Congressman Doyle Spearheads PASTEUR Act to Fight Antimicrobial Resistance
Washington, D.C. – U.S. Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.) and Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) 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.
“Tens of thousands of Americans die each year from antimicrobial-resistant infections,” said Doyle. “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.”
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, 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.
Statements of Support
“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,” said David Hyun, Director, The Pew Charitable Trusts’ Antibiotic Resistance Project.
“The PASTEUR Act would provide physicians with urgently needed new antibiotics to treat multidrug resistant infections, while providing resources to support antibiotic stewardship to ensure these life-saving drugs are used appropriately.” said Cornelius J. Clancy, MD; Chief, Infectious Diseases, VA Pittsburgh Health Care System; Associate Professor of Medicine, University of Pittsburgh School of Medicine.
“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,” said Barbara Alexander, MD; President, Infectious Diseases Society of America; Professor of Medicine, Professor of Pathology, Duke University School of Medicine.
“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,” said Kevin Outterson, Executive Director, CARB-X, Professor of Law & N. Neal Pike Scholar in Health and Disability Law - Boston University.
“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,” said Barrett Thornhill, Executive Director of the Antimicrobial Innovation Alliance.
“COVID-19 is showing that innovation and collaboration are necessary to strengthen global health security and prevent future crises, but COVID-19 will not be the last pandemic that the world faces. Now more than ever, the PASTEUR Act represents a global gamechanger in preparing for the silent pandemic of AMR. AMR is a shared priority for global leaders, with the G7 this month committing to ensure much-needed sustainable innovation in antimicrobial R&D. The global community welcomes the PASTEUR Act, and I applaud the US' leadership in encouraging investment in developing sustainable, accessible and affordable treatments for patients. The bold action of the PASTEUR Act today would enable humanity to contain the global challenges of tomorrow, protecting global citizens against drug resistance and preserving modern medicine for all,” said Professor Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance.
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.