US Senate and House / Call for Pull incentives in FY23 budget

Dear All,

The US Government is now building its budget for FY23 (Federal Year 2023, really runs 1 Oct 22 to 30 Sep 23). We had proposals from the House for the Department of Health and Human Services (DHHS) budget in late June;  and the proposal from Senate was released on 28 Jul 2022. Each budget is presented as both a proposed bill and a report; I am going to quote from the reports. Extended excerpts from the Senate report and a brief excerpt from the House report are found below my signature but here are the key excerpts related to pull incentives:

FY23 Senate report, pg. 214Antibiotic Resistant Infections. “The Committee supports the Administration’s proposal to combat antibiotic-resistant infections by encouraging the development of innovative antimicrobial drugs, which is in alignment with the United States’ obligations made at the December 2021 G7 Summit. The Committee believes that it is essential to delink revenue of antimicrobials from volume of sales and provide a robust contracting mechanism to incentivize the commercial availability of new and novel antimicrobials in order to protect Americans against highly dangerous drug-resistant microbes. …”

FY23 House report, page 239Antimicrobial Resistance. “… The Committee requests within 180 days of the date of enactment of this Act a professional judgement budget estimate to support a comprehensive, long-term program for the development and procurement of novel antibiotics.”

Although the House text is brief and neither report specifically mentions the PASTEUR Act, my reading is that this is a clear call for Pull incentives via PASTEUR. It’s really hard to see how else you could read the Senate text as “delink revenue of antimicrobials from volume of sales” and “robust contracting mechanism to incentivize the commercial availability” are the backbone of PASTEUR.

It is also interesting to see the shout-out to the G7’s calls for action with “in alignment with the United States’ obligations made at the December 2021 G7 Summit.” On this, I refer you to the 28 June 2022 newsletter about AMR-related language from the 2022 G7 process. The fact that AMR has risen to the level of being a discussion item at the G7 Head of State level is extraordinary! As an expansion on why this is so important, see this 5-minute video explainer:

Fabulous stuff, and fingers crossed that we’ll see PASTEUR folded into an appropriate piece of legislation in the near future!


And as a real-life example of how any of us could suddenly find we need a good antibiotic (and hence good motivation for getting to done with PASTEUR!), I’m going to drop in a video from our ongoing series of Movies to Discovery Antibiotics By. In this edition, we consider a real-life twist involving the filming of Cast Away, starring Tom Hanks. Check it out!

Cheers! 

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.

Extended text excerpts
FY23 Senate report, pg. 214Antibiotic Resistant Infections.The Committee supports the Administration’s proposal to combat antibiotic-resistant infections by encouraging the development of innovative antimicrobial drugs, which is in alignment with the United States’ obligations made at the December 2021 G7 Summit. The Committee believes that it is essential to delink revenue of antimicrobials from volume of sales and provide a robust contracting mechanism to incentivize the commercial availability of new and novel antimicrobials in order to protect Americans against highly dangerous drug-resistant microbes. The success of similar creative funding initiatives, such as Project BioShield, show the need for pursuing unique approaches to preparing for and countering serious threats to human health. The Committee requests the Department provide a briefing to the Committees on Appropriations within 60 days of enactment of this act that details the budgetary requirements for implementation of this proposal. In addition, the Committee directs OASH, NIH, ASPR/ BARDA, CDC, ASPE and AHRQ to jointly update the Committees on Appropriations no later than 60 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR-related efforts, as well as domestic and international AMR trends. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were achieved in the last fiscal year. Building on these results, agencies are directed to outline in briefings the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the current National Action Plan.
 
FY23 Senate report, pg. 224 (repeats language from page 214): Antimicrobial Resistance [AMR].—The Committee is encouraged by the Administration’s proposal to combat antibiotic-resistant infections by encouraging the development of innovative antimicrobial drugs, which is in alignment with the United States’ obligations made at the December 2021 G7 Summit. The Committee requests the Department provide a briefing to the Committees on Appropriations within 60 days of enactment of this act that details the budgetary requirements for implementation of this proposal. The Committee directs the Office of the Assistant Secretary for Health, NIH, ASPR/BARDA, CDC and AHRQ to jointly brief the Committees on Appropriations no later than 30 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR related efforts. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were sustained in the last fiscal year. Building on these results, agencies are directed to outline the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the applicable National Action Plan.
 
Other related AMR language in the Senate draft
Research on Antimicrobial Resistance [AMR] (page 119).—The Committee supports NIAID’s efforts to continue responding to the COVID–19 pandemic and prepare for future outbreaks while carrying out its broader role in infectious diseases research, including research on AMR. To that end, the Committee provides no less than $565,000,000, an increase of $25,000,000, to fund NIAID research to combat antimicrobial resistance. The Committee directs the Office of the Assistant Secretary for Health, NIH, ASPR/BARDA, CDC and AHRQ to jointly brief the Committees on Appropriations no later than 30 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR-related efforts. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were sustained in the last fiscal year. Building on these results, agencies are directed to outline the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the current National Action Plan.
 
Antimicrobial Resistance (page 178).—The Committee directs the Office of the Assistant Secretary for Health, NIH, ASPR/BARDA, CDC, and AHRQ to jointly brief the Committees on Appropriations no later than 30 days after the enactment of this act and each succeeding annual Appropriations bill detailing how HHS and its agencies are coordinating their AMR-related efforts. The briefing should include a comparison of actual performance for the most recent years available against the National targets established in the current National Action Plan for Combatting Antibiotic-Resistant Bacteria and whether those goals were sustained in the last fiscal year. Building on these results, agencies are directed to outline the focus of their plans for the next two fiscal years and how these are connected to longer-term objectives included in the applicable National Action Plan.

FY23 House Language, page 239
Antimicrobial Resistance.—The Committee provides an increase for efforts to combat antimicrobial resistance, recognizing the importance and challenges of this threat. BARDA’s Advanced Research and Development program support will be critical to support new products. The Committee requests within 180 days of the date of enactment of this Act a professional judgement budget estimate to support a comprehensive, long-term program for the development and procurement of novel antibiotics.

Current funding opportunities (most current list is here)


Upcoming meetings of interest to the AMR community (most current list is here):

  • 10 Aug 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled “Animal models to study the activity of antibiotics.” Go here for details. 
  • 10 Aug 2022 (virtual, 10a-4.30p ET): USDA ‘s APHIS (Animal and Plant Health Inspection Service) will host a public meeting on Antimicrobial Resistance. Co-hosted with USDA’s FSIS (Food Safety Inspection Service) and REE (Research, Education and Economics) mission area, the webinar will review lessons learned since the first AMR workshop 2012 as well as discuss plans for the future. Go here to register.
  • 23 August 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled “The Challenges and options in developing antibiotic combinations.” Go here for details. 
  • 30 August 2022 (virtual, 8.30a-5.00p ET): Webinar sponsored by CDC and FDA entitled “Drug Development Considerations for the Prevention of Healthcare-Associated Infections.” This is very timely as developing products for prevention is surprisingly hard. As just one example, see this 20 Dec 2018 newsletter about a valiant  (but failed, sadly) effort to develop a S. aureus vaccine. Go here for additional details and to register. 
  • 12-13 Sep 2022 (virtual, 9a-5p ET): This meeting of PACCARB is going to “identify key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.” Sounds like pandemic wargaming (Center for Health Security; pre-COVID 19 May 2020 NPR article) to me! Go here for details.
  • 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
  • 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
    • IDWeek has opened pipeline sessions for antibacterials, antifungals, and non-HIV, non-COVID antivirals as well as for diagnostics (no limitations). Go here to submit your abstract; this 14 July 2022 newsletter contains some additional details.
  • 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for details.
  • 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
  • 23 Oct 2022 (Cape Town, South Africa): Symposium entitled “Tackling AMR: How implementation research is vital in a One Health approach” that is sponsored by the AMR knowledge hub of TGHN (The Global Health Network). Go here for details.
  • 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
  • 17-20 Nov 2022 (Kuala Lumpur, Malaysia): The International Congress on Infectious Diseases will take place for the first time as a hybrid event. Go here for details. 
  • 27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.
  • 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.

Share

Impact of PASTEUR: 9.9m lives saved, ROI of 125:1

Impact of PASTEUR: 9.9m lives saved, ROI of 125:1 Dear All (and with thanks to Kevin Outterson for being lead author on this newsletter), (wonkish alert on this one … refresh your coffee and dig in!) The Center for Global Development have released a blog post and a paper estimating the potential impact of the PASTEUR Act.

Five FDA RFPs! Antifungal animal models, MIC breakpoints, and more!

Dear All, I just today learned that FDA have posted their FY 2023 funding opportunities. All the details are on this webpage and I’m just going to reproduce the text below my signature for your reference. I’ll also add a few details in italics. Lots of good opportunities here! –jr John H. Rex, MD |

WAAW! Must-Read Article, A Quiz, A Video, A Call to Action

Notes: Newsflash … BARDA have opened their long-running BAA-18-100-SOL-00003 to include support for antifungal agents. Search for “antifungal” in the posted .pdf to find the text. The first deadline for proposals is 15 Dec 2022 and further deadlines will doubtless follow: as shown on page 9, this BAA has offered 4 deadlines/year since 2018!  Dear All, In

Fireside Chat with AMR Action Fund CIO Martin Heidecker

Dear All, Ahead of World Antimicrobial Awareness Week, I sat down with AMR Action Fund Chief Investment Officer Martin Heidecker for a Fireside Chat. It was a fabulous conversation that covered everything from how the Fund’s investment process works to what it’s looking for in portfolio companies to broader investment trends in the AMR space.  As

Scroll to Top