FDA Issues New Guidance on Drug Labeling and Pharmacologic Class

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information. The good review practice guidance defines established pharmacologic class and helps to identify the most appropriate term for describing the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling.

A 2006 final rule requires that drug manufacturers include the following statement on labels for drug products that have an established pharmacologic class: “(Drug) is a (name of class) indicated for (indication(s)).” 

“Knowing the established pharmacologic class can provide health care professionals with important information about what to expect from a drug and how it relates to other therapeutic options,” says the guidance. FDA also explains in the guidance that the agency is “in the process of using structured product labeling (SPL) to index certain types of prescribing information content for all drug products” and that because of its importance, pharmacologic class is being indexed in the first phase of this process.

For purposes of this guidance, a pharmacologic class can be based on one of the following three drug attributes:

• Mechanism of action (MOA)-that is, pharmacologic action at the receptor, membrane, or tissue level;

• Physiologic effect (PE)- that is, pharmacologic effect at the organ, system, or whole body level;

• Chemical structure (CS).

The guidance further defines established pharmacologic classes, how to identify the most appropiate term for describing a class, and when to include a combination of classes on the drug product label.