In May, the FDA issued its draft guidance on “Presenting Risk Information in Prescription Drug and Medical Device Promotion." The guidance lays out in very explicit terms how the FDA wants risk information to be presented in drug and device promotional materials and provides examples of promotional material the FDA will consider to violate FDA regulations. Interestingly, FDA utilized both the formal regulations and the "science" of communication reception and interpretation in developing this draft guidance.

In this document, FDA addresses specific issues such as format, font size, placement and signaling of risk information. FDA also made clear that it assesses the “net impression” of a promotional piece viewed as a whole. Stated differently, even if each individual statement in the promotional piece is accurate, the piece is violative if the overall "net impression" is misleading. This subjective standard gives the Agency tremendous enforcement leeway. The guidance also makes clear that the FDA will be concentrating on the medium of the message, not just the content of the message.

Although this is a draft guidance document, the FDA likely will be informally using these concepts even before the guidance document is finalized. The new administration is closely reviewing promotional materials including the use of new communication medium such as sponsored links and banner ads. In April 2009, the FDA Division of Drug Marketing, Advertising, and Communications (“DDMAC”) issued fourteen warning letters covering forty-five products alleging that sponsored Internet links were misleading. DDMAC noted that the links made representations and/or suggestions about the efficacy of products but failed to communicate any risk information associated with the use of the applicable drugs.

In general, the industry should take away several key messages from this draft guidance:

  • FDA is watching both device and drug promotion closely.
  • Drugs and devices are being held to the same standard.
  • FDA is looking at both the content and format of the message.
  • Companies should review their internal policies and procedures in light of this guidance.
  • Close attention should be paid to each promotional piece.

Interested stakeholders can submit comments on the draft guidance to FDA by August 25, 2009.