March 8, 2023

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On behalf of the undersigned organizations representing health care providers, public health professionals, scientists, patients, and the pharmaceutical and diagnostics industries, we urge you to include the PASTEUR Act in any moving legislative vehicle this year, including the reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA).  The growing crisis of antimicrobial resistance (AMR) undermines U.S. public health preparedness and significantly hampers our nation’s ability to respond to a wide range of threats, including pandemics, outbreaks, natural disasters, and bioterror attacks. PASTEUR would increase our nation’s resilience by strengthening the antibacterial and antifungal pipeline to ensure clinicians and other medical professionals have the innovative products they need to treat patients, and ensuring antimicrobials are used appropriately. Every day we wait to address the crisis in the antimicrobial ecosystem is another year patients and providers must wait to have access to life-saving medicines. 

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In 2019, an estimated 1.27 million deaths worldwide were directly caused by AMR, and AMR played a part in nearly 5 million deaths. This makes AMR a leading cause of death globally.1  The AMR crisis was further exacerbated by the COVID-19 pandemic. In 2020, U.S. hospitals experienced a 15% increase in AMR infections and deaths, though pandemic-related data gaps suggest that the total national burden of AMR may be much higher. Experts do not expect a return to pre-pandemic levels without concerted action.2 Any emergency resulting in high levels of hospitalization, particularly high levels of ventilator use, creates a ripe opportunity for the spread of secondary drug resistant infections.

 

Addressing AMR is important for bioterror preparedness as well, as agents used by bioterrorists may be genetically engineered to resist current therapeutic antimicrobials.3 World Health Organization (WHO) has estimated that if 50 kg of Y. pestis were to be released as an aerosol over a city with a population of 5 million, 150,000 people might fall ill with pneumonic plague, 36,000 of whom would die.4 Drug resistant strains of Y. pestis have been reported, which can increase mortality.5 As another example, modeling suggests that deliberate release of aerosolized F. tularensis over London would result in an estimated 130,000 infections and 24,000 deaths.6 Natural resistance is already observed in tularemia, and the overuse of fluoroquinolones in the last two decades has led to treatment failure and relapses in tularemia patients.7 

Hurricanes and other natural disasters can also increase the spread of infections, including drug resistant infections. Loss of electricity increases the risk of food spoilage and foodborne illness.  Interrupted access to safe water supplies can lead individuals to turn to rivers or other ad hoc water sources.  This approach, along with the presence of floodwaters, can increase the risk of illness caused by waterborne pathogens. Studies have found higher levels of pathogenic bacteria and antibiotic resistance genes in floodwaters and soil in the Houston, TX area following Hurricane Harvey.8 9 Conditions in crowded shelters and severely damaged homes can significantly increase the spread of infection as well. All these infections can trigger sepsis among victims and emergency workers.10 Additionally, during natural disasters, those who are immunocompromised may not only lose access to crucial systems such as infusion or dialysis centers due to the loss of power but are also even more prone to these infections. 

Despite the urgent and increasing need for novel antimicrobials to treat superbugs, the antimicrobial ecosystem is broken and unable to meet patient needs. The current pipeline has fewer than 50 antibacterial therapeutics in clinical development worldwide – only a handful of which are for the most threatening gram-negative pathogens – a critical area of need.11 We know that the pipeline is already inadequate to address current resistant threats, let alone those that will come in the future.  

Novel antimicrobials must be used judiciously to limit the development of resistance, so payment based on volume fails to drive innovation. PASTEUR’s subscription model is an innovative way to pay for novel antimicrobials that will revitalize the pipeline and support appropriate use. Under PASTEUR, the federal government can enter into contracts with innovators to pay for a reliable supply of novel antimicrobials with payments that are decoupled from the volume of antimicrobials used.  Importantly, the federal government only pays once – the subscription payment is all-inclusive, and PASTEUR only pays for success. Furthermore, PASTEUR is designed to pay for FDA approved treatments that are available to patients and meet unmet AMR needs– those that experts agree will likeliest have a big impact for patients and public health.

 
The delinked approach is similar to Project Bioshield, which provides multi-year funding to support procurement of medical countermeasures (MCM) for national security. Antimicrobials, like MCM, have a very limited commercial market. PASTEUR will provide novel antimicrobial innovators with a more predictable return on investment necessary to revitalize the antimicrobial pipeline—just like Project Bioshield has done for MCMs. 

PASTEUR would also provide new funding for health facilities including rural, critical access and safety net hospitals to support antimicrobial stewardship, to ensure that antimicrobials are used appropriately to limit the development of resistance, and to ensure that the vulnerable patients served by these hospitals can have access to the benefits of antimicrobial stewardship. Stewardship teams also typically play critical roles in preparedness and response, including managing administration of novel therapeutics during emergencies and managing antimicrobial drug shortages. 

In his September 2022 remarks to the World AMR Congress, Secretary Becerra reiterated the Administration’s commitment to this issue, as evidenced by the inclusion of a proposal that aligns with PASTEUR in the President’s budget request for 2023, which was endorsed in the Consolidated Appropriations Act of 2023. At the end of 2022, PASTEUR had over 60 bipartisan cosponsors and the broad support of a diverse array of stakeholders. Delays in the passage of PASTEUR are delays in the development of novel antimicrobials to treat highly resistant, life-threatening infections—delays that erode our preparedness and that many patients, including those particularly susceptible to infections, such as patients with cystic fibrosis, cancer, or organ transplants, cannot afford.  

We urge you to enact PASTEUR in 2023.

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Thank you, 

Abgenics Life Sciences Pvt Ltd 
Acurx Pharmaceuticals, Inc. 
Adaptive Phage Therapeutics 
AdvaMedDx 
Aequor Inc. 
AGILeBiotics B.V. 
AIDS United 
AIIMS  
Allegheny Oral and Maxillofacial Surgery 
Alliance for Aging Research 
Alliance for Biosecurity 
Alpha-1 Foundation 

American Academy of Allergy, Asthma & Immunology  
American Academy of HIV Medicine 
American Association for Dental, Oral, and Craniofacial Research American Association of Bovine Practitioners 
American College of Allergy, Asthma & Immunology 
American College of Emergency Physicians 
American Gastroenterological Association 
American Kidney Fund 
American Liver Foundation 
American Public Health Association  
American Society for Biochemistry and Molecular Biology American Society for Microbiology 
American Society of Nephrology 
American Society of Plastic Surgeons 
American Society of Tropical Medicine and Hygiene 
American Urological Association  
AMR Insights BV 
AMR.Solutions 
AN2 Therapeutics 
Antibiotic Resistance Action Center, George Washington University Antimicrobial Development Specialists, LLC 
Antimicrobial Innovation Alliance (AIA) 
Antimicrobials Working Group 
Appili Therapeutics  
Aridis Pharmaceuticals Inc. 
Arizona Medical Association 
ArrePath Inc 
Arthritis Foundation 
Association for Professionals in Infection Control and Epidemiology

Association of Public Health Laboratories (APHL) 
Association of State and Territorial Health Officials 
Astellas Pharma Global Development, Inc. 
Autoimmune Association  
AVAC 
Aviva Investors  
BD (Becton, Dickinson and Co.) 
BEAM Alliance 
bioMerieux Inc. 
BioPharma Consultants 
Biotechnology Innovation Organization (BIO) 
BioVersys AG 
black, gifted & whole foundation 
Blacksmith Medicines 
Boehringer Ingelheim Venture Fund USA 
Boomer Esiason Foundation 
Bugworks Research Inc. 
Canadian Antimicrobial Innovation Coalition  
Cancer Support Community 
CancerCare 
Capital Alternatives 
Caregiver Action Network 
Case Western Reserve University 
Clarametyx Biosciences, Inc. 
Coalition for Improving Sepsis and Antibiotic Practices (CISAP) Coalition of Skin Diseases 
Colorectal Cancer Alliance 
Consumer Federation of America (CFA) 
COPD Foundation 

Crestone, Inc. 
CUBRC, Inc. 
Curza, Inc. 
Cystic Fibrosis Foundation 
Debiopharm International SA 
Doodhadhari Burfani Hospital & Research Institute 
DRJ Consulting LLC 
Duke University School of Medicine 
Duke-Margolis Center for Health Policy 
Ebright Laboratory, Waksman Institute, Rutgers University Elizabeth Glaser Pediatric AIDS Foundation 
EMH Consulting 
Emory Antibiotic Resistance Center 
Emory University 
Entasis Therapeutics 
Ethiopian Public Health Institute 
F2G Ltd 
Family Voices 
Federation of American Hospitals 
FHI Clinical  
Florida Osteopathic Medical Association  
Genentech, a member of the Roche Group 
Global Coalition on Aging 
Global Health Technologies Coalition 
Government College University, Institute of Microbiology  Greater San Diego Biological Solutions 
GSK 
Half Moon Bay Biotechnology Consulting  
Harvard Medical School, Brigham and Women's Hospital 

HealthCare Institute of New Jersey (HINJ) Healthcare Leadership Council 
HealthHIV 
Healthy Men Inc. 
HealthyWomen 
Hearts Consulting Group, LLC 
Helmholtz Centre for Infection Research 
HIV Medicine Association  
IAVI 
ICAN, International Cancer Advocacy Network Immune Deficiency Foundation 
Incubate 
INCubator for Antibiotic Therapies Europe Infectious Disease Association of California Infectious Disease Drug Development Consulting, LLC Infectious Diseases Society of America 
Innoviva, Inc 
Institute For Life Science Entrepreneurship International Technology Development Corporation JMI Laboratories 
Johns Hopkins Center for a Livable Future 
Kasturba Medical College Manipal  
Kathera Bioscience Inc. 
Keane Enterprise 
Kern Medical 
La Jolla Pharmaceuticals 
Life Sciences Pennsylvania 
LLBarrett Biopharmaceutical Consulting, LLC 
Locus Biosciences 

LUNGevity Foundation 
Lupus and Allied Diseases Association, Inc. 
Lymphoma Research Foundation 
Lynn interiors  
Madam Therapeutics 
Mahidol university 
Making-A-Difference in Infectious Diseases 
Marmion Partnership Ventures  
Melinta Therapeutics  
Merck 
MGB Biopharma  
Michigan Antibiotic Resistance Reduction Coalition 
Microbion Corporation 
Microbiotix, Inc. 
Microvioma, India 
Musculoskeletal Infection Society 
Mutabilis 
MyCare 
Mycoses Study Group Education and Research Consortium 
Mycovia Pharmaceuticals 
Nabriva Therapeutics 
NASTAD 
National Association of Nutrition and Aging Services Programs (NANASP) National Association of Pediatric Nurse Practitioners 
National Athletic Trainers' Association 
National Coalition for Cancer Survivorship 
National Consumers League  
National Grange 
National Health Council 

National Kidney Foundation 
National MS Society 
National Organization for Rare Disorders 
National Public Health Laboratory 
New York State Osteopathic Medical Society 
Novo Holdings Equity US Inc. 
NTM Info & Research 
Oak Ridge Institute for Science Education 
Oakrum Pharma 
Ohio Osteopathic Association 
Oklahoma Academy of Family Physicians 
Omniose 
Omnix Medical 
ONCORD, Inc. 
One Health Trust 
Opal Biosciences Ltd 
Oragenics 
Osteopathic Physicians & Surgeons of California Partnership to Fight Chronic Disease (PFCD) Partnership to Fight Infectious Disease (PFID) 
Pediatric Infectious Diseases Society 
Peggy Lillis Foundation for C.diff Education & Advocacy Peptilogics 
Phagelux Inc. 
Phages for Global Health  
Phare Bio 
Pharmaceutical Research and Manufacturers of America Prevent Blindness 
Qeen Biotechnologies Inc. 

Recombinant Films 
Regnum Corp 
RNA Medicines, LLC 
Sanderling Consulting LLC 
SCYNEXIS 
SCYNEXIS, INC 
Sepsis Alliance 
Sequella, Inc. 
Seres Therapeutics, Inc. 
Shionogi Inc. 
Small World Initiative 
Social Innovation in Drug Resistance Program - Boston University 
Society of Critical Care Medicine 
Society of Hospital Medicine 
Society of Infectious Diseases Pharmacists (SIDP) 
South Dakota State University - Medical Laboratory Sciences Program 
Spero Therapeutics 
Spina Bifida Association 
Stuart B. Levy Center for Integrated Management of Antimicrobial Resistance at Tufts (Levy CIMAR) Synthetivity 
Tanta University  
TB Alliance 
Terranova Medica, LLC 
The American College of Preventive Medicine 
The Bonnell Foundation: Living with cystic fibrosis 
The Broad Institute of MIT and Harvard 
The Gerontological Society of America 
The Joint Commission 
The Pew Charitable Trusts 

​Thunder Biotech, Inc. 
Treatment Action Group (TAG) 
Triage Cancer 
Trust for America's Health 
UC-Davis Medical Center 
UCSB 
United Spinal Association 
University of Alabama at Birmingham 
University of Anbar 
University of Colorado Denver School of Medicine University of New Mexico 
University of Port Harcourt Teaching Hospital  University of Texas at San Antonio 
VA Boston Healthcare System and BU School of Medicine Valley Fever Americas Foundation  
Valley Fever Institute 
Venatorx Pharmaceuticals 
Virginia Commonwealth University  
Vizient, Inc.  
Wayne State Yniversity 
Western Ridge 
WICN  
Zavante Royalty Co