Press Announcements > FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

Press Announcements > FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

New FDA Tool Allows Doctors to Better Manage
Antibiotic Use and Improve Patient Care

Website streamlines how FDA updates information used to help
healthcare providers choose an appropriate treatment
for a patient’s infection

The U.S. Food and Drug Administration (FDA) created a website to provide direct and timely information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid healthcare professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria. 

Updated Breakpoints Improves Patient Treatment

Physicians can use antimicrobial susceptibility test (AST) results to help choose an appropriate antibacterial or antifungal drug to treat a patient’s infection. These tests rely on criteria — called susceptibility test interpretive criteria or “breakpoints” — that help determine whether a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. Bacteria and fungi change over time, which may result in decreased susceptibility to some drugs. When this occurs, breakpoints may need to be updated. 

New Approach Updates Breakpoints Quicker

Under the old approach, each drug manufacturer updated its drug labeling with new breakpoint information, which had to be reviewed and approved by the FDA on a case-by-case basis. This process created unnecessary delay in reaching healthcare professionals with the information.  

The new approach, which was included by Congress as part of the 21st Century Cures Act, allows the FDA to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently via a dedicated FDA web page that will list FDA-recognized breakpoints.  

CDC applauds this new approach, which will get critical updates regarding antibiotics and antifungal drugs to healthcare professionals as part of an overall effort to combat antimicrobial resistance. 

Read FDA’s press release for more information.