As of April 15, 2010, FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) sent out 5 “notice of violation” (aka “warning”) letters to drug companies regarding various promotional pieces. One letter is of interest because it concerns a direct-to-consumer (DTC) adherence “wave 5 e-mail” (“Adherence Email”) for Voltaren, an NSAID topical gel marketed by Novartis. This may be the FIRST FDA warning letter issued for an email promotion. But is it justified?

Among other violations, the letter cites “minimization of risk information.” The letter (find it here) states:

“The Adherence Email prominently presents efficacy claims in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space. In contrast, the risk information is relegated to the bottom of the email and is presented below the indication for use in extremely small black font, and in single-spaced paragraph format that makes the information very difficult to read. Furthermore, while the Adherence Email presents efficacy claims for Voltaren Gel in language that is easily understandable to consumers, it presents risk information using complex medical terminology that is not likely to be comprehended by the same audience (e.g., “cardiovascular thrombotic events” and “hematological effects”). The overall effect of this presentation undermines the communication of important risk information, minimizing the risks associated with Voltaren Gel, and misleadingly suggesting that Voltaren Gel is safer than has been demonstrated.”

“For me, that is a little out of left field,” said Mark Senak over at EyeOnFDA Blog. “To my knowledge,” said Senak, “FDA/DDMAC has not issued any standards on how to do this [present risk information] aptly.” I disagree with Senak. The FDA has issued “standards” about presenting risk information.

In my previous analysis of DDMAC warning letters (see “An Analysis of DDMAC Warning Letters Regarding Risk Information in Broadcast Drug Ads“), I noted that the FDA Amendments Act (FDAAA), which was signed into law in 2007, requires that the FDA issue new regulations regarding the presentation of risk information in broadcast (TV and radio, specifically) drug ads directed to consumers (DTC ads). On March 29, 2010, the FDA published the proposed regulations in the Federal Register (see here).

FDA had issued guidance relating to presentation of risk information previously and most experts agree that the proposed regulations pretty closely resemble that guidance (see “Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion“; pdf file). Specifically, the regulations focus on determining whether a drug ad’s “major statement” (ie, disclosure of the major side effects and contraindications of the drug) is presented in a “clear, conspicuous, and neutral manner” as required by FDAAA. FDA says that a major statement would be considered to be presented in this manner if:

  1. Information is presented in language that is readily understandable by consumers;
  2. Audio information is understandable in terms of the volume, articulation, and pacing used;
  3. 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
  4. 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.

The Voltaren Adherence Email (find it here) seems to violate “rules” #1 and #3 above. That is, it would violate those rules IF it were in the category of “broadcast” DTC. FDAAA requires FDA to enforce “clear and conspicuous” risk information in TV and radio ads that are broadcast to a mass audience. The Voltaren Adherence Email does not seem to fit in that category of ad because it was not a TV or radio ad and it was likely sent to a select group of consumers, not a mass audience.

However, in the draft guidance mentioned above, FDA states: “Unless otherwise specified in this draft guidance, the principles set forth below apply to all promotional pieces, regardless of the medium used or the target audience.”

So I am a bit confused as to whether or not, in the case of the Voltaren letter, the FDA has overstepped the authority given it by Congress to regulate risk information in non-broadcast media. What do you think?