Let’s make a pull incentive happen in the US during the 116th Congress!

Dear All:

I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage). 

Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress.

The essential document can be found here. This is a letter that has been sent with appropriate adjustments to all the relevant legislative committees: the Senate Committee on Health, Education, Labor & Pensions (HELP), the Senate Committee on Finance, the House Committee on Ways & Means, and the House Committee on Energy & Commerce.

After explaining the background and the need for a fundamental fix via a package of incentives, the letter reads as follows:

“Key principles of a pull incentive package:

  1. Incentives should be paid after FDA approval, rewarding only successful development of novel antibiotics that address the greatest public health need.
  2. A package of incentives should aim both to stabilize today’s novel antibiotic market and to ensure the viability of future development – meaning they must be substantial and viewed as highly valuable to private markets.
  3. Economic incentives should provide predictability for drug developers – assurance that the company can commit R&D funds today, knowing that the economic incentive will be available if the new drug meets eligibility criteria.
  4. Incentives must be aligned with appropriate antibiotic stewardship and surveillance.

“We commit to working with Congress and the Administration to further develop and advance a package of antibiotic incentives, at least some of which must be enacted in 2019 to meet growing patient needs and help mitigate a public health crisis. Such a package could, for example, include a mix of tax incentives, novel pull incentives, reimbursement changes, and even a low-interest loan program, along with continued investment in NIAID and BARDA.”

The letter is signed by a very broad coalition of stakeholders who are now working closely together:

  • Achaogen
  • Antimicrobial Innovation Alliance
  • Antimicrobials Working Group – (Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc., ContraFect Corporation, Entasis Therapeutics Inc., Iterum Therapeutics Ltd., Melinta Therapeutics Inc., Motif Bio plc, Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., Qpex Biopharma Inc., SCYNEXIS Inc., Summit Therapeutics plc and VenatoRx Pharmaceuticals Inc.)
  • Biotechnology Innovation Organization
  • GlaxoSmithKline
  • Infectious Diseases Society of America
  • Merck
  • Pfizer Inc.
  • Shionogi Inc.
  • Spero Therapeutics
  • Tetraphase Pharmaceuticals
  • The Pew Charitable Trusts
  • Trust for America’s Health

There is active progress even now on a bipartisan bill that would be introduced to the House and Senate simultaneously in which a fundamental DRG fix is proposed as an initial step. In parallel, we are going to seek to explain and develop support for a delinked reward model to follow the initial DRG-focused fix.

Cross your fingers!

Now is the time for all people of good will to support this effort, with time, energy and money. We can’t afford to wait until the 117th or 120th Congress!.

If we fail, it won’t be for lack of trying. And if your company wants to join in, please let me know and I’ll connect you appropriately. 

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

  • 7 Feb 2019 (London): Opportunity to comment in person on the IACG draft recommendations. See this tweet for more details.
  • 21 Feb 2019 (everywhere, 17:00-18:30 CET): GARDP-sponsored webinar entitled “NIAID Resources to Facilitate Discovery & Development of Anti-Infectives.” Register here.
  • 5-6 Mar 2019 (Washington): NIAID-sponsored workshop: Vaccine strategies for endemic fungal pathogens. Register here.
  • 14-15 Mar 2019 (Berlin): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-ENABLE-sponsored (among a long list!) Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here. Poster submissions are being accepted through 9 Jan (details here).
  • 18 Mar 2019 (everywhere): Deadline for responding to the WHO call for data on preclinical antibiotic programs. Details here.
  • 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.
  • 26 Mar 2019 (London, UK): Sponsored by The Economist, a 1-day symposium entitled “Antimicrobial Resistance: Preventing an antibiotic apocalypse.” Register here.
  • 28 Mar 2019 (everywhere, 4-5.30p GMT): GARDP-sponsored webinar entitled “Clinical development for non-developers Part 3: Antibacterial Drug Enhancer Combinations and Non-traditional Products.” Register here.
  • 11-12 Apr 2019 (Amsterdam): ESGAPSWAB (European Study Group for Antibiotic Policies – Stichting Werkgroep Antibioticabeleid) Technical Workshop on measuring quantity and quality of antimicrobial use. Register here
  • 13-16 Apr 2019 (Amsterdam): Annual ECCMID meeting
  • 16-18 Apr 2019 (Utrecht): ICOHAR, International Conference on One Health Antimicrobial Resistance. Organized by the ESCMID Study Group for Veterinary Microbiology (ESGVM).
  • 24-26 Apr 2019 (Boston): Annual SHEA (Soc. for Hospital Epidemiology of America) Spring meeting
  • 6-11 May 2019 (Ljubljana, Slovenia): 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Details here.
  • 3-6 Jun 2019 (Philadelphia): Annual BIO meeting
  • 10-11 June 2019 (Research Triangle Park, NC): AMR Action Summit on R&D and Commercialization. Sponsors include the British-American Business Council, the UK Gov’t, CARB-X, the NC Biotechnology Center, and others. Details here.
  • 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
  • [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with the main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
  • 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
  • 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
  • [Mark your calendar now!] 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Not yet online, but the date is firm. Will share a link when it becomes available.


The road to UNGA 2024 is paved with … reports!

Dear All, We’re now well into the run-up to the HLM (High-Level Meeting) on AMR during UNGA 2024 (the UN General Assembly, September 2024, see the 15 Apr 2023 newsletter for details). In preparation, reports providing data to support policy and decision-making are continuing to appear. Today, for example, GCOA and IDSA released their report entitled “2024

Leaving the lab: The decline in AMR R&D professionals

Dear All, The AMR Industry Alliance has today released a fascinating and disturbing report. Entitled “Leaving the Lab: Tracking the Decline in AMR R&D Professionals” (press release, report itself), its key message of “Researchers Are Leaving the AMR Field – Even as the Threat Rapidly Grows” is illustrated vividly by the report’s graphics. I’m going

ADVANCE-ID seeks antibiotic for P2/3 development Asia!

Dear All, Yow! Led by David Paterson,  ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) is a research group launched March 2023 as a network of more than 30 hospitals across Asia. The exciting news is that ADVANCE-ID have just announced that they are seeking a novel antimicrobial agent vs. MDR Gram-negatives that could be advanced in the clinic

Which came first: The drug or resistance to the drug?

Dear All, Although it seems entirely reasonable that the “Which came first?” chicken vs. egg riddle can be resolved in favor of the egg, a pair of papers in CID suggest that the answer to the parallel question of “drug vs. resistance to the drug” is changing in a way that is NOT in our favor!

Scroll to Top