FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion (2009) Draft Guidance

This week, the U.S Food and Drug Administration (FDA) issued a draft Guidance for Industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” Within this document, the FDA describes factors it considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations.

The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors.

As the guidance asserts, the FDA believes it is critically important to disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers.

Current industry guidelines encourage manufacturers to develop prescription medicine promotion that is “designed to achieve a balanced presentation of both the benefits and the risks associated with the advertised” product.

However, according to the FDA omission or minimization of risk information is the most frequent violation of the regulations cited in advertising and promotion enforcement letters sent to sponsors. In addition, research in one of the areas the guidance covers, direct-to-consumer prescription drug advertising, has shown that 66 percent of patients believe ads directed at them do not provide enough information about risks, 60 percent of physicians believe that patients have little or no understanding from these ads about what the possible risks and negative effects of the products are, and 72 percent of physicians believe that patients have little or no understanding from these ads about who should not use the product.

LEGAL OVERVIEW

To comply with the FD&C Act and FDA’s implementing regulations, such promotional pieces:

• Cannot be false or misleading in any particular

• Must reveal material facts about the product being promoted, including facts about the consequences that can result from use of the product as suggested in the promotional piece; and

• Should present information about effectiveness and information about risk in a balanced manner

As a result, when the FDA evaluates the risk communication in a promotional piece, FDA looks not just at specific risk-related statements, but at the net impression – i.e., the message communicated by all elements of the piece as a whole. The purpose of the evaluation is to determine whether the piece as a whole conveys an accurate and non-misleading impression of the benefits and risks of the promoted product.

GENERAL CONSIDERATIONS and CONSIDERATIONS OF CONTENT

In evaluating risk communication, the FDA considers the following:

• Consistent Use of Language Appropriate for Target Audience

• Use of Signals – Headlines and subheads are examples of commonly used signals

• Framing Risk Information – how a particular piece of information is 268 stated or conveyed, such as by emphasizing either the positive or negative aspects of the information or 269 by presenting the information in vague versus specific terms.

• Hierarchy of Risk Information – the ordering of risks within a presentation an important factor in determining the risk 310 profile conveyed by a piece

• Quantity – the amount or quantity of information conveyed by a promotional piece. The FDA considers these factors when determining the comparability of benefits and risks in a piece:

• The number of statements about benefits and risks

• The completeness and depth of detail given about benefits and risks

• The amount of time (in both the audio and visual portions) devoted to benefits and risks in a video, audio, or broadcast communication

• The amount of space devoted to benefits and risks in a print communication

• The use of audio or visual components that enhance or distract from the presentation of risk or benefit information

• Materiality and Comprehensiveness – the degree to which information is objectively 390 important, relevant, or substantial to the target audience

CONSIDERATIONS OF FORMAT

FDA also considers formatting factors when assessing whether a piece is false or misleading such as:

• The layout of a print promotional piece (generally, its plan, design, or arrangement)

• Overall Location of Risk Information

• Font Size and Style & White Space

• Contrast between text and background should not highlight the benefit information more than the riskinformation.

• Non-Print Promotion

Comments

Comments are due in 90 days by Friday August 21st, after which the FDA will release final guidance.

Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact (COER) Kristin Davis at 30 J-796- J200, (CBER) Ele Ibarra-Pratt at 301-827-3028, (CVM) Martine Hartogensis at 240-453-6833, or (CDRH) Ann Simoneau at 240-276-0100.

FDA Draft Guidance:Presenting Risk Information in Prescription Drug and Medical Device Promotion

FDA Draft Guidance:Presenting Risk Information in Prescription Drug and Medical Device Promotion