Advertising & Promotion for Medical Products Conference
October 17–18, 2024 In-Person & Virtual Event
Agenda
Subject to Change
All Times Are Eastern Standard Time
To view the session description, please click on the session title.
Thursday, October 17
Christine M. Simmon, President & CEO, FDLI
Dale Cooke, President, PhillyCooke Consulting, and Co-Chair, Advertising and Promotion for Medical Products Conference Planning Committee
Elizabeth R. Jungman, Chief of Staff, Office of the Commissioner, FDA
Annie Ugurlayan, Assistant Director, National Advertising Division, BBB National Programs
Serena Viswanathan, Associate Director, Division of Advertising Practices, FTC
Moderated by Christine M. Simmon, President & CEO, FDLI
FDA panelists provide updates on regulatory advancements and address frequently asked questions about medical product promotion.
Catherine B. Gray, Office Director, Office of Prescription Drug Promotion, CDER, FDA
Kristine T. Khuc, Consumer Safety Officer, OCBQ/DCM/APLB, CBER, FDA
Deborah A. Wolf, Regulatory Counsel, Office of Product Evaluation and Quality, CDRH, FDA
11:10–11:20 AM | Networking Break
The broad-spectrum potential of AI renders it a powerful tool for optimizing promotional accuracy and effectiveness. This session reviews FTC’s regulatory framework and panelists’ perspectives in leveraging AI tools to create content and interact with platform subscribers over messaging, when drafting medical responses, and more.
Andrew Hasty, Attorney, FTC
Christina Anderson Mooney, Senior Legal Director, FDA/Life Sciences, Medtronic
Moderated by Komal Karnik Nigam, Counsel, Hogan Lovells US LLP
12:30–1:30 PM | Lunch Break
1:45–2:45 PM | Concurrent Breakout Sessions
Influencer promotion may amplify and expand messaging to broader and more diverse audiences. But recruiting and managing these quasi-independent contractors poses challenges. This session discusses strategies to perform background checks, draft clear contractual requirements, and construct influencer monitoring programs. Panelists will review recent enforcement actions and FTC warning letters to demonstrate how industry can compliantly use influencer promotion to advertise products and services.
Richard Cleland, Of Counsel, Arnall Golden Gregory LLP
David Gibbons, Division General Counsel, Pharma, Nestlé Health Science U.S.
Cassandra Rasmussen, Staff Attorney, Division of Advertising Practices, FTC
Moderated by Sharon M. Bradley, Principal, Sharon Bradley Law PLLC
Telehealth services have the potential to broaden patient access, provide personalized care for patients’ diverse needs, and improve public health education. This session considers strategies to harness telehealth benefits while mitigating risks through a discussion of enforcement arising from false claims, platforms implying or directly promoting off-label uses, and other actionable activities.
Evan M. Hellman, Senior Counsel, Foley & Lardner LLP
Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC
Moderated by Colleen M. Heisey, Partner, Jones Day
2:45–3:00 PM | Networking Break
Radios and TVs were once mainstream media broadcasting. Now, communication tools have expanded to include streaming platforms, in-office displays, and more. This session opines on the scope of FDA’s recent broadcasting rule, and considers the dos and don’ts of compliant advertising through real-world examples.
Joel Davis, Principal Consultant Regulatory Affairs, Opus Regulatory, Inc.
Stefani Klaskow, Director, Health and Wellness, Google
Marc J. Scheineson, Partner, Alston & Bird LLP
Moderated by Dale Cooke, President, PhillyCooke Consulting, and Co-Chair, Advertising and Promotion for Medical Products Conference Planning Committee
On June 28, 2024, the Supreme Court overruled its landmark 1984 decision in Chevron v. Natural Resources Defense Council. Panelists will share views on the future of off-label promotion without Chevron deference and explore how civil and criminal liability for pharmaceutical companies may evolve.
Hannah R. Bornstein, Partner, Nixon Peabody LLP
Ashley Zborowsky, Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory, Medtronic
Moderated by Kalah Auchincloss, Executive Vice President, Regulatory Compliance & Deputy General Counsel, ELIQUENT Life Sciences
5:00–6:00 PM | Reception (In-Person Only)
Friday, October 18
Lauren-Caroline Tadros Potter, Assistant Director, FDLI
Jae Kim, Partner, DLA Piper LLP (US), and Co-Chair, Advertising and Promotion for Medical Products Conference Planning Committee
In February, a bipartisan group of Senators sent a letter to FDA urging the agency to address gaps in social media oversight. This session will consider how FDA could update policies and approaches to meet the need for accurate information dissemination over rapidly evolving digital platforms.
Joshua M. Oyster, Partner, Ropes & Gray LLP
Moderated by Carolina M. Wirth, Shareholder, Hall, Render, Killian, Heath & Lyman P.C.
10:30–10:45 AM | Networking Break
Harnessing medical, legal, and regulatory (MLR) experience can produce accurate, compliant, and diverse promotional material in theory. In practice, selecting, convening, and engaging representatives to serve on promotional committees can pose challenges. Panelists will share best practices on getting the most from MLR committees and creating meaningful advertising.
Kelly Belnick, Senior Counsel, Regulatory Law, MedTech, Johnson & Johnson
Alicia Kantor, Senior Legal Program Manager, Enterprise Legal Regulatory, Medtronic Vascular
Alicia Whittlesey, Principal, Porzio, Bromberg & Newman, P.C.
Moderated by Anisa Mohanty, Of Counsel, DLA Piper LLP (US)
12:00–1:00 PM | Lunch Break
1:15–2:15 PM | Concurrent Breakout Sessions
This session explores the role of analytics in translating complex data from diverse clinical trials and patient-reported outcomes (PROs) to advertising that meets patient needs, improves safety and efficacy, and add credibility to advertising campaigns. Panelists provide strategies for aligning promotional content with recent FDA guidance and creating action plans.
Kristin Zielinski Duggan, Partner, Global Regulatory, Hogan Lovells US LLP
Gregory Ringenberg, Director Regulatory and Medical Review, One Source Regulatory
Moderated by Sarah Thompson Schick, Counsel, Reed Smith LLP
Panelists shed light on the gray space in FDA’s determination of “homologous use” for HCT/Ps and its interpretation in caselaw, emerging challenges in balancing scientific innovation with regulatory oversight, and novel advertising issues in this field.
Julie C. Tierney, Deputy Director, CBER, FDA
Mark Gardner, Managing Partner, Gardner Law, PLLC
Moderated by Eva A. Temkin, Partner, Arnold & Porter LLP
In the wake of phased LDT regulation, this session reviews LDT regulatory history, implementation stages, and the importance of this change to public health. Panelists analyze challenges to FDA’s authority to regulate and consider steps for industry to align with forthcoming standards.
Phillip R. Desjardins, Partner, Arnold & Porter LLP
Alberto Gutierrez, Partner, NDA Partners LLC
Peter Lurie, Executive Director, Center for Science in the Public Interest
Moderated by Son Nguyen, Special Counsel, Cooley LLP
In this session, hear from FDA, NAD, and legal experts on various strategies and pathways to address competitor misconduct in the advertising and promotion space. These pathways include submitting complaints to regulatory and self-regulatory bodies, such as NAD and FDA’s “Bad Ad” program. Understanding the critical factors involved in decision-making before filing a lawsuit, submitting a complaint, or drafting a cease-and-desist letter, can enable industry to select a strategy that best meets its needs.
Catherine B. Gray, Office Director, Office of Prescription Drug Promotion, CDER, FDA
August Horvath, Partner, Foley Hoag LLP
Jennifer Santos, Attorney, National Advertising Division, BBB National Programs
Moderated by Jae Kim, Partner, DLA Piper LLP (US), and Co-Chair, Advertising and Promotion for Medical Products Conference Planning Committee
3:30 PM | Closing Remarks and Conference Adjournment
