FDA has finalized its guidance on how to coordinate development of antimicrobials and the tests that determine whether pathogens are vulnerable to them.
The guidance is designed to address an R&D coordination problem that has resulted in time lags between the approval of new antimicrobial drugs and devices that inform their use.
To eliminate the slowdowns, FDA wants drug and device developers to start collaborating early in the R&D process.
The dual development of drugs and companion tests has long posed challenges to the pharma and medical device industries. In 2011, The New York Times illustrated the problem with the analogy that relationships between pharma and diagnostic companies are like "a dance between a giant and a pixie, locked in an embrace but with a tendency to move in opposite directions."
Since then, there has been some progress in improving the coordination of companion diagnostics in general, but there remains scope to better synchronize development of antimicrobial medicines and antimicrobial susceptibility tests (ASTs).
AST devices, such as qualitative disc diffusion and elution tests, play an important role in the era of antimicrobial resistance by providing insights into the susceptibility of bacterial pathogens to drugs. Equipped with these insights, physicians can make informed treatment decisions and thereby cut the time it takes to provide effective treatment.
However, in some cases development of an AST device only starts as a drug nears approval, or even after it has come to market. This asynchronous development creates periods in which new drugs are available but physicians lack devices to show whether they will work for particular patients.
FDA wants drug and diagnostic companies to improve the situation by discussing opportunities for coordinated development, ideally early during the drug R&D process. By involving test developers early, FDA thinks drug companies can use trials to generate isolates and information that support the creation of AST devices, and in turn benefit from the availability of tests that aid development.
The agency released a draft version of the guidance and held a public workshop to discuss it in 2016. In finalizing the guidance, FDA has rewritten large sections of the text while retaining the focus on how to improve coordination between the development of antimicrobials and AST devices.
For example, the final guidance advises developers of AST devices to use the Q-Submission Program to obtain feedback from FDA as the coordinated development effort progresses. The draft version, in contrast, makes no mention of the Q-Submission Program, an initiative that FDA has worked to refine since the earlier text was published 2016.
Having finalized the guidance, FDA now plans to host a webinar Feb. 12 to discuss its implications for developers of AST devices and antimicrobial drugs.