Addendum: This is the second in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the next newsletter.
Dear All: Two somewhat overlapping ideas at the start of the week:
First, FDA today announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. The agency also posted a list of the affected products. Applications are due 3 June 2019 and you can find a bit more detail (including a summary of the list of affected products) just below my signature.
Second, my note last week on the upcoming FDA AMDAC on IM bacitracin in infants provoked two interesting streams of correspondence that I thought I’d share.
- The pediatricians were agog with comments such as “You must be kidding … this is a registered product?” and “That is NOT in the text books … and I’ve certainly NEVER used it.”
- The veterinarians / animal health gurus noted that bacitracin is an important agent for the poultry industry as a means to treat necrotic enteritis (similar to clostridial necrotizing enteritis). As bacitracin is so little used in human medicine (e.g., you won’t find it in the list published with the RFA above), it carries a “Not Medically Important at this time” designation at FDA-CVM. If the goal of the AMDAC is to agree that we can withdraw this compound from human use, that would help ensure its continued availability for the food industry.
Very interesting to see these ideas in parallel! We’ll now have to wait and see what the AMDAC briefing materials say.
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://amr.solutions/blog/
More detail on FDA’s RFA on antibiotic dosing duration: From April 1 to June 3, 2019, the FDA’s Center for Veterinary Medicine (CVM) will accept research applications for the Fiscal Year (FY) 2019 program, which will fund up to $1.5 million in support of applications for studies in FY 2019, with a maximum of $250,000 provided to any individual awardee. Subject to resources and awardee performance, awardees will be eligible for an additional year of support in FY 2020 up to $250,000. The number of awards is contingent upon FDA funding availability and the number of suitable applications.
The FDA is offering funding to help generate publicly available data that sponsor(s) of affected approved animal drug applications can use to update product dosage regimens to better target when and for how long the drug may be used. Defining more targeted durations of use supports the FDA’s ongoing efforts to slow the development of antimicrobial resistance by fostering the judicious use of medically important antimicrobial drugs in animals. This important work helps to preserve the effectiveness of these antimicrobials in both veterinary and human medicine and is one of the actions highlighted in CVM’s five-year plan for supporting antimicrobial stewardship in veterinary settings.
I was intrigued by the list of the affected products and compiled this list of components from the posted list. Some I recognize but some not!
| Amprolium Bacitracin Chlortetracycline Clopidol Decoquinate Diclazuril Fenbendazole Halifuginone Hygromycin B Laidlomycin | Lasalocid Lincomycin Melengestrol Monensin Neomycin Ormetoprim Oxytetracycline Pyrantel Ractopamine Robenidine | Salinomycin Semduramicin Sulfadimethoxine Sulfamethazine Sulfaquinoxaline Tetracycline Tylosin Virginiamycin Zilpaterol Zoalene |
Upcoming meetings of interest to the AMR community:
- 26 Mar 2019 (everywhere): First day of Harvard-sponsored course entitled “FDA and Prescription Drugs: Current Controversies in Context.” Register here.
- 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.
- 1 Apr 2019 (University of California, Los Angeles): Longitude Prize AMR Diagnostic Workshop and evening Lecture on the Longitude Prize. Details here.
- 8 Apr 2019 (FDA White Oak Campus): Workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease”. Register here.
- 9 Apr 2019 (everywhere, 17:00-18:30 CEST): GARDP-sponsored webinar entitled “Mining Chemical Libraries for New Antibacterials.” Register here.
- 11-12 Apr 2019 (Amsterdam): ESGAP–SWAB (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.
- 20 May 2019 (everywhere): Application deadline for NIAID solicitation (HHS-NIH-NIAID-BAA2019-1) for proposals to support new vaccine or therapeutics candidates targeting antibiotic-resistant bacterial infections. Go here for more details.
- 3-6 Jun 2019 (Philadelphia): Annual BIO meeting
- 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
- 10-11 Jul 2019 (Madison, WI): Tiny Earth Symposium, a teaching consortium that uses crowd-sourcing of antibiotic-producing microbes to improve undergraduate education. Details here.
- [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.
- 12-13 Mar 2020 (Berlin?): 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.