Update: Apparently some people are weighing in on this issue who don't follow FDA ad-promo issues. For their benefit, I'm including a link to my post about why a link to the risk information doesn't suffice, i.e., why one-click isn't a rule.
Today, FDA's Office of Prescription Drug Promotion posted a letter citing Duchesnay for violative promotion relating to social media posts made by Kim Kardashian. The violative materials clearly included a discussion of the product's indication combined with the use of the product name, and a picture of Ms. Kardashian holding the product's bottle with the name prominently displayed.
|Instagram Post from Violative Materials on FDA Website|
It should come as no surprise that FDA objected to this presentation. In its letter, FDA cited both an omission of material fact and the omission of risk information.
And though I risk being accused of doing this solely for the clickbait, I'd like nonetheless to spend a bit of time looking at the violations, and the promotional material because there were options to engage in this promotional activity while complying with FDA's regulations and guidances.
First, look at the image above. Clearly, the image itself included the product name, and the submission to the FDA included a note stating that "image of Diclegis bottle will be prominent enough to read established name." This image (if used alone) would probably have been OK as a straight reminder promotion, which is only required to include the brand and generic names. It is, admittedly a bit difficult to tell from the material posted by the FDA whether the note on the material is indeed accurate, i.e., whether the generic (established) name would indeed have been legible, but it certainly is within the realm of possibility that both the brand and generic name would have been legible, and thus that the image alone might have been acceptable promotional material.
And if the image had been used alone (and the generic was actually legible), then it would have been compliant, so that was Duchesnay's first option. Engage in Reminder Promotion. Just show Ms. Kardashian holding the product bottle.
Option 2 would have included additional copy but still remained within the reminder ad format. You could easily imagine copy along the lines of: "I use Diclegis. You should ask your doctor about it." Such copy would not inherently have provided any indication or representation of the product's usage, and thus would appear to be acceptable within the reminder ad format.*
However, the accompanying text did not limit itself to the reminder ad format. Instead, that copy clearly alluded to the product's indication with Ms. Kardashian's message discussing her morning sickness and making a claim about the product's efficacy and its safety.
Of course, another option for Duchesnay (and Ms. Kardashian) would have been to omit the product mention and simply redirect followers to a location where the full product promotion could have been delivered. Such a communication could have teased the product, "Guess what helped me alleviate morning sickness" so long as it didn't refer to, or imply, the specific product.
That would have been tricky to do since Diclegis is currently the only FDA-approved treatment for morning sickness, but I think it would have been possible to do so, especially in a product category where there are tons of home remedies, homeopathic, and other OTC drugs that are used (sometimes off-label) for morning sickness.
So, this is Option 3: A redirecting ad that omitted product mention (or picture) but that took people to a location where the full product promotion could have been supplied.
Would it have been possible for Duchesnay to take advantage of the space-constrained product guidance released by the FDA on National Social Media Guidance Day?
The first thing to notice here is that although I've only posted and discussed one post from Ms. Kardashian, there are at least three that were involved in the violative materials. In addition to the Instagram post shown above, there was a Tweet and a Facebook post:
|Tweet from Violative Materials on FDA Website|
|Facebook Post from Violative Materials Posted on FDA Website|
Of course, the third post is a Tweet, and the Tweet makes use of precisely the redirecting ad format discussed above in Option 3. However, instead of redirecting users to a page with all of the elements required to meet the product promotion requirements, the Tweet directed users to the Instagram post, which the FDA found to be violative.
I've previously commented on how difficult it is to fit all of the required elements into a Tweet, and it's an open question whether Duchesnay could have done so.
Required elements are:
- Brand name
- Generic name
doxylamine succinate and pyridoxine hydrochloride--49 characters
But taking advantage of FDA's willingness to accept abbreviations, we can shorten that to doxylamine succinate & pyridoxine HCl--37 characters
- Non-misleading indication statement
It's unclear exactly what FDA would have considered an acceptable statement of the indication. We know from the letter that FDA considered the omission of the limitation that the product has not been studied in those with severe vomiting (hyperemesis gravidarum) an omission of material fact, so presumably that would have been needed in the Tweet. Let's try
For morning sickness, but not w severe vomiting--47 characters
- Contraindications (other than mere hypersensitivity to the active ingredients)
In the case of Diclegis, this means those using MAOIs
Don't use w MAOIs--17 characters
- Abbreviated risk statement*
Risks incl severe drowsiness--28 characters
- Link to full risk info
Putting it all together, you'd have
Diclegis(doxylamine succinate & pyridoxine HCl) For morning sickness, but not w severe vomiting Don't use w MAOIs-Risks incl severe drowsiness Diclegis.com/riskThat's a total of 165 characters, and I'm taking some liberties by using abbreviations FDA has not formally endorsed, and perhaps underestimating the characters FDA might require to communicate some of the elements.
Now, though, consider the context. Imagine for a moment that the character count were 139 instead of 165. Could anyone imagine Ms. Kardashian sending out that Tweet?
I can't either.
So, this takes us back to the options above:
- Option 1: Picture Reminder Ad (Product pic with generic name prominent and legible)
- Option 2: Reminder Ad with Additional Copy
- Option 3: Redirecting Ad
Absent any changes, that's where prescription product promotion in social media stands, and we'll need to do some work to keep up with...(just can't finish that sentence).
* I'm assuming that the bottle would have been a more prominent presentation of the generic name than the copy, but the specific execution of this option might have required inclusion of the generic in the copy as well.
** Note that in the following, I am taking advantage of several abbreviations that have not been explicitly endorsed by FDA (such as the use of "w" for the word "with" and "incl" for the word "include"). These abbreviations are extremely common on Twitter, but they do go beyond FDA's explicit endorsement of the "&" for the word "and."
*** For more on why this is 22 characters long, see my earlier post on counting characters.