Pharma and Fame: Keeping Up with the Kardashians and FDA Regulations

Kim Kardashian made an unexpected splash this summer when she ran afoul of the Food and Drug Administration (FDA). While public opinion of Kim Kardashian and her family are mixed (at best), there is no doubt a very large crowd who is interested in what she has to say, as indicated by her social media profiles. She has 44 million Instagram followers and 26 million Facebook followers—her social clout is undeniable.

As her millions of followers know, Kim is pregnant with her second child. She posted a photo on Instagram of her holding a medication, Diclegis®, prescribed for morning sickness. In the caption, she promoted the benefits of the prescription pill and personally endorsed it as having helped her with her pregnancy-related nausea struggles.

Unfortunately, Kim’s statements on social media promoting the benefits of Diclegis failed to include the necessary fair balance. FDA regulators swiftly asked for the post to be taken down and issued a warning letter to Duchesnay Inc., Diclegis’ manufacturer, asking the drug maker to outline a plan to avoid future violations. This warning letter reflects the FDA’s guidance that regardless of the channel, balance needs to be included in all marketing copy.

In this case, the risks—including sleepiness that can make it dangerous to drive or perform other activities that require mental alertness—were completely omitted. While celebrity endorsements of products are nothing new, the Diclegis example goes to show how tricky it can be to mix drug promotion and social media. (Although it should be noted Kim Kardashian reposted the photo to Instagram a few weeks later, with a revised caption that met the FDA’s guidelines.)

While each social media platform has its own characteristics—from character limits to general audience type—the FDA’s rules are pretty clear, and have been for some time. Even with the space limitations of social media, pharmaceutical companies must provide fair balance. While Instagram and Facebook posts do not have character limits, Twitter and Facebook advertisements do (140 and 90 characters, respectively). Thus, in many cases, there simply is not enough room to include all of the required balance.

Another challenge is exerting control over posted content. For celebrity endorsements in particular, statements are often written by marketers, not the celebrity, but are then posted to social media accounts where the celebrity has the ultimate say. While the pharmaceutical company is paying the celebrity to promote its product, the celebrity is far from a typical employee. Unlike a pharmaceutical marketing manager, celebrities are unlikely to know—or care, for that matter—about the risks of and requirements for these types of posts.

Pharmaceutical companies also run the risk of a celebrity going rogue and posting something beyond or in place of what was written by the marketing team. Celebrity endorsements also pose a unique situation should something go wrong. Pharmaceutical companies can terminate an endorsement deal with a celebrity or other third-party spokesperson, but doing so usually makes headlines in its own right.

All of this begs the question: Can pharmaceutical marketers effectively use social media to promote their products via paid spokespeople? There are naysayers, but it is possible, so long as pharma marketers take the appropriate steps to build a strategy and help ensure successful execution. Here are six steps to help pharma marketers and their celebrity spokespeople survive and thrive together on social media:

1. Establish a playbook. A brand playbook is the holy grail of social engagement. It should outline the potential scenarios, team members, goals, and steps and best practices to resolve any issues. The playbook will help guide the whole project or campaign.

2. Create and approve an editorial calendar. For every social media post, creating a calendar and approval process, and documenting the exact content which will be published by the spokesperson is a key step. Pre-approvals ensure the content is FDA compliant and also within the spokesperson’s comfort level, and documenting the content as agreed upon is a good backup system to settle any conflicts on the planned content that may arise later.

3. Train your spokesperson(s). This is the most important step. This is no different than more common executive speaker or spokesperson training: Establish objectives, boundaries and timing for engagement.

4. Monitor the conversation. An abundance of powerful tools are available to help marketers monitor their campaigns and send notifications regarding new conversations of interest. Measurement and social listening are important to ensure campaigns are successful and engaging.

5. Deal with conversations of interest (if necessary). If an adverse event is reported in a conversation stream, follow the steps documented in the playbook as established by the pharmacovigilence team.

6. Report the conversations back to the FDA. Depending on the campaign, the pharma company may need to report the conversations for product promotions back to the FDA every 30 days. Before conducting a campaign, pharma marketers should review the FDA guidelines to see if this rule applies to their campaign.

Pharma and celebrity spokespersons do have a productive role together within social media—but marketers need to be extremely mindful of the latest FDA guidelines and the ever-changing social landscape. Using the steps above can help brand teams build an effective and compliant campaign for their product, and help them to keep up with the Kardashians and the FDA.

  • Gene Yuchin Miller

    Gene Yuchin Miller is Director of Commercial Strategy and Innovation at Cadient, a Cognizant company. He is focused on finding the confluence of brand goals and the unique challenges of patients, caregivers, and physicians to help meet everyone’s challenges. He brings 21 years of digital marketing experience to Cadient.


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