No one can possibly know what is about to happen: it is happening, each time, for the first time, for the only time.
– James Arthur Baldwin
Hey, remember those proposed DTC advertising rules that the FDA published recently? Well, we may be getting a preview of a world where those rules are in effect.
I’ve posted about the proposed rules already, but the gist was that all DTC advertising would have to present risk information in a “clear, conspicuous, and neutral manner”. The FDA also proposed the criteria for determining whether something was clear, conspicuous, and neutral:
- 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.
Keep those criteria in mind when reading this email for Voltaren Gel (a topical NSAID approved for “the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands”). The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a warning letter for this ad claiming that it:
- Minimized Risk Information
- Overstated Efficacy
- Broadened the Indication (or that it engaged in misleading communication about the indication)
Note that the warning letter does not use the phrase “clear, conspicuous, and neutral manner” (or any variant; conspicuous in their absence, actually) nor does it mention the four criteria when discussing the risk information from the email. Again, the proposed rules are just that: proposed. They certainly cannot be used as part of any current enforcement action (in fact, the absence of any specific language that could be construed between the two is notable). However, there is a relevant FDA guidance called Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion that one could refer to.
Of course, guidances represent the agency’s “current thinking” on a topic and are not binding…but they are extremely important. Consider, though, that this guidance was published in May 2009 and the proposed rules were published in March 2010. It’s fair to assume that, even though they are not currently implemented, the more-recently-proposed rules represent the agency’s “more current” thinking.
Given that, did you see anything in that email that would violate the proposed rules? Reasonable people can disagree on whether the email crosses the threshold of violation, but one can objectively say that the risk information looks different than the benefit information.
Thanks to Eye on FDA and Pharma Marketing Blog for bringing this warning letter to my attention. Also, I believe that John Mack (from Pharma Marketing Blog) is correct when he says “This may be the FIRST FDA warning letter issued for an email promotion”. Interesting.
