Social Media "Corrective Messages": Closing the Barn Door After the Cow Has Left!

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?

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