FDA Streamlines Approach for Bacterial, Fungal Breakpoint Information

Scott Gottlieb, MD

The US Food and Drug Administration (FDA) has announced that it has opened a new webpage that will serve as a new approach to distribute critical information and updates to health care professionals regarding antimicrobial resistance.

The website will reportedly provide access to information about when infections—bacterial or fungal—are likely to respond to specific drugs. The FDA seeks to keep health care professionals up to date and informed when prescription decisions are being made in order to benefit the patient and the physician, as well as work against the spread of drug-resistant bacteria.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “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.”

Currently, physicians can utilize antimicrobial susceptibility tests (ASTs) to pick the correct antibacterial or antifungal drug for a specific infection. While ASTs are helpful, they depend on “breakpoints” to determine whether or not a bacteria or fungi are susceptible to certain drugs, and as bacteria and fungi change and adapt, these breakpoints become less and less useful.

“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,” Gottlieb said. “Our new tool is aimed at making this process more efficient and informed.”

Previously, each drug’s manufacturer needed to update drug labeling with new breakpoint information, which in turn needed to be approved by the FDA, after which corresponding AST manufacturers could update their testing criteria to match the new data. However, this process took time and created delays in information sharing.

Now, the FDA can simultaneously update the breakpoints of multiple drugs with the same active ingredients, then share that information on the FDA’s webpage. The work will be done but the standards-development organizations that develop the breakpoints, after which the FDA will leverage and agree upon the appropriate ones to be recognized. According to the FDA, it will retain “full authority to accept a standard in whole or in part, or to establish alternative breakpoints.”

Drug companies can then update their labeling with a reference the FDA webpage, and will no longer need to continuously update their labels. The FDA will be issuing guidance on how manufacturers should go about updating their breakpoint labeling.