVID-19 pandemic exposed critical weaknesses in our national infrastructure for infectious disease testing and surveillance. In order to prevent the next pandemic and protect the health of the American people, the Cures legislation should include provisions to invest in and support pandemic prevention and response. Infectious disease surveillance and the development of diagnostics, vaccines and treatments for emerging infectious diseases are inherently based on microbiology and build on investments in the microbiology workforce. Below are ASM’s recommendations for Cures 2.0. 

Establishment of a National Testing and Response Strategy for Future Pandemics 

ASM supports Section 102 that was included in the prior Cures 2.0 discussion draft and focused on preparing for the inevitable outbreaks in the future. 

Many of our members, including those in hospital and state public health clinical laboratories, were on the front lines helping our nation address the unprecedented challenges the COVID-19 pandemic virus presented to our society, our healthcare system and our economy. They understand first-hand the supply chain challenges and regulatory hurdles that might have been addressed through a more effective national testing strategy. Our response to future pandemics depends on a multifaceted, coordinated effort at the federal, state and local levels and across many sectors of society. ASM shares and appreciates your recognition of the essential role that the federal government plays in this effort, given that it has the resources, coordinating ability and public platform to lead our nation through times of crisis. Two essential elements that should be included in the national testing and response strategy are support for pathogen genomics and wastewater surveillance.

Support Pathogen Genomics and Diagnostic Development and Deployment 

Support for the development and deployment of effective diagnostics is essential in an outbreak since diagnostics enable and inform all aspects of infectious disease management, from surveillance and detection to response, containment and recovery. Testing not only serves to diagnose acute illness, but also plays an integral role in understanding how an infectious disease is being transmitted through communities, determining vaccine effectiveness against the primary pathogen and its variants and preventing the spread of antimicrobial resistance. 

Advances in diagnostic technologies, such as next generation sequencing made possible through the Centers for Disease Control and Prevention (CDC) Advanced Molecular Detection (AMD) program, will continue to be essential in our fight against both emerging and persistent infectious disease threats. With American Rescue Plan funding, the AMD program expand training for public health and clinical laboratory professionals in genomics and bioinformatics and established 5 Pathogen Genomics Centers of Excellence, which are partnerships between public health agencies and academic laboratories. These centers ensure that our public health system can continue to benefit from rapidly evolving, cutting-edge science and technology that is driven by research institutions and is well-connected to public health. However, these investments in public health infrastructure and precision public health are at risk of evaporating with the end of supplemental funding. ASM and other public health organizations urge Congress to provide $175 million annually to maintain these investments. 

Support for Wastewater Surveillance

ASM supports passing legislation to reauthorize the National Wastewater Surveillance System (NWSS), including Senators Angus King, Cory Booker and Mitt Romney’s PREDICT Act () and Representatives Robert Garcia and Don Bacon’s SEWER Act (), and urges that the next cures legislation include these provisions.

A national strategy must include, robust surveillance, timely reporting and communication, which are key to understanding when, where and how a pandemic may disproportionately affect specific demographic and/or geographic groups. 

One promising innovation in public health surveillance is the CDC’s NWSS, which works with health departments to track the presence of SARS-CoV-2, Influenza A and Mpox in wastewater, allowing communities to take action to protect public health. Despite the popularity and efficiency of the program, NWSS’ future is uncertain as the current network is funded through emergency coronavirus supplemental funding. Without sustained funding, this important program could be forced to shut down, despite its efficiency. The program shows potential for use to track other viruses, such as West Nile virus and noroviruses. 

Support for Vaccine and Immunization Programs 

We encourage you to include provisions from the VACCINES Act of 2019 () that would allow CDC to develop and deploy a national system for surveillance of vaccination rates that would allow for data to be collected and used to improve access to vaccines across the country.

ASM strongly supports the universal application of vaccines to prevent illness and death caused by infectious diseases. Thanks to federal investments in basic and clinical research, there is a sound evidence-based foundation for U.S. immunization strategies. There is no doubt that the development and effective use of vaccines for a broad range of life-threatening illnesses has saved countless lives in our nation and around the world. The recent re-emergence of vaccine preventable diseases is alarming since outbreaks of once nearly-eradicated diseases not only harm the patient, but also put the local populations at risk, especially the most vulnerable members of these communities. 

ASM appreciated that Cures 2.0 included a provision to authorize additional funding in Sec. 104 for the CDC to carry out an awareness campaign about the safety and importance of vaccines, as well as funding to strengthen immunization information systems. These provisions are particularly needed as seasonal flu vaccination rates have fallen annually since 2021, particularly among vulnerable groups, such as children and pregnant people. 

Combating Antimicrobial Resistance 

ASM is pleased that the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ( & ) is included in Sec. 105 of the Cures 2.0 discussion draft and encourages the committee to consider the need for supporting diagnostic development and services in the U.S. and abroad, particularly in low- and middle-income countries (LMIC).

Antimicrobial resistance (AMR) is one of the most daunting challenges in safeguarding public health in the U.S. and globally. Every year, approximately 700,000 people die from drug-resistant infections. Infectious disease experts predict that by 2050, this number will dramatically increase to as many as 10 million people worldwide. The problem is particularly serious in developing countries in which, for example, drug resistant strains of tuberculosis cause 200,000 deaths every year. To date, the U.S. and global response has not sufficiently dealt with the breadth and complexity of this threat—it is now considered a global crisis by the World Health Organization, the G20 and the °®¶¹´«Ã½ Nations. 

ASM has endorsed this legislation, which would establish a subscription program that provides a predictable return on investments for critically needed new antibiotics through federal payments delinked from antibiotic sales and use. It will also incentivize the development of antibiotic and diagnostic stewardship guidelines to encourage appropriate use of antibiotics and includes critical transition measures to stabilize the fragile antibiotic ecosystem in the near-term. 

Antibiotic stewardship programs have proven effective in improving patient outcomes, reducing inappropriate antibiotic use, limiting antibiotic resistance and lowering health care costs. During the COVID-19 pandemic, stewardship programs were critical in efforts to successfully launch novel therapies for patients with COVID-19. However, many stewardship programs lacked sufficient resources to sustain stewardship activities during the pandemic. Even prior to the pandemic, many hospitals lacked adequate resources to implement evidence-based stewardship practices fully. The PASTEUR Act would provide support for hospitals to strengthen their stewardship programs and encourage hospitals to report data on antibiotic use and resistance to the CDC National Healthcare Safety Network to enhance our national understanding of antibiotic resistance and evaluate our interventions. 

One challenge to improving AMR surveillance is that available diagnostic solutions are insufficient (both domestically and globally), which means we often find out about resistant bacteria only after treatment failure. Research and development investments in AMR diagnostics lags behind investments in basic research, therapeutics and operations, and incentives to developing new diagnostic tools, such as rapid tests, are limited. Current diagnostic solutions are out of reach in many LMICs due to an insufficient workforce to run and analyze diagnostics tests, the high costs of running tests and limited infrastructure to keep samples and tests at the needed temperatures. The U.S. government currently supports global laboratory capacity building programs through the CDC and USAID. ASM supports further investments in these programs and U.S. coordination with the UN Quadripartite Joint Secretariat on AMR.

NIH Programs

We urge Congress to provide separate and stable funding for the Innovation Account in the next generation Cures legislation, and this funding should supplement robust annual NIH funding, consistent with the intention of the original Cures legislation.

ASM echoes the submitted by the Ad Hoc Group for Medical Research. We support the Innovation Account, established in the Cures legislation, which was intended to supplement NIH’s annual appropriation and allow NIH to support specific large-scale initiatives without redirecting resources from other existing and emerging fields of study. However, we are concerned that limits on discretionary spending have led NIH to use Innovation Account funding to make up for deficits in other areas. Meanwhile, programs originally funded by the Innovation Account are currently facing a funding cliff as the original Cures funding runs out. 

ASM recently convened members to provide feedback to the National Institute of Allergy and Infectious Diseases’ (NIAID) draft strategic plan. NIAID is the largest funding agency for U.S.-based ASM members, and any proposed reforms or new NIH initiatives involving NIAID are of great interest to ASM members. 

ASM’s comments to NIAID urge the agency to consider mechanisms for funding research projects that span human, animal and environmental health with non-health research funders, such as the National Science Foundation and the Department of Energy, as well as public-private partnerships. Funding agencies may need additional authorities from Congress to fund these collaborations. 

Support and funding for these programs for data infrastructure programs from Congress in Cures legislation is essential and would improve the return on investment on current NIH and NIAID funded research programs.

ASM also encouraged NIAID to invest in research and data infrastructure. Common infrastructure for storing and sharing data about microbes, infectious diseases and omics and genomics is needed, particularly as AI is generating more biological data and models. Researchers often struggle to identify where and how to store data. For example, microbiologists working with genomic data from human patients struggle to store and securely share this data with other researchers and public health officials. NIAID can improve its data infrastructure and strategy by funding research infrastructure for sharing, storing and analyzing data, as well as collaborating with NIH’s Office of Data Science Strategy. To produce robust and reproducible studies, researchers need both infrastructure and training to share data with context. 

Conclusion  

Thank you for the opportunity to share our feedback on the next step in the 21st Century Cures initiative. We look forward to working with your offices as you continue to advance this important legislation. Should you have any questions, please reach out to Nicole Zimmerman, Senior Specialist, Federal Affairs, at nzimmerman@asmusa.org.

Thank you,



Amalia Corby


Amalia Corby
Director of Federal Affairs
American Society for °®¶¹´«Ã½