Regulatory Focus™ > News Articles > New FDA Guidance Details How to Convey Patient Counseling Information Through Labeling

New FDA Guidance Details How to Convey Patient Counseling Information Through Labeling

Posted 18 September 2013 | By Alexander Gaffney, RAC

A new guidance document released by the US Food and Drug Administration (FDA) on 17 September 2013 is intended to assist industry with the development of the "Patient Counseling Information" section of drug and biological labeling, including what topics to include and how information should be presented and organized.


Drug labeling has been standardized in the US since 1979, when measures to introduce uniformity were first passed. Since that time, drug labeling has become considerably lengthier and more complex to account for improvements in regulatory science and additional requirements, generally related to the safety of the product.

In 2000, FDA began an evaluation of its labeling processes and requirements with the ultimate goal of improving the labeling to make it more effective at its given purpose: informing its user about the drug's properties, including the risks and benefits associated with its use.

That process resulted in a 2006 final rule, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, better known as the Physician Labeling Rule (PLR).

The regulation required a new section in the labeling known as the Patient Counseling Information (PCI) section which serves to summarize the information a healthcare provider should convey to a patient or caregiver when discussing the proper use of the product. FDA notes two aspects of particular importance:

  • The information must include everything necessary for the safe and effective use of the drug.
  • There must be reference to the full prescribing information (FPI), the full text of which must immediately follow or accompany the PCI.

"By requiring a dedicated section to such information in labeling in the PLR format, FDA underscored the importance of health care providers' counseling of patients," the agency explains in a Federal Register posting.


Now FDA is out with guidance that-as with most other guidance documents-is intended to assist industry with generating the content contained within each drug's respective PCI.

The key takeaway, FDA writes, is that the PCI will differ from the FDA-approved patient labeling in that it is intended for health care providers to identify topics for the purposes of counseling a patient and/or caregiver. Accordingly, both the content and presentation of the information will contain the "most important information" on how to use the drug safely and effectively. Consequently, all topics in the PCI should be in the FPI, though different language may be used.

Related to this point is FDA's insistence that any summary points in the PCI reference the corresponding section in the FPI labeling, allowing health providers to learn more if they so choose. FDA includes several approved statements to this effect in its guidance which industry may use or modify depending on the intended audience (caregiver or health care provider).

The guidance observes that "not every risk discussed in labeling" will need to be in the PCI section, just those believed to be "critical" for safe and effective use of the drug. "These would typically include the most important risks about which patients should be informed and those for which a patient may need to do something actionable (e.g., contact the prescriber, immediately discontinue the drug, or seek emergency medical care)," FDA explained. In other words, focus on what FDA calls the "major risks of the drug" and how they can be prevented, mitigated or managed.

Information: What to Include and How to Include It

Information presented within the PCI should be a brief summary of each topic, ordered by decreasing order of clinical significance using the active (rather than passive) voice. For example, the labeling should instruct the provider to "Advise the patient" to do something rather than saying the "patients should be advised" to do something.

Information should not be presented as a list of risks associated with the use of the drug, FDA said. In addition, a listing of common adverse events should not be included in the PCI unless it is important to convey a particular risk to a patient. Similarly, contraindications are generally not included in this section, as it is not information a patient generally needs to know (though it is for the health provider). Drug-drug interactions or food interactions, however, should be included, as patients ingesting grapefruit or an over-the-counter drug could be affected, for example.

A full list of information to include and exclude, as well as requirements for subheadings and cross-referencing, is available in the guidance document, Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format.

Draft Guidance on PCI

Federal Register

Regulatory Focus newsletters

All the biggest regulatory news and happenings.