FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All,

FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for the concept paper posted in advance of the meeting. 10 Apr 2021 update: Per this Federal Register notice, The comment period has been extended to 22 April 2021.

As context for this meeting, WHO and FDA’s Center for Veterinary Medicine (CVM) use four broad categories to rank the importance of human antibiotics that might be used in animals: Critically Important, Highly Important, Important, and Currently Not Used in Humans. A super category of “Highest-Priority Critical Important Antibiotics” is also used by WHO. As examples, the current WHO classification identifies later generation cephalosporins and aminoglycosides as Critically Important, tetracyclines as Highly Important, and nitrofurantoin as Important. As a counterpart to this, OIE has list of antimicrobial agents ranked for importance to animal health and veterinary medicine (go here for an OIE webpage that discusses the list and here for the 2019 OIE list itself).

The intent of these lists is to guide country-level recommendations on antibiotics that really must be preserved for use in man vs. those where animal use is appropriate (e.g. treating or controlling disease in individual animals or groups of animals). Such information guides regulatory risk management options seeking to create an appropriate balance between animal health and welfare vs. public health and food safety.

As an example, consider National Action Plan (NAP) goal 1.2 from the 2015 US NAP (link, jump to page 9): “Eliminate the use of medically-important antibiotics for growth promotion in food- producing animals and bring other agricultural uses of antibiotics, for treatment, control, and prevention of disease, under veterinary oversight.” To guide implementation, you can see the importance of having an appropriately maintained list of antibiotics that should/should not be used.

Here are sources for current guidance documents and relevant commentaries:

  • WHO’s list was last updated in 2019
    • The 2019 WHO 6th edition list is found on this WHO webpage (link)
    • For further reading, this 2016 paper is an excellent tour of work through the 5th edition of the WHO list and a good way to appreciate the challenging nuances of creating these lists: link to Collignon et al., “World Health Organization Ranking of Antimicrobials According to Their Importance in Human Medicine: A Critical Step for Developing Risk Management Strategies to Control Antimicrobial Resistance From Food Animal Production.” CID 63(8):1087–1093, 2016.
  • FDA’s list was launched in 2003
    • The list is found here in CVM (Center for Veterinary Medicine) Guidance for Industry #152 (aka, GFI152) entitled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” 
    • This 2019 paper has a very US-based group of authors and is another good tour of this topic: link to Scott et al., “Critically important antibiotics: criteria and approaches for measuring and reducing their use in food animal agriculture.” Ann NY Acad. Sci 1441:8-16, 2019.
  • This 2020 paper provides an instructive comparison of six different classification lists (WHO, OIE, US (FDA), EU (EMA), Canada, Australia): link to Watts et al. “Current and future perspectives on the categorization of antimicrobials used in veterinary medicine.” J Vet Pharmacol Ther.  2020 Feb 28. doi: 10.1111/jvp.12846.

So, the purpose of this workshop now becomes clear: Per FDA’s summary of CVM guidance documents being revised during 2020 (link), FDA GFI152 is slated to be revised. This workshop thus makes good sense as part of such a process — the online meeting description shows that FDA is seeking input via this list of questions:

  1. Are the criteria and the tier-based framework described in the potential revised process for ranking antimicrobial drugs according to their relative human medical importance clear, complete, and consistent? 
  2. What changes do you think are needed to the criteria or tiers, if any? 
  3. Have the proposed criteria been applied correctly to the antimicrobial classes as reflected in their proposed rankings? 
  4. Are there other issues we should consider regarding these criteria and the tier-based framework? 
  5. How often and by what process should FDA update the ranking of medically important antimicrobials?  

There’s lots of nuance here and it’s great to have the public conversation. I’m not deeply into this area but you can readily sense the tension around preserving antibiotics for human use vs. enabling use that preserves food supply. Potential for impact on innovation in the veterinary antibiotics pipeline is apparent — and one also wonders about the impact of things like consumer preference for “antibiotic-free.” In any case, a few minutes spent with any of the above-cited papers would be time well spent on this important topic. 

All best wishes (and with thanks to Tom Shryock and Jeff Watts for critiques of this newsletter), –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.

Current funding opportunities (most current list is here):

  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • You might also be interested in the most current lists of R&D incentives (link) and priority pathogens (link)

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

  • In case you missed it, the 24 Sep 2020 Bootcamp #1 (“Moving from preclinical to clinical-stage: Challenges & opportunities”) is now available for replay: Get it here. The video for the 8 Oct 2020 Bootcamp #2 (“Exploring safety issues in antimicrobial drug development”) will follow shortly — check back at the current meetings webpage (link) to find it.
  • 15 Oct 2020 (online, 9-10.30am EST) webinar chaired by Andrew Morris entitled “Prevention is Stronger than Cure”, the second webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
  • 21 Oct 2020 (online, 9:00-10:30 CEST): GARDP-sponsored webinar entitled “Building better breakpoints: data and methods needed to determine breakpoints for new agents” moderated by Gunnar Kahlmeter. Go here to register.
  • 21-25 Oct 2020 (online meeting): IDWeek 2020. Go here for details.
  • 26-29 Oct 2020 (online meeting): Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 27 Oct 2020 (online, 9a-5p EST): FDA Workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” Go here to register.
  • 27 Oct 2020 (online meeting): BARDA Industry Day, a discussion of U.S. Government medical countermeasure priorities. Mark your calendar now and watch this website for details.
  • 29 Oct 2020 (online, 4-6pm Paris): 5th anniversary ICARe (Interdisciplinary Course on Antibiotics and Resistance) webinar. This fabulous week-long residential course can’t be held this year but Patrice Courvalin is organizing a 2-h anniversary webinar both for former attendees and anybody else who is interested. Speakers will include Patrice as well as Helen Boucher, Gerry Wright, Erin Duffy, and me. Go here to register.
  • 3-27 Nov 2020 (online, 4-week course, 10 sessions, 2-3h/session): First WHO Training Course in Infodemic Management. Infodemic = “information” + “epidemic” = rapid and far-reaching spread of both accurate and inaccurate information making it difficult to learn essential information about an issue. This is a training program for country-level preparedness. Application deadline is 18 Oct 2020. Go here for more.
  • 5 Nov 2020 (online, 9-10.30am EST) webinar entitled “Aiming in the dark: what happens when disease spreads without diagnosis”, the third webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
  • [NEW] 16 Nov 2020 (online, 9.30a-4.00p EST): FDA workshop entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Public Meeting.” Go here for the FR notice and here for extended details, including registration.
  • 17 Nov 2020 (online, 17:00-18:30 CET): GARDP-sponsored webinar entitled “Discovery of new antibacterials using artificial intelligence (computational chemoinformatics)” moderated by Laura Piddock. Go here to register.
  • 18-24 Nov 2020 (everywhere): World Antimicrobial Awareness Week. For resources, go here for WHO’s home page for the week. The focus will be on two messages: “Antimicrobials: handle with care” and “United to preserve antimicrobials.”
  • 19 Nov 2020 (online, 9-10.30am EST) webinar chaired by Jeremy Knox entitled “Responding to difficult-to-treat infections: Role and responsibilities of governments, researchers, clinicians, industry and patients”, the final webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
  • [NEW] 26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students.
  • 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.


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