The FDA is launching a new website to get critical updates about antibiotics and antifungals out faster to health care professionals to help them make more informed prescribing decisions. The site will provide “direct and timely access” to information about when bacterial or fungal infections are likely to respond to a specific drug.
“When you are treating critically ill patients, you want as much information as possible about the pathogen…and the susceptibility of that pathogen to various treatment,” said FDA Commissioner Scott Gottlieb, MD. Under the old approach, he said, updating each drug’s individual labeling took too long. Only after the revised drug labeling was approved could a drug or device manufacturer update testing criteria and labeling for the latest antimicrobial susceptibility test results. Each drug and device labeling had to be updated whenever criteria changed.
The new tool will allow the FDA to simultaneously provide updates multiple drugs that have the same active ingredient and share that information transparently via a dedicated web page.