Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance
Posted 13 December 2017 | By
The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections.
The website is part of an effort mandated by the 21st Century Cures Act to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive criteria, also known as antimicrobial "breakpoints."
Antimicrobial susceptibility testing is performed to discover whether certain bacteria or fungi will be susceptible to particular drugs. In the past, susceptibility test interpretive criteria have been listed in the microbiology section of the labeling for individual drugs.
Due in increasing levels of antimicrobial resistance, FDA says that in vitro susceptibility test methods and the interpretive criteria for those tests must be reviewed and updated on a regular basis to stay relevant.
"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," said FDA Commissioner Scott Gottlieb. These delays also impacted diagnostic test makers, who had to wait for revised drug labeling to be approved before they could update the labeling for their corresponding tests.
Cures also authorizes FDA to recognize susceptibility test interpretive criteria developed by third-party standards development organizations and requires the agency to update the website every six months to reflect newly recognized interpretive criteria or to withdraw recognition from outdated criteria.
FDA says these changes will allow it to update breakpoints for multiple drugs with the same active ingredient more quickly than in the past, and says that drugmakers will no longer need to continuously update their labeling to reflect new breakpoint information. Instead, FDA says drugmakers will need to update their labeling to direct healthcare professionals to the susceptibility test interpretive criteria website to find the most up-to-date information about a particular drug.
Alongside the launch of the new website, FDA has issued a new guidance detailing how drugmakers should update their labeling to reflect the new breakpoint website.
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria Website