The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs” (Draft Guidance).  The Draft Guidance significantly revises the FDA’s January 2004 draft guidance on the brief summary requirement for disclosures in consumer-directed print advertisements and also covers promotional labeling.  In the revised Draft Guidance, the agency strongly recommends the use of either a Drug Facts Box or a series of questions and answers for displaying risk information in consumer-directed print advertisements and promotional labeling in order to improve patient comprehension of important product-related information.  According to the FDA, these “research-tested” formats are designed to be an alternative to the use of lengthy and technical risk information that currently appears in traditional print advertisements and promotional labeling.

Scope of the Draft Guidance

The Draft Guidance applies to prescription drug and biological product print advertisements and promotional labeling, if such materials are directed to consumers.  The Draft Guidance does not apply to promotional materials directed at health care professionals, or to radio, television or broadcast advertisements.  Additionally, the Draft Guidance does not address risk information included in the main portion of the advertisement or promotional labeling.  Rather, the Draft Guidance focuses on a new “consumer brief summary.”

A New Approach to the Content and Format of Brief Summary and Adequate Directions for Use Requirements: The Consumer Brief Summary

The Draft Guidance discusses how manufacturers, packers, distributors and those working on their behalf (firms) traditionally approach the “brief summary” and “adequate directions for use” requirements contained in the Federal Food, Drug, and Cosmetic Act in the context of consumer-directed prescription advertisements and promotional labeling pieces.  The brief summary requirement mandates the disclosure of each side effect, warning, precaution and contraindication from the prescription drug’s labeling in drug advertisements.  Currently, firms typically meet the brief summary requirement by providing the entire risk-related portion of the FDA-approved package insert.

The adequate directions for use requirement provides that prescription drug promotional labeling materials distributed by or on behalf of a firm must contain adequate information for use and additional labeling information as set forth in 21 C.F.R. § 201.100(d).  Firms generally fulfill the adequate directions for use requirement by including the full package insert.

In the Draft Guidance, the FDA sets forth its strongly preferred streamlined approach for fulfilling the brief summary and adequate directions for use requirements.  The FDA refers to its recommended approach of combining the information in the brief summary and adequate directions for use requirements as the “consumer brief summary.”  The FDA’s suggested approach allows firms to provide consumers with the same content in print advertisements and promotional labeling pieces.

The FDA states that it “does not intend to object if a firm does not include ‘each specific side effect and contraindication’” from the package insert in the brief summary.  Similarly, if firms follow the Draft Guidance, the FDA states that it “does not intend to object for failure to include the entire [package insert] to fulfill the requirements of [21 C.F.R. §] 201.100(d) for consumer-directed promotional labeling pieces.”  

The Draft Guidance discusses three key aspects of the consumer brief summary: 

• Language and readability

• Content

• Format

Language and Readability Recommendations

The Draft Guidance was informed by studies of how well consumers absorbed the detailed information contained in the package insert, which was the means of conveying the required information in the traditional approach.  The studies found that this lengthy technical information was difficult for consumers to understand.  In order to create advertisements and promotional labeling pieces that are more consumer friendly, the FDA recommends that firms take the following steps:

• Write for varying levels of literacy skills

• Avoid technical, scientific and medical jargon

• Use a conversational tone

• Use signals, such as headlines and subheadings

• Repeat the use of logos and branded colors from the main body of the advertisement in the consumer brief summary

• Maximize background or white space to improve readability

• Select font sizes and styles based on readability

• Use text boxes with headings, bullets and other attention-drawing mechanisms

Content Recommendations

The consumer brief summary should focus on the most significant clinical information and the most serious and common risks.  To determine which serious and common risks to include in the consumer brief summary and which to omit, the Draft Guidance recommends that firms take the following steps:

• Review risk information in FDA-approved patient labeling and Medication Guides

• Include information about relevant drug risks that does not appear in the patient labeling

• Examine the criteria for selecting risk information for the Highlights of Prescribing Information for risk topics to add to the consumer brief summary, but provide more detailed and material information than the information that appears in the Highlights

• Display information in the consumer brief summary in an order substantially similar to the Highlights of Prescribing Information

According to the Draft Guidance, the following information should be included in the consumer brief summary:

• Boxed Warning (if applicable to the particular drug or biologic)

• All contraindications

• From the Warnings and Precautions sections of the package insert, the most clinically significant information, including 
  o Information that would affect a decision to prescribe or take a drug
  o Whether monitoring or laboratory tests are needed during treatment
  o Special precautions not included in other parts of the package insert
  o Measures that patients should take to prevent or mitigate harm

The FDA also recommends that the consumer brief summary include the following:

• The most frequently occurring adverse reactions for each indication for which the product is being promoted, listed in the same order as in the package insert

• Serious adverse reactions and other important adverse reactions, unless mentioned elsewhere

• Material information regarding risks, including severity or early warning signs of risks

• The indication for the use being promoted and information relevant to each indication being promoted

• Clinically significant drug interactions

• Topics consumers should discuss with their health care providers

• Information relating to special populations of concern based on the drug’s safety profile

• A reminder that the information in the summary is not comprehensive

• A suggestion that consumers speak to their health care provider or pharmacist

• A toll-free number or website where consumers can find the FDA-approved labeling

The Draft Guidance also outlines topics that can be excluded from the consumer brief summary:

• Information that appears in the Directions for Use section

• Dosage, administration and clinical pharmacology information

• How the drug is supplied

• How long the drug takes to work

Format Recommendations

The FDA’s recommended formats for presenting risk information to consumers in the consumer brief summary are as follows:

• A Prescription Drug Facts Box similar to the Over-the-Counter Drug Facts Box

• A Question and Answer format

Comparison of the 2004 Draft Guidance and the 2015 Revised Draft Guidance

In the revised Draft Guidance, the FDA expanded the application of the 2004 draft guidance to biologics and consumer-directed promotional labeling, and changed its position regarding how firms should present risk information.  In the 2004 version, the FDA offered firms three options for presenting risk information in consumer-directed print advertisements:

• Present all risk information from the FDA-approved professional labeling

• Reproduce FDA-approved patient labeling, in its entirety or without less important risk information

• Provide risk information that would be appropriate for the FDA-approved Highlights of Prescribing Information

Although the FDA emphasized that it would not object to advertisements that omitted less important risk information in 2004, the agency still endorsed the presentation or reproduction of all risk information in consumer-directed advertisements.

In contrast, the 2015 Draft Guidance strongly recommends against the inclusion of all risk information and verbatim reproductions of risk information.  Both versions of the Draft Guidance similarly discourage firms from using small type and scientific, technical and medical terms that are less likely to be understood by consumers.

Although the 2004 draft guidance did not provide specific “research-tested” formats for presenting risk information, it contained similar recommendations to the 2015 Draft Guidance regarding content.  For example, the 2004 draft guidance recommended that firms include a reminder that the information presented is not comprehensive and a toll-free number or website where consumers could find additional information.  The 2015 Draft Guidance additionally recommends that each advertisement suggest that the consumer speak with his or her health care provider or pharmacist.

Implications for Regulated Manufacturers, Packers and Distributors

The agency’s approach is a constructive effort to optimize readability and consumer comprehension of important risk information presented in prescription drug materials.  By offering an alternative to the inclusion of the entire risk-related section of the FDA-approved package insert in print advertisements or the full package insert in promotional labeling pieces, the revised Draft Guidance offers a new regulatory approach to communicating with consumers in advertising and promotional materials.  However, the revised draft guidance will likely impose new challenges for firms seeking to adapt their overall advertising and promotion program to these changing regulatory enforcement policies, while also mitigating risk with regard to product liability and consumer protection laws.

Comment Deadline

Firms should consider submitting comments regarding the Draft Guidance to the FDA.  Any comments must be submitted by May 11, 2015, in order to be considered by the agency before it begins work on the final guidance document.