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- The CAP, Infectious Disease Groups Ask FDA to Update ‘Breakpoint’ Criteria
The CAP and three infectious disease organizations asked the Food and Drug Administration (FDA) to update the antimicrobial susceptibility interpretive criteria (called breakpoints). The American Society for Microbiology, the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, and the CAP are concerned that updated breakpoints are not being recognized by the FDA promptly, putting patients at risk and compromising diagnosis and treatment of infections.
In the January 6 letter to the FDA, the group outlined how more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result. The group said it’s critical to determine how to speed up updating breakpoints in cooperation with the FDA. In the absence of an FDA-recognized breakpoint, laboratories are forced to either apply off-label testing or use grandfathered tests, which in many cases, are obsolete.
The 21st Century Cures Act allowed the FDA to codify the recognition of breakpoints from the recognized standards development organization such as the Clinical Laboratory Standards Institute. However, since the Cures Act’s enactment, the Center for Drug Evaluation and Research has been slow to accept current, updated breakpoints, which puts patients at high risk and increases the likelihood of disease transmission and proliferation of antibiotic-resistant infections.
The group has requested a meeting with the FDA to discuss this critical matter further.