Debut of FDA Susceptibility Test Interpretive Criteria (STIC) website

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: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

Share

Leaky pipe(line)s, Part 2 / CARB-X reboot / WHO 2021 pipeline review

Dear All, We have a 3-part discussion today on the theme of “I want a new drug … so how do I find it?” Off we go! First, the 14 June 2022 newsletter entitled “Leaky Pipe(lines) / When Is A Molecule A Drug” generated further discussions that are worth sharing: It was noted the microdosing

Antibiotic procurement models for LMICs / G7 Leaders call for Pull!

Dear All, Two stops on our tour today: (i) an excellent survey of incentive models and (ii) a final communique from the recent G7 meetings. First up, CGD (Center for Global Development) have released a report (link) entitled “Leveraging Purchasing Systems to Ensure Access, Stewardship, and Innovation: A Landscape Review of Current and Potential Market Structures

Leaky pipe(lines) / When is a molecule a drug? (Part 1 of 2)

Dear All, I was fascinated by this recent paper in AAC: Neha K. Prasad, Ian B. Seiple, Ryan T. Cirz, and Oren S. Rosenberg. Leaks in the Pipeline: a Failure Analysis of Gram-Negative Antibiotic Development from 2010 to 2020. Antimicrob Agents Chemother. 2022 May 17;66(5):e0005422. doi:10.1128/aac.00054-22. (Addendum: This newsletter has a follow-up newsletter.) In brief,

FDA/CVM: Antimicrobial use in companion animals

Dear All, Post-newsletter addendum: I’ve learned that USDA will host a 10 Aug 2022 (virtual, 10a-4.30p ET) workshop on AMR in food agriculture. See the meetings calendar for more details; go here to register. I’ll confess to having missed entirely the request back in February 2022 from FDA’s Center for Veterinary Medicine (CVM) for comments on antimicrobial

Scroll to Top