US Food and Drug Administration (FDA) has issued guidance on 'Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products' related to the content and format. The information is crucial for patients to use the drug safely effectively. In this regard, the regulatory authority is  awaiting the pharma industry to comment before the October 31.

According to the industry representatives from Biocon, Micro Labs and Bal Pharma, the guidance provides clear cut format on what should be indicated on the labels. “The purpose is to inform the patient about the contents and ensure his safety. In an age of an educated patient environment, it is only proper for the regulatory authority to come up with such rules.”

This guidance is intended to assist applicants with developing the patient counseling information required under 201.57(c)(18) (21 CFR 201.57(c)(18)). The recommendations are intended to make sure that labeling is clear, useful, informative to the extent possible be consistent in content and format, said the regulatory authority.

“It is intended to assist applicants on how to decide what topics to include in the patient counseling information section. It also details on information presentation and how to organise the patient counseling information section,” said the regulator.

However, the FDA’s guidance documents does not establish legally enforceable responsibilities. Instead, it describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. If applicable, reference to FDA-approved patient labeling; the full text of such patient labeling must be reprinted immediately following the full prescribing information (FPI) or, alternatively, accompany the prescribing information.

Before FDA published the final rule, labeling regulations required that any information necessary for patients to use the drug safely and effectively be presented under information for patients, a subsection of the precautions section of labeling.

By requiring a dedicated section to such information in labeling in the PLR (physician labeling rule) format, FDA has underscored the importance of healthcare providers’ counseling patients.

Since the regulatory requirements in the patient counseling information section are worded and many different presentations have been approved in PLR format, the guidance seeks to provide recommendations on how to select information to include and bring greater consistency to the content and format of the patient counseling information section.

The section is written for use by a health care provider to identify topics for a counseling discussion. Therefore, the content and presentation of information in the patient counseling information section typically will differ from those in FDA-approved patient labeling like for instance the patient package inserts, medication guides, and instructions for use.

Further, the patient counseling information section should focus on the effective use of a drug. The reference to patient labeling informs healthcare providers of the existence of approved patient labeling and directs them to advise patients to read the same, said the regulatory authority.