Weekly Policy Update: World Antimicrobial Awareness Week + Cures 2.0 & PASTEUR Act
By: Colorado BioScience Association Date: 11/24/2021
World Antimicrobial Awareness Week, hosted by the World Health Organization last week, focused on increasing awareness of global antimicrobial resistance (AMR). and encouraging best practices among the general public, health workers, and policymakers to avoid the further emergence and spread of drug-resistant infections. Over 700,000 people worldwide die every year from AMR infections. Without new antibiotics and antimicrobials, AMR infections could impact ten million people by 2050.
AMR infections occur when bacteria, viruses, fungi, and parasites no longer respond to medicines, making common infections harder to treat and increasing the risk of disease spread, severe illness, and death. Many factors have accelerated the threat of AMR worldwide, including the overuse and misuse of medicines in humans, livestock, and agriculture, as well as poor access to clean water, sanitation, and hygiene.
Colorado’s Congressional Delegation and in particular Congresswoman Diana DeGette and Senator Michael Bennet have taken the lead in addressing the emerging threat AMR infections pose to our communities. In addition to understanding the necessity of ensuring the nation is better prepared to deal with future public health emergencies.
21st Century Cures 2.0 Act
Notably, last week also saw the introduction of the 21st Century Cures 2.0 Act, sponsored by Reps. Diana DeGette and Fred Upton (MI-06). The Act includes provisions related to pandemic preparedness. It also includes measures to modernize and increase diversity in clinical trials by using patient experience data and real-world evidence. The legislation authorizes $6.5B to create the Advanced Research Projects Agency for Health (ARPA-H) which would be housed within the National Institutes of Health (NIH).
CBSA hosted a virtual roundtable discussion with Congresswoman DeGette last year where the Act was the focal point of the conversation. The roundtable was a great opportunity for CBSA and our members to showcase the critical health innovations being developed and delivered by our ecosystem and to provide meaningful feedback on policy ideas that aim to modernize the delivery of new treatments for patients globally.
Senator Michael Bennet’s Pioneering Antimicrobial Subscriptions to End Up Surging Resistance (PASTEUR) Act seeks to stabilize the AMR market. The legislation is now included in the 21st Century Cures 2.0 Act. The market for AMR products faces unique challenges. This is because generally, the profit from a new drug is related to the number of patients who take it, but for antimicrobial products, increased use of a drug will ultimately lead to resistance. New drugs are actually intended to have limited use, which undermines the normal incentives for manufacturers to invest in the development of new products.
The PASTEUR Act would create new incentives through a subscription reimbursement model, in which the federal government would enter into a subscription contract with a drug developer if they receive a ‘critical need antimicrobial’ designation. CBSA is encouraged that the Act could be an effective strategy to promote the development of new antimicrobial medications to fight drug-resistant infections. The Association provided the Senator’s Office with a comment letter last year outlining support for the Act along with giving feedback on areas of improvement to enhance the critical legislation. And the Act has been a topic of conversation in follow-up conversations with the Office over the past year.
Along with the PASTEUR Act, the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM), originally sponsored by Senators Bob Casey (D-PA) and Johnny Isakson (R-GA) in 2019, would alter the hospital payment system to incentivize the use of newer antimicrobial drugs when appropriate.
CBSA appreciates Congresswoman DeGette and Senator Bennet’s leadership on these critical pieces of legislation that will modernize the development and delivery of life-changing innovations. Along with strengthening the development pipeline for antimicrobial products and accelerating the breakthrough work of Colorado companies focused on drug-resistant infections.