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Kim Kardashian is promoting Diclegis® on social media once again. But this time, she is posting about the drug to correct her prior actions.
On August 12, we discussed Kim Kardashian’s Instagram and Facebook post in which she discussed the drug Diclegis® and the positive effect that she claims it has had on her morning sickness. Her social media post grabbed the attention of the Office of Prescription Drug Promotion (OPDP) of the FDA, which issued a Warning Letter to Duchesnay (Duchesnay paid Kardashian to promote her experience), Inc. for Kardashian’s presentation of efficacy claims for Diclegis® but failure to communicate any risk information associated with the use of the drug and her omission of material facts, which, according to OPDP, caused the post to be false or misleading. Because OPDP considered Duchesnay’s violations “serious and repeated” it requested that the company in its response to the Warning Letter include a “comprehensive plan” to disseminate corrective messages. The agency stated that 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. Kardashian took to Instagram with such corrective messaging.
She stated: “#CorrectiveAd I guess you saw the attention my last#morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis.” Kardashian then included Limitation of Use Information, Important Safety Information, the most common side effects, information for users to share with their healthcare providers, the Diclegis website for more information, and FDA contact information to report negative side effects.
Interestingly, Kardashian posted her corrective ad just as the MTV VMAs were starting and at which her husband, Kanye West announced his candidacy for President in the 2020 election. Perhaps this timing and West’s attention-grabbing actions were all part of Kardashian’s attempt at minimizing exposure of her correction actions. Nonetheless, whether or not this type of Instagram post was really what OPDP was seeking as corrective action, FDA is certainly getting more media attention than ever before. And while the company received a Warning Letter, all of this attention is surely a win for Duchesnay, Inc. Kim’s ad had over 7500 comments on Instagram and nearly 400,000 “likes”.
For more cutting edge commentary on developing issues, visit Norton Rose Fulbright’s Brand Protection blog.
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