On Friday the U.S. Food and Drug Administration (FDA) sent a warning letter to Duchesnay, manufacturer of DICLEGIS, a morning sickness drug, based on a social media post by ubiquitous social media user, Kim Kardashian. Kardashian posted a picture of herself with the drug while touting its safety and efficacy. However, Kardashian failed to mention risk information and other material facts about the drug. FDA found this false and misleading.
To respond to this incident, FDA has asked Duchesnay to, among other things, send out corrective messaging through the “same media” and with “the same frequency” as the violating material. Thus, perhaps an “FDA Approved” selfie will be hitting Instagram soon.
Drug companies seeking to use social media to promote their products should bear in mind that endorsers must spell out material risks and information in posts, not in separate links. Companies should use approved produced labeling in all forms of advertising, as FDA applies the same rules across all mediums. And, as the Kardashian episode illustrates, FDA is ready and willing to enforce violations.
Image courtesy of Flickr by Eva Rinaldi.