Recently, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion issued a Warning Letter to drug maker Duchesnay, Inc., after reality TV star Kim Kardashian endorsed the company’s morning sickness drug, Diclegis, on her Instagram account. A copy of the Warning Letter can be found here.
FDA alleged in the Warning Letter that the social media posts were false and misleading because they presented efficacy claims for Diclegis, but failed to provide risk information. FDA further asserted that the social media posts were misleading because they failed to provide material information regarding Diclegis’ full approved indication, including important limitations of use – specifically that they failed to convey that Diclegis has not been studied in women with hyperemesis gravidarum. For these reasons, FDA found the social media posts misbranded Diclegis within the meaning of the Federal Food, Drug, and Cosmetic Act, making the distribution of the drug violative of the law. FDA’s letter further criticized the posts, noting “the promotions on social media are concerning from a public health perspective because they suggest that Diclegis is safer than has been demonstrated."
FDA provided the following social media post as an example of what it said was the misleading promotion of the product by Ms. Kardashian:
OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, 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. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more...
FDA’s regulatory guidance requires prescription drug advertisements to be “fairly balanced” by requiring promotions to include product risk information when product efficacy and therapeutic use information is presented. By omitting the risks associated with Diclegis, FDA found that the social media post misleadingly failed to provide material information about the consequences that may result from the use of the drug and suggests that it is safer than has been demonstrated.
The Warning Letter directs Duchesnay to immediately cease “misbranding” Diclegis and/or cease introducing the “misbranded” drug into interstate commerce, as well as to submit a plan for correcting any violative promotional materials in use. FDA has also requested that Duchesnay provide in its response to FDA a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to the audience(s) that received the violative promotional materials.
FDA scrutiny and enforcement actions stemming from Internet and social media promotions has increased significantly in recent years. Thus, drug manufacturers and other FDA-regulated industries will need to ensure their Internet promotions are compliant with FDA and FTC marketing and advertising requirements.