The regulator issued guidance containing recommendations meant to ensure that the “Patient Counseling Information” section of labeling is clear and useful, as well as consistent.
In 2006, the FDA issued a final rule amending the requirements for the content and format of drug labeling, and creating a section in labeling called “Patient Counseling Information.”
This month, the agency published guidance titled “Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products – Content and Format,” which is aimed at helping applicants in developing that particular labeling section. In the document, the FDA covers how to choose topics to include in the Patient Counseling Information section, how to present it and how to organize it. The document states that since regulatory requirements for the section are “broadly worded” and that multiple different presentations have been used in labeling, the FDA is publishing guidance to offer recommendations on selecting the information to include, and to increase consistency as it relates to the content and format of the section.
The guidance elaborates on the FDA’s thinking on the content of the section, including its purpose and aim — which is to allow healthcare providers to identify topics for a counseling discussion with a patient once a prescribing decision is made.
The FDA also includes specific recommendations regarding content, starting with the reference statement language as well as where it should appear. The guidance also contains the FDA’s recommendation concerning counseling topics, describing how the information should be presented and listing the types of information to include, as well as information that should not be included in the patient counseling section.
Lastly, the FDA informs applicants of its recommendations relating to the format of the section, elaborating on the subject of subheadings, cross-referencing and appending.