FDA panel mixed on proposed changes to antibiotic breakpoints

FDA's Anti-Infective Drugs Advisory Committee was mixed on whether or not susceptibility breakpoints for marketed antibiotics should be updated to reflect the emergence of resistance as well as how the new breakpoints should be determined. Susceptibility breakpoints define the concentration or dose of an antibiotic where the bacteria remain susceptible to treatment and where they develop resistance.

At the meeting, FDA proposed two hypothetical scenarios based on data for two approved drugs where resistance had developed since the antibiotics were launched. The agency also then proposed potential solutions to address the resistance: increasing dosing, or creating indication- and pathogen-specific breakpoints. ...