Key Insights on FDA’s Actions on DTC Advertising

FDA Enforcement Activity: September 2025 Overview

The discussion opened with a review of the September 9, 2025 White House memorandum and accompanying HHS and FDA statements announcing heightened oversight of prescription drug promotion. As part of this coordinated initiative, FDA has issued more than 60 warning and/or untitled letters to companies holding approved NDAs or BLAs. The letters included a range of allegations, most commonly allegations that ads had:

• Unsubstantiated benefit claims
• Distracting visual or audio elements that interfered with comprehension of risk information
• Complete or partial omission of risk information

The agency also announced its intent to revise the “adequate provision” rule to enhance the disclosure of risk details in broadcast advertising, signalling a potentially sustained focus on presentation of risk information.

Patterns and Enforcement Focus

Data shared during the session indicated that DTC television ads accounted for the majority of recent warning and untitled letters, followed by earned media and sponsored digital content.

The presentation also highlighted examples of earned media reviewed under the enforcement action, such as broadcast or online interviews where product information was discussed. These cases raise significant constitutional legal questions about the extent to which appearances in editorial or influencer settings constitute promotional communications.

Participants discussed several open questions that have arisen from the FDA’s enforcement initiative, including:

• Whether further enforcement activity can be expected.
• The potential for AI-assisted technologies to support future FDA review of promotional content.
• The implications of “clear, conspicuous, and neutral” allegations and how they relate to prior FDA interpretations.
• Broader policy and constitutional considerations associated with regulating earned media content.

These topics reflected the current uncertainty across the industry as companies assess how best to interpret and respond to recent developments.

Engagement on this topic was high and this is a fast evolving area necessitating a follow up meeting on the 23rd October. This meeting will also explore the FDA SIUU guidance and industry implementation considerations.

Industry Perspectives and Ongoing Dialogue

The discussion reflected a shared recognition that companies are approaching the new environment with differing strategies.

Participants agreed that effective navigation of these changes depends on close collaboration among regulatory, legal and marketing functions.

Feedback from attendees indicated that the roundtable provided valuable context for interpreting the recent developments and for understanding how organizations can prepare for future enforcement trends.

Continuing the Conversation

In view of the strong engagement and continued interest, Navitas Life Sciences announced that a third Ad Promo Roundtable will be held on October 23, 2025, to extend the conversation and examine ongoing regulatory evolution in DTC advertising and scientific communication.

These sessions continue to serve as a trusted, collaborative forum for professionals seeking clarity and alignment in an increasingly dynamic compliance landscape.

Register for the event here.

Navitas Life Sciences’ experts continue to support sponsors in managing this evolving terrain, helping them translate complex regulations into actionable promotional strategies that uphold integrity and compliance.

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