IDSA is working with the Food and Drug Administration (FDA), Congress, and other stakeholders to advance policies to incentivize the timely development of antimicrobial susceptibility test (AST) devices. Both IDSA and FDA recognize that approved ASTs enhance patient care and assist in the fight against antimicrobial resistance.
IDSA member and liaison to the Clinical and Laboratory Standards Institute (CLSI) Amy Mathers, MD, served on a recent panel for a FDA stakeholder workshop on AST diagnostic devices. The workshop continued an ongoing dialogue generated by the 2016 FDA draft guidance, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices.” Dr. Mathers provided an infectious diseases clinician perspective on the use of isolates in clinical trials, clinical trial networks, and the importance of accurate clinical breakpoints. IDSA reps emphasized the importance of having AST devices available to guide appropriate use of antimicrobial drugs.
The 21st Century Cures Act requires FDA to establish a website for interpretive criteria no later than December of this year. Breakpoints will be reviewed every six months, and FDA will publish an annual notice of all website updates in the Federal Register for public comment. FDA also is now permitted by the Cures law to review and utilize breakpoints updated by external standard setting organizations such as CLSI, rather than conducting all breakpoint updates internally, which was extremely time-consuming and contributed to delays in breakpoint updates. FDA is planning an FAQ to address common issues and streamline submissions and reviews.
Following the workshop, IDSA submitted a comment letter to the FDA containing recommendations to address the challenges of AST development, including:
- Ways to increase coordinated development of ASTs and decrease time to market;
- Requirements for the use of isolates in clinical trials; improving access to specimens and isolates; age and number of isolates;
- Fast track/priority review for AST device applications;
- AST coverage of additional organisms beyond labeled indications;
- Development of clinical trials networks to reduce time and cost associated with AST development; and
- Speed and ease of obtaining new antimicrobial agents for device development.
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