The FDA recently published revised draft guidance on “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.” (see “Disclosing Risk in DTC Print Ads: Introducing the ‘Consumer Brief Summary’“).

The brief summary is the part of direct-to-consumer (DTC) ads that conveys detailed risk information. Typically, this information appears on the back side of the print ad and is sometimes written in small type.

In the original guidance published in 2004, FDA suggested a “less is more” approach (see “FDA Draft Guidance for Print DTCA: Less than Feared”). At that time, FDA said it “believes that exhaustive lists of minor risks detract from and make it difficult to comprehend and retain information on the more important risks.” In the revised guidance, FDA suggests specific, more readable formats for the brief summary. As shown in the example below, some DTC print ads have already used these formats in the brief summary section of the ad.

What no one is talking about, however, is the “fair balance” section of the ad. Let’s look at a typical Rx drug print ad.

A=benefit image/statement; B=fair balance; C=brief summary (click on image to enlarge)

In this ad, the “Important Facts” (i.e., brief summary of risks) are on the back side of the ad itself. The reader has to turn the page to see this information. Notice that the format and text are very consumer-friendly and incorporates many, if not all, of the recommendations made by the FDA in the revised guidelines. These recommendations include:

  1. use consumer-friendly language in all consumer-directed materials (duh!) – avoid scientific/medical jargon and use a “conversational tone”
  2. the consumer brief summary should be presented visually in a manner designed for ease of use by consumers; e.g., use “signals” such headlines and subheadings
  3. the consumer brief summary should provide “clinically significant” information on the “most serious and the most common risks” associated with the product and omit less pertinent information
  4. the most frequently occurring Adverse Reactions should be included in the consumer brief summary
  5. include a statement reminding consumers that the information presented is not comprehensive

In addition to the brief summary required in print ads, the FDA requires “fair balance” in the creative area of the ad itself (section B in the above image). According to the Federal Food, Drug, and Cosmetic Act, fair balance is “[T]he presentation of true information relating to side effects and contraindications is comparable in depth and detail with the claims for effectiveness or safety.”

Whereas no pharma company to my knowledge ever received a NOV/warning letter from the FDA concerning the brief summary section of a print ad, several have received letters regarding inadequate (or complete lack of) fair balance within the main section of the ad. The revised guidelines do not address the fair balance section, which is actually more important than the brief summary, IMHO.

If most consumers are like me, they will see the ad but not bother to flip the page to see, let alone read, the brief summary, although I am sure when asked most consumers will say that the format used by Pfizer in ads like the one above make it easier for them to read and understand the brief summary information.

But how easy is it to read the fair balance? Here’s an enlarged view of that section of the Lyrica ad above:

Click on image to enlarge.

While the language is “consumer-friendly,” the format is not. For one thing, the font size is much smaller than the benefit statement (“Having less DIABETIC NERVE PAIN Means Everything to Me”). Also, it’s all jammed into one boring block of text. Of course, if a drug has a lot of important safety information that needs to be mentioned, then the fair balance section must crowd it in.

Perhaps the FDA should revise its 2009 guidance on “Presenting Risk Information in Prescription Drug and Medical Device Promotion” and specifically address how to improve the fair balance section of print ads.