Weekly Policy Blog: CBSA Urges Congress to Pass the PASTEUR Act
By: Colorado BioScience Association Date: 09/25/2023
Earlier this month, CBSA participated in PASTEUR Advocacy Day, joining Biotechnology Innovation Organization (BIO) and other organizations, including Infectious Diseases Society of America, Cystic Fibrosis Foundation, Partnership to Fight Infectious Disease, and The Pew Charitable Trusts, in raising awareness about the public health crisis of antimicrobial resistance (AMR). We encouraged policymakers to take action on the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act.
The PASTEUR Act establishes a delinked subscription program to encourage innovative antimicrobial drug development targeting the most threatening infections, to improve the appropriate use of antibiotics, and to ensure domestic availability when needed.
As superbugs grow stronger and the effectiveness of current antibiotics fades, many common medical procedures could become far more dangerous. CBSA urges Congress to protect modern medicine by taking action to pass the PASTEUR Act.
We thank U.S. Senator Michael Bennet (D-CO) for his role in reintroducing this critical legislation.
Antimicrobial resistant (AMR) infections contributed to the deaths of nearly five million people in 2019, and killed at least 1.27 million. By 2050, that number is expected to rise to more than ten million deaths each year, outpacing annual deaths from cancer. In 2023 alone, at least four superbug outbreaks have gripped the attention of health experts, the media, and the public.
Despite the vital need for antimicrobials as part of virtually any pandemic or public health emergency response, the medicines the U.S. relies upon to treat serious infections have remained largely the same for nearly 40 years and are increasingly ineffective against quickly evolving bacteria and fungi.
As explained in the PASTEUR Act Sponsors’ Summary, the AMR crisis has been further exacerbated by a lack of new drug development by the pharmaceutical industry due to reduced economic incentives and challenging regulatory requirements, creating a severe market failure. In recent years, many of the innovative antibiotic companies working to develop new antimicrobials have filed for bankruptcy and stopped producing these innovative antibiotics completely.
The PASTEUR Act
The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act seeks to 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 reimbursement between the government and drug makers base payment on volume, the PASTEUR Act would be a $6 billion down payment to protect public health and address the growing threat of AMR. The 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 healthcare system is prepared to treat resistant infections.
The PASTEUR Act would:
- 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.
- Establish a Subscription Model to encourage innovative antimicrobial drug development aimed at treating drug-resistant infections. This model will be delinked from federal health programs, meaning that participating developers would not receive reimbursement from these health programs based on volume or quantity of sales, but receive a regular subscription payment for patients to access the drugs.
- Terms & Conditions of the subscription contracts would include product availability to individuals on a government health insurance plan, supporting appropriate use, and completion of post market studies. These contracts could be valued between $750 million and $3 billion.
- Build on Existing Frameworks to improve appropriate use through the CDC National Healthcare Safety Network and other programs to collect and report on antibiotic use, resistance, and patient outcomes data.
- Include Transition Measures such as smaller subscription contracts to support novel antimicrobial drug developers that need a financial lifeline.
On April 27, 2023, U.S. Senators Michael Bennet (D-CO) and Todd Young (R-Ind.), along with U.S. Representatives Drew Ferguson (R-GA-3), Scott Peters (D-CA-50), Jake LaTurner (R-KS2) and Mike Levin (D-CA-49) reintroduced the PASTEUR) Act. The sponsors first introduced the PASTEUR Act in 2020, and most recently in 2021 (HR 3932; S. 2076). The core of the bill remains the same, but several notable changes have been made in the PASTEUR Act of 2023 (HR 2940; S 1355).
CBSA applauds U.S. Senator Michael Bennet (D-CO) for serving as the sponsor of this key legislation in the Senate. CBSA also thanks U.S. Senator John Hickenlooper (D-CO) for co-sponsoring in the Senate and U.S. Representative Diana DeGette (D-CO-1) for co-sponsoring in the House. CBSA continues to advocate the importance of this legislation to the entire delegation and is encouraging additional co-sponsors to sign on. CBSA is encouraged that the Act could be an effective strategy to promote the development of new antimicrobial medications to fight drug-resistant infections.