Tens of millions of people around the world follow Kim Kardashian's every move on social media. So apparently does the FDA's Office of Prescription Drug Promotion. Last week, the FDA issued a Warning Letter to Canadian drug manufacturer Duchesnay concerning Kardashian's social media posts promoting the morning sickness drug Diclegis. The FDA warned that the posts unlawfully misbranded Diclegis under the Federal Food, Drug, and Cosmetic Act.
On July 19, Kardashian's over forty million Instagram followers were treated to a selfie of the reality TV queen and perpetual paid product endorser holding a bottle of Diclegis. The photo was accompanied by text reading:
"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. DiclegisImportantSaftetyInfo.com."
The post also appeared on Kardashian's Facebook page and Kardashian tweeted a truncated version of the text with a link to the Instagram post. The FDA found that the posts were false or misleading because they contained efficacy claims, but not any communication of the risk information associated with the drug's use. Links to websites containing the risk information, the FDA said, did not mitigate the "misleading" risk information. Also, the FDA found that the posts omitted a material fact concerning a limitation on the use of Diclegis, the fact that Diclegis has not been studied in women with hyperemesis gravidarum. The FDA characterized the alleged violations as "serious and repeated," and requested that Duchesnay cease the "misbranding" of Diclegis.
It is not surprising that a widely disseminated Kardashian social media post (the Instagram post received at least 464,000 "likes") would not escape the FDA's scrutiny, but it is only the latest example of the FDA's close monitoring of social media in recent years. In addition to complaints that risk information was missing in posts promoting prescription drugs, the FDA has issued Warning Letters to dietary supplement manufacturers based on their "liking" certain consumer posts made on their Facebook pages. In another Warning Letter sent last year, the FDA warned the dietary supplement manufacturer Zarbee's about its response to a consumer's post on Zarbee's Facebook page saying that Zarbee's supplements helped her daughter with cerebral palsy sleep through the night. The FDA disapproved of Zarbee's comment in response, which simply read, "Mary, Thank you for writing this!!! We love to hear that we have helped people..."
The FDA is undoubtedly keeping a close eye on social media and anybody involved in the promotion of FDA-regulated products through social media, not just Kardashians, must be aware of their compliance responsibilities in messages conveyed through that medium.
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