FDA public hearing on Fecal Microbiota Transplantation (FMT) to Treat Clostridium difficile

Dear All, On 4 Nov 2019 at their White Oak Campus, FDA will hold a public hearing from 9a-4p on fecal microbiota transplantation (FMT) to treat Clostridium difficile infections that are not response to standard therapies. Go here for the online FR notice and here for the .pdf version.

The background on this topic goes back several years and is well summarized in the FR notice. In brief, FDA started working on the question of FMT in 2013 and has released and then updated a guidance document on how/when FDA would closely regulate this process.

To quote from the FR notice on the purpose of this meeting:

“…fecal microbiota collected from healthy individuals are being investigated for use in the treatment of C. difficile infection. Published data suggest that the use of fecal microbiota to restore intestinal flora may be an effective therapy in the management of refractory C. difficile infection. However, the efficacy and safety profiles of this intervention have not yet been fully evaluated in controlled clinical trials. To inform FDA’s understanding of the current scientific status of FMT, especially as it relates to the use of FMT to treat C. difficile infection not responsive to standard therapies, we are interested in obtaining information, including data and studies, from all stakeholders, including patients, clinicians, research scientists, industry, healthcare providers and stool banks on the following topics:

  1. Clinical Evidence of Effectiveness: What is the strength of the evidence for the use of FMT to treat C. difficile infection not responsive to standard therapies?
  2. Safety Evaluation: What is the strength of evidence for the safety of FMT in patients with C. difficile infection not responsive to standard therapies?
  3. Impact of FDA’s current Enforcement Policy on FMT Product Development
  4. Future and Path Forward: What additional scientific information is needed to determine the safety and effectiveness of FMT for C. difficile infection not responsive to standard therapies?

This looks like a very timely discussion and update both for the FMT community as well as for anyone interested in developing therapies for C. difficile infections. 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: https://13.43.35.2/blog/

Upcoming meetings of interest to the AMR community:

  • 10 Sep 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Models for antimicrobial R&D: Advanced and complex in vivo models for infectious disease research.” Go here to register.
  • 3 Oct 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Natural product antibiotics: from traditional screening to novel discovery approaches.” Go here to register.
  • 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
  • [CORRECTED DATE] 8 Oct 2019 (London): Launch of “Reviewing Antimicrobial Resistance: Where Are We Now and What Needs to Be Done?”, a follow-up to the UK AMR Review‘s report and recommendations. Go here to register. 
  • 10 Oct 2019 (online): Deadline for feedback to the Global AMR R&D Hub on their draft Collaboration Framework. Go here to tell them what you think! 
  • 11 Oct 2019 (online): Deadline for Novo REPAIR’s 2019 US-Canada investment round. Go here for details — you need to dig all the way to the bottom of the web page.
  • 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.
  • [NEW] 4 Nov 2019 (FDA, White Oak): Public hearing on FDA’s proposed rules for “Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile.” Go here for the online FR notice and here for the .pdf version.
  • 7 Nov 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Converting Gram-positive-only compounds into broad-spectrum antibiotics.” Go here to register.
  • 19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
  • 28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
  • 16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
  • 21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
  • 20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
  • 26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 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.” Go here for details.
  • 12-13 Mar 2020 (Basel, I’m told): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now. 
  • 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • 1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now, details to follow.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.

Share

ENABLE-2 funding now includes Hit Identification & Validation

Dear All, I wrote on 25 Aug 2023 about the ENABLE-2 program and its support for hit-to-lead compound development. As a reminder, that program is focused on molecules with the potential to be direct-acting therapies for one or more of the following priority pathogens: ESBL-producing/carbapenem-resistant Enterobacteriaceae (E. coli, K. pneumoniae), P. aeruginosa, A. baumannii, methicillin-resistant S. aureus, or vancomycin-resistant E. faecium. Adding to that program, there is now an ENABLE-2

NIAID/DMID thinking for FY2026: Antibacterials, Phage, and Antifungals

Dear All, NIAID’s DMID (Division of Microbiology and Infectious Diseases) recently held a council meeting during which they proposed program concepts that encompassed both antibacterial therapies (including phage) as well as antifungal therapies for funding in FY 2026 (the year that would run from 1 Oct 2025 to 30 Sep 2026). There is no guarantee that

WHO Antibacterial Pipeline Review: Update thru 31 Dec 2023

Dear All, WHO have released an update through 31 Dec 2023 of their ongoing series of antibacterial pipeline reviews! Here are the links you need: The report: 2023 Antibacterial agents in clinical and preclinical development: an overview and analysis and a press release about the report. Infographics: Key facts and recommendations from the 2023 antibacterial agents in clinical

The (confusing!) language of AMR: ChatGPT tries to help!

Dear All (Wonkish alert! Not technical but lengthy … so settle in and enjoy the ride!): Regular readers will know of my fascination with language: e.g., this 20 Feb 2020 newsletter entitled “Language Matters: CRE vs. CPE; SDD vs. I; And MDR, XDR, PDR, UDR vs. DTR.” How about that for acronymics taken to Olympian

Scroll to Top