FDA Commissioner Scott Gottlieb, M.D., said antimicrobial resistance remains a major public health challenge.
“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 the more appropriate use of these treatments in patient care,” Gottlieb said in a news release published in December 2017. “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.”
The old approach did not allow for a streamlined process when updating an individual drug’s labeling with the necessary information for susceptibility testing. Each drug manufacturer had to update its drug labeling with new breakpoint information before the FDA had to review and approve it. Once the revised drug labeling was approved, a device manufacturer could then update its testing criteria and labeling. This lengthy processes created delays and it was clear there needed to be a change.
“Our new tool is aimed at making this process more efficient and informed,” Gottlieb said.
The dedicated FDA website will allow for transparency through a list with FDA-recognized breakpoints. Companies will also be able to submit data to support alternative breakpoints
Drug manufacturers will need to update the labels on products so they reference the FDA web page, however, this will be the last update they need to make to labels. They will not have to change the labels every time there is new breakpoint information because the FDA web page will have the most up-to-date information needed.
Physicians use antimicrobial susceptibility test (AST) results to choose the best antibacterial or antifungal drug for their patient’s infections. These tests rely on criteria referred to as susceptibility test interpretive criteria (STIC) or breakpoints which help determine if a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs.
As time goes on, bacteria and fungi will inevitably change. This can lead to decreased susceptibility to some drugs, which means the breakpoints may need updates.
Holders of approved drug applications will have until December 13, 2018 to remove the STIC information from the labeling of approved systemic antibacterial and antifungal drugs and replace it with reference information. This will ensure the most up-to-date STIC is available.
The FDA’s requirement explanations are published here.
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