Antibiotic resistance is a serious and growing public health threat that is increasingly limiting the drug choices available to providers for effectively treating bacterial infections.
The Food and Drug Administration has launched a new website to help clinicians make more informed prescribing decisions by ensuring they have direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific antibacterial or antifungal drug.
According to the Centers for Disease Control and Prevention, more than 2 million people are infected with antibiotic-resistant organisms, resulting in about 23,000 deaths each year. The FDA’s new website is meant to prevent the spread of resistant bacteria by providing critical updates on antibiotics to healthcare professionals so they can choose an appropriate treatment for their patients.
Specifically, the website provides information about the in vitro susceptibility of bacteria or fungi to certain drugs.
“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 Scott Gottlieb, MD, commissioner of the FDA. “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.”
To address the problem, Congress in the 21st Century Cures Act created a system to expedite the recognition of antimicrobial susceptibility test interpretive criteria—also known as “breakpoints”—and provide up-to-date information to the healthcare community in a more streamlined manner.
“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,” added Gottlieb. “Our new tool is aimed at making this process more efficient and informed.”
Because bacteria and fungi evolve, resulting in decreased susceptibility to some drugs, breakpoints must be updated. As part of the new approach, the FDA will simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information through the agency’s dedicated website.
Edward Cox, MD, director of the Center for Drug Evaluation and Research’s Office of Antimicrobial Products at FDA, said the new approach will take advantage of online tools to modernize how the agency updates breakpoints and will leverage the work of Standard Development Organizations (SDOs) that develop breakpoints.
“FDA assesses any changes in breakpoints made by SDOs and retains full authority to decide whether any changes should be recognized,” according to Cox. However, if companies disagree with the recognized standard, they can submit data to support alternative breakpoints.
While drug manufacturers will no longer have to constantly update their labeling with new breakpoint information, they will have to update their labeling to reference the FDA website containing the breakpoint information. The agency has published guidance to assist drug manufacturers with the transition from drug labeling to the online tool.
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