Blog Post #1: Presenting Risk Information in Prescription Drug and Medical Device Promotion

Rosalyn Finlayson

September 12, 2010

Name of Guidance:

Presenting Risk Information in Prescription Drug and Medical Device Promotion

Status of Guidance

Draft

Date of Guidance

May 2009

Link to the Guidance

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

Target audience

Manufacturers, advertisers, and sponsors who produce promotional materials for prescription drugs and medical devices.

Laws An Regulations Referenced

21 CFR 1.3 Defines label and specifications for the labeling of products in interstate commerce.

21 CFR 202.1 Contains the statutes and regulations regarding truth in advertising.

21 CFR 314.50 Stipulates that the manufacturers draft of a label is subject to review and approval by FDA as part of the new drug application.

103 F.T.C. 110 Federal Trade Commission Policy Statement on Deception, (Oct. 14, 1983)

21 U.S.C. 321 Defines label and specifies that labels failing to reveal material facts will be considered misleading.

21 U.S.C. 352 Stipulates that the manufacturing, sale and distribution of drugs and devices in the United States is regulated by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.

Kordel v. United States, 335 U.S. 345, 350 (1948) Stipulates that supplemental materials of an article do not require physical attachment but must have a textual relationship.

Summary

The FDA recommendations in this guidance apply to all forms of print, audio and video advertising for prescription drugs and medical devices, including promotional materials produced for the healthcare industry and general public consumers. In formulating compliance recommendations the FDA relied on social science principles and data from cognitive science research studies regarding how the human brain processes visual and auditory information.

Contained within the guidance are clear directives and concrete examples of the factors considered by the FDA in assessing the degree of compliance. The concrete examples provided demonstrate how to present benefit and risk factors as well as the overall presentation of the product. In assessing the overall impression of a promotional piece, the FDA relies on the Federal Trade Commission’s interpretation of social science principles for net-impression to determine if any aspect of the promotional material could be determined as misleading.

Rationale

The FDA seeks to guide manufacturers of prescription drugs and medical devices in the overall design of promotional advertising materials in order to ensure that accurate, truthful and adequate information is being given to consumers and health care professionals.

The FDA provides information from cognitive science studies to encourage the producers of promotional materials to design materials that are compatible with the manner in which a human brain processes visual and auditory information.

Resulting Recommendations

The FDA recommends the following guidelines for drug and medical device promotional materials.

• Language and Terminology: Manufacturers of promotional materials need to use language appropriate for the intended audience by using medical terminology with healthcare professionals and laymen’s terms with general public consumers.

• Signal Clues: The use of signal clues guides the audience’s attention to key components of information. With print materials use a change of graphic or visual context clues as a signal. When producing video, broadcast, and audio mediums use changes in the announcer, voice characteristics, background music, graphics and visual context clues as a signal.

• Framing of Information: Consistently use the drugs name, numerically state the risks statistics, and present the benefit and risk factors with equal tone.

• Hierarchy of Risk Information: Risk factors need to be listed in order of severity taking into consideration the research on cognitive processing. Place the most important risks at the beginning and end of the list when using broadcast and auditory mediums. For print materials place the most important risks first on the list.

• Material Facts: All material facts must present the essential qualities of the products benefits and risks in an accurate and truthful manner. This includes relevant properties about the product such as the appropriateness for use within certain consumer demographics as well as the type of feedback that needs to be communicated between the consumer using the product and their healthcare provider.

• Appearance and Format: Follow cognitive processing principles by using statements in bold type for categories, keep paragraph and sentence length brief, colors and background should enhance readability, use easy to read font size and style, keep non-print superimpositions in video and broadcast on the screen long enough to be read and understood, quality of speech in audio needs to be presented at a pace that can be understood by the target audience, and use background music that has a suitable tone for the type of product.

• Net Impression: Ensure that the overall promotional material conveys a message that is appropriate for the targeted audience.

Impact:

Well-enforced compliance with this guidance will hold the manufacturers of promotional materials accountable for truth in advertising of their product. Responsible advertising and promotion can serve to educate individuals about the variety of drugs and devices available to treat a specific medical condition. Consumers are able to become better self-advocates for their medical treatment when they have truthful and adequate information. Healthcare providers and consumers are ensured of receiving the type of information that will help them understand the benefits and risks of a particular prescription drug or medical device when all of the recommendations presented by the FDA are followed.