Source: United States Senator for Indiana Todd Young
WASHINGTON – Today, U.S. Senators Todd Young (R-Ind.) and Michael Bennet (D-Colo.), along with U.S. Representatives Scott Peters (D-CA-50), Drew Ferguson (R-GA-3), Mike Levin (D-CA-49), and Jake LaTurner (R-KS-2), reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act to encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability of antibiotics when needed.
“Americans understand that we must take every reasonable and responsible measure to prevent future public health crises,” said Senator Young. “Antimicrobial resistance has become a growing crisis in recent years. Market failures have resulted in a lack of needed research and development in this field which is a threat to public health. Our bill would incentivize the development of new innovative antibiotics and focus on educating health care providers on how to avoid overuse or misuse of these life-saving medications in order to slow the emergence of antibiotic-resistant pathogens.”
“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 Senator Bennet. “The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.”
“Antimicrobial resistance poses a growing and significant threat to Americans’ health,” said Representative Peters. “The PASTEUR Act will help us develop better antibiotics to counter resistant infections and help doctors ensure these drugs are used responsibly to stop the emergence of new superbugs. In the wake of the COVID-19 pandemic, we must do everything in our power to prevent the next public health crisis.”
“Antibiotics make modern medicine possible and the U.S. is at risk of losing these critical drugs. Antibiotic resistant infections are becoming more commonplace, and Congress must take action so that the foundation of modern medicine doesn’t crumble,” said Representative Ferguson. “The PASTEUR Act brings together the public and private sectors to address these drug development market failures, increase public health preparedness, and help usher in a new era of antibiotic development. This essential legislation will also improve appropriate antibiotic use across the healthcare system while enhancing and safeguarding new antibiotic development. Simply put, we must act now to keep research and development from falling behind.”
“Each year in the United States, at least 2.8 million people become infected with pathogens that are resistant to treatment and for which advanced antimicrobials are needed. Unfortunately, as the COVID-19 pandemic made clear, our country needs stronger resources to develop those antimicrobials and prevent another global pandemic,” said Representative Levin. “Our PASTEUR ACT empowers the Department of Health and Human Services to seek expertise on the development of antimicrobials and devise a plan to make them widely available. I thank Sen. Bennet and Rep. Ferguson for leading this bicameral, bipartisan legislation and look forward to it moving through the legislative process.”
“The COVID-19 pandemic reminded us how crucial it is for our nation to continue investing in healthcare research to prevent future public health emergencies,” said Representative LaTurner. “America can’t afford to be asleep at the wheel when it comes to the threat of antimicrobial resistance. That’s why I’m proud to join my colleagues in introducing the bipartisan PASTEUR Act to bolster new antibiotic development and help medical professionals prevent the overuse of lifesaving drugs.”
The PASTEUR Act would:
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Establish a subscription model to encourage innovative antimicrobial drug development aimed at treating drug-resistant infections. This model will be fully delinked, meaning that participating developers would not receive income, as a part of their subscription payments, based on volume or quantity of sales.
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Subscription contracts would contain terms and conditions including product availability to individuals on a government health insurance plan, supporting appropriate use, and completion of postmarketing studies. These contracts could be valued between $750 million and $3 billion.
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Build on existing frameworks to improve usage of the CDC National Healthcare Safety Network, the Emerging Infections Program, and other programs to collect and report on antibiotic use and resistance data.
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Include transition measures such as smaller subscription contracts to support novel antimicrobial drug developers that need a financial lifeline.
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Form a Committee on Critical Need Antimicrobials, consisting of representatives from federal agencies, doctors, patients, and outside experts, to develop and implement necessary guidance regarding infections of concern, and the favored characteristics of potential treatments.
Senators Young and Bennet first introduced the PASTEUR Act in 2020.
Full legislative text can be found here. A summary of the bill can be found here.
Background:
According to the Centers for Disease Control and Prevention’s (CDC) Antibiotic Resistance Threats in the United States report, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and at least 35,000 people die as a result. In March 2015, the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria directed federal agencies to accelerate a coordinated, full government response to antibiotic resistance and take action to expand the ability of our health care system to prevent, identify, and respond to the infection pandemic threat posed by antimicrobial resistance. Part of this plan was to increase and incent development of innovative antimicrobial drugs to treat resistant infections. Because of severe market failures in the health care system, many of the innovative antibiotic companies doing this work have filed for bankruptcy and stopped producing their critical drugs completely.
The PASTEUR Act would address this market failure and increase public health preparedness by keeping novel antibiotics 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, this legislation would establish a subscription-style model which would offer antibiotic developers an upfront payment in exchange for access to their antibiotics, encouraging innovation and ensuring our health care system is prepared to treat resistant infections.