By making this information available the FDA hopes to help improve patient outcomes, better manage antibiotic use, and decrease antimicrobial resistance.
The US Food and Drug Administration (FDA) announced that it is making strides toward helping health care practitioners choose appropriate treatments for infections by launching webpages that provide in vitro susceptibility of bacteria or fungi to certain drugs. By making this information available the FDA hopes to help improve patient outcomes and decrease antimicrobial resistance.
Health care experts have been asking for increased access to antimicrobial susceptibility testing (AST) data for years. Indeed, Contagion®’s own Editor-in-Chief, Jason Gallagher, PharmD, FCCP, FIDSA, BCP, recently wrote on the importance of AST, stating that, “the value that AST provides to clinicians to inform antimicrobial selection in support of antimicrobial stewardship (AMS) efforts cannot be overstated. Unfortunately, the role of AST in AMS is undermined by delays, often by years, between approval of an antimicrobial agent by the FDA and FDA-approved inclusion of susceptibilities to that agent in commercial automated AST panels.”
According to the FDA, the old approach for providing information on the susceptibility test interpretive criteria (or breakpoints) that was the reason for these delays required that “each drug manufacturer updated its drug labeling with new breakpoint information, which had to be reviewed and approved by the FDA on a case-by-case basis. Only after the revised drug labeling was approved could a device manufacturer of a corresponding AST update its testing criteria and labeling for its AST. This process created unnecessary delay in reaching health care professionals with the information. Each individual drug and device labeling had to be updated whenever breakpoints changed.”
FDA Commissioner Scott Gottlieb, MD, echoed Dr. Gallagher’s sentiments on the detriment of delays in the process, stating in the FDA press release that, “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. … 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.”
Therefore, the FDA created the webpages to streamline the process to make it easier for health care practitioners to gain access to these data in a more efficient and timely manner. According to the FDA website, “The new approach, which was included by Congress as part of the 21st Century Cures Act, allows the FDA to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently via a dedicated FDA webpage that will list FDA-recognized breakpoints. The FDA will leverage the work done by standards-development organizations that develop breakpoints, and recognize them when the FDA agrees that they are appropriate. The FDA retains full authority to accept a standard in whole or in part or to establish alternative breakpoints. In addition, companies can submit data to support alternative breakpoints, if they disagree with the recognized standard.”
It will be the manufacturer’s responsibility to update their labels to reference the FDA webpages with the appropriate breakpoint information; however, they will no longer be required to make constant label updates as new breakpoint information comes to light, making the process more streamlined and timely. To help manufacturers in this process, the FDA also issued guidance on how companies can update their labeling to point to the new information.
On the FDA’s official blog, Edward. M. Cox, MD, MPH, director of FDA’s Center for Drug Evaluation and Research’s Office of Antimicrobial Products also remarked on the importance of this new tool, stating that, “Up-to-date breakpoints are an important part of the public health response to address antimicrobial resistance… Our new online system identifying FDA-recognized breakpoints will help laboratories report the most up-to-date information to health care providers… By keeping susceptibility test interpretive criteria up-to-date [we will be better equipped to ensure that] health care 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; and health care 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.”