This week, the FDA issued its draft guidance on “Presenting Risk Information in Prescription Drug and Medical Device Promotion." The comprehensive document 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 what the FDA will consider to be violative promotional material. Even before becoming final, the FDA will likely use this guidance to assess whether to bring an enforcement action against a company for its advertising and promotional activity.

Several key points emerge from the draft guidance document:

  • The FDA is regulating device promotion the same as drugs.
  • The guidance applies to all forms of promotion and advertising (e.g., Internet Web sites, blogs, Twitter, etc.).
  • The FDA is relying on “scientific” communication measurement tools to evaluate compliance (e.g., reading level measurements, quantity measurements of data communicated and framing studies).
  • The FDA most likely will not bring an enforcement action against a company that follows the examples set forth in the guidance.
  • Information can be misleading (and thus violative), even if it is not actually false.
  • Accurate content isn’t enough.
  • The FDA is serious about enforcement.

The FDA also made clear that it assesses the “net impression” of the 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 leeway in deciding whether a promotional piece is misleading. This net impression standard includes – but is broader than – fair balance. The agency stated that the guidance, including the “net impression” approach, is based on “well developed social science principles” and is supported by “decades of scientific research” and a “vast scientific body of knowledge." The FDA will be concentrating on the medium of the message, not just the content of the message.

In addition, the FDA will use the same general approach for health care professional directed advertising and patient/consumer advertising. While the FDA recognizes that different audiences have a different knowledge base and understand different words, the “reasonable reader” standard will be used by the FDA to evaluate materials directed to each.

More specifically, the FDA will assess promotional pieces based on an analysis of:

  • Consistent and audience appropriate language;
  • Signaling;
  • Framing;
  • Hierarchy of importance and materiality of risk disclosures;
  • Quantity, comprehensiveness, relevance and quality of risk disclosures;
  • Target audience (health care professionals or consumer subpopulations); and
  • Format, location, placement, font, color, contrast, etc. of the risk discussion.

The industry should take away several key messages from the draft guidance:

  • The FDA is watching both device and drug promotion closely.
  • The FDA is looking at more than the content of the message.
  • Internal policies and procedures should be reviewed in light of this guidance.
  • Some understanding of the ‘science” of communication is helpful.

Again, this is a draft guidance document. Having said that, the FDA likely will be informally using these concepts even before the guidance document is finalized. Any comments on the draft can be submitted to the FDA on or before August 25, 2009.

Companies needing clarification on the information provided in the FDA draft document should contact legal counsel for additional guidance.