As part of the 21st Century Cures Act, the Food and Drug Administration (FDA) announced a new website that provides direct access to information about when bacterial or fungal infections are likely to respond to a specific drug. The resource is meant to help healthcare professionals make better prescribing choices that will benefit patients and prevent the spread of resistant bacteria.
“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,” stated FDA Commissioner Scott Gottlieb, MD.
Antimicrobial susceptibility test (AST) data can help guide a prescriber to choose the right antibacterial or antifungal agent to treat their patient. These tests rely on susceptibility test interpretive criteria (“breakpoints”) that help determine whether a specific bacteria or fungi are susceptible to the drugs. Decreased susceptibility to drugs can develop as the microbes change over time, requiring updates in breakpoints.
Previously, drug manufacturers would need to update drug labeling with new breakpoint data, which then underwent FDA review. Once approved, the device manufacturer of a corresponding AST could then update testing criteria and labeling; this process would delay the time in alerting healthcare professionals.
Now, the FDA is able to update the breakpoints for multiple drugs that have the same ingredients at once. This information can be shared transparently on the FDA website that will list the recognized breakpoints. The FDA has the authority to accept a standard breakpoint in whole or part, or to determine an alternative breakpoint. Manufacturers can also submit data to support alternative breakpoints if they do not agree with the recognized standard.
Manufacturers will be required to update their drug labeling to display the FDA website containing the breakpoint information, eliminating the constant need to update new breakpoint information. As further support, the FDA is issuing guidance on how companies should update their labeling to reference the information online established by the Agency.
For more information visit FDA.gov.