FDA Announces New Tool to Improve Antibiotic Use

As part of a larger effort to curb antimicrobial resistance, officials with the FDA have announced a new tool for providing critical information to health care providers about better managing antibiotics and antifungal drugs.

According to an FDA announcement, the new website will streamline how the FDA updates information used to help providers choose the most appropriate treatment for a patient’s infection.

Since bacteria and fungi change over time, which may result in decreased susceptibility, it is crucial that providers have access to updated testing criteria, or “breakpoints,” on whether resistance to a particular drug has occurred. The FDA intends the website to provide direct and timely access to this information to allow them to make more informed prescribing decisions.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “Our new tool is aimed at making this process more efficient and informed.”

Under the old approach, drug manufacturers updated their drug’s labeling with new breakpoint information, which had to be reviewed and approved by the FDA on a case-by-case basis. Only after its approval could a device manufacturer of a corresponding antimicrobial susceptibility test (AST) update its testing criteria and labeling.

However, the new approach allows the FDA to streamline the process by simultaneously updating the breakpoints for multiple drugs that have the same active ingredient and share that information with providers. Drug manufacturers will be able to update their labeling to reference the FDA web page that contains the breakpoint information.

Reference

FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588836.htm?utm_campaign=12132017_PR_FDA%20launches%20tool%20for%20antibiotic%20presribing&utm_medium=email&utm_source=Eloqua. Accessed December 13, 2017.