On May 27, 2009, the Food and Drug Administration (FDA) posted a draft guidance for the medical device and pharmaceutical industries titled Presenting Risk Information in Prescription Drug and Medical Device Promotion (Draft Guidance Document). This guidance describes how the FDA evaluates medical device and prescription drug promotional materials directed to both consumers and healthcare professionals to determine whether the advertising adequately presents risk information. Its intended purpose is to assist promoters of medical device and pharmaceutical products with factors relevant to development of content and format of marketing/advertising communications.
Risk information informs consumers and healthcare professionals about proper use, side effects or contraindications related to medical devices and pharmaceuticals prescribed for or by them. The FDA states that, increasingly, omission or minimization of risk information is the most frequent basis for Warning Letters and other enforcement actions taken by the agency with regard to medical device and pharmaceutical advertising. The agency also cites that over half of consumers state that they do not receive enough risk information in advertising, and that a higher percentage of physicians believe that the ads fail to provide adequate information regarding contraindications and negative side effects.
In the Draft Guidance Document, the FDA emphasizes that while individual components in advertising may be accurate, it is the message conveyed on the whole that often triggers enforcement, stating that "[a] promotional communication that conveys a deceptive net impression of the product could be misleading, even if specific individual claims or presentations are not misleading." The Draft Guidance Document describes how the FDA considers both content and format in determining misleading advertising, and provides several examples.
Some of the factors the FDA cites as relevant to advertising review include consistent use of language appropriate for the target audience, use of headlines and subheads, emphasis of positive or negative information, failure to list risks in hierarchical order, the amount of risk information contained in a 30-second versus 60-second broadcast, omission of material representations, consideration of the target audience, accuracy and comprehensiveness of risk information, location of risk information, font size and style, contrast used to highlight benefit and risk information, and audio and visual considerations.
Interested parties may submit comments on the Draft Guidance Document to the FDA within 90 days of the release date. A final guidance document will be published at a later date. While non-binding, the Draft Guidance Document does provide marketers of medical device and prescription pharmaceutical products with a better understanding of the factors the FDA considers when evaluating advertising for regulatory compliance.