On July 19th, Kim Kardashian posted a photo of herself to her Instagram feed holding a bottle of DICLEGIS®, an FDA approved treatment for morning sickness. (Update: This post has subsequently been taken down, see update below.) What ensued was a virtual firestorm of controversy over celebrity endorsements of drugs and the regulatory questions surrounding a branded post on a platform that has limited characters for disclosing endorsements and providing fair balance.
Celebrity Drug Endorsements
It’s a long-standing practice to connect your brand with a well-known celebrity. The benefits are myriad. Exposure is piggy-backed on the public awareness of the celebrity themselves. When they speak about BRANDX they may do so at major televised or media supported events. When they are in commercials for BRANDX they may add credibility to the brand. They can be spokespeople for the brand or simply raise awareness of the disease from which they are suffering. Often times, fans will have little to no awareness of the condition before hearing about it from the spokesperson. This can be highly positive for a brand that might otherwise struggle to rise above the chatter of their competitors or to get traction in a market typically stigmatized or underserved. Kim Kardashian has been vocal about her suffering from morning sickness prior to promoting DICLEGIS® and medical treatment of morning sickness can be a stigmatized topic.
Likely, there is great value in celebrity endorsement of your brand or promotion of awareness of the condition your brand treats, if budgets can support it. Once you have a celebrity onboard, the selection of natural channels where your spokesperson may regularly communicate with fans like Facebook, Twitter, Instagram, etc. can be a challenge. These channels that restrict character limitations can lead to some interesting regulatory questions.
Disclosure of Endorsements in Character Limited Platforms
First, let’s define “Endorsement.” The FTC, the independent agency of the U.S. government that is tasked with promoting consumer protection defines it in their published document “.com Disclosures.” They define endorsement as “any advertising message that consumers are likely to believe reflects the opinions, beliefs, findings, or experiences of a party other than the sponsoring advertiser.”
So if someone is actively endorsing a product online, what does the FTC say about how they need to disclose that endorsement? Well, again, the FTC has a pretty explicit position on what you need to do in digital advertising to clearly define that you are getting paid for your post, tweet or pin. The document breaks out some directives that apply specifically to platforms like Instagram with character limitations. See a subset of those directives below:
- Place the disclosure as close as possible to the triggering claim.
- Take account of the various devices and platforms consumers may use to view advertising and any corresponding disclosure. If an ad is viewable on a particular device or platform, any necessary disclosures should be sufficient to prevent the ad from being misleading when viewed on that device or platform.
- When a space-constrained ad requires a disclosure, incorporate the disclosure into the ad whenever possible. However, when it is not possible to make a disclosure in a space-constrained ad, it may, under some circumstances, be acceptable to make the disclosure clearly and conspicuously on the page to which the ad links.
- When using a hyperlink to lead to a disclosure, make the link obvious; label the hyperlink appropriately to convey the importance, nature, and relevance of the information it leads to; use hyperlink styles consistently, so consumers know when a link is available; – place the hyperlink as close as possible to the relevant information it qualifies and make it noticeable; take consumers directly to the disclosure on the click-through page; – assess the effectiveness of the hyperlink by monitoring click-through rates and other information about consumer use and make changes accordingly.
- Preferably, design advertisements so that “scrolling” is not necessary in order to find a disclosure. When scrolling is necessary, use text or visual cues to encourage consumers to scroll to view the disclosure.
Fair Balance on Character Limited Platforms
So the FTC has provided guidance on disclosure of endorsements, but what about fair balance for digital ads on platforms that don’t allow for the hundreds, if not thousands of characters in a typical Important Safety Information footer? Instagram has been used historically for unbranded pharma ads, but this looks like the first branded foray into the space.
What is the FDA’s guidance on these types of platforms? The FDA issued draft guidance in June, 2014 titled Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
Here’s what they say (in draft) about channels like Instagram with character and space limitations:
- Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).
- Benefit information should be accompanied by risk information within each individual character-space-limited communication.
- If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.
How Does the DISLEGIS® Kardashian Promotion Hold Up?
From the FTC and FDA’s perspective, the ad could be seen as problematic for the following reasons:
- Kim’s post states “… I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness.” While this a reasonable disclosure of the fact that she isn’t just posting about DICLEGIS® on her own, it may not meet the standard of the full disclosure of her being paid to promote the drug (assuming that she is being compensated.) Adding some disclaimer hashtags like #PaidAd or #advertisement might have helped.
- Neither of the links to the diclegis.com site or diclegisimportantsafetyinformation.com provide any better clarity on the endorsement and even if they did, unfortunately Instagram doesn’t allow for hyperlinks in the text of posts.
- The fair balance on this ad is minimal at best with only a single un-clickable link to diclegisimportantsafetyinformation.com. In fact Kardashian writes “it’s been studied and there was no increased risk to the baby…” which is a very strong statement to make. It should be noted the DICLEGIS.com site does clearly state that “the FDA has granted DICLEGIS® Category A status, which means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy.” Even though there are no listed risks on the Important Safety Information page for the unborn child, there are some mentions of risks of using the drug while breast feeding, which should probably be disclaimed.
- While the full text is visible on a desktop computer, someone using the Instagram app would have to scroll to read the full text in order to see the link to the safety information URL.
- The comments on the Instagram post should be monitored for Adverse Events (AEs). While Kardashian herself may not have the responsibility to report on the comments of her fans if she is unpaid, I would question whether the makers of DICLEGIS® can avoid a similar obligation if Kardashian is posting on their behalf. Instagram may add additional challenges here as some people will use their real names when commenting, and others may use handles or pseudonyms making AE reporting difficult.
So What Might this Mean for Pharma and Instagram?
It is exciting to see a pharma brand expand into such a new territory. Even with some of the challenges of the space, it is clear from the 466K likes and over 11K comments on the post that this partnership between Kardashian and DICLEGIS® could be a lucrative one. The challenge will be in finding the appropriate balance between the promotion of efficacy and safety in such a small space.
It seems that the FDA agreed. On August 7th, they issued a Warning Letter to Duchesnay. The letter from the FDA chastised the post, indicating that it “entirely omits all risk information” (emphasis in original). The letter goes on to suggest that the social post “misleadingly fails 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.”
As a follow-up, the FDA has required that Duchesnay must create corrective advertising to appropriately balance the post by Kardashian. According to the letter, this corrective post “… 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.” This means that the post will likely have to come from Kim Kardashian’s Instagram account. It will be very interesting to see how a celebrity’s retraction and corrective post will be generated, especially considering the character limitations of the channel that are described above.
I would hope that this type of reaction from the FDA doesn’t dissuade pharma brand marketers from utilizing the services of paid spokespeople and their very active social channels. There are regulatory-safe ways to balance safety and efficacy in branded social posts. I’ll be watching Instagram closely, hoping that another brand takes advantage. These channels are where patients are socially engaged and for topics with stigma or without much share of voice, they might be the best chance of getting information in the hands of condition sufferers. Whatever you may feel about the approach Duchesnay took in promoting DICLEGIS®, you can’t deny that thousands of women who may have been suffering from morning sickness are now more empowered with information to speak to their physicians about it.