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The (H.R. 6000) seeks to bolster the scientific workforce, significantly fund biomedical research, and address public health challenges including antimicrobial resistance. The bi-partisan bill was introduced on November 17, 2021 by Representatives Diane DeGette (D-CO) and Fred Upton (R MI) and is a continuation of the 21^st Century Cures Act.

In December, ASM submitted comments to the House of Representatives in support of several provisions within Cures 2.0. The following is an abridged version of the full letter.
 

Dear Representatives DeGette and Upton: 

On behalf of the American Society for °®¶¹´«Ã½ (ASM), we appreciate the opportunity to submit this response on H.R. 6000, the Cures 2.0 Act, as introduced. 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 30,000 researchers, educators and health professionals across 109 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.

We are pleased to see that Cures 2.0 includes several provisions that reflect ASM priorities, from support for the scientific workforce, to pandemic preparedness, to strategies for addressing major public health challenges including vaccine uptake and addressing antimicrobial resistance. In response to your request for feedback on the legislation, ASM offers the following comments for your consideration as you continue to advance this legislation.

Support for the Research Community:

ASM supports the inclusion of Section 502, the Research Investment to Spark the Economy (RISE) Act provisions, including the authorization of $25 billion in research relief for independent research institutions, public laboratories and universities throughout the country to continue work on thousands of federally-backed projects that were interrupted by the COVID-19 pandemic. Appropriating the funds envisioned in the RISE Act will provide much-needed supplemental funding for federally funded research. Microbial science is a cross-cutting endeavor, and our members’ federally funded research is fundamental to advances in human health, agriculture, energy and the environment. ASM has been deeply concerned about the serious consequences of the disruptions to the broader research enterprise, and this funding is critical to mitigating the negative scientific and economic impacts of the COVID-19-related laboratory closures and disruptions on research already in progress.

Establishment of a National Testing and Response Strategy for Future Pandemics

ASM supports the inclusion of Section 102 in Cures 2.0 to prepare for the inevitable outbreaks in the future. Many of our members, including those in hospital and state public health clinical laboratories, have been on the front lines helping our nation address the unprecedented challenges the COVID-19 pandemic presented to our society, our health care system and our economy. They understand firsthand the supply chain challenges and regulatory hurdles that might have been addressed through more effective national testing strategy. Our continued recovery from COVID-19 and 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. However, this section could be strengthened by including more specifics on the components of the national plan. There are 4 key pieces of a national strategy that ASM believes are missing from the current legislation, including:

• Support for diagnostic development and deployment
• Support for a strong clinical microbiology laboratory workforce
• Support for disease surveillance and genomic surveillance
• Alleviating testing supply shortages

Additional information on each of these topics is included in the full letter.

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 legislative text. 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.

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.

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.

Beyond the PASTEUR Act provisions, we encourage you to consider additional ways to promote the concept of “One Health” to combat antimicrobial resistance, since at its root, AMR is ultimately an environment problem, where the health manifestation is its sequel. Surveillance is one way to accomplish this, because considering all areas—human health, animal health and environmental health—and tracking resistance across multiple vectors will ensure a complete picture of where resistant organisms are developing and how they are transmitted. ASM is also supportive of government providing pull and push incentives to help overcome the economic market failure problem that is at the core of the knotty AMR menace.

Support for Vaccine and Immunization Programs

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 reemergence of vaccine preventable diseases is alarming since outbreaks of once nearly eradicated diseases not only harm the patient, but put the local populations at risk, especially the most vulnerable members of these communities. 

ASM is pleased that Cures 2.0 authorizes additional funding in Sec. 104 for the Centers for Disease Control and Prevention (CDC) to carry out an awareness campaign about the safety and importance of vaccines, as well as funding to strengthen immunization information systems. We encourage you to include the following language from the VACCINES Act of 2019 (H.R. 2862) 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.

See full letter for additional information. 

Authorizing an Advanced Research Projects Agency for Health (ARPA-H) 

The creation of an Advanced Research Projects Agency for Health (ARPA-H) at the National Institutes of Health (NIH) in Sec. 501 is an intriguing concept intended to boost translating research into urgently needed capabilities for the benefit of human health. Recent initiatives such Operation Warp Speed and RadX demonstrate how focused work on urgent needs, when supported by federal funding and conducted through public-private partnerships, can lead to the development of lifesaving products and capabilities in record time. This model could prove useful in developing more effective and urgently needed solutions to global threats like antimicrobial resistance and seasonal threats like influenza. It is also important to recognize that these innovative partnerships were successful in the absence of a new, dedicated agency of this nature at the NIH, and there is risk in establishing a permanent entity that will require continued, robust support and staffing indefinitely.

We appreciate that the President’s budget proposed and the House and Senate Appropriations Committees’ FY 2022 Labor, Health and Human Services, Education and Related Agencies bill include funding for an ARPA-H that is separate and supplemental to base funding for existing NIH Institutes and Centers. If established, the funding for the new entity must be maintained in this way. Sustained, robust support for basic and clinical research at NIH provides the foundation for the discoveries and technologies that lead to products that treat and cure disease or advance health care capabilities. We also know that budget parameters can and do change. We remain concerned that ARPA-H could ultimately result in less investigator-initiated research funded by NIH Institutes and Centers, and reduced paylines.

We recognize this concept is a priority for many and is intended to fill a critical gap in the development of therapies and platforms that is preventing progress against diseases and conditions that affect millions of Americans and people around the globe. We look forward to working with you to find a path forward that can address concerns but also meet the needs of the scientific and patient community and advance innovation.

Support for Long COVID, Integrative Learning Collaborative 

ASM supports the interdisciplinary Learning Collaborative with the Department of Health and Human Services in Sec. 101. The importance of an integrative approach with experts from multiple sectors is crucial to further the understanding of long COVID. ASM applauds Cures 2.0 for including developers of diagnostics and therapeutics along with clinical laboratories in the Learning Collaborative. Clinical laboratories have a unique position of being both behind the scenes and on the front lines of an infectious disease outbreak. For the last 18 months, clinical laboratories across the country have adapted to supply chain and workforce shortages despite an immensely high demand for COVID-19 test kits. They consistently provide accurate and reliable COVID-19 diagnostic testing and will give a unique perspective to the Learning Collaborative.

Thank you for the opportunity to share our feedback on Cures 2.0. We look forward to working with your offices as you continue to advance this important legislation.