This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains that a recent social media post by reality TV star Kim Kardashian touting the benefits of the morning sickness pill Diclegis (doxylamine succinate and pyridoxine hydrochloride) was false and misleading because it did not present any risk information about the drug. FDA also noted that the post failed to include material information about significant limitations of use for Diclegis, including the fact that it has not been studied in women with hyperemesis gravidarum, a rare but serious pregnancy side effect that causes extreme morning sickness. There are also several warnings and precautions in the approved labeling for Diclegis that were not communicated alongside Kardashian’s glowing review of the product’s effectiveness. Finally, according to the FDA, these issues with the drug promotion render the product misbranded under the Federal Food, Drug, and Cosmetic Act.
Because Kardashian was acting as a paid spokesperson for Duchesnay’s drug product Diclegis, her statements are attributable to the company and therefore must meet the same requirements for prescription drug promotion as advertisements that the company disseminates directly. The situation serves as a reminder to drug manufacturers and distributors that they should review and pre-clear all promotional statements made by endorsers paid to promote the company’s products (celebrity or not), as well as a reminder that regulatory issues related to drug advertising arise in all venues, even in social media. Of course, if Kardashian were not a spokesperson for the company, she would not be bound by FDA’s rules, and she could say anything without regard to meeting the “fair balance” standards for benefits and risks.
The company has confirmed that the posts were removed from the Internet immediately after the FDA Warning Letter was received, but Duchesnay and Diclegis still may have benefited from the widespread media coverage that the Kardashian post and subsequent FDA action has received. Besides removing any violative advertising from the marketplace, the company has to prepare a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages” due to Duchesnay's previous run-in with FDA. It will be interesting to see how the company and FDA negotiate the terms of a corrective messaging plan that uses “the same media” for its distribution as the original message. This situation could be the first time that a manufacturer specifically disseminates corrective messaging through social media venues like Instagram, Twitter, and Facebook.