º£½ÇÖ±²¥

Paul Plummer, DVM, Ph.D., DACVIM, DECSRHM Chair, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria Office of the Assistant Secretary for Health U.S. Department of Health and Human Services 1101 Wootton Parkway Rockville, Md. 20852

Dear Dr. Plummer,

On behalf of º£½ÇÖ±²¥, thank you for the opportunity to comment on the next iteration of the U.S. National Action Plan on Combating Antibiotic-Resistant Bacteria (CARB). º£½ÇÖ±²¥ 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). º£½ÇÖ±²¥’s response is structured around the goals of the U.S. National Action Plan on Combatting Antibiotic Resistance (NAP).

Goal 1: Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant Infections

º£½ÇÖ±²¥ strongly recommends a continued focus on strengthening infectious disease surveillance and data systems. We cannot make progress toward this goal without understanding the scope of the problem, and this requires real-time data sharing across jurisdictions and institutions, from public health to clinical laboratories to the patient’s bedside. Accurate, timely data can detect emerging resistance as well as inform antimicrobial stewardship strategies from healthcare setting to the farm.

However, the best way to prevent the development of resistance is to prevent infection. Vaccination reduces infections, in turn reducing the need for antibiotics. º£½ÇÖ±²¥ encourages the CARB to highlight the importance of human and veterinary vaccines in the prevention of AMR.

Recent disruptions to federal support for scientific research are slowing progress toward understanding the fundamental microbial functions and hindering progress toward the development of new antimicrobials and diagnostics. º£½ÇÖ±²¥ encourages the CARB to express strong support for federal investment in scientific research, from discovery to application. 

Goal 2: Strengthen National One Health Surveillance Efforts to Combat Resistance

As the previous NAPs have emphasized, AMR inherently requires a One Health approach spanning human, animal and environmental health to better understand how resistance emerges, how AMR spreads and how pathogens react to countermeasures. Recent investments in wastewater surveillance have demonstrated its value in detecting outbreaks and emerging resistance— º£½ÇÖ±²¥ encourages the CARB to continue prioritizing this work and explore the connection between environmental detection of resistance to its impact on human and animal health. When paired with syndromic surveillance and pathogen-specific testing, wastewater surveillance can guide timely public health decisions. 

With the advent of next generation sequencing technologies, there is untapped potential in utilizing genomic data to better understand resistance patterns in both human and animal health. The National Center for Biotechnology Information’s Pathogen Detection platform provides real time genomic information about resistance in humans, food and the environment, but is not widely used by the scientific and clinical community. º£½ÇÖ±²¥ recommends that the federal government promote wider adoption of this resource and build data infrastructure for widespread sharing and analysis of resistance data to inform clinical decision making.

Federal research funding has historically reinforced silos across the different One Health domains. This approach neglects the intricate connection between microbes, host organisms and the biosphere. º£½ÇÖ±²¥ recommends that the CARB work with federal science funding agencies to encourage funding mechanisms for transdisciplinary research projects that span human, animal and environmental health.

Goal 3: Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification and Characterization of Resistant Bacteria

Inappropriate antimicrobial prescribing remains pervasive. Federal investment is needed to support the research and development of novel, rapid and more accurate diagnostic tools. According to studies cited in the Global One Health Diagnostics Access Compact (GO-Dx), of which º£½ÇÖ±²¥ is a signatory, hospital studies demonstrate that faster organism identification and antimicrobial susceptibility testing can generate approximately $1,000 USD in savings per patient with bloodstream infections by enabling earlier appropriate therapy, and rapid, accurate diagnostics can cut the length of hospital stay by 1-2 days per patient with acute respiratory infections. º£½ÇÖ±²¥ encourages the CARB to strongly support investment in academia, NGOs and industry partnerships to accelerate development of new, innovative diagnostics. 

º£½ÇÖ±²¥ encourages the CARB to support implementation science in the NAP, including clinical outcomes studies to validate the use of novel diagnostics. º£½ÇÖ±²¥ requests that the CARB Task Force work with federal agencies to improve guidance and clinical standards for optimal use of diagnostics in all health care settings. As resistance profiles change, both domestically and globally, and as diagnostic technology advances, timely standards will optimize clinical care and antibiotic utilization.

Finally, while accurate diagnosis ensures that the right antimicrobials are used to treat the right infection, there remains a shortage of laboratorians and clinicians, in both human and animal health, that are trained in the effective interpretation of the diagnostics we currently employ to combat resistance. Funding for apprenticeships, fellowships or other incentives must be provided to bolster the critical workforce needed to appropriately interpret our AMR-related diagnostics.

Goal 4: Accelerate Basic and Applied Research and Development for New Antibiotics, Other Therapeutics and Vaccines

Microbiomes play a critical role in fighting infections and show immense potential to treat resistant infections, as evidenced through use of Fecal Microbiota Transplant to treat resistant and recurrent C. diff infections. º£½ÇÖ±²¥ requests that the NAP include a directive to develop a microbiome roadmap to address the gap between microbiome characterization and real-world use of microbiome therapies and diagnostics, as well as recommendations for targeted federal research to characterize “healthy” microbiome measurement and standards. 

Despite rapid scientific advances, microbiome research is still unevenly applied and rarely integrated into clinical care, public health or policy. º£½ÇÖ±²¥ recommends that the CARB emphasize the need to address barriers to widespread adoption of microbiome therapies to treat and stop the spread of AMR, including a lack of standardized clinical guidelines and regulatory pathways to approve microbiome-based diagnostics and therapies.

Bacteriophage therapy offers a potentially life-saving option against drug-resistant infections, yet its utilization remains limited by scientific and clinical complexity and uncertainty. º£½ÇÖ±²¥ requests that the NAP include targeted federal research investments and coordination across federal agencies to address barriers to widespread use of phage therapy in clinical settings that could accelerate the adoption of these novel therapeutics. This includes modernizing FDA regulations to more quickly assess the safety and efficacy of phage therapies, so phage therapy is available for patients when needed. º£½ÇÖ±²¥ also recommends that the U.S. government begin to take steps to understand how individualized therapies, like phage therapy, can enter the anti-infectives supply chain, assessing how to apply stewardship practices to this novel therapy and how Medicaid and Medicare reimbursement can include phage therapy.

Goal 5: Improve International Collaboration and Capacities for Antibiotic-Resistance Prevention, Surveillance, Control and Antibiotic Research and Development

Global collaboration is fundamental to the advancement of science and public health. Microbes know no borders, and nowhere is this more apparent than the global spread of infectious diseases and AMR. Low- and middle-income countries have the highest burdens of AMR, yet these countries often do not have adequate public health surveillance systems and diagnostics. º£½ÇÖ±²¥, through our federally funded Global Public Health Programs, works with partners in LMICs to bolster laboratory capacity. We request that the CARB continue to uphold the importance of a global approach to AMR and to include language in the NAP supporting continued U.S. investment in diagnostic and surveillance capacity in LMICs.

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
º£½ÇÖ±²¥