Â鶹Çø

Dear Dr. Plummer,  

On behalf of Â鶹Çø, thank you for the opportunity to provide comments to the Council. Â鶹Çø is a global scientific society of more than 38,000 members whose mission is to shape the future of the microbial sciences to tackle some of the world’s most pressing challenges, including antimicrobial resistance (AMR).

Growing evidence links gut microbiomes to chronic disease, immune function, antimicrobial resistance, nutrition and environmental health. Yet microbiome science has not translated consistently into patient care because measurements, interpretation and evidence standards vary across the field. Before microbiome information can reliably guide prevention and treatment decisions, the field needs greater consistency, validation and clinical relevance.  

Â鶹Çø appreciates the focus of this convening of PACCARB on AMR and the microbiome. Microbiomes play a critical role in fighting infections and show immense potential to treat resistant infections and advance AMR strategies beyond eliminating pathogens. As you develop recommendations, Â鶹Çø suggests the following considerations to advance microbiome research and to integrate microbiome applications into patient care. 

Strategy and Coordination

The Human Microbiome Project was a seminal investment in the microbial sciences that laid the groundwork for our understanding of our bodies’ microbial ecosystems and their functional and metabolic capabilities. Notably, it spawned an exponential increase in the amount and breadth of investments in microbiome research and laid the groundwork for interagency strategic coordination. In the years since, strategic support and capacity for interagency coordination have faded. Â鶹Çø encourages the committee to recommend a high-level microbiome strategy to bring research innovations to application and renewed interagency coordination to ensure a strong, connected and coordinated microbiome research community that spawns innovative approaches to intractable problems like AMR. Â鶹Çø appreciates the One Health approach that the PACCARB has taken to AMR, integrating perspectives from human, animal and environmental health and encourages that the microbiome strategy uses a similar approach.

As a scientific society, Â鶹Çø is uniquely positioned to connect microbiome discovery science, clinical medicine, diagnostics, therapeutics, nutrition, public health and regulatory science. This enables microbiome applications to be grounded in biological function, clinical evidence and real-world implementation. We encourage you to consider Â鶹Çø as a partner in developing a national scientific roadmap to make microbiome science useful for prevention, resilience and chronic disease management. This includes the standards, measurements, evidence frameworks and coordination needed to make microbiome-based health tools credible and actionable, and a format to inform consumers regarding the standards.

Foundational Research and Innovation 

Invest in foundational microbiome research and other innovative approaches to AMR, including bacteriophage therapy. Phage therapy offers a potentially life-saving option against drug-resistant infections. Across the United States, expertise, resources, clinical programs and research efforts to advance bacteriophage therapy have been growing rapidly. However, these capabilities remain fragmented, making it difficult to connect patients, clinicians, researchers and other stakeholders when AMR patients need phage therapy. Â鶹Çø recommends the creation of a Phage Therapy Coordination Platform to bridge these gaps.

Unclear regulatory pathways have historically stymied microbial innovation. Â鶹Çø asks the committee to take a closer look at pathways for approving microbiome treatments for animals used in food production in addition to human applications, and to work alongside the FDA and other regulatory agencies to build a strong case for appropriate pathways.  

Diagnostics 

Â鶹Çø strongly encourages investment in the development of microbiome-based diagnostics using pathogen-agnostic and functional approaches. Â鶹Çø further requests that federal agencies work to improve guidance and clinical standards for optimal use of diagnostics in all healthcare and veterinary settings. As resistance profiles change, both domestically and globally, and as diagnostic technology advances, timely standards will optimize clinical care and antibiotic utilization. Furthermore, funding for apprenticeships, fellowships or other incentives must be provided to bolster the critical workforce needed to appropriately interpret AMR-related diagnostics.  

Policymaker Engagement 

Â鶹Çø recognizes and supports the advisory role of PACCARB to the federal government, and we appreciate the dedication of HHS and other leaders in the Executive Branch to address AMR. AMR is a non-partisan issue that impacts millions of patients around the world. Key pieces of legislation, including the PASTEUR Act (/) and the Stop Superbugs Act () have been introduced in the current Congress—however, most lawmakers have limited understanding of the dire need for these policies. As such, we encourage the committee to invite members of Congress and their staff to observe the proceedings of the committee and to consider further engagement, as appropriate.  If you have any questions or would like to further discuss these comments, please contact Amalia Corby, Director of Federal Affairs, at acorby@asm.org.

Thank you, 

Amalia Corby
Director of Federal Affairs
Â鶹Çø