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Footnotes and Fair Balance

Exploring the intricate world of medical animation, where strict regulations, creative branding, and evolving technology converge.

In my last piece, I wrote about how the complexity of the body can be explained with animations — but that wasn’t the whole story. Within the medical animation space there are rules and regulations that govern much of the content, including those notoriously awkward lists of side effects in drug commercials.

Two major categories of marketing content produced by medical education agencies exist: “Branded” and “Unbranded.”  

  • Branded content is advertising for a specific pharmaceutical after it has been approved by the FDA. By law, branded content is required to be accompanied by Important Safety Information (ISI) and often has to meet “Fair Balance” requirements, which mandate an equal amount of information on the screen including possible adverse effects of the drug.  
  • Unbranded or “Promo” content is education-focused around disease awareness and new research but cannot mention a specific drug’s name, although these programs can be “brought to you by” the pharmaceutical company whose drug conveniently addresses the medical condition. These videos and animations must be accompanied by footnotes citing medical journal entries that support the medical points in the video.
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Another related category of content is Continuing Medical Education, or CME, which tends to consist of live discussion panels of Key Opinion Leaders (KOLs). This content may be supported by static PowerPoint slides and doesn’t often use animated content, but we are starting to see that change with higher production values including 3D animation and virtual sets. As pharmaceutical companies race to get their products to market, it’s not uncommon that both branded and unbranded Mechanism of Action (MOA) and Mechanism of Disease (MOD) animated videos are being produced while the medication is still in the clinical trials pipeline so they can be shown immediately after approval. Because science messaging is subject to change at any time with new research during clinical trials, medical animation production needs to be ready to pivot at any time — fortunately, well planned 3D/computer generated imagery (CGI) has the benefit of flexibility as a story changes. That said, the benefits of a flexible or extended schedule need to be weighed against the realities of cost.

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It may sound counterintuitive, but approvals are an ongoing process. In general, there are three phases that need legal approval: Script, animatic w/scratch voice over, and final delivery approval. Because the law requires so much attention to detail, agencies would be wise to work with an animation studio that understands the subtleties and idiosyncrasies of meeting medical/legal approval requirements. This will greatly reduce the agency’s need to hold the studio’s hand during initial costing and timing estimates — and, of course, through project delivery.

Originally published: 11/11/2021

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