Antimicrobial resistance is a growing concern among healthcare providers, and providing physicians with updated information on the effectiveness of antibiotic and antifungal drugs is imperative for optimal patient care. Now, the US Food and Drug Administration (FDA) has introduced a new website that aims to communicate up-to-date information about the likely effects of an antimicrobial drug on a given pathogen.
“Antimicrobial resistance remains one of our most pressing public health challenges,” said FDA Commissioner Scott Gottlieb. “While we’re continuing our policy efforts to encourage the development of new drugs and limit the use of antibiotics in livestock, we also need to take new steps to encourage more appropriate use of these treatments in patient care.”
When deciding on a treatment plan for a patient with an infection, physicians refer to antimicrobial susceptibility test (AST) results which rely on criteria known as “breakpoints” to indicate a pathogen’s susceptibility to an antimicrobial drug. Since bacteria and fungi evolve over time – in some cases developing resistance mechanisms to treatment – drug manufacturers must update their breakpoint.
The FDA previously required individual drug manufacturers to update their drug labeling with the breakpoint information, and secure approval of the updated information from the FDA. AST device manufacturers would then need to update their own testing criteria to reflect the breakpoint change, creating delays in getting this critical information to healthcare providers treating patients.
“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,” said Gottlieb. “Prescribing a drug that’s only going to be met with resistance from the bacteria or fungus it’s intended to treat doesn’t help that patient, and it has broader public health consequences that cannot be ignored.”
The FDA will now automatically update the breakpoint information for drugs containing the same active ingredient via an FDA website. These breakpoints will be developed by standard-development organizations, and not by the drug companies themselves, however, drug manufacturers will have the chance to contest the changes and will be required to update their labeling.
“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,” explained Gottlieb.