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Saturday, November 23, 2024

What They Are Saying: Support for the PASTEUR Act

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Senator Todd Young | Wikipedia

Senator Todd Young | Wikipedia

WASHINGTON, D.C. – Patients, medical providers, and health care associations in Indiana and across the country are voicing support for the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act.

The bipartisan legislation, recently reintroduced by Senators Todd Young (R-Ind.) and Michael Bennet (D-Colo.), would encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability of antibiotics when needed.

Here’s what patients, medical providers, and health care associations are saying about the PASTEUR Act:
 “As someone living with cystic fibrosis, I applaud congress for reintroducing the PASTEUR ACT. Only a few antibiotics are left to treat my multi-drug resistant pseudomonas, one of those few being one that caused life threatening hemolytic anemia. We need more options to treat these infections and combat antimicrobial infections,” Dustin Brown, patient from Santa Claus, Indiana.

“The PASTEUR Act is crucial for patients in Indiana and throughout the country who need more antibiotic options to treat serious and life-threatening drug-resistant infections—something I see all too often as an infectious diseases physician. PASTEUR will also provide much needed resources for our health care facilities, especially in more rural areas, to build antimicrobial stewardship programs and educate prescribers about how to use antibiotics appropriately. We need to ensure every patient gets the right drug for the right bug and to protect the efficacy of our antibiotics,” said Haley Pritchard, MD, MS, Medical Director for Antimicrobial Stewardship, IU Health University and Methodist Hospitals Antimicrobial Resistance Committee, Infectious Diseases Society of America.

“It’s not often that we see bipartisan leaders working together on major health care legislation, but the urgent need to address the threat of antibiotic resistance has rightly drawn that focus. Senator Young’s recently reintroduced PASTEUR Act is an important bill that addresses market challenges and helps to pave the way for the development of new, urgently needed antimicrobials. These medicines are essential to modern medicine – for patients in need of joint or organ replacement, those battling cancer, those with chronic conditions – all of us. We appreciate Senator Young’s continued leadership on this bill and hope Congress will pass it this year,” said Kristin Jones, president and CEO of the Indiana Health Industry Forum. 

Millions will continue to die from resistant bacteria because we are out of treatment options. Antibiotics aren't working any more for most people who contract a superbug. The science is extraordinary, it's the business model that's broken. We desperately need a new way to pay for these drugs - antibiotics, antifungals, and phage therapy. The Pasteur Act is that rare, bipartisan idea that solves an incredible problem for an affordable price,” said Professor Kevin Outterson, Boston University.

“Antibiotics play a vital role in modern medicine, and we know that preserving access to these drugs is essential to any pandemic or public health emergency response. Yet the medicines that the U.S. relies on to treat serious infections have remained largely the same for nearly 40 years and are increasingly ineffective against quickly evolving bacteria. In 2023, the U.S. has already experienced several alarming antibiotic-resistant threats—and the emergence of new superbugs will continue and will only get worse. The bipartisan PASTEUR Act has the support of a diverse group of more than 230 public health and health care organizations, because it will help us fix the broken antibiotic drug pipeline and deliver important new therapies to physicians and the patients who need them. Reintroduction of the bill is an encouraging sign that policymakers remain committed to ensuring that lifesaving antibiotics are available when Americans need them most,” said David Hyun, director of The Pew Charitable Trusts’ Antibiotic Resistance Project.  

"The need for legislative solutions to address the public health challenges posed by antimicrobial resistance (AMR) has been mounting for quite some time now, and we applaud the sponsors of the PASTEUR Act for their leadership. This bill will make new novel antibiotics a reality for patients and providers and fortify our healthcare system for future generations. AMR impacts us all and protection against the increasing threats of infection is not a partisan issue. We encourage broad support and quick passage of the PASTEUR Act,” said Candace DeMatteis, Vice President of Policy, Partnership to Fight Infectious Disease.

"For decades, we have seen antimicrobial resistance (AMR) soar around the world, while the pipeline for new treatments slows to a trickle due to the broken ecosystem for antimicrobial innovation. The PASTEUR Act is an integral solution to addressing the global public health crisis of AMR. The bipartisan bill will help repair the foundational challenges of the antimicrobial marketplace and drive the development of new, innovative treatments for patients,” said Rachel King, Interim President and CEO of the Biotechnology Innovation Organization.  

“Infectious diseases physicians see firsthand the devastating impact of antimicrobial-resistant infections on our patients. We urgently need novel antimicrobials and investments in antimicrobial stewardship to preserve the efficacy of these precious drugs and optimize patient outcomes. The PASTEUR Act will deliver the tools we need to protect modern medicine and strengthen our preparedness for future emergencies,” said Carlos del Rio, MD, FIDSA, President, Infectious Diseases Society of America; and Interim Dean, Emory University School of Medicine.

“For people living with cystic fibrosis, difficult-to-treat infections are an unfortunate but common occurrence, and the fear of not having enough treatment options is an all too familiar concern. There is an urgent need to pass the PASTEUR Act to help ensure availability of novel antibiotics, not only for the CF community today, but for patients everywhere who could face a public health crisis tomorrow if Congress refuses to take action now,” said Mary Dwight, Senior Vice President and Chief Policy and Advocacy Officer, Cystic Fibrosis Foundation.

“Patients with drug resistant diseases are defenseless without new treatments, many of us are fighting rare diseases and we desperately need the treatments supported by the PASTEUR Act. PASTEUR is a bill for patients, and without it, too many of us will not survive our fight and those that do are facing a reduced quality of life. The new treatments created through the PASTEUR Act could one day cure me and others fighting disease with limited or no treatment options. Until then, I wake up every day hoping the medications available do not fail me again,” said Rob Purdie, Cofounder, MyCARE (MyCology Advocacy, Research & Education). 

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:

  • 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. 
  • 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.
  • 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.
  • Include transition measures such as smaller subscription contracts to support novel antimicrobial drug developers that need a financial lifeline.
  • 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.

Original source can be found here.

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