The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R. § 201.57(c)(18). The Guidance contains recommendations on the types of information to consider for inclusion in the section, how to present and organize the information, as well as information not to include.

What’s in the Guidance?

The Guidance finalizes draft guidance issued on September 18, 2013. It reiterates the FDA’s position that the “Patient Counseling Information” section is intended to facilitate provider-patient discussion, but is not to serve as a script for the provider The Guidance specifically lists the following types of information to consider including:

Important adverse reactions and other risks. The information should include identification of the risk, management recommendations, self-monitoring information, and information on when to contact a health care provider, seek emergency help, or discontinue the drug.

Contraindications. While most contraindications are not appropriate for a patient counseling discussion, contraindications for conditions that may develop after starting drug therapy are warranted.

Drug interactions. Interactions or effects from other drugs or foods should be included in the section if they concern an important risk.

Information on use in pediatric patients, pregnancy, and lactation. A discussion of the risks of a drug in pediatric patients, pregnancy, or during lactation should be included in the section if the information concerns an important risk.

Information on preparation and administration. The section should summarize the most important points relevant to a counseling conversation (e.g. instructions to take the drug with a high-fat meal or on an atypical dosing schedule) as opposed to full details on proper preparation and administration of a drug.

Products with restricted distribution as a component of a Risk Evaluation and Mitigation Strategies (REMS) program. Reference to the existence of a REMS program that includes restricted distribution should be included in the section along with a brief description of only those program elements that directly impact the patient.

Instructions related to storage and handling. Instructions should be included in the section only in rare cases where there is atypical storage or handling information that would be appropriate for a provider-patient discussion.

Additional requirements. Certain products have additional, specific requirements for the section based on the product’s therapeutic or pharmacologic class that can be included in the section.

The Guidance emphasizes that not all information related to use of a drug should be included in the section. Examples of information that should not be incorporated include: indication or use of a drug, general advice that could apply to any drug, information that informs prescribing decisions, routine administration or storage and handling information that would be conveyed to a patient at the time of dispensing, and graphics.

As for presentation of the information, the FDA suggests that the “Patient Counseling Information” section should summarize each topic, be ordered by the relative clinical significance of the information, and be presented using active voice. The section is subject to applicable formatting requirements under §§ 201.56(d) and 201.57(d) but the FDA also recommends using subheadings to enhance readability, cross-referencing to direct the reader to a more detailed discussion elsewhere, and appending FDA-approved patient labeling.

The Guidance communicates the FDA’s recognition that information contained in the “Patient Counseling Information” section, along with provider-patient conversation, are essential components for the safe and effective use of prescription drugs. In conveying this recognition, the Guidance ensures that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

A Refresher on the Label Rule

On January 24, 2006, the FDA published a final rule commonly referred to as the “Physician Labeling Rule” in the Federal Register. 71 Fed. Reg. 3,992. This rule amended the requirements for the content and format of labeling for human prescription drug and biological products. In pertinent part, the rule created a new required section in labeling entitled the “Patient Counseling Information” section, which provides important drug information that practitioners must communicate to patients when a counseling discussion is taking place (e.g. a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy.) See 21 C.F.R. § 201.57(c)(18).

Under § 2701.57(c)(18), the “Patient Counseling Information” section of labeling must contain: (1) information necessary for patients to use the drug safely and effectively and (2) if applicable, reference to FDA-approved patient labeling; the full text of such patient labeling must be reprinted immediately following the full prescribing information or, alternatively, accompany the prescribing information. The new Guidance clarifies the requirements found in this section.

Next Steps for Providers

Since the “Patient Counseling Information” section is required in all labeling subject to § 201.57, including for drugs used in an inpatient setting or other health care setting, such as a clinic or physician’s office, health care providers should pay close attention to the FDA’s recommendations.