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FDA launches tool to improve antibiotic usage
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The FDA announced the launch of a new website that streamlines its approach to updating critical information regarding antibiotics and antifungal drugs, according to a press release.
The website was created by the FDA to help health care professionals make more informed prescribing decisions to enhance patient care and prevent antimicrobial resistance, according to the release. The website will provide physicians with information about bacterial or fungal infections and their likelihood to respond to specific drugs, according to the FDA.
“Antimicrobial resistance remains one of our most pressing public health challenges,” Scott Gottlieb, MD, commissioner of the FDA, said in the release. “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.”
The new tool eliminates the old process that unnecessarily delayed updated information from antimicrobial susceptibility tests (AST) from reaching physicians because the information had to be reviewed and approved by the FDA on a case-by-case basis, according to the FDA.
Under the new approach, the FDA can update susceptibility test interpretive criteria, or “breakpoints,” for multiple drugs with the same active ingredient while concurrently sharing that information on a specific FDA webpage, according to the release. If companies disagree with the recognized standard, they will be able to submit data to support alternative breakpoints, according to the release.
The process for drug manufacturers will also be more efficient and timely, as they will only have to reference the FDA website containing the breakpoint information, according to the FDA.
“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,” Gottlieb said. “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,” he continued. “Our new tool is aimed at making this process more efficient and informed.”