Blog Post #5: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements

Rosalyn Finlayson

Name of Guidance:

Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements

Status of Guidance

Draft Guidance

Date of Guidance

January 2004

Link to the Guidance

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm069984.pdf

Target audience

Manufacturers of prescription drug products and the advertising industry

Laws An Regulations Referenced

Section 502(n) of the Act (21 U.S.C. 352(n)) Federal Food, Drug, and Cosmetic Act (the Act)

21 CFR 202.1(e)(1): Requires that an advertisement contain a true statement of information in brief summary relating to side effects, contraindications and effectiveness.

21 CFR 202.1(e)(3)(iii)): Requires disclosure of each specific side effect and contraindication.

Summary

This draft guidance replaces the April 2001 guidance on Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements. Provided in this January 2004 draft guidance are revised recommendations on the disclosure of risk information in print advertisement for prescription drug products marketed to the general public. The guidance encourages the use of consumer-friendly language in all advertising materials created specifically for the consumer. The focus of this guidance is on the content of the FDA brief summary requirement for the true statement and disclosure of side effects.

Rationale

This draft guidance is proposing revisions to the manner in which risk factors of prescription drugs are presented in print media directed towards consumers. The FDA has taken the stance that the approved professional labeling guidelines are inappropriate for consumer-directed print advertisements because many consumers do not have the technical background to understand the information presented. Under FDA guidelines, advertisements for prescription drugs must contain the product's established name, quantitative composition and a "true statement" including information in brief summary relating to side effects, contraindications, and effectiveness. In order to fulfill the brief summary requirement, consumer-directed print advertisements frequently include all of the risk-related sections of the FDA approved professional labeling. Although the agency has drafted guidance discouraging this practice many consumer directed advertisements continue to contain the FDA approved professional labeling, which is written with highly technical medical terminology, contains extensive lists and printed in small type.

Resulting Recommendations

The FDA is making the following recommendations for consumer-directed print advertisements. All information intended for the general public consumer should be presented in language that can be fully understood by a lay reader and presented in an easily readable format. An easily readable format is defined as a format consisting of larger easy to read type and a manageable volume of material. Utilizing a smaller volume of material related to the major risk factors is recommended rather than extensive lists containing all of the major and minor risk factors. Including extensive lists of minor risk factors makes it difficult for the consumer to comprehend and retain the more important information about the major risk factors.

The FDA is also encouraging the use of Highlights for consumer-directed print advertisements. Highlights are to be written in a language that is easy to understand by the general public consumer. The guidance provides the following example of a Highlight for industry to follow. Instead of using the term “contraindications” in the Highlight the FDA recommends using phrasing that the general public is more than likely to understand. For example: “You should not take drug X if you….”

Impact

Compliance with this guidance will assist drug manufacturers and the advertising industry in creating materials that are easily understood by the ordinary general public consumer under normal conditions. The general public will be able to receive materials in layman’s terms about the risk factors associated with prescription drugs.