Hale Advisors

This fantastic group of regulatory and legal colleagues joined co-chairs Georgia Gayle and Zoë Dunn to unwind after a packed first day at Momentum Events 6th Annual Promotional Review Summit. We shared valuable conversations (and inside jokes) about marketing compliance, governance, and innovation. Nothing beats connecting in person with colleagues who truly understand the challenges (and rewards) of navigating pharma ad promo. #ItDepends Cheers to PRC and thank you to Jonathan Banchs Lauren Arcady Bryon Main and team for another excellent conference! #PharmaMarketing #MarketingGovernance #PromoReview #MLR Georgia Gayle Alia Montgomery Melissa Sadowski Faiza Poshni Larry Herring, RN, BSN Darshna Vasani, PharmD, RPh Heather McFalls Christi Bruce Juliana Abdallah Lynn Carroll Yemisi Oluwatosin, Ph D., MBA Leah Donohue Ilyssa Levins-Pimienta Michael Levins Ana Cardenas

Just 10 days away! Join FDA insider Jason Cober for a live deep dive into Form FDA 2253 compliance, exceptions, and real-world application. Get your toughest questions answered during 30 minutes of audience Q&A — no replays, no second chances. Reserve your spot now — no submissions team can afford to miss it! https://qrco.de/bgDnx6

Following the RIF and re-org at OPDP, access to guidance has never felt more limited. That’s why our Insider Insights Webinar Series brings former OPDP leaders and industry experts directly to you. Each session dives into the hottest ad promo issues and gets your questions answered by the people who know the system best. Next up? October 22, former FDA/OPDP lead project manager Jason Cober will present, "Slipping Through the Cracks: Insider Insights on 2253's." It's everything you want to know about 2253 exceptions, the do's and don'ts of Interactive Submissions, and more. Save your seat: https://qrco.de/bgDnx6 #PharmaMarketing #MarketingGovernance #InsiderInsights

The FDA provides exceptions to the Form FDA 2253 submission requirement?? Yep, this has our attention too. Don't miss this live webinar with former OPDP lead project manager Jason Cober as he presents, "Slipping Through the Cracks: Insider Insights on 2253's." Jason will walk us through exceptions, topics like SIUU and Addressing Misinformation, and how to avoid improper application of the Interactive 2253 Guidance to social media and digital content submissions. Plus, there's 30 minutes for audience Q&A. JOIN US: https://qrco.de/bgDnx6 #PharmaMarketing #MarketingGovernance #InsiderInsights

Is it still a humblebrag if it's about your terrific collaborator? Thank you to Heather McFalls and others for glowing reviews of our first two INSIDER INSIGHTS webinars featuring Jason Cober, the former FDA/OPDP lead project manager. Don't miss him on October 22, when Jason will present, "SLIPPING THROUGH THE CRACKS: INSIDER INSIGHTS ON 2253's." Everything you want to know about 2253 exceptions and a chance to ask Jason questions during a 30-minute audience Q&A. Register: https://qrco.de/bgDnx6 Hale Advisors created the Insider Insights webinar series to fill the gap in OPDP information and access left by the April reduction in force. The series focuses on essential pharma ad promo compliance topics. Follow us to learn about upcoming webinars. #PharmaMarketing #MarketingGovernance #InsiderInsights

Registration is open! Join us Oct. 22 for a live webinar featuring the incomparable former FDA digital and AI project lead, Jason Cober. Learn from Jason’s extensive insider knowledge about exceptions to the 2253 submission requirement. Topics will include guidances such as SIUU, Addressing Misinformation, and Interactive 2253. PLUS, Jason’s set aside 30 minutes for audience Q&A. Don’t miss him, register now: https://qrco.de/bgDnx6 *About Jason Cober* From 2016-2025, Jason was the Lead Project Manager at OPDP / OMP / CDER / FDA, where he partnered with industry on digital, modular, and GenAI content submissions. Jason joined FDA in 2008 and has over 15 years’ experience with the Agency’s electronic Common Technical Document (eCTD). *About the Insider Insights Webinar Series* Hale Advisors developed Insider Insights to fill the gap in OPDP information and access left by the April reduction in force. The series focuses on essential pharmaceutical advertising and promotion compliance topics. Follow us to learn about future webinars. #PharmaMarketing #MarketingGovernance #InsiderInsights

There are several differences between WARNING and UNTITLED Letters, but two stand out: (1) the severity of the violation, and (2) the consequences of a failure to act promptly. Warning Letters are more grievous, but take both seriously. Warning Letters are for violations of “regulatory significance” and warn of enforcement action if the violations aren’t promptly and adequately corrected. Untitled Letters request correction for violations that may not meet that threshold of regulatory significance, and they don’t warn of enforcement action. Both Letters expect “voluntary compliance” and provide an opportunity to dispute the statements in the Letter. Do you have a streamlined response and correction process for Warning and Untitled Letters? #PharmaMarketing #MarketingGovernance #DTC #PromotionalReview

The FDA's shock and awe campaign has even hit Oprah. Last week's FDA Warning Letters from CDER/CBER have been posted—including 8 letters to 5 pharma/biotech companies about 9 brands. The letters cited violations in 1 TV ad, 3 paid search, 2 TV specials/videos (Oprah!), and 2 interview videos. There were also 60 letters issued to online pharmacies and telehealth companies. https://lnkd.in/eiRgtwE #PharmaMarketing #MarketingGovernance #DTC #PromotionalReview

MM+M's Jack O'Brien and Steve Madden dove into the Untitled Letter that the FDA sent FluMist last week, noting "a larger shift toward stricter FDA enforcement of DTC pharma ads and a more aggressive look at the stylistic choices brands take with their marketing efforts." As Hale Advisors CEO Zoë Dunn noted, "if there’s a long-term adjustment that can be made...it’s to engage with MLR review teams earlier in the process to ensure the spots don’t run afoul of these regulatory landmines." What's your view? #PharmaMarketing #MarketingGovernance #DTC #PromotionalReview

FDA has published last week's Untitled Letters from OPDP to pharma/biotech: • 40 letters – 35 TV, 3 video, 1 web page, 1 print ad • 22 companies • 29 brands In comparison, OPDP issued 35 total letters in the 8-year period May 2017-May 2025. Ready, set, read: https://lnkd.in/gYefVUTi #PharmaMarketing #MarketingGovernance #OPDP #DTC #PromotionalReview