U.S. Representatives Drew Ferguson (R-Ga.) and Mike Doyle (D-Pa.), and U.S. Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.), today reintroduced the Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act to encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability when needed.
“Antimicrobial resistance is a looming public health and national security crisis that may one day be our next pandemic if left unaddressed,” Ferguson said. “Applying the lessons learned from COVID by investing in pandemic preparedness now will save lives later, which is why I am so proud to be a part of this bipartisan, bicameral effort. We must bring together the unique capabilities and resources of the public and private sectors to solve the market failures impeding the development of new lines of antibiotics. The PASTEUR Act accomplishes this, and I look forward to working with my partners on this legislation towards its enactment.”
“Tens of thousands of Americans die each year from antimicrobial-resistant infections,” Doyle said. “Infectious disease experts agree that antimicrobial resistance is an urgent public health threat that requires a comprehensive, effective solution now. The PASTEUR Act will help scientists and researchers bring better antimicrobials to market, and it will help hospitals and doctors ensure these drugs are used properly.”
“After witnessing the COVID-19 pandemic, it has never been more clear that we need to invest in research to prepare for the next public health crisis,” Bennet said. “Infectious disease experts are already sounding alarms, and they need resources to prepare for the threat that antimicrobial resistance infections pose. With our bipartisan PASTEUR Act, we have the chance to not only learn from the mistakes we have made up to this point, but to invest in tools to better prepare for the future.”
“Americans understand – now more than ever – that we must take every reasonable and responsible measure to prevent future public health crises,” said 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. That’s why I’m proud to reintroduce our Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act to incentivize development of new antibiotics. At the same time, the PASTEUR Act will 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.”
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 country 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 valuated 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.
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, the PASTEUR Act 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.
Ferguson and Doyle first introduced the PASTEUR Act in the U.S. House in December 2020. A section-by-section summary of the bill is available HERE. A one-page summary of the bill is available HERE.
WHAT THEY ARE SAYING (WTAS):
“The PASTEUR Act would help revitalize the pipeline of urgently needed new antibiotics and support their appropriate use, making significant and necessary strides in the fight against antimicrobial resistance,” Nadine Rouphael, MD, Professor of Medicine, Emory University School of Medicine said.
“The global pandemic is a stark reminder that the nation must prepare for threats to public health—and we must act now on the growing threat of antibiotic resistance. Too many drug companies have already left the field, and the pipeline of new drugs is running dry. This bipartisan bill puts forth an innovative strategy to spur development, and make sure these lifesaving drugs will be available when we need them,” David Hyun, Director, The Pew Charitable Trusts’ Antibiotic Resistance Project said.
“Antimicrobial resistance (AMR) threatens to unravel the gains of modern medicine, as lifesaving procedures including cancer chemotherapy, transplantation and other surgeries all rely upon the availability of safe and effective antibiotics. AMR also weakens our preparedness and response to public health emergencies, as we have seen during the current pandemic with outbreaks of antibiotic resistant secondary infections in COVID-19 treatment units. The PASTEUR Act takes critical steps to address the threat AMR poses,” Barbara Alexander, MD; President, Infectious Diseases Society of America; Professor of Medicine, Professor of Pathology, Duke University School of Medicine said.
“Antibiotics are the quiet infrastructure undergirding modern medicine. For cancer patients, the second-leading cause of death is infection. The PASTEUR Act ensures that patients who win the fight against cancer don’t succumb to infections. It uses subscriptions to pay for antibiotics over a decade, based on value, not volume. It is the best solution for the AMR innovation gap, the final missing piece in the US National Action Plan on Combating Antibiotic-Resistant Bacteria, and demonstrates US leadership to keep us safe from the next pandemic,” Kevin Outterson, Executive Director, CARB-X, Professor of Law & N. Neal Pike Scholar in Health and Disability Law - Boston University said.
“The Antimicrobial Innovation Alliance has been working with Congress since 2012 on developing incentives in response to global AMR crisis, the silent pandemic. The PASTEUR Act represents the most thoughtful, balanced and meaningful mechanism to ‘pull’ through life-saving medicines for patients in need and we are eager to work for its implementation,” Barrett Thornhill, Executive Director of the Antimicrobial Innovation Alliance said.
Original source can be found here.
