FDA Requests Public Comments By August 25, 2009
In response to industry requests for better insight into how FDA evaluates promotional materials for prescription drugs and medical devices for compliance with statutory and regulatory requirements, FDA issued a Draft Guidance document on May 26, 2009, titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion."
The Draft Guidance covers all prescription drugs and medical devices, including those regulated by CDER (Center for Drug Evaluation and Research), CBER (Center for Biologics Evaluation and Research), CVM (Center for Veterinary Medicine), and CDRH (Center for Devices and Radiological Health) and explicitly states that its principles apply to "all promotional pieces, regardless of the medium used or the target audience." In addition to traditional types of promotional materials, such as television ads, brochures, and print ads, the Draft Guidance notes that the term "promotional piece" also includes Internet websites.
The two main purposes of the guidance are to: 1) describe the factors FDA considers when evaluating the adequacy of risk disclosures in prescription drug and medical device advertisements and promotional materials and 2) provide the industry with recommendations on how to comply with statutory and regulatory requirements when developing promotional materials. The guidance describes both content and format factors that are relevant to FDA's review and provides 20 examples to illustrate the factors that are taken into consideration when reviewing prescription drug advertisements, restricted device advertisements, and prescription drug and device promotional labeling. The recommendations and considerations in the Draft Guidance reflect FDA's long-standing policies, comments, and objections previously raised in untitled and warning letters and public statements.
Comments on the Draft Guidance should be submitted to FDA by August 25, 2009.
How FDA Evaluates Promotional Materials
Net Impression View
When FDA evaluates the risk communication in a promotional piece, it looks at the "net impression" of all the risk and benefit statements combined, as well as each individual statement of risk. In other words, FDA determines whether the piece as a whole conveys a truthful and non-misleading view of the risks and benefits of the product. The Draft Guidance notes that this "net impression" analysis is based on the results of decades of scientific research and is also used by other agencies, including the Federal Trade Commission (FTC), in determining whether a promotional piece is likely to mislead.
Reasonable Consumer Standard
In evaluating the "net impression" of a promotional piece, FDA will apply the "reasonable consumer standard," as it does for food and dietary supplements. This standard is also comparable to the FTC's reasonable consumer standard, in which a promotional piece is examined from the perspective of a consumer acting reasonably in the circumstances. FDA articulated the "reasonable consumer standard" as: "[W]e examine the practice from the perspective of a consumer acting reasonably in the circumstances. If the representation or practice affects or is directed primarily to a particular group, the Commission examines reasonableness from the perspective of that group." In other words, if a promotional piece is targeted at a particular group, the evaluation is from the perspective of a reasonable member of that group. The Draft Guidance notes that there may be multiple reasonable interpretations of various claims; however, if even one interpretation is false, the seller may be liable for misleading promotion.
FDA's Factors For Evaluation Of Risk Communication
The Draft Guidance describes factors that relate to both the content and format of a promotional piece. Use of language, signals, and framing of information will all be considered in evaluating the balance of the risk and benefit information presented.
Consistent Use of Language Appropriate for Target Audience. FDA notes that the language used to communicate the risks and benefits of a product should be comprehensible to the same audience. If the piece is directed to professionals, risks and benefits can be described in medical language. If directed to consumers, the language used to convey risks and benefits should be in terms understandable to consumers.
Use of Signals. Signals are devices used in written, broadcast, or other types of promotion pieces to emphasize particular content and draw attention to it. Headlines and subheadings are examples of written signals, whereas broadcast signals may be audio announcements or on-screen visuals that draw attention to items of information. When evaluating risk communication, FDA looks to see if the use of signals is clear and consistent in both the benefit and risk information. Content of signals is also important and should not mislead or falsely emphasize or minimize the importance of benefits or risks.
Framing Risk Information. Framing refers to the way in which information is communicated, such as in vague versus specific terms, or with emphasis on particular items. FDA warns that risk information can be minimized by stating it in vague terms or by framing it in such a way as to downplay the risks. The Draft Guidance provides examples of framing that minimizes risk information, including the use of a generic product name rather than the branded name when describing risks, or using phrases to downplay risks, such as "like all medicines, Drug X has some side effects." Another cited example of misleading use of framing is the use of a vague phrase such as "continuation of therapy may necessitate certain monitoring," when the product actually requires specific therapy or testing.
Hierarchy of Risk Information. FDA highlights the ordering of risks within a promotional piece as an important factor in determining the risk and benefit balance. In print promotional pieces, the most important risks should be stated at the beginning of a list, where readers are more likely to take note and remember. In broadcast promotions, important risks should be stated at the beginning or end, or both, which are generally the easiest portions of the broadcast for viewers to process. Important risks should not be relegated to the middle of a list of less important risks, and risk information is best dispersed throughout the piece, rather than just one location.
In addition to the manner in which risk information is presented, the content of risk presentations is important in evaluating the balance and accuracy of promotional materials. An insufficient amount of information or the omission of certain types of information can render a promotional piece misleading.
Quantity. The amount of information provided in a promotional piece can affect the net impression it provides. As the amount of benefit information provided increases, so should the amount of risk information. FDA notes that it will look to see that sufficient time and space are allotted to both risk and benefit information to ensure that the net impression is accurate and non-misleading. In assessing the balance of risk and benefit information, FDA will consider:
• The number of statements conveying risks and benefits, although the amount of each need not be identical;
• The amount of detail given about risks and benefits;
• The amount of time allotted to risks and benefits in broadcast/audio promotions;
• The amount of space in print promotions allotted to risks and benefits;
• Use of audio or visual components to enhance or distract from items of risk and benefit information.
Materiality. A promotional piece must include the most material information about a product's risks in order to provide balance and not be misleading. In the Draft Guidance, FDA considers "material facts" those facts about a product that influence the consumer's understanding of the relevant properties of a product, whether or not a product is appropriate for them, and whether they are willing to accept the risks associated with use of the product.
In determining whether or not particular information is material, FDA considers the target audience for the product. Because different information can be material to different consumers, if a product is targeted for a specific class of patients, the risks associated with that patient class are material. FDA also looks to the package insert to aid in determining materiality. A product's most serious or most frequently occurring risks, as listed on the insert, are likely to be material, regardless of other claims made in the piece.
Comprehensiveness . FDA evaluates not only the quantity of the information provided, but also the quality and comprehensiveness. If a promotional piece conveys a similar number of risk and benefit statements, but lists only the least serious risks or provides an inadequate list of its serious risks, balance has not been achieved and the piece may be misleading.
In addition to evaluating the content of promotional pieces, FDA also considers the formatting in determining whether a piece is balanced and non-misleading. Formatting can be used to draw attention to various items of information or aid in understanding. Regardless of the medium involved, the Draft Guidance notes that risk and benefit information should be comparably noticeable and easily read in promotional pieces. Because formatting issues vary greatly between print and non-print materials, the Draft Guidance covers each separately.
For Print Promotional Materials. The Draft Guidance lists several of the formatting factors that FDA uses when evaluating print promotional pieces, including overall location of risk information, location of risk information within a part of the promotional piece, font size and style, contrast, and white space. FDA believes that risk information should be included in the main part of the piece, rather than relegated to a separate section, and recommends that risk information generally appear in the same parts of the piece, with similar prominence, as the benefits. In evaluating fonts, minor differences in font size may not be misleading, but FDA will look for substantial differences in size or for risk information printed in a font or size that makes it more difficult to read. FDA suggests printing risk and benefit information in similar font styles and type-face weights in order to be equally prominent.
Contrast, provided in the form of background and font colors or other ways, should not bring more attention to benefit information than risk information. Again, FDA recommends using a similar contrast for risk and benefit information to provide balance. In a similar vein, the amount of white space in and around various items of information may serve to highlight some items more than others. Risk and benefits should be portrayed in a similar manner.
For Non-Print Promotional Materials. Some of the same formatting issues that apply to print materials also apply to non-print materials, as well as other issues unique to non-print media. When evaluating non-print promotional pieces, FDA will also consider textual elements, audio and visual elements, and the interplay between audio and visual elements. Textual elements include text superimposed over images (SUPERs) in a broadcast piece, which can be difficult to read or comprehend. For claims that may be misinterpreted or misleading, FDA recommends that the claims be vocalized, illustrated with visual images, or prominently placed in a SUPER that runs concurrently with the claim. If items of information require text of more than one line, which could be difficult for viewers to quickly read and comprehend, FDA recommends other means of conveying that information. With respect to textual elements, the Draft Guidance recommends:
• SUPERs be reasonably visible to a person under typical viewing conditions;
• SUPERs remain on screen long enough to allow the viewers to read and comprehend;
• Not presenting several competing SUPERs at the same time, preventing viewers' ability to read and understand the information presented.
When considering audio elements in promotional pieces, FDA considers the qualities of speech, pacing of speech, volume and articulation, and background music or noise. The qualities and pacing of speech and volume should be consistent for both benefit and risk information. Background music should also be comparable during benefit and risk presentations and should not distract from the information being provided.
When paired with visuals in a broadcast piece, audio and visual components should not distract from the other. Busy scenes or particularly vivid visuals may distract a viewer from risk information being provided in a voiceover, as might cheerful music in the background during presentation of risks. The overall tone of the piece can also affect the comprehension by viewers of risks, especially if the tone is inconsistent with the information presented.
FDA identifies Internet websites as "promotional material" covered by the Draft Guidance. However, no information is provided in the guidance that specifically addresses issues that arise in product promotion on the Internet, such as "sponsored link" advertising or linking to other websites not controlled by the product manufacturer.
Christina M. Markus is Deputy Chair of and a Partner in King & Spalding's FDA & Life Sciences Practice Group and Kelly N. (Nikki) Reeves is a Partner in the firm's FDA & Life Sciences Practice Group, both in Washington, DC. Elaine H. Tseng is a Partner in the firm's FDA & Life Sciences Practice Group in the San Francisco office. Laura B. Snodgrass is an Associate in the firm's Washington office and a member of the FDA & Life Sciences Practice Group.