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Aug 28, 2015

OMG! The FDA Is Keeping Up With Kim Kardashian, Too

By Alex Butler, Product Manager, Life Science Applications (LS APPs), MasterControl                                                                    

Love her or hate her, reality-star Kim Kardashian knows how to get our attention. Whether she’s trying to break the Internet with risqué photos or agonizing over which Rolex to wear, people are watching. Kardashian boasts more than 34 million Twitter followers; 26, 074, 878 likes on her Facebook fan page; and 42 million Instagram followers. Forty-two million! That’s how many people may have seen her infamous July 19 Instagram post praising the morning sickness drug Diclegis® that landed her and drug maker Duchesnay in hot water with the FDA. Kim Kardashian’s greed finally got the better of her,” the author of one op-ed piece for the popular U.K. tabloid the Mirror gleefully exclaimed.1 I’m not so sure. Perhaps Kim Kardashian is smarter than we think.

“OMG. Have You Heard About This?”

“OMG. Have you heard about this?” Kardashian asks, striking one of her trademark come-hither selfie poses. She then proceeds to tell her fans about the terrible nausea she has been experiencing during her second pregnancy and credits Diclegis®, the only FDA-approved prescription treatment for morning sickness, with making her feel “a lot better…with no increased risk to the baby.” What she fails to mention are the drug’s potential side effects and interactions. These omissions violate the FDA’s drug-promotion rules.
  
The FDA was swift to respond, sending a short but stern warning letter to Duchesnay Executive Vice President Eric Gervais on August 7. “The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information,” the letter states. Therefore, her “violations are concerning from a public health perspective because they suggest DICLEGIS is safer than has been demonstrated.” The FDA requested that the drug maker correct the claims “using the same media,” meaning that another Instagram post from Kardashian is probably in the works.
This article is related to the Whitepaper: 21 CFR Part 11 Industry Overview: Ready for an FDA Inspection? To get the full details, please download your free copy.

Is the FDA’s Social Media Draft Guidance “Impractical?”

After the offending post was removed on August 11, Duchesnay issued a press release noting the reality star’s support of the drug. The statement included all of the safety information Kardashian failed to provide—a full page and a half of disclaimers—plus instructions to report any negative side effects to the FDA. Given the character space limits on most social media platforms, it seems highly unlikely that any drug could be promoted to FDA’s satisfaction using social media. Perhaps that’s why many drug makers have urged the FDA to alter its draft guidance on social media rules, citing it as impractical. The Pharmaceutical Research and Manufacturers of America even went so far as to say the guidance would have a “chilling” effect on manufacturers’ ability to use social media to reach consumers.2

The draft guidance, issued in June of 2014, requires drug and medical device makers to disclose the benefits and potential risks of their products when posting on social platforms, even if the social media platform only offers limited character space. Surely, as a paid spokesperson for the drug, Kardashian’s post was at least vetted (if not provided) by Duchesnay’s marketing and/or legal people. This makes me wonder: Could the post have been by design? Perhaps Duchesnay felt having a direct pipeline to Kardashian’s tens of millions of followers would be worth a slap on the wrist from the FDA? Think about it. The post received more than 460,000 likes, the media is all over it, and who is to say how many women have asked their doctors about the drug as a direct result of Kardashian’s urging. The TODAY Show is reporting that Duchesnay has seen a 500 percent spike in digital awareness since their run in with the FDA. That type of brand awareness is hard to come by. 


Another Boost to Kardashian’s Brand Empire

And don’t worry about Kim K. She’s suffered worse media backlash than this. She’s not going to have to start doing her own nails or pawning her Rolex collection. Although the drug maker has denied their relationship with the reality star was intended to go beyond the initial post, it seems unlikely that it can fulfill the FDA’s request to correct the messaging “using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated,” without calling on Kardashian again.  


Upside for Drug Makers

Duchesnay isn’t the first drug manufacturer to be cited for false or misleading marketing claims, but it is one of the first to be cited due to a claim made on social media, a medium that most drug and device makers tend to shy away from because the rules are either too strict or too difficult to understand.

At least that’s the impression I got when I attended Scott Liebman’s “FDA’s Social Media Draft Guidance & Complaint Management” presentation at the 13th Annual Products Complaints Congress for Life Sciences in June. Liebman, an attorney and FDA Regulatory & Compliance Partner at Loeb & Loeb LLP, drew a standing-room-only crowd of attendees who seemed desperate for some, well, guidance about the guidance. A few things he pointed out during his presentation have become clear in the Kardashian/Duchesnay aftermath:
  • Drug companies cannot hide behind their celebrity sponsors, marketing departments or legal advisors when direct-to-consumer advertising goes wrong. Notice the warning letter was sent to Duchesnay’s top executive, not Kardashian.
  • If Kardashian had praised the drug as a consumer rather than a paid spokesperson, her post and comments would not have attracted the FDA’s ire.
  • No medication is completely safe, no matter who endorses it.

IMHO, celebrity endorsements can be a good thing, when done correctly. How long would it have taken for the manufacturer and health professionals to spread the word about Diclegis® to women suffering from severe morning sickness without Kardashian’s support? Judging from the comments received on Kardashian’s Instagram page, many women have already requested the drug from their physicians and are (hopefully) finding relief, which is great. The question is: What is the correct way for life sciences companies to engage celebrities to endorse their products on social media without engaging the FDA? It seems only appropriate that the Internet’s self-crowned social media queen has sparked the debate on a larger scale. 
 
Editors Note: September 1, 2015--Kardashian issued a lengthy 'corrective' Instagram post on Aug. 30.
 
As product manager of life science applications (LS APPs), Alex Butler is responsible for developing and/or improving several MasterControl QMS solutions, including MasterControl Complaints, Bill of Materials (BOM), Projects, Risk and PDM Connector. Prior to joining MasterControl, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector. With more than four years of direct medical device experience, as well as a deep understanding of the FDA’s submission process and audit procedures, Butler is a welcome addition to the MasterControl team.


Sources:
(1) Hind, Katie, “Kim Kardashian’s greed has finally got the better of her with drug company plug.” Mirror Online. 15 August 2015. http://www.mirror.co.uk/3am/celebrity-news/kim-kardashians-greed-finally-better-6260737

(2) “Pharma Companies Urge FDA to Alter Draft Social Media Rules.” iHealthBeat. September, 24, 2014.

http://www.ihealthbeat.org/articles/2014/9/24/pharma-companies-urge-fda-to-alter-draft-social-media-rules









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