PASTEUR (v2.0) reintroduced in the US Congress!

Dear All,

I’m delighted to be able to say that PASTEUR 2026 was (re)introduced into the US Congress this week! It’s an improved version relative to the version introduced into the prior 3 sessions of the US Congress (see below for discussion of that), so I think we can safely call it “PASTEUR v2.0” as well as by its more official name of PASTEUR 2026. Here are the links you need:

• PASTEUR 2026 (v2.0)
  • On congress.gov, it is “H.R.7352 – To amend the Public Health Service Act to establish a program to develop innovative antimicrobial drugs targeting the most challenging pathogens and most threatening infections, and for other purposes.”
  • But, you can’t (yet) download from congress.gov … instead, use this text (.pdf) of the newly introduced version
  • A section-by-section analysis of the Act
• Press releases and commentary
  • One-pager about the newly introduced version of PASTEUR
  • Press release by the five house representatives who are sponsoring the bill
    • And excitingly, six additional representatives have joined the bill as of today (to follow this, look at the “Date Cosponsored” column on that webpage)
  • Press releases from IDSA and BIO
• Background and context on the ideas behind PASTEUR as well as its potential value
  • 16 June 2021 newsletter (“PASTEUR Act re-introduced and levels up antimicrobial economics for strong innovation!”). This newsletter gives a good tour of the ideas behind PASTEUR v1.0.
    • There is also an excellent op-ed by Sen. Todd Young on the ideas of PASTEUR
  • 29 Nov 2022 newsletter (“Impact of PASTEUR: 9.9m lives saved, ROI of 125:1”). This is a deep discussion of the value of PASTEUR to the US and the rest of the world. The data discussed are as close to a slam dunk economic analysis as you will ever see.
    • There is an 8 Dec 2022 follow-up on value for Canada, EU, Japan, and the UK.
  • Newsletters on 28 Feb 2024 and 19 Mar 2024: This pair of newsletters discusses the way(s) that economists think about the problem of AMR. There are great discussions here of the key concepts of market failure and the “Tragedy of the (Antibiotic) Commons.”

So what’s in the new Act? Importantly, the key elements are unchanged: PASTEUR creates a volume-delinked payment model (a Pull incentive) under which:

• The federal government would sign a subscription-style contract with pharmaceutical companies that develop critically needed new antibiotics and antifungals AND
• The companies would receive fixed annual payments from the government, ranging from $75 million to $300 million per year, based on measures such as innovation, contribution to patient care, and public health benefits.

What’s changed relative to prior version? In addition to some process simplification, the big change is clarity on how antibiotics would be scored for purposes of the contract mechanism. Rather than the relatively vague language in PASTEUR 1.0, the new Act specifies the creation of a consistent, transparent, scoring methodology based on a set of defined elements. Not surprisingly, these look a lot like the criteria in the UK’s Pull incentive in which value comes from measures of innovation (novelty, etc.), patient benefit (better outcomes, less toxicity, etc.), and public health benefit. See below my signature for the full text of the proposed scoring methodology.

Overall, it’s felt that these changes have retained the best parts of PASTEUR v1.0 while creating a v2.0 that will be more likely to move forward through Congress. 

Woot, woot! Oh, so very exciting! Many thanks here to the bipartisan team of Reps. Earl L. “Buddy” Carter (R-GA), Scott Peters (D-CA), Nick Langworthy (R-NY), Mike Levin (D-CA), and Mike Carey (R-OH) who introduced this bill! 

And, also, we all owe a great debt of thanks to the AMR stakeholders who have been working to update PASTEUR based on feedback received from policymakers. This is largely the same group who sponsored a day of advocacy for an earlier effort to advance PASTEUR (15 Sep 2023 newsletter: “How the sausage is made: A day of advocacy for PASTEUR”) … and to them I can only say “Well done! THANK YOU!”

Such great news! I’m sure there will be ways for all us to pitch in to support the Act at at various points along the way. Stay tuned!

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Text from PASTEUR 2026 on the numerical scoring methodology:
“METHODOLOGY: An eligible antimicrobial shall receive a score, calculated by points awarded based on criteria developed in consultation with the Advisory Group established under section 399PP-1 within the following three categories, with a weighting assigned to each criterion established under such categories and a greater number of points resulting in a higher score:

1. CATEGORY I.- The eligible antimicrobial’s major contributions to patient care, including-
   1. improving clinical outcomes for patients with multi-drug-resistant infections;
   2. improved dose frequency;
   3. reduced toxicity;
   4. reductions in adverse events; and
   5. benefits from the eligible antimicrobial’s route of administration, especially through oral administration or more than one administration method.
2. CATEGORY II.- The innovative characteristics of the eligible antimicrobial, including-
   1. being a first-approved antimicrobial drug that has the potential to address, or has the evidence of addressing, unmet medical needs for the treatment of a serious or life-threatening infection, or, to a lesser extent, second and third drugs that treat such infection;
   2. containing no active moiety (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in any other application under section 505(b) of the Federal Food, Drug) and Cosmetic Act and containing no active ingredient licensed in any other biological product license application under section 35l(a) ofthis Act;
   3. being a member of a new class of drugs with a novel target or novel mode of action that are distinctly different from the target or mode of any antimicrobial drug approved under such section 505(b) or licensed under such section 351(a); and
   4. addressing a multi-drug resistant infection through a novel chemical scaffold or mode of action.
3. CATEGORY III.- The benefit of the eligible antimicrobial to health systems and public health, including-
   1. not being affected by cross-resistance to one or more antimicrobials approved under such section 505(b) or licensed under such section 351(a);
   2. manufacturing capabilities within the United States;
   3. improved product stability and storage;
   4. increased activity against resistance mechanisms; and
   5. reduction of the economic or population burden of antimicrobial resistance in the United States.”