Bipartisan Bill Would Encourage Development of Innovative Antibiotics to Treat Resistant Infections and Improve Appropriate Antibiotic Use
Washington, D.C. – Today, U.S. Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) introduced 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 when needed.
“We are living through the worst pandemic in a century, and infectious disease experts are sounding the alarm that drug-resistant bacteria will lead to another public health crisis,” said Bennet. “The PASTEUR Act would provide antibiotic researchers and developers with the resources and certainty they need to prepare for the threat that resistant infections pose. Our bipartisan legislation will better arm hospitals and providers in the fight against antimicrobial resistance by incenting development, targeting the most threatening infections, and encouraging the appropriate use of antibiotics.”
“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 am proud to be working with Senator Bennet to introduce the 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,” said Young.
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.
“We need a sustainable, smart solution to the crisis of antibiotic resistance — and the PASTEUR Act really delivers, using subscriptions to keep costs reasonable for the US taxpayer, combined with the world’s most thoughtful delinked stewardship to protect future generations,” said Kevin Outterson, Executive Director of Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and Professor of Law at Boston University.
“Our ability to fight infections underpins modern medicine, but, in the battle between innovation and resistance, resistance is currently winning. COVID-19 has underscored the importance of preparedness and the threat of AMR looms large – the PASTEUR Act is an important step forward in that fight against antimicrobial resistance and infectious disease,” said Ken Thorpe, Chairman, Partnership to Fight Chronic Disease; Advisory Board, Partnership to Fight Infectious Disease.
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 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 bill text is available HERE. A one-pager is available HERE.