The Food and Drug Administration (FDA) has evidently been keeping a close eye on Kim Kardashian’s social media pages. The agency recently issued a Warning Letter targeting posts from Kardashian that promoted Diclegis, a morning sickness medication by Duchesnay, Inc. FDA found that the social media posts were false or misleading in that they presented efficacy claims but failed to properly communicate any risk information associated with the drug.
FDA was concerned with a fairly short post on Kardashian’s Instagram and Facebook pages promoting her experience with the drug (image from the Food and Drug Administration, view link here):
Diclegis is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The FDA’s Office of Prescription Drug Promotion (OPDP)–the agency’s ad watchdog–found Kardashian’s post to be misleading because, while it presents Diclegis as effective at curbing morning sickness related to pregnancy, it failed to communicate any risk information. The agency received information about the post both from the company’s submitted Form FDA 2253 as well as in a complaint to the FDA Bad Ad Program, which provides a way for people to report allegedly misleading ads to FDA.
The Warning Letter reiterates that FDA demands the same level of risk information in patient testimonials posted on social media as it does to other mediums. For example, the Letter admonishes the company for failing to include risks such as that Diclegis is “contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation, as well as in women who are taking monoamine oxidase inhibitors (MAOIs).” This is not exactly the type of description you’d expect from Kim Kardashian, or almost any other patient relaying their experiences about relief from morning sickness. However, the FDA cautions that while Kardashian’s post included the statement “find out more www.diclegis.com,” and a bolded website plainly entitled “www.DiclegisImportantSafetyInfo.com,” this does “not mitigate the misleading omission of risk information.”
Interestingly, the promotion at issue here received a “Warning Letter” from OPDP, rather than a less serious “Untitled Letter.” Whereas Untitled Letters require companies to cease using violative materials and recall them, Warning Letters may also require the company to make a plan for “corrective advertising,” which includes “[p]rompt dissemination of accurate and complete information.” This is only the third Warning Letter ODPD has issued since January of 2014 (they have issued 19 enforcement letters altogether in that timeframe, 16 of which were Untitled Letters).
Why did Kim Kardashian’s post get the harsher treatment? Judging from OPDP’s letter, the agency was “particularly troubl[ed]” because it had already expressed concern regarding Duchesnay’s promotion of Diclegis. On November 12, 2013, OPDP sent Duchesnay an Untitled Letter over the company’s announcement of the approval of Diclegis that similarly omitted all risk information (view the company letter here).
Furthermore, it’s plausible that FDA believes drug promotions on a well-known celebrity’s social media page (which has 25 million followers according to FDA’s image), may warrant additional corrective advertising in addition to simply deleting the post. “To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated,” OPDP writes. Thus, it is likely Kardashian will post a correction on her social media page, and it will be interesting to see what form that message takes.
Engaging celebrity spokespeople for promotional outreach can bring a company’s message to a wider audience of patients who may benefit from new drugs; however, as seen in this case, it also adds an additional layer of scrutiny and potential backlash. It is important for companies to double and triple check social media posts for FDA compliance, and err on the side of caution when it comes to including risk information. FDA’s Diclegis Warning Letter shows the agency continues to be concerned with omission of risks violations, and may require additional corrective measures for promotions that are disseminated widely.