It was great to meet our customers and partners in person.
The industry leaders shared invaluable insights on navigating today's complex pharmaceutical marketing landscape. The discussions were eye-opening and the networking opportunities phenomenal. These discussions were insightful, and the connections genuinely valuable.
Top 10 Takeaways:
1️⃣ FDA scrutiny of influencer marketing has intensified, with 4 of 12 recent Untitled Letters addressing social media content and specific concerns about inadequate safety information display.
2️⃣ The Clear, Conspicuous, and Neutral (CCN) Rule is fundamentally changing TV advertising with dual modality requirements and specific standards for safety information presentation.
3️⃣ 86% of HCPs report patients discussing social media content during clinical visits, highlighting the growing influence of digital information on healthcare decisions.
4️⃣ AI adoption in promotional review remains cautious, with most companies in early implementation stages despite significant potential for standardization and efficiency.
5️⃣ FDA enforcement has shifted dramatically, with efficacy claims now accounting for 90% of citations compared to just 38% before the Amarin case.
6️⃣ The final SIUU guidance provides greater flexibility by expanding acceptable data sources beyond RCTs to include observational studies and real-world evidence.
7️⃣ Disease awareness campaigns can increase diagnosis rates by 15-20% for underdiagnosed conditions when properly separated from branded promotion.
8️⃣ Digital Opinion Leaders (credentialed HCP influencers) are emerging as powerful, trusted voices who can effectively communicate complex medical information.
9️⃣ Early integration of promotional expertise in labeling discussions significantly reduces launch obstacles and regulatory risks.
🔟 The FDA's new Tailored Responsive Communications (TRCs) framework offers a pathway to address misinformation without triggering promotional requirements.
The regulatory landscape continues evolving at breakneck speed, but the core principles remain: truthful, balanced, and compliant communications that ultimately serve patient needs.
What regulatory changes are most affecting your promotional strategy? I'd appreciate hearing your perspectives in the comments.
Nicol George, Georgina Lee, Lynn Bowen, Anthony Genovese, Moulakshi R., Virginia Foley, Heta Zaveri, Mark Gaydos, Micheline Awad, Kimberly B., Renee Ambrosio, Lisa Hubbard, Shruti Gadhia, Kevin Hollister, MS, MBA, MPH, Jan Owen, Josephine Secnik, Gina Vestea, PharmD, Jasson W. Gilmore, Amit Patel, Orna Bresler MBA, RAC, Chris Lewis, Kavita Philips, Matthew Lupo, Amber Cummins, Govardhan Dande, Diana Mason, Seema Patel, Noah Byrd
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