Kim Kardashian is everywhere. But there were some bumps in the road when she took to social media on behalf of the drug company Duchesnay, Inc. to promote its morning sickness drug Diclegis. On Instagram, Ms. Kardashian breathlessly told her followers “OMG. My morning sickness has been bad. My doctor prescribed me Diclegis, and I felt a lot better.” The FDA was not impressed. It issued a warning letter saying the post is false and misleading.
So what was wrong with Kardashian’s ungrammatical post? It trumpeted only the positive and said nothing of the risks associated with taking the drug. Similarly, the post is misleading because it fails to provide a full description of the drug’s approved indications for use (“treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management”), including the limitations on its use that it had not been studied in women with certain conditions. Ms. Kardashian may plead ignorance, saying she does not know about the drug’s risks or any limitations on its use, but the manufacturer, Duchesnay, cannot make such a plea and so it got the warning letter.
While risk information and limitations on a product’s use are not customary content in most social media posts, they are required when the post is promoting a drug. Kardashian’s post attempted to mitigate its omissions by including a link to the company’s website where curious readers could “find out more.” As the FDA made clear, this was far from adequate. Digital media does not alter the basic rule that a drug promotion is false and misleading unless it includes relevant risk and other material information.
In the interest of being fair and balanced, it is only fair to note that Duchesnay’s problems started before, as Ms. Kardashian so delicately put it, she began “partnering with Duchesnay USA to raise awareness about treating morning sickness.” As FDA explicitly noted in the warning letter, the company was the recipient in November 2013 of a so-called untitled letter, a less formal warning. That letter, like FDA’s current blunt formal epistle, took the company to task for omitting all risk information and omitting material facts regarding Diclegis.
FDA’s letter closes by asking Duchesnay to cease immediately misbranding Diclegis by not making false and misleading claims. The company was also directed to submit a written response to the agency by August 21. Perhaps Ms. Kardashian’s partnership with Duchesnay will extend to assisting in preparing that response, and if so maybe it will be in 140 characters or less with trending hashtags?