FDA Releases Draft Guidance on Risk Information in Advertising
By: ROBERT J. KLEPINSKI
May 29, 2009
The Food and Drug Administration (FDA) has issued a new draft guidance entitled, “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” The guidance explicitly covers disclosure of risk information in:
- ads and promotional labeling for prescription drugs
- ads for “restricted medical devices,” which includes devices subject to restriction regulation and devices that are restricted in the order granting a pre-market approval (PMA), which in effect covers all PMA devices.
While the FDA does not have direct authority to regulate advertising for 510(k) devices, we recommend considering the draft guidance when advertising all medical devices. In addition, while the title of the guidance focuses on “risk information,” the FDA makes it clear in the text of the guidance that it considers the factors discussed in the guidance to apply equally to benefits information provided in promotional materials.
The FDA believes that omission or minimization of risk information “is the most frequent violation of the regulations cited in advertising and promotion enforcement letters to sponsors…” The draft guidance seeks to provide further clarity to the industry by highlighting several factors, including factors relating to content and format, that the FDA uses to evaluate the adequacy of risk communication in promotional materials directed both at consumers and at healthcare professionals. The FDA also emphasizes that it reviews not just specific risk-related statements, but of the “net impression” of the communication, taking into account all elements of the piece together.
Specific factors discussed in the guidance include:
- consistent use of language appropriate for target audience
- use of signals
- framing of risk information
- hierarchy of risk information
Considerations of content:
- quantity of content
- materiality and comprehensiveness of risks included
- consideration of target audience
- important of the package insert
- the nature of the benefits claims
- accuracy and comprehensiveness of risk information;
Considerations of format (which may vary from print to non print promotion):
- location of risk information within the promotional piece
- font size and style
- use of white space
- textual elements
- interplay of visual and audio elements
- audio considerations
Because there has been more enforcement activity regarding risk information in drug ads, many of the examples included in the guidance are drawn from that area, but the lessons apply equally to devices.
Comments on the draft are due within 90 days of publication. The full text of the draft is available on the FDA web site at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0253-gdl.pdf.
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