About Promotional Intelligence, by Compliance Forward
Our guests and topics range from Pharma/Biotech Regulatory Ad Promo insights, FDA Enforcement activities, Commercial Regulatory Strategy to pioneering approaches for compliance enablement with AI.
The dynamic duo is back again. This time, get Virginia and Jason's take on the latest enforcement letter from FDA-OPDP. Jeuveau is an injectable treatment for lines and wrinkles that got issued a letter for an Instagram post. What went wrong and more importantly, how can industry get it right without specific guidance from FDA-OPDP on social media?
26 Sept 2026
PI: 13 Filspari Untitled Letter
Virginia Foley (https://www.linkedin.com/in/virginiafoley/) and Jason Cober (https://www.linkedin.com/in/jason-cober/) are back from the Regulatory Affairs Professionals Society (RAPS) (https://www.linkedin.com/company/regulatory-affairs-professionals-society-raps-/) conference and are ready to break down the recent #FDA (https://www.linkedin.com/search/results/all/?keywords=%23fda&origin=HASH_TAG_FROM_FEED) #OPDP (https://www.linkedin.com/search/results/all/?keywords=%23opdp&origin=HASH_TAG_FROM_FEED) Untitled Letter for FILSPARI.
This letter hits on some key points:
✅ Why it's important to accurately represent approved product Indications and why minor changes in the presentation of the Indication can have major consequences
✅ Exploratory data without an alpha control do not support conclusory claims like "PROVEN"
✅ Characterizing a product with a double Box WARNING and a REMS as "Well Tolerated" is a minimization of risk--despite having ISI sprinkled throughout the material
2 Sept 2026
PI: 11 (Part 2)
Inside the FDA Layoffs
Virginia Foley "Industry Insider" and Jason Cober "Regulatory Authority" discuss the April 2025 Reductions in Force (RIF) at HHS, specifically at FDA. Hear a first hand account about how the Reductions in Force were executed on April 1, 2025.
2 Sept 2026
PI: 11 (Part 1) Inside the FDA Layoffs
Virginia Foley "Industry Insider" and Jason Cober "Regulatory Authority" discuss the April 2025 Reductions in Force (RIF) at HHS, specifically at FDA. Learn about what is a RIF and why these were different.
2 Sept 2026
PI: 09 Beyfortus & Tobi Podhaler Untitled Letters
In the newest episode, Virginia Foley and Jason Cober discuss the recent FDA-OPDP Untitled Letters issued for BEYFORTUS and TOBI PODHALER.
Unclear on how the FDA expects product Indications to be presented in promotional materials? What can patients and caregivers say about a product in a testimonial?
@complianceforward (https://www.youtube.com/@complianceforward)
2 Sept 2026
PI: 08
A Journey in Time--Rx Drug Ads on TV
We are back... this time to talk about the history of how the Adequate Provision requirement is being fulfilled with DTC drug advertising on television.
The 1999 FDA guidance didn't permit DTC TV ads—yet it's being described today by FDA as a regulatory "loophole". 🧐
Spoiler: the first branded TV ad was actually in 1983, and the regulations' roots go much deeper.
Virginia Foley and Jason Cober from @complianceforward (https://www.youtube.com/@complianceforward) take a trip down memory lane and discuss what DTC Television ads looked like before 1999 and how we got to today with the recently added (2023) CCN regulations.
Whatever happens next, one thing’s for sure—policy decisions aren’t made in a vacuum, and understanding the history helps us see the bigger picture.
2 Sept 2026
PI: 10 New Era of Enforcement w/special guest John Driscoll
In this latest episode of the Promotional Intelligence podcast, Virginia Foley and Jason Cober from @complianceforward (https://www.youtube.com/@complianceforward) welcome special guest John Driscoll, Founder of OPDP Resources. Get their take on this breakout year of FDA enforcement action following the HHS announcement from September 2025 announcing the "crackdown" on DTC Rx advertising
2 Sept 2026
PI: 07 From Payor Guidance to PIE and Back w/ special guest
Dara Katcher Levy
Virginia and Jason are joined by Dara Katcher Levy to discuss the FDA's recently revised Payor Guidance.
2 Sept 2026
PI: 06 CFL Gone Wild -
Vyepti Untitled Letter
Jason and Virginia from @complianceforward (https://www.youtube.com/@complianceforward) complete a rapid response review of the recent enforcement letter issued for violative promotion using CFL (consistent with FDA approved labeling) data to promote efficacy claims and also PRO (patient reported outcomes) data from post-hoc analyses. Listen and learn! Like what you hear, subscribe to the Promotional Intelligence podcast to stay up-to-date on all things related to Regulatory Ad Promo in pharma & biotech.
2 Sept 2026
PI: 05 Why is FDA Calling Adequate Provision a "LOOPHOLE"?
The FDA's latest proposal targets what they refer to as the "adequate provision loophole" in advertising, pushing for full disclosure of risk information in TV and radio ads. What does this mean for the future of drug marketing?
Application of the final rule could result in a veritable ban on DTC broadcast advertising. Expect longer ads or a shift in advertising strategies, especially towards social media, as companies adapt to these changes. 📺➡️📱
Watch the latest episode @complianceforward (https://studio.youtube.com/channel/UCJr4ElOCm2Az8HcMXTkNTJA)
What are your thoughts on this potential shift? Discuss in the comments below.
2 Sept 2026
PI: 04
What do we need to know about ELSA 4.0 - FDA's AI Tool
Virginia (Industry Insider) and Jason (Regulatory Authority) discuss the FDA's recent press release announcing ELSA 4.0 - what do we know about the Agency's use of AI and what remains unknown?
AI is transforming industries, and the FDA is no exception. With the recent announcement of ELSA 4.0, the FDA has taken a significant step forward in integrating AI into its review processes. But what does this mean for Industry? In this podcast, Jason Cober explores the implications of ELSA 4.0, its potential benefits, and what industry professionals need to know to navigate this evolving landscape.
*Understanding ELSA 4.0*
The May 6 Press Release from the FDA highlighted several key features of ELSA 4.0, including the consolidation of over 40 applications into a single system named HALO (Harmonized AI and Lifecycle Operations). This consolidation aims to streamline data processing and improve the efficiency of the review process. ELSA now includes functionalities such as custom agents, data visualization, voice-to-text dictation, and document generation. These enhancements are designed to support FDA staff in their day-to-day tasks, potentially speeding up review and approval timelines.
*The Importance of AI Integration in FDA Reviews*
The integration of AI tools like ELSA could significantly impact the FDA's operational efficiency. With the ability to query data and build workflows without manual document uploads, ELSA has the potential to reduce the overall workload on FDA reviewers. However, the success of this technology largely depends on its adoption across the agency. Understanding how frequently FDA staff are using ELSA is crucial for industry professionals looking to optimize their submissions and align with the FDA's new processes.
*What We Still Need to Learn About ELSA*
Despite the promising features of ELSA 4.0, there are still many unanswered questions. For example, we need clarity on the underlying large language model (LLM) that powers ELSA. Knowing which LLM is in use is vital for industry professionals as it impacts how submissions are processed and evaluated. Without this information, companies are left guessing how to format their submissions to align with the FDA's expectations.
*The Role of Communication in Navigating Regulatory Changes*
As the FDA continues to implement AI-driven solutions, maintaining open lines of communication with FDA reviewers is essential. Industry professionals are encouraged to engage with their reviewers, asking questions about how ELSA is being utilized and what specific features may help streamline their submission process. This proactive approach can provide valuable insights into the review process and ensure submissions are optimized for the current AI environment.
*Key Takeaways*
1. ELSA 4.0 is a significant advancement in the FDA's use of AI, with the potential to improve review efficiency.
2. Understanding which AI model powers ELSA is critical for optimizing submissions.
3. Open communication with FDA reviewers can provide insights into how to navigate the new AI landscape effectively.
2 Sept 2026
PI: 12 ASA-3000 Untitled Letter - Pre-approval Promotion
Virginia and Jason from @complianceforward (https://studio.youtube.com/channel/UCJr4ElOCm2Az8HcMXTkNTJA) discuss the August 2026 Untitled Letter issued by OPDP for pre-approval promotion of ASA-3000 - an investigational product.
This letter includes several key violations and highlights the importance of ensuring medical communication regarding investigational products - especially those in the pre-approval phase - remains non-promotional.
7 Jul 2026
PI: 03 - Photofrin Untitled Letter (June 22, 2026)
Virginia (Industry Insider) and Jason (Regulatory Authority) breakdown the details of the Photofrin Untitled Letter issued by OPDP on June 22, 2026.
In Part 2 of this episode Jason Cober (Regulatory Authority) and Virginia Foley (Industry Insider) continue the conversation and talk about the trend of FDA enforcement in oncology time-to-event data presentations in the recent bolus of letters, coming from both CDER and CBER.
Jason Cober (The Regulatory Authority) and Virginia Foley (The Industry Insider) from @complianceforward (https://studio.youtube.com/channel/UCJr4ElOCm2Az8HcMXTkNTJA) take a deep dive into the world of time-to-event endpoints as measured by single-arm trials. They dissect the FDA's position on development of these types of clinical trials and explain why the promotional enforcement letters are stacking up. Enjoy part 1 and stay tuned for part 2.
4 Jun 2026
PI: 01 - SUCRAID Untitled Letter
In this episode, Jason and Virginia break down the recent enforcement letter regarding Sucraid, highlighting its misleading promotional materials. The FDA has flagged two emails targeting healthcare professionals for their claims about the product's indication and presentation of safety.
We dive into the details—what was wrong with the promotional emails? And what should be done differently to ensure compliance?
This conversation sheds light on the importance of accurate communication in healthcare. Let’s not forget: clarity in presenting risks is crucial for patient safety!
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