Publications

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In response to industry requests for more clarity, FDA has issued draft guidance explaining the agency's thinking on the way companies present risk information in prescription drug and medical device promotion.

The guidance emphasizes the importance of stylistic issues in promotional communications—not just the content of the risk information, but the way it is presented.

The draft guidance, available here, applies to FDA evaluation of:

• Advertisements and promotional labeling for prescription drugs;
• Advertisements for restricted medical devices; and
• Promotional labeling for all medical devices.

In enforcing advertising and promotion standards, FDA most frequently cites companies for omitting or minimizing risk information. The general requirements for compliant promotional pieces are that the pieces:

• cannot be false or misleading;
• must reveal material facts, including potential consequences of use; and
• should provide balanced information about benefits and risks.

The proper presentation of risk information is critical to all three issues.

When FDA evaluates a promotional piece, it looks at the net impression created by all the elements; there is no formulaic language that can be included to cure all concerns if the piece as a whole conveys inaccurate, misleading, incomplete or unbalanced information. The net impression is important to FDA because it is tied to an evaluation of what a "reasonable consumer" will take away from the promotional piece. In applying this standard, FDA will take into account the different level of knowledge and experience between lay consumers and health-care professionals. Nevertheless, the agency believes even "experts" are influenced and limited in their ability to process information, depending on the way it is presented.

Specific points in the draft guidance are summarized below.

General Considerations

Consistent Use of Language Appropriate for Target Audience. Both benefits and risks should be communicated in an audience-appropriate way. For example, a consumer-directed ad that presents benefit information in lay terminology should not describe risks in technical terms that a consumer would not understand (for example, you should say "fainting," not "syncope").

Use of Signals. "Signaling" to emphasize certain text or audio information can be problematic if the signaling is not consistent across benefit and risk information. Examples include headlines and subheadings. The content of signals is also important.

Framing Risk Information. The way risks and benefits are "framed" (that is, the way information is stated or conveyed) can affect the perception of risks and benefits. Phrasing and the level of specificity can significantly influence the way a message is received. Risk information should be presented in the same terms or with the same degree of specificity as benefit information, and in a way that accurately reflects the nature of the risk.

Hierarchy of Risk Information. The order in which information is presented impacts how effectively it is conveyed to the reader or viewer. In broadcast ads, the most important information should be at the beginning, end or both. In written materials, this information should be placed first, because readers may lose interest and not read the entire piece.

Considerations of Content

Quantity. The quantity of information can affect the reader or viewer's net impression. The amount of benefit information should be balanced with the amount of risk information. Companies should consider the space or time devoted to benefit versus risk, the comprehensibility of the language used for each and the type of information provided for each.

Materiality and Comprehensiveness. Materiality generally means the degree to which information is objectively important, relevant or substantial to the target audience. Even if similar time and space are devoted to benefits and risks, an ad could be considered misleading if it leaves out material information that would influence a consumer or health-care professional's views about a product. FDA evaluates the quality, and not just the quantity, of risk information presented.

• Different information may be material to different target audiences. For example, what is material to a prescriber could differ from what is material to a patient.
• The Package Insert is key to FDA's determination of what is material.
• The specific benefit claims being made may influence what risk information is material.
• Consumers expect that all of the most relevant risks have been included in ads, especially if some risks are mentioned. Omitted risk information can have serious effects.

Considerations of Format

"Format" includes such elements as the size, shape and layout of all portions of a print piece, and the way a non-print piece (such as a broadcast ad) is planned in terms of organization, arrangement and theme.

Print Promotion. When assessing the comparable prominence of benefit and risk information, FDA considers the following, in addition to the issues described above:

• Overall location of risk information;
• Location of risk information within a section of the promotional piece;
• Font size and style;
• Contrast; and
• Background or "white space."

Non-Print Promotion. The unique features of non-print media such as videos, broadcast ads and other audio and visual pieces add complexity to risk presentation. FDA considers proximity, type size, type style and contrast, which are especially important in connection with text superimposed on other images (SUPERs) and other visual components in any scene. FDA also considers additional aspects unique to non-print pieces, including the combination of audio and image components. FDA's guidance specifically addresses the following elements:

• Textual elements, including the impact on readability, comprehensibility and proximity between benefit and risk. SUPERs can present particular problems if used to disclose risk-related qualifying information; if they do not appear close enough to the claim or statement that needs qualifying, the resulting impression may be misleading.
• Contrast, because it is critical that risk disclosure be presented in a way that provides sufficient contrast with the background and avoids obstacles to prominence and readability.
• Dual mode considerations, meaning the interplay of visual and audio components. A visual depiction of a joyous moment could distract from a risk-related voiceover delivered in low tones, resulting in an inaccurate impression about product risks.
• Audio considerations, such as the quality and tone of speech, pacing, volume and background music, all of which have the potential to create a misleading net impression.

FDA requests that comments on the draft guidance be submitted by August 25, 2009.