WASHINGTON – Today, U.S. Senators John Hickenlooper, Michael Bennet, Todd Young, Kirsten Gillibrand, and Mike Rounds reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act to encourage innovative antimicrobial development. The bill focuses on drugs targeting the most threatening infections, improves the appropriate use of antibiotics and antifungals, and ensures domestic availability of critical antibiotics.
“Superbugs are outsmarting our current defenses,” said Hickenlooper. “We need to make new antibiotics and antifungals now, before a drug-resistant outbreak turns into a public health emergency.”
Antimicrobials, including antibiotics and antifungals, are medicines used to treat and prevent infections in humans, animals, and plants. Antimicrobial resistance (AMR) occurs when bacteria and fungi mutate and no longer respond to these medicines. As a result, treating infections becomes much harder, increasing the risk of disease spread, severe illness, and death.
In the United States, more than 2.8 million antibiotic-resistant infections occur each year, resulting in over 35,000 deaths. A 2022 CDC special report found that the United States reversed its progress on AMR during the COVID-19 pandemic. In 2020, antimicrobial-resistant infections and deaths increased in hospitals by at least 15 percent. The estimated national cost is more than $4.6 billion annually, and recent analyses estimate that the broader impact of superbugs on the U.S. economy could reach tens of billions of dollars each year.
The AMR crisis has been further exacerbated by a lack of new drug development due to reduced economic incentives and challenging regulatory requirements, creating a severe market failure. In recent years, many of the innovative antibiotic companies working to develop new antimicrobials have filed for bankruptcy and stopped producing these innovative antibiotics completely.
The PASTEUR Act seeks to address this market failure and improve public health by keeping new antimicrobials on the market and improving appropriate use across the health care system. While current contracts between the government and drug makers base payment on volume, the PASTEUR Act would establish a subscription-style model which would offer antibiotic developers predictable payments in exchange for access to their antibiotics. The new payment model encourages innovation and ensures our health care system is prepared to treat resistant infections.
“Right now, we don’t have the tools to address the threat posed by antimicrobial resistance and infectious disease experts are warning us that it will only get worse,” said Bennet. “The bipartisan PASTEUR Act is one of the strongest bills ever written to strengthen antibiotic development and use. It will help fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as the next public health crisis arrives. We have to act now.”
“Superbugs have become a growing public health crisis in recent years,” said Young. “As antimicrobial resistance has spread, market failures have resulted in a lack of needed research and development. Our bill would incentivize the advancement of new innovative antibiotics and focus on educating health care providers on how to avoid overprescribing of these life-saving medications in order to slow the emergence of antibiotic-resistant pathogens.”
“Antimicrobial resistance increasingly threatens the health of Americans at home and abroad,” said Gillibrand. “By combining public and private investment to strengthen the pipeline of innovative, effective antibiotics, the PASTEUR Act will help ensure that patients receive the most impactful treatment available. I am proud to introduce this essential and comprehensive legislation to help prevent future public health crises and ensure every American has access to safe, lifesaving medications.”
“America is at risk of a public health crisis in the coming years due to the continued development of new strains of bacteria and viruses that are resistant to common antimicrobial drugs,” said Rounds. “Our legislation would incentivize development of new antibiotics and prevent the overuse and misuse of many antimicrobial medicines on the market today.”
Specifically, the PASTEUR Act would:
- Establish a Federal Subscription Model that provides annual payments to developers of eligible antibiotics and antifungals. Contract values range from $75 million to $300 million per year, with terms up to 10 years or until a generic or biosimilar enters the market. The annual predictable, set level of payment for a given product would be reduced by net revenues the manufacturer makes from its product each year, ensuring no more federal support is provided than necessary to provide a predictable return on investment.
- Use a Transparent Scoring System to determine eligibility and contract value, rewarding products that address urgent threats and unmet medical needs and that demonstrate major clinical and public health benefits.
- Establish a Critical Need Antimicrobial Advisory Group, consisting of infectious disease physicians, antimicrobial resistance and R&D experts, and patient advocates to guide the design of the program.
- Set Terms & Conditions of the subscription contracts that would require developers to ensure commercial availability, reliable supply, public reporting of resistance data, implementation of stewardship and education plans, adherence to manufacturing and environmental best practices, and completion of post-market studies.
- Support Antimicrobial Stewardship and Surveillance by funding pilot programs for expanding stewardship efforts, including in outpatient settings (e.g. urgent care, retail clinics) and build on existing frameworks to enhance data collection on antibiotic use, resistance, and diagnostics through the CDC’s National Healthcare Safety Network and other surveillance systems.
The text of the bill is available HERE. A summary of the bill is available HERE.
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