FDA Releases Tool to Help Providers Make Better Prescribing Decisions for Antibiotics, Antifungals

The FDA announced a website tool aimed at healthcare providers to help them make more educated prescribing decisions about antibiotics in an effort to prevent the spread of resistant bacteria.

The tool will provide information about when bacterial or fungal infections are likely to respond to a specific drug.

“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, 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.”

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.

Previously, 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. Only after the revised drug labeling was approved could a device manufacturer of a corresponding AST update its testing criteria and labeling for its AST. The FDA said this created unnecessary delay, since each individual drug and device labeling had to be updated whenever breakpoints changed.

Congress included the new approach as part of the 21st Century Cures Act. The FDA will now simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information via a dedicated FDA web page that will list FDA-recognized breakpoints. Standards development organizations will develop the breakpoints. The FDA retains full authority to accept a standard in whole or in part, or to establish alternative breakpoints. In addition, companies can submit data to support alternative breakpoints, if they disagree with the recognized standard.

Drug manufacturers will have to update their labeling to reference the FDA web page containing the breakpoint information. They will no longer have to continuously update their labeling with new breakpoint information. The FDA also issued guidance on how companies should update their labeling on breakpoints to point to the information online generated by the agency.