In pharmaceutical marketing, we’ve long known the power of a good claim. Efficacy data. Safety outcomes. Statistical significance. But increasingly, the most compelling claims aren’t coming from the clinical section of the label, they’re coming from how a brand makes people feel, how it fits into their lives, and how it solves real-world problems.
Sitting at the intersection of research, brand strategy, and real-world impact are non-clinical claims. When done right, they can be just as impactful as their clinical counterparts.
Non-clinical claims are statements about a product’s emotional, experiential, behavioral, or operational value, without relying on traditional clinical endpoints like overall survival, progression-free survival, or adverse event rates.
They can be patient-centered (e.g., “Designed with mobility in mind”), provider-centered (e.g., “Streamlines infusion workflow”), or even system-centered (e.g., “Reduces burden on nursing staff”).
These claims don’t necessarily prove the drug works better. Instead, they help position it more effectively in the real world.
As markets become more crowded and treatment options more clinically comparable, non-clinical claims become a key battleground for differentiation.
They create space for:
They’re also often more flexible than clinical claims when it comes to creative deployment across digital, social, and DTC channels, where attention spans are short and emotional resonance matters.
But here’s the catch, just because a claim isn’t about clinical outcomes doesn’t mean it’s easier to use.
The FDA still considers non-clinical promotional claims subject to a high standard: they must be truthful, non-misleading, and substantiated.
That means vague assertions, hand-picked anecdotes, or fluffy creative headlines are not enough. The claim must be:
Just as you wouldn’t bring a new efficacy claim to legal without clinical data, you shouldn’t bring a non-clinical claim forward without credible research behind it.
This is where many teams go wrong. They generate claims in silos, creative writes the language, insights rubber-stamp it, and legal gets brought in only to strip it down.
Instead, the process should look more like this:
Done well, this approach doesn't just lead to better claims, it leads to stronger cross-functional alignment and faster approvals downstream.
The biggest breakdowns in developing non-clinical claims tend to fall into a few predictable categories:
Avoiding these pitfalls means slowing down early so you can move faster, and with more certainty, later.
The strongest non-clinical claims are not just “nice to have.” They are:
· Strategically aligned with your brand’s positioning
· Emotionally compelling to your customer
· Backed by real evidence, with the research plan to prove it
· Clear and specific enough to stand up to regulatory scrutiny
· Flexible enough to live across personal and non-personal promotion
In a world where customers expect more from pharma, more relevance, more humanity, more understanding, non-clinical claims are a powerful way to close the gap between clinical promise and lived experience.
Whether you’re preparing for launch, refreshing your positioning, or crafting a new campaign, don’t overlook the potential of non-clinical claims. When built on a foundation of insight and rigor, they can be the connective tissue that brings your brand to life and brings your customers closer.