Letter to Senate Leadership on the Pasteur Act

September 11, 2024 

The Honorable Chuck Schumer
Majority Leader 

The United States Senate
322 Hart Senate Office Building
Washington, DC 20510 

The Honorable Mitch McConnell
Minority Leader 

The United States Senate 
317 Russell Senate Office Building
Washington, DC 20510 

Dear Majority Leader Schumer and Minority Leader McConnell: 

On behalf of the undersigned organizations representing millions of patients who face serious acute and  chronic health conditions, we urge you to address the growing crisis of antimicrobial resistance by prioritizing the passage of the Pioneering Antimicrobial Subscriptions To End Upsurging Resistance  (PASTEUR) Act (H.R. 2940 / S. 1355) this year. Addressing antimicrobial resistance (AMR) through this  important legislation simply cannot wait any longer. 

AMR poses a rapidly growing threat to the United States and the world. According to the 2019 CDC  Antibiotic Resistance Threats in the United States report¹, over 2.8 million AMR infections occur in the  United States each year, with over 35,000 people dying as a result. In 2019, 1.27 million deaths were  directly caused by resistant infections around the world, and played a role in 4.95 million deaths²;  without action, antimicrobial resistance is predicted to be a leading cause of death by 2050³. Every day  we wait to address the AMR crisis is another day that lives are lost.  

The economic toll of AMR is also staggering – annually, only six of the worst resistant pathogens  increase U.S. health care costs by $4.6 billion annually. Notably, antimicrobial resistance increases a  patient’s risk for developing sepsis, the body’s overwhelming response to infection, which already  impacts 1.7 million patients in the U.S. and costs Medicare more than $41 billion in sepsis-related  inpatient and skilled nursing facility admission costs each year. As resistance worsens, the financial and  human costs of sepsis will only increase. 

Along with patients experiencing sepsis, data from the Centers for Medicare and Medicaid Services  published in 2021 found that Medicare beneficiaries account for the majority of cases of both new  diagnoses of AMR infections and resulting deaths in United States hospitals, spending hundreds of  thousands of additional days in hospitals each year due to AMR and costing taxpayers billions in extra  heath care costs annually.⁴ These data indicate that efforts to address AMR will not only improve patient  outcomes for Medicare beneficiaries but may also yield net savings to the federal government. 

As patients and providers wait to access life-saving treatments, these delays put the entire country – particularly individuals with cystic fibrosis, Valley Fever, cancer, organ transplants, and other  conditions—at risk. The PASTEUR Act is targeted legislation that directly addresses these patients most  at risk for AMR. As you may know, the necessary and frequently routine use of antimicrobials to treat patients with chronic conditions associated with infections, including combat veterans who have  sustained traumatic injuries, too often leads to patients battling antimicrobial-resistant infections. For  example, the highly contagious methicillin-resistant Staphylococcus aureus (MRSA), which can cause  invasive infections, sepsis, and death, is found in 2% of the total United States population⁵ but 14% of  people with CF, highlighting the risk for AMR among chronically ill patients.  

Despite the magnitude of the AMR crisis and the increasingly urgent need for antimicrobial products,  the antimicrobial ecosystem is remarkably weak. Fewer than 50 antibacterial therapeutics are currently  in clinical development worldwide, only a handful of which are for the most threatening gram-negative  pathogens.⁶ Antimicrobials are incredibly expensive and time-consuming to develop, typically command a lower price and need to be used sparingly to minimize resistance. These factors make it difficult for  new products to stay on the market and for their developers to stay in business.  

That’s why the PASTEUR Act is so important. Under PASTEUR’s subscription model, the federal  government can enter into contracts with developers to pay for a reliable supply of product of  innovative antimicrobials that have been approved by the FDA and meet established innovation criteria. Payments are decoupled from the volume of antimicrobials used, thereby removing the incentive for  companies to promote the widespread use that often results in the development of drug-resistant  pathogens. The subscription contract is all-inclusive, and the federal government only pays once.  Economic modeling performed by the Center for Global Development suggests that a subscription-based  approach to incentivizing antimicrobial development, such as that authorized by the PASTEUR Act,  would generate a significant return on investment (ROI) in both the short- and long-term.⁷ 

Importantly, bill sponsors are pursuing the authorization of this bill without funding attached as a  critical first step to set up a PASTEUR office. Removing funding from the bill allows it to abide by  regular order and determine funding levels through the appropriations process. 

The time to address the threat of AMR is now. Without innovative, cost-effective strategies for tackling  this crisis, the tremendous impact of AMR on patients who face serious, acute, and chronic health  conditions and for the broader United State population will continue to worsen. The millions of patients  we represent know all too well how underprepared we are to meet their AMR treatment needs today. 

Please include the PASTEUR Act in a future mark up so that it can be included in any moving vehicle to  ensure its passage this year – our patients and all Americans simply cannot wait any longer. 

Respectfully, 

American Kidney Fund 

Autoimmune Association 

Boomer Esiason Foundation 

CancerCare 

Coalition of Skin Diseases 

Colorectal Cancer Alliance 

COPD Foundation 

Cystic Fibrosis Foundation 

Elizabeth Glaser Pediatric AIDS Foundation Foundation for Sarcoidosis Research  

Global Liver Institute 

HealthHIV 

HealthyWomen  

Immune Deficiency Foundation 

MyCARE Foundation 

National Organization for Rare Disorders NTM Info & Research 

Peggy Lillis Foundation 

Sepsis Alliance 

Spina Bifida Association 

Stop TB USA 

The Bonnell Foundation: Living with cystic fibrosis We Are TB 

CC: 

The Honorable Bernie Sanders 

The Honorable Bill Cassidy

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¹ CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019. 

² Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic  analysis [published correction appears in Lancet. 2022 Oct 1;400(10358):1102. doi: 10.1016/S0140-6736(21)02653- 2]. Lancet. 2022;399(10325):629-655. doi:10.1016/S0140-6736(21)02724-0 ³ The Review on Antimicrobial Resistance. TACKLING DRUG-RESISTANT INFECTIONS GLOBALLY: FINAL REPORT AND  RECOMMENDATIONS. 2016. 

⁴ Aligning Payment And Prevention To Drive Antibiotic Innovation For Medicare Beneficiaries | Health Affairs

⁵https://www.cdc.gov/mrsa/healthcare/index.html#:~:text=Studies%20show%20that%20about%20one,not%20develo p%20serious%20MRSA%20infections. ⁶ 2021 antibacterial agents in clinical and preclinical development: an overview and analysis (who.int) ⁷ Adrian Towse and Rachel Silverman Bonnifield. 2022. “An Ambitious USG Advanced Commitment for Subscription-Based Purchasing of Novel Antimicrobials and Its Expected Return on Investment.” CGD Policy Paper 277. Washington, DC: Center for Global Development.

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