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Paul Zimmerman
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FDA is “Keeping up with the Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the medication called Diclegis.

Pursuant to FDA regulations, promotional materials for drugs are misleading if they fail to reveal facts that are material in light of the representations made. They are also misleading if they omit information with respect to consequences that may result from the use of a drug as recommended or suggested by the materials. The social media post in question was misleading because it made various efficacy claims for Diclegis, but failed to communicate any risk information. For example, the social media post includes the following claims:

OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com

According to the FDA, the social media post entirely omits all risk information. The FDA noted the statement, “[F]ind out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com[,]” appears at the end of the social media post; however, the federal agency believes this does not mitigate the misleading omission of the information. By omitting the risks associated with Diclegis, the social media post misleadingly fails to provide material information about the consequences that may result from the use of the drug, and further suggests that it is safer than has actually been demonstrated.

This matter reminds marketers that traditional laws and regulations still apply to new technology and marketing on social media. Companies that want to market on social media need to make sure they are “keeping up” with legal requirements.  

This article is not offered as, and should not be relied on as, legal advice. You should consult an attorney for advice in specific situations.