But it may break them…well, give them a fracture. Or a good hard marketing lesson. Specialty pharma Duchesnay thought it had hit the jackpot with negotiating a promotional spokeswoman endorsement from pregnant celebrity Kim Kardashian of its morning sickness drug Diclegis. The Kardashian Marketing Machine cranked up. Kim (and mom Kris Jenner) took to Instagram, Facebook and Twitter in late July with (scripted) singing of Diclegis’ praises to their tens of millions of followers. The Instagram posts linked to an ‘important safety page’ a/k/a The Disclaimers. That wasn’t near enough for the Federal Drug Administration (FDA) which governs the acceptable marketing of all drugs in the US. On August 7th a tartly worded letter arrived at Duchesnay’s Pennsylvania HQ cited multiple violations of marketing regulations, notably risk information, and told Duchesnay to cease these communications immediately or withdraw the drug, which would be highly unlikely as it is successful. They also were require to provide “corrective messages” to the “violative materials”.
* Duchesnay reaped a bounty of free media (see below), on top of the (undoubtedly expensive) Kardashian endorsement. Yes, they did pay the cost of a FDA nastygram and a legal response, and the warning will live on in their file. However, a lot of target-age women now know Diclegis and others know about the relatively obscure Duchesnay.
* This was a calculated marketing risk that tested the boundaries of social media and celebrity endorsement. Pharmas and their marketing/PR agencies know well the regulatory limitations of social media in their campaigns. Lapses are unusual. Duchesnay and PR agency Makovsky must have known that omitting all risk information was not going to fly for long. They must have expected FDA to object, but with a lag time.
Multiple ‘someones’ at the company approved this walk up to the edge, and to look over it.
The lessons for health tech, particularly for those involved with trendy areas like genomics. Two years ago this month, the pacesetting 23andme started US television advertising promoting their Personal Genome Service reports and broad consumer claims, despite failing to complete its clinical data to validate its 510(k) filing. By Thanksgiving, the FDA delivered a turkey labeled ‘cease-and-desist’ that shut down their business for a time [TTA 27 Nov 13]. While this Editor doubts in the near term that any digital health company will be hiring any of the Kardashians anytime soon, we still see unsupported claims. Social media without sufficient disclosure presents pitfalls for MDDS and CE-regulated devices, and while risks are fewer, there’s a penalty anywhere–legal and with your credibility– when performance is overstated.
This Editor thanks the following Twitter tipsters for the conversation, sharing thoughts and articles: Marty Kady (@mkady) for Sarah Karlin’s article in Politico; @NicoleOran at MedCityNews and also her colleague Stephanie Baum (@StephLBaum); @PracticeUnite; @JoanneKenen. Also Bloomberg and the NY Times