FDA Tools Up to Help Providers Fight Resistance and Get Timelier Antibiotic Updates

The Food and Drug Administration unveiled a new tool designed to give urgent care physicians and other providers more timely access to updates on antibiotics and antifungal drugs this week. The overarching aim is to help clinicians anticipate when bacterial or fungal infections are likely to respond to a specific drug. Under the new approach, FDA can simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently through a dedicated FDA website that will list FDA-recognized breakpoints. Companies that disagree with the recognized standard can submit data to support alternative breakpoints. The new tool, to be housed on the FDA’s website, will require drug companies to update their labeling to reference the FDA web page containing the breakpoint information. However, they will no longer have to continuously update their labeling with new breakpoint information, which the FDA says should make the process more efficient.