SHM Joins Multi-Stakeholder Letter Supporting PASTEUR Act

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The Honorable Nancy Pelosi
Speaker
US House of Representatives
Washington, DC 20515

The Honorable Kevin McCarthy
Republican Leader
US House of Representatives
Washington, DC 20515

The Honorable Chuck Schumer
Majority Leader
US Senate
Washington, DC 20510

The Honorable Mitch McConnell
Republican Leader
US Senate
Washington, DC 20510

 

Dear Speaker Pelosi and Leaders McCarthy, Schumer and McConnell:

On behalf of the undersigned organizations representing health care providers, public health professionals, scientists, patients, and the pharmaceutical and diagnostics industries, we write to urge you to enact the PASTEUR Act in an end of year package to address the growing crisis of antimicrobial resistance (AMR) by strengthening the antimicrobial pipeline to ensure clinicians 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.

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 It is also clear that the COVID-19 pandemic exacerbated AMR. In 2020, the U.S. experienced a 15% increase in AMR infections and deaths due to COVID-19, and experts do not expect a return to pre-pandemic levels without concerted action.² Because antimicrobials enable modern medicine, growing rates of resistance and a shrinking arsenal of products jeopardize our ability to safely provide organ transplants, cancer chemotherapy and surgeries such as hip and knee replacements and cesarean sections. Additionally, AMR is a significant economic burden here in the U.S.; the direct healthcare costs of treating only six of the most threatening multidrug-resistant pathogens is estimated to be $4.6 billion per year³.

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 only 43 antibacterial therapeutics in clinical development worldwide – only 19 of which are for the most threatening gram-negative pathogens – a critical area of unmet need.⁴ We know that the pipeline is already inadequate to address current resistant threats, let alone those that will come in the future. This reinforces the need to urgently stimulate investment in novel antimicrobials to quickly bolster the pipeline.

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 will only pay for FDA approved treatments that are available to patients and meet unmet AMR needs– those that will 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 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.

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 Senate released Labor-Health and Human Services appropriations bill for 2023. PASTEUR has 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 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 an end of year package in 2022.

Thank you,

Organization (as it will read on the letter)

American Academy of Allergy, Asthma & Immunology

AdvaMedDx

AGILeBiotics BV

Alliance for Aging Research

Alliance for Biosecurity

Alpha-1 Foundation

American Association for Dental, Oral, and Craniofacial Research

American Association of Bovine Practitioners

American Association of Small Ruminant Practitioners

American College of Allergy, Asthma & Immunology

American College of Emergency Physicians

American College of Preventive Medicine

American Dental Association

American Gastroenterological Association

American Kidney Fund

American Liver Foundation

American Society for Biochemistry and Molecular Biology

American Society for Microbiology

American Society of Plastic Surgeons

American Society of Transplant Surgeons

American Urological Association

Amputee Coalition

AN2 Therapeutics

Antibiotic Resistance Action Center, George Washington University

Antimicrobial Innovation Alliance

Arizona Medical Association

ArrePath Inc

Arthritis Foundation

Asociación de Oatomizados de Puerto Rico, Inc.

Asociación Puertorriqueña de Diabetes

Association for Professionals in Infection Control and Epidemiology

Autoimmune Association

BD (Becton, Dickinson and Co.)

BIO

Bioomix

BioVersys AG

Black, Gifted & Whole Foundation

Boehringer Ingelheim Venture Fund USA

Boomer Esiason Foundation

Boston College

BUGWORKS

CancerCare

Cancer Support Community

CARB-X

Caregiver Action Network

CircaGene

Clarametyx Biosciences

Coalition for Improving Sepsis and Antibiotic Practices (CISAP)

Coalition of Skin Diseases

Color of Crohn's and Chronic Illness

Colorectal Cancer Alliance

Connecticut Plastic Surgery Society

COPD Foundation

Crestone

CT Association of Ambulatory Surgery Centers

Cūrza, Inc

Cystic Fibrosis Foundation

Debiopharm International

Duke Margolis Health Policy Center

Entasis Therapeutics

Family Voices

Federation of American Hospitals

FHI Clinical

Florida Academy of Family Physicians

Florida Osteopathic Medical Association

Forge Therapeutics, Inc.

GARDP North America

Genentech

Georgia State Medical Association, Inc.

Global Coalition on Aging

Global Health Technologies Coalition (GHTC)

GSK

HCA Healthcare

Healthcare Leadership Council

HealthHIV

Healthy Men Inc.

HealthyWomen

Hesed Medical Associates

Hezekiah Beardsley Connecticut Chapter of the American Academy of Pediatrics

HIV Medicine Association

ICAN, International Cancer Advocacy Network

Immune Deficiency Foundation

Incubate

Infectious Disease Association of California

Infectious Diseases Society of America

International Foundation for AiArthritis

Invitris

Johns Hopkins Center for a Livable Future

Kathera Bioscience Inc

Kentucky Academy of Family Physicians

Kern Medical

Kineticos LIfe Sciences

La Jolla Pharmaceuticals/Innoviva

Locus Biosciences

Louisiana Hemophilia Foundation

LUNGevity Foundation

Lymphoma Research Foundation

Making-A-Difference in Infectious Diseases

Marigold Innovation

Medical Association of Georgia

Medical Society of Northern Virginia

Melinta Therapeutics

Merck

Michigan Antibiotic Resistance Reduction Coalition

Michigan State Medical Society

Microbion Corporation

Musculoskeletal Infection Society

Mycovia Pharmaceuticals

Mycoses Study Group Education and Research Consortium (MSGERC)

Nabriva Therapeutics

National Association of Nutrition and Aging Services Programs

National Coalition for Cancer Survivorship

National Consumers League

National Grange

National Health Council

National Kidney Foundation

National Organization for Rare Disorders

New Mexico Osteopathic Medical Association

Novo Holdings Equity US Inc.

NTM Info & Research

Ohio Osteopathic Association

Oklahoma Academy of Family Physicians

Omniose

Omnix Medical

ONCORD, Inc.

One Health Trust (formerly CDDEP)

Oragenics, Inc.

Osteopathic Physicians & Surgeons of California

Partnership to Fight Chronic Disease

Partnership to Fight Infectious Disease

Peggy Lillis Foundation

Peptilogics Inc.

Phare Bio

Pharmaceutical Research and Manufacturers of America (PhRMA)

Prevent Blindness

Qpex Biopharma

SCYNEXIS

Sepsis Alliance

Seres Therapeutics

Shionogi Inc.

Social Innovation in Drug Resistance, Boston University

Society of Hospital Medicine

Society of Infectious Diseases Pharmacists (SIDP)

Spexis

Spina Bifida Association

Stuart B. Levy Center for Integrated Management of Antimicrobial Resistance

TB Alliance

The Bonnell Foundation: Living with cystic fibrosis

The Broad Institute of Harvard and MIT

The Gerontological Society of America

The National Association of Pediatric Nurse Practitioners

The Pew Charitable Trusts

Triage Cancer

Trust For America's Health

UCSF

United Spinal Association

University of Zurich

Utah Nurse Practitioners

UTILITY therapeutics Ltd

Valanbio Therapeutics

Valley Fever Institute

Venatorx Pharmaceuticals Incorporated

Vizient, Inc.

Vocespr.org

 

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¹ https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
² https://www.cdc.gov/drugresistance/pdf/covid19-impact-report-508.pdf
³ National Academies of Sciences, Engineering, and Medicine. 2022. Combating antimicrobial resistance and protecting the miracle of modern medicine. Washington, DC: The National Academies Press. https://doi.
org/10.17226/26350.
⁴https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/03/tracking-the-global-pipeline-of-antibiotics-in-development