Treating Infections – FDA is Forging a More Efficient Path to Help Healthcare Providers Treat their Patients

Posted on December 13, 2017 by FDA Voice

By: Edward M. Cox, M.D., M.P.H.

When a patient has an infection, healthcare providers often order a test to help them select a drug that is likely to work against that infection. This testing is performed by laboratories and is called antimicrobial susceptibility testing.

Over time, bacteria (in the image) and fungi change and may become less susceptible to some drugs. When this happens, breakpoints may need to be changed so that laboratories are using the most up-to-date information to help healthcare providers choose an appropriate treatment.

The criteria used to determine whether bacteria or fungi are considered “susceptible” or “resistant” to a particular drug are referred to as “breakpoints” or more formally, as Susceptibility Test Interpretative Criteria (STIC). Over time, bacteria and fungi change and may become less susceptible to some drugs. When this happens, breakpoints may need to be changed so that laboratories are using the most up-to-date information to help healthcare providers choose an appropriate treatment.

Up-to-date breakpoints are also an important part of the public health response to address antimicrobial resistance. For example, antimicrobial susceptibility testing results are used to monitor for antimicrobial resistance in hospitals and determine if additional infection control procedures should be put in place to reduce the chance of spread.

Today, we took an important first step in implementing a more streamlined process of updating breakpoints for antimicrobial drugs. FDA launched new web pages that contain Susceptibility Test Interpretive Criteria (www.fda.gov/STIC). Our new online system identifying FDA-recognized breakpoints will help laboratories report the most up-to-date information to healthcare providers. This important step is a result of the recently-passed 21st Century Cures Act, which FDA and other agencies are now implementing.

Before the Cures Act, the process was laborious, duplicative, and time-consuming. It began with each manufacturer updating its drug labeling with new breakpoints. Only then could-up-to date breakpoints be incorporated in the antimicrobial testing devices used by laboratories. Updating and re-updating labeling for hundreds of drug and device products was inefficient, and delayed healthcare providers receiving the most current information.

Now under the Cures Act, FDA will leverage the work of Standard Development Organizations (SDOs) who keep up with the ever-changing standards needed to run laboratories. FDA assesses any changes in breakpoints made by SDOs and retains full authority to decide whether any changes should be recognized. This new approach will take advantage of online tools to modernize how we update breakpoints.

By keeping Susceptibility Test Interpretive Criteria up-to-date:

Healthcare providers will have the information they need to pick an antimicrobial drug to treat a patient’s infection.
Patients are more likely to get the treatment they need to get well.
Healthcare staff are more likely to know if a patient is carrying a drug resistant infection and may be better able to take enhanced infection control measures to reduce its spread.

In the Cures Act Congress recognized the importance of improving the process of updating breakpoints. The Cures Act created a system to expedite the recognition of these breakpoints so that up-to-date information is provided to healthcare providers. Transitioning this information from drug labeling to an online source is a first step in this new updating process. FDA has published a guidance to assist drug manufacturers with this transition. We look forward to working with the healthcare community to improve and further streamline this process.

Edward. M. Cox is the Director of FDA’s Center for Drug Evaluation and Research’s Office of Antimicrobial Products