Good advertising does not just circulate information. It penetrates the public mind with desires and belief.
– Leo Burnett
The FDA recently published a proposed rule for how risk information should be presented in Direct-to-Consumer (DTC) advertising. Per FDAAA 2007, the FDA was mandated to ensure that the description of side effects and contraindications (the ‘major statement’) in advertised prescription drugs are presented in a “clear, conspicuous, and neutral manner”.
This is the key phrase in the proposed rule, so I’ll say it again: “clear, conspicuous, and neutral manner”. It appears almost 30 times in the 12 page document, but what it means is up for discussion. Neutrality is, of course, always a matter of perspective, so the FDA has specifically requested comments on how to establish standards to determine what is “neutral”.
The proposed rule has sparked a lot of conversations and opinion pieces in the drug/biologic development community (eg, FDA Law Blog, The Pink Sheet, Pharmalot, DTC Perspectives). However, it is an interesting read in and of itself, so I strongly recommend starting there. The FDA opens with an informative background on how other federal agencies have regulated advertisement (eg, FTC, SEC) and then presents its proposed standards for determining if the major statement is presented in a “clear, conspicuous, and neutral manner”:
- Information is presented in language that is readily understandable by consumers;
- Audio information is understandable in terms of the volume, articulation, and pacing used;
- Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
- The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
Note that this is a proposed rule, not a new guidance. The FDA currently has a number of guidance documents on advertising in general, including one that focuses on presenting risk information in promotions: Presenting Risk Information in Prescription Drug and Medical Device Promotion.
Many feel that these standards are too vague, while a few feel that they allow an appropriate amount of flexibility. Without offering an opinion on vagueness versus flexibility (although rest assured, I certainly have one), I will say that I agree with DTC Perspectives when they say “there is no major change to what FDA required in the guidance previously”. The real question is whether or not finalizing the rule will lead to more enforcement action. Here are two quotes from the FDA (via the Federal Register) to help you ponder this possibility:
“FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads.”
“Guidance documents, however, are not legally enforceable. Even if most firms would comply voluntarily, FDA needs to ensure that standards would be implemented for all important risk messages in prescription drug television and radio ads.”
In addition, the FDA also presented a Division of Drug Marketing, Advertising, and Communications (DDMAC) analysis of radio and TV advertisements from 2008 and found that a considerable proportion (about one third) of them would violate the proposed clear, conspicuous, and neutral standard (Table 1 below from the Federal Register containing the proposed rule). However, the FDA admitted that because of the rapid turnover of advertisements, these 2008 advertisements may not be indicative of current advertisements…but still.
Finally, note that enforcement action has been on the rise since Margaret Hamburg took office as FDA Commissioner in mid-2009. We’re likely to see that trend continue.
Comments on this proposed rule can be submitted through 28 June 2010 (reference Docket No. FDA–2010–N–0155).
