Disclaimer: These images are for illustrative purposes only.
If you read through each of those and noticed a glaring error, join the Green Room crowd! In the first instance, the word “cures” is used as an unsubstantiated, absolute claim. It implies FDA approval and guaranteed results, which is prohibited if the product is still investigational and the call-to-action suggests commercial availability where there may be none.
In the second example, the press release overstates results from an exploratory Phase 2 trial and in the third, the web copy suggests efficacy and safety are proven, even though the product is still in clinical trials.
What do they all have in common?
They are non-compliant, misleading, overly promotional or unbalanced.
In our industry, proactively communicating pipeline progress and new data is essential for attracting investors, enabling scientific collaboration, laying the groundwork for approval and reinforcing corporate credibility. But companies must do so while navigating strict regulatory guidance from the FDA. Getting it wrong can result in reputational damage, investor concern or even regulatory action.
However, the FDA’s guidance on investigational product communication can be complex and open to interpretation. Missteps like overstating efficacy, omitting risks or promoting unapproved drugs can lead to public-facing enforcement like warning or untitled letters.
Coloring Within the Lines
The FDA expects that external communications about investigational or approved products ensure:
- Accuracy: All claims must be scientifically valid and evidence-based
- Non-misleading language: Avoid overstating benefits or minimizing risks
- Balanced presentation: Benefits must be accompanied by risks
- Adherence to pre-market restrictions: No promotion of unapproved drugs
Seasoned healthcare PR practitioners can mitigate risk. At Green Room, we regularly work with clients to appropriately share phase 1/2 data at major medical meetings and highlight topline results into a press release. Our team is trained to ensure the release is compliant by clearly separating exploratory findings from statistically significant endpoints and avoiding promotional language about unapproved use.
Having an agency well versed in cross-functional Medical, Legal and Regulatory (MLR) collaboration is also key here. Regulatory, legal and PR and communications teams must work together with shared commitment to transparency and consistency.
Best Practices to Ensure Compliance at Every Turn
Our Green Room team can reduce regulatory risk by:
- Implementing robust internal review processes for all public-facing content
- Training employees on FDA standards across functions
- Engaging regulatory affairs early in content planning
- Monitoring enforcement trends and adapting accordingly
Proactive, transparent communication builds trust. But to protect reputation and ensure long-term success, companies must pair transparency with compliance. That means grounding communications in both science and regulatory strategy because compelling storytelling only works when it stays within the lines.
