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by Cori Goldberg and Saul Perloff
Kim Kardashian’s recent Instagram post yielded 466,000 “likes” and one FDA Warning Letter. In her social media post, also posted on Facebook, Kardashian discussed the drug DICLEGIS and the positive effect she claims it has had on her morning sickness. She indicated that “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.” Kardashian, who was apparently paid for the promotion, provided a link to the DICLEGIS website for more information.
We know that Ms. Kardashian loves attention and this post grabbed the attention of many, including the Office of Prescription Drug Promotion (OPDP) of the FDA, which issued a Warning Letter to Duchesnay, Inc. OPDP determined that the social media post was false or misleading in that it presents efficacy claims for DICLEGIS but fails to communicate any risk information associated with its use and it omits material facts. Warning Letter at 1. Specifically, FDA pointed out that while DICLEGIS is approved for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management (e.g. lifestyle and dietary changes do not work), the drug has not been studied in, and is not approved for, women with hyperemesis gravidarum, a severe form of pregnancy nausea and vomiting. Id. at 2.
As a result OPDP determined that the post misbrands DICLEGIS under the Federal Food, Drug, and Cosmetic Act (FDCA) and makes its distribution a violation of that law. Id. at 3. OPDP determined that the violations raise public health concerns because they suggest that DICLEGIS is safer than has been demonstrated. Id.
According to OPDP, Duchesnay’s “false and misleading promotional materials” were “particularly troubling” because the agency had previously written to Duchesnay to express concerns regarding “violative promotional activities” associated with the launch of DICLEGIS in 2013.
OPDP requested that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing product into interstate commerce. OPDP requested that Duchesnay submit a written response to the Warning Letter on or before August 21, 2015, stating whether the company intends to comply with the request, listing all promotional materials for DICLEGIS that contain presentations as described in the Warning Letter, and explaining its plan for discontinuing the use of such materials or for ceasing distribution of the drug.
Because OPDP considered Duchesnay’s violations “serious and repeated” it also requested the company to include a “comprehensive plan” to disseminate corrective messages. The agency stated: “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 indicated that the failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
The issuance of this Warning Letter makes clear that the FDA does monitor social media promotional activities and is willing to take enforcement action against companies that use the internet to promote drugs in violation of the FDCA.
Kardashian’s Instagram post has been removed.
For more cutting edge commentary on developing issues, visit Norton Rose Fulbright’s Health Law Pulse blog.
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