New FDA Web Page Has Latest Info on Best Antibiotic Choice

Megan Brooks

December 14, 2017

As part of ongoing efforts to combat antimicrobial resistance, the US Food and Drug Administration (FDA) has created a Web page to provide constant, up-to-date information for clinicians on antimicrobial drug susceptibility.

The Web page will provide "direct and timely" access to information about when bacterial or fungal infections are likely to respond to a certain drug, the FDA said in a news release. The goal is to help providers make more informed prescribing decisions that will benefit their patients and help prevent the spread of resistant bacteria.

Susceptibility test interpretive criteria, also known as "breakpoints," help determine whether specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. Changes in bacteria and fungi over time may result in decreased susceptibility to some drugs. When this occurs, breakpoints have to be updated.

Under the old approach, each drug manufacturer had to update drug labeling with new breakpoint information, which had to be reviewed and approved by the FDA on a case-by-case basis.

The new approach allows the FDA to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and to share that information transparently and immediately via the new Web page, which will list FDA-recognized breakpoints.

"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," FDA Commissioner Scott Gottlieb, MD, said in the FDA news release.

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

Congress included the new approach as part of the 21st Century Cures Act.

Drug manufacturers will be required to update their labeling to reference the FDA Web page that contains the breakpoint information, but they will no longer have to continuously update their labeling with new breakpoint information. This should make the process "more efficient and, it is expected, more timely," and it should also ease the burden for both drug manufacturers and developers of antimicrobial susceptibility testing devices, the FDA said.

The FDA has issued guidance on how companies should update their labeling regarding breakpoints to include information that appears on the agency's new Web page.

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