OPDP Issues Warning Letter on Social Media Posting

OMG.

Can’t say that I ever thought I would be writing about Kim Kardashian here on Eye on FDA, but that just goes to show you, life always entertains surprises.

This week FDA posted a Warning Letter issued to a company for a posting on Instagram and on Facebook by none other than the public figure, Kim Kardashian, promoting the use of a prescription product for morning sickness during pregnancy. In the posting, Kardashian writes about her use of the product – using the product name and providing a link to the website – but without the inclusion of any risk information. There was a link to fuller risk information. The material was submitted to FDA under Form 2253, but was also turned in under the Bad Ads Program.

The omission or provision of incomplete risk information is the most common of violations, but the letter is noteworthy for the fact that it not only employs a high profile celebrity, but that it was put out on multiple social media channels. The existence of the letter may spook those who may view social media with greater trepidation, but had this language been contained in a brochure and not a posting on Instagram, it would have been the same story. In the end, the lesson here is FDA’s old adage – it’s not the medium, it’s the message.

One other thing, as written in this space before, one must take particular care with patient testimonials, not only to include risk information, but to ensure they are well scripted to be compliant.

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