The FDA was none to happy with the stunt Kim Kardashian pulled with Diclegis. Here's why.
August 2016 marked a pretty dubious one-year anniversary for Duschesnay, makers of Diclegis and promotional partner of the celebrity, Kim Kardashian. Last year, the company was in hot water with the FDA over the reality TV queen’s social media posts regarding her endorsement of Diclegis as a medication for morning sickness. In her “OMG Have you heard about this” post, Kim talked about how she got great results and BOOM: FDA Warning Letter.
We’ve already talked about how pharmaceutical communications must equally balance risks and benefits in order to avoid being false or misleading. But Kim’s obvious omission in failing to communicate risk information isn’t the point here. The issue for healthcare PR pros is accountability and control over the people distributing your content.
The Harsh Consequences of a Little Tweet
While it’s taking the FDA awhile to issue regulations on healthcare PR and marketing efforts online, the Agency did release lengthy Guidance on compliance in January 2014. The discussion relevant to Kim Kardashian’s blunder is the FDA’s statement that:
“A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.”
The italics are added here to point out the three issues for healthcare communications professionals to avoid the dreaded FDA Warning Letter:
- What qualifies as content? Anything that falls under the definition of “interactive promotional media” is content, including blogs, blog comments, website material and – yes – social media posts. That means a Like, Tweet, Re-Tweet, Share, +1 and the like is content falling under your umbrella of responsibility.
- Who qualifies as being an agent? Someone acting on behalf of the firm would be an agent, no matter what moniker they may self-assign. Kim mentioned that she was “partnering with Duchesnay USA,” so it’s pretty safe to say a partner would be an agent. Any person you pay or provide some benefit for promoting your product qualifies.
- What conduct is considered promoting the product? There is no legal bright-line test here, but a little common sense can tell you whether certain content is promotional in nature. It could be a subtle product mention all the way to pulling out the pom-poms to tell the world how great your firm is – and anything in between. The qualifying factor: If the agent is posting content that you’re paying him or her to publish, you can be sure it’s promotional.
This analysis should help pharmaceutical PR executives with the “who” and the “what” as far as responsibility for the people promoting your products; the “how” you retain control over your agent can a little bit tricky. Fortunately, your legal department knows that a little rider in a contract can keep a reality TV star from having an oops moment on social media.
Next up in our Regulatory Series for pharmaceutical communications and PR professionals:
Why pharma is slow to get on board with social media AND
Get to know the FDA’s alter ego across the pond: European Medicines Agency
By Marc DeLeuw