Posted 14 August 2015
By Michael Mezher
FDA warning letters rarely make it into mainstream media, but this week one warning letter took the Internet by storm.
If you're reading this site, you've most likely seen the headlines already. An Instagram post from reality television star Kim Kardashian, in which she raved about the morning sickness drug Diclegis, was the focus of a warning letter from FDA.
The story first broke in mid-July, when Kardashian posted a photograph of herself to Instagram with the accompanying text:
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.
The mainstream media, already fascinated with Kardashian's pregnancy, picked up the story, reporting on the phenomenon of Kardashian advertising a drug with her social media presence. Duchesnay, the maker of Diclegis, even issued a press release touting Kardashian's endorsement. Shortly after, on 31 July, Forbes released a four-page article discussing Kardashian and social media with an extensive background on Diclegis' development and safety profile.
Celebrities are often paid to endorse products on social media, using their popularity and appeal to add a personal touch to promotional statements. According to Politico, both Kardashian and her mother, Kris Jenner, were paid by Duchesnay to endorse Diclegis.
Only a week later, on 7 August, FDA sent a warning letter to Duchesnay, instructing the company to remove the aforementioned post and develop a "plan of action to disseminate truthful, non-misleading, and complete corrective messages" about Diclegis.
The letter was sent from Robert Dean, division director for the Office of Prescription Drug Promotion (OPDP) at FDA and addressed Eric Gervais, executive vice president at Duchesnay.
The letter reveals that Duchesnay submitted the post to FDA using Form 2253. The agency also received a complaint about the post to its OPDP Bad Ad Program.
The letter states, "The social media post is false or misleading in that it presents efficacy claims … but fails to communicate any risk information … and omits material facts, and goes on to say that the post "misbrands Diclegis" under the Food, Drug, and Cosmetic Act (FD&C Act), and "suggest that Diclegis is safer than has been demonstrated."
Specifically, FDA said Kardashian's post omitted risk information. While the post itself includes a link to a website which presents Diclegis' risks, it gave no indication of the risks the drug poses.
Second, the post left out the fact that Diclegis has not been studied in women with hyperemesis gravidarum.
Warning Letter, Duchesnay Press Release