HHS Secretary Robert F. Kennedy Jr. is famously skeptical of DTC advertisements, and under his authority in September 2025 FDA sent out 30 times as many warning letters as would typically be sent in an average year. Requirements for DTC ads have narrowed considerably, with newfound regulatory focus on scene changes, distracting visuals, or anything that could pull viewer eyes away from major drug statements. What have been the key takeaways from this new attention on CCN guidelines and how do your teams need to adjust?
- Track the responses of companies that received letters in Fall 2025
- Determine what FDA considers to be background visuals or scene changes that could distract from safety information
- Evaluate changing trends and new liability issues concerning derivative works, older DTC ads, and the need for more detailed storyboards
If you use a paid search advertisement with a novel name that redirects viewers to your product website, how much product-related information do you need to present?
- Find the ideal balance with disease-state messaging that includes a vanity link to product sites
- Extrapolate the next likely steps based on FDA enforcement patterns and statements
Recent post-marketing studies give more needed details on how to present information in promotional materials even if they aren't on the label. If you have compelling QOL data measured by a validated tool, is it safe to include in promotional pieces or can FDA say that they have enough doubts in your tool that they find the ad misleading?
If two companies are joining forces on a product, you will want to avoid having both of them undertake a full review if possible. The two companies may have differing risk expectations, so how do you set up your escalation process?
- Clarify roles for each step of review, NDA ownership, and e2253 submission
- Establish whether there is one joint decision-maker
- Anticipate tiebreakers when the two PRCs disagree on acceptable risk
Current review timelines are mostly based on page numbers, which is not a good proxy for review time needed. Your teams need a more complex rating regime that accounts for conceptual difficulty, novelty of claims, number of references, and other difficulty factors that may be harder to quantify. How can you turn this need into an actual product?
- Review development of pilot program for new complexity rating systems
- Weigh preliminary metrics suggested by marketing operations against those suggested afterwards by medical / legal / regulatory
- Ensure coordinators know which factors are and are not important for prioritizing
Omnichannel and digital marketing outlets constantly pressure PRCs to work ever faster; the material volume is growing and the infrastructure of human-based reviews can't match it. By selecting or building the right technology tool, you can rank promotional items by the type of review depth needed, thus removing human oversight from some steps. What is your comfort zone in doing this and what are the essential criteria for a tiered review structure?
- Spotlight items such as translations and reapprovals that could carry on without direct oversight
- Distinguish projects that need full team review, or oversight by a particular team, or could get by with self-certification from the project owner
- Guarantee your CRM can accommodate the increased speed of submission
Upper management is likely pressuring your team to quickly roll out omnichannel content and prove ROI, but the natural bottleneck of MLR risk mitigation can slow that down. How can you navigate the push/pull dynamics between those responsible for managing risk and those who focus on the bottom line?
- Grasp managerial expectations for messaging and content volume
- Properly frame to higher-ups that team members who prioritize risk management may not always be flexible
- Strike the proper balance among different global groups
If PRC members don't have specific training in acceptable starting points or use-cases in managing risk, it can be surprisingly hard to get them up to the same level as their teammates. What is the best approach if team members seem confused over not being allowed to see every possible output?
- Compensate for the lack of clear documentation or precedents that serve as quick primers
- Address the incentives of omnichannel marketing towards personalized content that resonates with customers across every point
- Bridge the gap of explaining to new team members why some content cannot be released
It is easier said than done to balance the speed of rigorous approvals while maintaining compliance checks. While you always want to expedite and automate some steps, the concern is whether potential problems will be overlooked.
- Walk through the expediting procedures that work best for you
- Weigh the pros and cons of a 7-day turnaround (compared to usual 31)
- Explore options for automation on PromoMats and other tools
Many PRCs settle into a stereotypical role where Marketing is always pushing for particular messaging and goals while Regulatory and Legal have to reign it in. What are the most important insights that Marketing teams can bring to PRC meetings? How can they most efficiently convey marketplace trends and unmet needs to colleagues who might not attend as many congresses?
- Ensure PRC teams are clear on the difference between marketing and marketing operations
- Find the best way forward if marketing does not have a voice in the room
- Highlight the most common complaints within marketing teams and the areas where they can convince colleagues to cut them some slack
- Review the proper messages for therapeutics for fatal diseases that may be suspected of being placebos
To get your team to embrace the use of AI tools, first you need to convince them that these aren't their replacements! New tools can make the first pass, catch larger errors, check ISI verbatim, and cut down on other time-consuming steps -- but how confident are you in their development, training, and use?
- Anticipate less staff time spent on reviews once larger issues are auto-handled
- Grasp impact on submissions to major CRMs
- Clarify where new tools for PRCs fit within your larger corporate AI initiatives
The rise of automation and AI in this space can directly impact the marketing coordinator role. What new risks and opportunities will your team face if the human element is lessened?
- Evaluate the likelihood of AI recognizing and properly handling a first-level submission
- Keep realistic expectations about where AI is likely to go in your processes
- Consider ethical and legal implications of AI-driven materials -- and who owns them
Celebrities and influencers are proven to capture audience attention, but they can also heighten your exposure to risk and enforcement letters. What problems have they led to in the recent past, and how can your team learn from this?
- Review recent enforcement actions related to Serena Williams, HGTV, and others
- Pinpoint the risks of overstating efficacy or insufficient balance of safety
- Keep messaging at a level consumers can understand while staying transparent
The use of QOL claims can significantly complicate your promotional piece and raise questions about maintaining consistency with the label. Many tools used for clinical trial evaluation are not commonly used in real-world practice; how can you be sure you are conveying meaning properly?
- Map out how RWD claims remain consistent with label
- Select QOL claims that you are certain correlate to increased happiness or satisfaction
- Rely on RWE to gain approval after setbacks in international markets