Dear All:
I knew that the idea of an online and frequently updated website for FDA-recognized Susceptibility Test Interpretive Criteria (STIC) was brewing based on the 21st Century Cures Act … and now it has happened! Check this out:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm
There is also a short URL link that remaps to the longer URL just above: https://www.fda.gov/STIC
In addition, there is a brief guidance document that explains both how the new process works (the website is updated every 6 months, FDA can draw on [and amend as desired] data from recognized standards development organizations) and how sponsors need to update their existing labels by removing current breakpoints and inserting a reference to the website:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588747.pdf
The newly released initial version of the STIC website covers antibacterial, antimycobacterial, and antifungal breakpoints by recognizing breakpoints from CLSI’s M100, M27, and M44 documents and then amending some (about half by my quick count) in some fashion.
Finally, the website notes that sponsors of AST devices may rely upon these FDA-recognized or listed STIC to support premarket authorization of their devices so long as certain conditions are met.
Commissioner Gottleib says it well in his quote in the FDA News Release (emphasis added is mine): “Antimicrobial resistance remains one of our most pressing public health challenges. While we’re continuing our policy efforts to encourage the development of new drugs and limit the use of antibiotics in livestock, we also need to take new steps to encourage more appropriate use of these treatments in patient care. When you’re treating critically ill patients, you want as much information as possible about the pathogen your patient is fighting and the susceptibility of that pathogen to various treatments. Prescribing a drug that’s only going to be met with resistance from the bacteria or fungus it’s intended to treat doesn’t help that patient, and it has broader public health consequences that cannot be ignored. Under the old approach, it took too long to update each individual drug’s labeling with information needed for susceptibility testing and it was clear a more centralized approach was needed. Our new tool is aimed at making this process more efficient and informed.”
I agree entirely — this tool has long been needed as a way to quickly and widely disseminate important breakpoint updates. We should all thank our colleagues at FDA for making it happen!
All best wishes, –jr
PS: As an aside for your long-range planning, note the new announcement below of the 2018 edition of Patrice Courvalin’s ICARe course
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:
- 12-14 Feb 2018 (Baltimore): ASM Biothreats Conference
- [NEW] 11 Jan 2018 (Washington): FDA AMDAC on Aradigm’s inhaled ciprofloxaxcin for non-CF bronchiectasis
- [NEW] 28 Feb 2018 (Brussels): Deadline for responses to IMI2 Call 13 (Topic 3) on AMR diagnostics
- 11-16 Mar 2018 (Ventura Beach): Gordon Research Conference on Antibacterial Discovery
- 21-24 Apr 2018 (Madrid): ECCMID
- 7-11 Jun 2018 (Atlanta): ASM Microbe
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
- 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (Lisbon, Portugal) (initial flyer)
- [NEW] 6-14 Oct 2018 International Course on Antibiotics and Resistance (ICARe, Les Pensières, Annecy, France) (link to 2017 program — details pending for 2018)