FDA Guidance: Regulations in Disguise? 

(Bloomberg Law)

• FDA announced the launch of a new tool that will give healthcare providers direct and timely access to critical updates about antibiotics and antifungal drugs. A new website will provide information about when bacterial or fungal infections are likely to respond to a specific drug. According to FDA, "This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria." Physicians use antimicrobial susceptibility testing to help select an appropriate antibacterial or antifungal drug to treat a patient's infection. The tests use criteria, known as "breakpoints," that help determine whether a specific bacteria or fungi is susceptible to antibacterial or antifungal drugs. However since bacteria and fungi change over time, the breakpoints need to be updated.
• Previously, each drug manufacturer updated its drug labeling with new breakpoint information, which FDA reviewed and approved on a case-by-case basis. Under the new approach, FDA can simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently through a dedicated FDA website that will list FDA-recognized breakpoints. Companies that disagree with the recognized standard can submit data to support alternative breakpoints, FDA noted. Drug companies will have to update their labeling to reference the FDA webpage containing the breakpoint information-but will no longer have to continuously update their labeling with new breakpoint information, which should make "the process more efficient and more timely." The agency is also issuing guidance on how companies should update their labeling on breakpoints to point to the information online generated by FDA.

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