Enduring Principles in Practice: The FDA’s Latest on HCP Promotion

What you’ll learn:

Executive Summary

Following the FDA’s September 9th, 2025 announcement and the release of 49 enforcement letters focused on DTC promotional materials, the FDA has now released an additional set of enforcement letters. 

As we assessed in our previous POV, Evolving Standards, Enduring Principles, the first group of enforcement letters largely focused on consumer-facing DTC materials, this latest subset highlights the FDA’s parallel scrutiny of HCP-directed promotion. Of the 12 letters, 11 were issued on September 9th and addressed webpages, tradeshow booth panels, a sales aid, and a newsletter; one letter was issued on September 23rd and returned attention to a DTC TV ad, citing issues with distracting narrative sequences during efficacy and major statement delivery. The therapeutic areas that received letters were led by oncology, with additional actions in dermatology, gastrointestinal, immunology, and hematology. 

Across these materials, the FDA cited recurring issues, including reliance on single-arm trial data and unsupported superiority claims, overstated or exaggerated benefit presentations, and the omission or minimization of risk information. Together, these actions reinforce that both consumer and HCP promotion are under heightened FDA oversight, and that presentation style—not just content or disclaimers—remains central to compliance.

Notable Observations

Oncology

The FDA cited multiple products for relying on data from single-arm trials. Without a comparison group, results like stable disease or time-to-event outcomes (progression-free survival, overall survival, cystectomy-free survival) can’t be reliably attributed to the drug. These results may just reflect the natural course of the disease. The FDA reiterated that while single-arm studies can support response rates, they cannot justify promotional claims about disease control or survival. 

Off-Label Promotion

Companies attempted to mitigate non-label data (open-label, exploratory, or otherwise off-label) by including disclaimers that noted trial limitations. The FDA consistently identified that when the net impression overstates efficacy or minimizes risk, disclaimers are not considered sufficient to balance misleading efficacy claims once they are presented in promotional materials. 

Risk Omission in Conference Materials

Tradeshow booth panels featured before/after imagery and bold efficacy claims without any risk information. The FDA also emphasized that directing people to the Prescribing Information does not fulfill the requirement of fair balance and considered it an omission of risk information. 

Superiority Claims

An emerging theme in this batch of letters was the focus on superiority claims. The FDA highlighted that superiority claims based on mechanistic theories (e.g., formulation, size, process) or a single open-label/exploratory study do not meet evidentiary standards. 

Key Takeaways

Oncology received significant attention in both the September 16th and 30th releases of Untitled and Warning letters. Consider presenting therapeutic response rates in alignment with the label without suggesting broader clinical benefit.

Improper Consistent with the FDA-Required Labeling (CFL) use is a dominant trigger. Non-label data presented in promotional contexts may prompt enforcement.

Conference and trade show materials are within the scope of FDA enforcement. Ensure that all conference materials and components strike a balance between risk and benefit.

Superiority claims are the strongest and most credible when supported by pre-specified, adequately powered, head-to-head trials demonstrating consistent, clinically meaningful results, with risks presented transparently alongside benefits. 

Disclaimers are not a shield, and language surrounding study limitations does not mitigate misleading or off-label claims.

Risk and benefit imbalance is a clear red flag, as the FDA continues to take action on omissions, minimizations, and exaggerations.

Consistent with our initial POV, these latest letters don’t shift the rules, but reinforce the FDA’s enduring priorities: clarity, balance, and neutrality in promotion. Regardless of channel or audience, compliance depends on how the entire experience conveys benefits and risks. 

Continue to watch this space for additional updates and timely insights from Klick’s Science + Regulatory team.

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