It’s rare that a pharma ad gets people talking. Given the regulatory environment that we work under, the amount of market research that usually goes into a creative concept, and the various layers of approval that a typical pharma ad is required to obtain, it’s no wonder that hard-hitting, creative advertisements often get watered down to the point that they are unrecognizable from their original form. Hence, we’re left with a large number of pharma ads that feature happy “patients” gardening or casually strolling along a beach.
It’s especially rare when an ad breaks these traditional rules and we’re still talking about it nearly a year later.
As part of our internal training initiatives, the Fingerpaint medical team puts together an annual review of the previous year’s OPDP letters. This presentation often generates lots of debate as we discuss why letters were issued and whether or not OPDP was justified in sending them. I’ve had the opportunity to give the presentation summarizing 2015’s letters multiple times over the past several months (at each of our 3 offices and for several client groups), and, without fail, the 2015 OPDP letter that generates the most discussion is the one issued for Diclegis.
The liveliest discussion isn’t about the Instagram post itself, though. It’s about the story behind the post.
On the surface, the initial Instagram post is nothing more than another celebrity endorsement that went a little too far by failing to include safety information and not clearly conveying the limitations of use (Diclegis has not been studied in women with hyperemesis gravidarum). Sure, the fact that Duchesnay teamed up with Kim Kardashian is interesting. And the somewhat passive-aggressive corrective ad that Duchesnay posted has some educational value. But that in itself does little more than raise a few eyebrows (case in point, no one is talking about the TussiCaps corrective ad, which is still front and center on the TussiCaps home page (nearly a year after that letter was issued).
What really gets the discussion going is the apparently calculated strategy behind Kardashian’s endorsement. Despite the widespread attention that the Instagram posts received, there’s been relatively little online discussion about what went on leading up to the post. To me, the strategy behind gaining the endorsement for Diclegis is more interesting than the actual endorsement itself.
An article by Leigh Householder on the Health Experience Project blog, provides some insight into the planning behind the now infamous Instagram post. According to Householder, the Kardashian endorsement was orchestrated by Makovsky after research showed that pregnant women frequently turn to online sources for information and do vast research ahead of their appointments, and that most are likely to ask for specific products by name when speaking with their healthcare provider. They had also apparently been keeping up with the Kardashians and knew that Kim suffered from morning sickness. When they reached out to let her know about Diclegis, it turns out she was serendipitously already taking the medication, and a celebrity endorsement was born.
According to Householder, “Makovsky had been careful to understand all the draft FDA guidance and made their best recommendations on how to build the post to work within them.” OPDP has a long history of issuing letters for omission of risk information, and the June 2014 Guidance regarding presentation of risk information in social media platforms clearly states, “Benefit information should be accompanied by risk information within each individual character-space-limited communication.” The FDA has also made it abundantly clear that there is no such thing as a “one click rule” and that a link to Important Safety Information is not sufficient to take the place of actual safety information. So while Makovsky and Duchesnay may have claimed to take FDA guidance into account, I find it hard to believe that they ever expected the post to pass regulatory muster.
It turns out that, indeed, they may have planned on getting a letter all along. According to Householder, “The contract with Kardashian included the creation of a corrective post, if needed.” It seems they may have known there was a good chance that the Instagram post would result in a warning letter and decided it was a worthwhile risk to take. I’ve spent more time sitting in PRC meetings than I care to admit, and strong battles of will between marketing and regulatory teams often erupt. I would love to have been in the meeting where these posts were discussed and approved. Based on the documents available on the FDA’s warning letter website, it appears that the Diclegis promotional materials (Instagram, Twitter, and Facebook posts) were submitted to OPDP under form 2253, as required for all pharmaceutical promotion. Therefore, I’m assuming that the Duchesnay regulatory team signed off on the promotional strategy (or were overruled).
It’s also worth noting that OPDP’s letter requested that the corrective messaging be “distributed using the same media, and generally for the same duration of time and with the same frequency” as the original post. However, the corrective ad went up just as the MTV Video Music Awards started and was likely quickly buried.
Did it pay off?
It appears that in exchange for an OPDP letter, Duchesnay came away with a marketing slam dunk. According to Householder, the Instagram posts netted “752 million social media impressions, 800+ online print articles and TV/radio segments, $12+ million advertising value, a 388% growth in trafifc [sic] to the site.” It’s also worth noting that not only did the original Instagram post generate lots of discussion, but the corrective post generated buzz as well. On the surface, by breaking the FDA rules, the short-term payoff was substantial for what has been estimated to be anywhere from a $10,000 to $200,000 product endorsement from Kim Kardashian. Duchesnay took a gamble and won handsomely.
While it’s hard to deny that this was brilliant marketing, the question remains of whether it was a smart business strategy in the long term. This isn’t the first run-in that Diclegis has had with OPDP. In 2013, Duchesnay received an untitled letter for a “Dear Doctor” letter communicating the approval of Diclegis. That Dear Doctor letter was cited for omission of risk information (for including no safety information) and omission of material fact (for not mentioning that Diclegis has not been studied in women with hyperemesis gravidarum). If those violations sound familiar, it’s because they are the exact same violations cited in the 2015 warning letter regarding the Kardashian Instagram post. This means that Duchesnay has now received multiple letters for the exact same violations.
Tom Abrams, OPDP director, has emphasized in the past that OPDP uses a risk-based approach to enforcement. One of OPDP’s “high priority” areas is products that have been cited for violations in the past. Given Diclegis’ rocky history with OPDP, I think it’s probably fair to say that any promotional communications from the brand will be receiving additional scrutiny from OPDP reviewers. While I don’t think the FDA holds grudges, I also wonder what this means for other products that Duchesnay may eventually market in the United States. Will those products also receive additional scrutiny given that Duchesnay has demonstrated that it is willing to bend—if not deliberately break—the rules that govern pharmaceutical marketing?
The Streisand effect is “the phenomenon whereby an attempt to hide, remove, or censor a piece of information has the unintended consequence of publicizing the information more widely.” There is no doubt that OPDP contributed to the media attention that Diclegis received by sending Duchesnay a warning letter related to Kim Kardashian and that requesting a corrective post raised awareness of the product even further. Perhaps that was part of the original strategy, or maybe it was icing on the cake. Regardless, few pharmaceutical products have received the level of attention that Diclegis enjoyed last summer. Nearly a year after the original Instagram post went live, we’re still occasionally talking about it here at Fingerpaint.
What other prescription drug ad has garnered 800+ print and online articles in a matter of weeks? Make that 801.
Ian DeMeritt heads up the medical team at Fingerpaint’s headquarters in Saratoga Springs. While he holds a PhD in microbiology and immunology and has mastered a lot of things (science, the written word, unicycle riding, the Rubik’s Cube, and marathons), space travel still eludes him. He’s applied multiple times to the NASA astronaut program, but has yet to make the final cut. But since he’s also mastered optimism, he couldn’t be more proud of his official NASA rejection letter.