You undoubtedly know about Kim Kardashian’s Instagram post that promoted Diclegis® for treating morning sickness and which resulted in a warning letter from the FDA because it “entirely omits all risk information” (read “Kim Kardashian’s Diclegis Instagram Post Raises Issues of Transparency, Drug Safety, and Learning from History”).
A Klick Wire email newsletter said that this may have been the “quickest warning letter in history.” The FDA knew about the post at the time it was made or beforehand because Duchesnay — the company that makes & markets Diclegis — and all other drug companies are required by law to submit any promotional material to FDA’s OPDP “at the time of first use” together with a form called Form 2253. The Instagram post was also submitted as a complaint to the OPDP Bad Ad Program.
So, it’s no surprise that the FDA acted quickly in issuing the Warning Letter, which requested that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce. Duchesnay complied quickly and removed the violative Instagram post.
But so far Duchesnay/Kim Kardashian has not complied with another FDA request: to disseminate truthful, non-misleading, and complete corrective messages. What’s the process for doing that? How long will it take? Will it work?
FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising can be used to dissipate or correct erroneous beliefs resulting from a false claim. In 2009, for example, Bayer HealthCare Pharmaceuticals produced and aired corrective advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims. In that case, however, it took the FDA several months to issue the warning letter and more months for corrective ads to appear (read “FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?”).
According to the FDA letter to Duchesnay, the corrective post “… should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.”
According to a Klick Health opinion piece, “this means that the post will likely have to come from Kim Kardashian’s Instagram account. It will be very interesting to see how a celebrity’s retraction and corrective post will be generated, especially considering the character limitations” of social media channel s such as Instagram.
The original post generated 466,000 likes and 11,100 comments, according to Klick Wire. Will a corrective post generate as much interest or even reach as many or the same people as the violative post? More importantly, will the corrective post have any impact on correcting consumers’ misleading Diclegis beliefs or make up for deficiencies identified by the FDA in the original post?
As usual, FDA has said it needs to study this. Back in 2012, FDA published in the Federal Register a plan for examining the effectiveness of Corrective Direct-to-Consumer Television Advertising (see here). FDA explained in its original Federal Register notice that it wanted to look at three independent variables: Message exposure, similarity of the original and corrective ads, and the length of time between exposure to the original advertisement and the subsequent corrective advertisement. According to Alexander Gaffney, RF News Editor, the results of that study were due to be published in February, 2015, but I have not been able to find those results.
But there is no study that I am aware of to determine whether or not “corrective messages” work in social media. In any case, Duchesnay has until August 21, 2015, to submit a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”