The FDA has launched a new tool aimed at getting critical updates regarding antibiotics and antifungal drugs to health care professionals faster in an effort to combat antimicrobial resistance.
The FDA has created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. The tool is designed to help health care professionals in making more informed prescribing decisions that will benefit the patient and prevent the spread of resistant bacteria.
Physicians are encouraged to use antimicrobial susceptibility test results to help choose an appropriate antibacterial or antifungal drug to treat a patient’s infection. These tests rely on criteria that help determine whether a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. The criteria for these tests is called susceptibility test interpretive criteria or “breakpoints.”
This new approach will allow the regulatory agency 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. The FDA will leverage the work done by standards-development organizations that develop breakpoints, and recognize them when the FDA agrees that they are appropriate.
Comparatively, 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. According to the FDA, this process created unnecessary delay in reaching health care professionals with the information. Each individual drug and device labeling had to be updated whenever breakpoints changed.
Drug manufacturers will have to update their labeling to reference the FDA web page containing the breakpoint information with this new method. Health care works will no longer have to continuously update their labeling with new breakpoint information, making the process more efficient and, it is expected, timelier.
“Antimicrobial resistance remains one of our most pressing public health challenges. While we’re continuing our policy efforts to encourage the development of new drugs and limit the use of antibiotics in livestock, we also need to take new steps to encourage more appropriate use of these treatments in patient care,” said FDA Commissioner Scott Gottlieb, MD.
“When you’re treating critically ill patients, you want as much information as possible about the pathogen your patient is fighting and the susceptibility of that pathogen to various treatments. Prescribing a drug that’s only going to be met with resistance from the bacteria or fungus it’s intended to treat doesn’t help that patient, and it has broader public health consequences that cannot be ignored. 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. Our new tool is aimed at making this process more efficient and informed.”
—Julie Gould
