- The FDA isn't too happy with reality star and model Kim Kardashian West and drug maker Duchesnay over the former's promotion of a morning sickness drug on social media platform Instagram.
- The agency sent a warning letter to the company and asked that the promotional post, which was for the medication Diclegis, be taken down.
- Promotional content must include adverse risk information and clarify which patient populations a drug is indicated for—a threshold that the FDA says that Kardashian's post did not clear. Duchesnay has gotten into some hot water over Diclegis promotion before, in November 2013.
"Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials," wrote the agency in its warning letter.
"The social media post is misleading because it presents various efficacy claims for DICLEGIS, but fails to communicate any risk information."
Strikingly, Kardashian did include an external link to Diclegis-related safety information in her post. But the FDA decided that this did not place sufficient emphasis on the risks and full indication. "We note the statement, “[F]ind out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com[,]” appears at the end of the social media post; however, this does not mitigate the misleading omission of risk information," wrote the agency.
Social media promotion of drugs has been a notorious gray area for pharma, and the FDA has at times given mixed signals about what it deems as acceptable promotional material and risk clarification on platforms such as Instagram, Facebook, and Twitter. For now, it's best for pharma companies to play it safe and include as much safety and label information as possible in promotional posts.