Why Attend

Agenda

Location & CLE

Agenda Subject to Change
All Times Listed in Eastern Time

Thursday, October 13

8:15–9:00 AM
Registration & Continental Breakfast

9:00–9:15 AM
Welcome and Opening Remarks
Christine Simmon, President & CEO, Food and Drug Law Institute (FDLI)
Matthew Hegreness, Partner, Covington & Burling LLP and Co-Chair FDLI Advertising & Promotion for Medical Products Conference

9:15–9:45 AM
Fireside Chat
Arun G. Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, U.S. Department of Justice
Julia C. Tierney, Chief of Staff, Office of the Commissioner, FDA
Moderated by Christine M. Simmon, President & CEO, Food and Drug Law Institute (FDLI)

9:45–10:45 AM
FDA Updates in Advertising & Promotion
Kathryn Dennehy, Veterinary Medical Officer, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
Catherine B. Gray, Office Director, Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, FDA
Lisa L. Stockbridge, Branch Chief, Advertising and Promotional Labeling Branch, Center for Biologics Evaluation and Research, FDA
Deborah A. Wolf, Regulatory Counsel, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, FDA
Moderated by Julie B. Chronis, Senior Counsel II, Gilead Sciences, Inc.

FDA panelists will provide an update on regulatory developments and address frequently asked questions in the field of advertising and promotion for medical products.  

10:45–11:15 AM
Networking & Refreshment Break

11:15 AM–12:15 PM
Proactive Scientific Exchange: Evolving Definitions and Applications
Jesse Atkins, Senior Attorney, Gardner Law, PLLC
Kelly F. Goldberg, Vice President, Law/ Senior Counsel for Biopharmaceutical Regulation, PhRMA
Coleen E. Klasmeier, Partner, Sidley Austin LLP
Michael S. Labson, Partner, Covington & Burling LLP
Moderated by Melissa Hoffman, Vice President, Regulatory Counsel, Edwards Lifesciences LLC

Does proactive scientific exchange exist? This session will address this question, explore what constitutes scientific exchange and distinguishes it from promotion and disease awareness, and discuss the impact of virtual tools and environments on the scientific and global community. Panelists will engage in a discussion on the first amendment and its boundaries in scientific exchange, as well as methods of current and emerging information sharing such as passive dissemination of reprints, social media postings, and communication through medical affairs groups.

12:15–1:15 PM
Networking Luncheon

1:30–2:30 PM
Concurrent Breakout Sessions

  • Marketing Ambiguities Surrounding Pre-Approval Promotion
    Kellie B. Combs, Partner, Ropes & Gray LLP
    Mark Gaydos, Vice President & Global Head, Advertising, Promotion & Labeling, Global Regulatory Affairs, Sanofi
    Ashley A. Zborowsky, Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory, Medtronic
    Moderated by Wayne L. Pines, President, Healthcare, APCO Worldwide

This session will discuss the regulatory framework for product pre-approval, review requirements for compliant pre-approval communications, and opine on recent trends in the medical products field regarding pre-approval, including the impact of emergency use authorizations (EUAs) on FDA enforcement activity and whether issuance of EUAs can go beyond the scope of public health emergencies to include other diseases. Panelists will use practical examples to assess risk and provide best practices in the pre-approval promotion space.

  • Emerging Technologies and the Regulatory Landscape: Cell, Gene, and Novel Therapies
    Kalah Auchincloss, Executive Vice President, Greenleaf Health, Inc
    Lisa L. Stockbridge
    , Branch Chief, Advertising and Promotional Labeling Branch, Center for Biologics Evaluation and Research, FDA
    Eva Temkin
    , Partner, King & Spalding LLP
    Moderated by Collin Stabler, Senior Associate, Exponent, Inc.

CBER has recognized the regulation of cell and gene therapy as a priority under the upcoming PDUFA VII. Many believe these therapies will fundamentally change the way the biopharmaceutical industry treats and cures diseases. This session will address regulatory developments in advertising and promotion and challenges corresponding with rapid growth in the field of cell and gene therapy. Panelists will provide a brief overview of the cell and gene regulatory landscape and engage in a broad discussion of important topics in the field of advertising and promotion, including HCT/Ps and novel therapies.

  • Regulatory Fences: Staying Compliant in Veterinary Drug Advertising
    Kristin M. Kaplan
    , Of Counsel, Shook, Hardy & Bacon LLP
    Karl M. Nobert, Senior Counsel, Michael Best & Friedrich LLP
    Moderated by Kinsey S. Reagan, Partner, Kleinfeld, Kaplan & Becker, LLP

This session will discuss the regulatory framework for advertising and promotion in the veterinary products field. Panelists will engage in a discussion about what boundaries exist in marketing veterinary products, given that some industries rely on marketing rules regarding analogous human products because recent guidance in the veterinary products field has not been released. This session will further discuss how to help clients in navigating these ambiguities and implement best practices in marketing veterinary products.

2:30–2:45 PM
Networking & Refreshment Break

3:00–3:45 PM
ESG Considerations in Advertising: Promoting Transparency, Patient-Engagement, and Health Equity
Dara Katcher Levy, Director, Hyman, Phelps & McNamara, PC
Katherine N. Rogers, Special Counsel, Kelley Drye & Warren LLP
Moderated by Alan G. Minsk, Partner, Food and Drug Practice Team, Arnall Golden Gregory LLP

ESG has risen in importance amongst shareholders, consumers, and policy makers seeking to manage investment risk and support ethical purchases. Increasingly, medical products entities are launching ESG initiatives to create equitable, patient-centric business models. This session will discuss ESG considerations for industry and how promoting ESG culture can increase health equity in the medical products field and globally. 

4:00–5:00 PM
DTC Without Borders: Global Promotion and Compliance with non-DTC Countries
Terry Crandall, General Counsel and Chief Compliance Officer, Merz North America, Inc.
Dara Katcher Levy, Director, Hyman, Phelps & McNamara, PC
Alexander Roussanov, Partner, Arnold & Porter LLP
Moderated by Mark Carlisle Levy, Partner, Eckert Seamans Cherin & Mellott, LLC

This session will cover legal and regulatory challenges in Direct-to-Consumer Advertising (DTC), including use and dissemination of press releases, transparency and disclosures requirements, and global enforcement actions. Panelists will discuss common pitfalls experienced by entities established in DTC countries that market to consumers in non-DTC countries, provide an EU promotional regulatory perspective, and present practical examples of issue resolution.

5:00–6:00 PM
Networking Reception (In-Person Only)

Friday, October 14

8:15–9:00 AM
Registration & Continental Breakfast

9:00–9:15 AM 
Welcome and Opening Remarks
Laura A. Brown, Director, Educational Programs, FDLI
Virginia Foley, Head of Marketing & Strategic Business Development, Opus Regulatory, Inc. and Co-Chair FDLI Advertising & Promotion for Medical Products Conference

9:15–10:15 AM
Promoting Diversity and Inclusion through Advertising and Promotion
Bryant Godfrey, Partner, Foley Hoag LLP
Jae Kim, Associate, DLA Piper (US)
Madison Wheeler, Director of Technical Operations, EMMA International
Moderated by Virginia Foley, Head of Marketing & Strategic Business Development, Opus Regulatory, Inc. and Co-Chair FDLI Advertising & Promotion for Medical Products Conference

Healthcare advertising and language used in promotional materials may be used to benefit underserved communities, broaden disease awareness, and further the inclusivity of healthcare access. This session will address the evolving landscape of advertising and opine on the implications of recently proposed privacy legislation–the American Data Privacy and Protection Act and the Banning Surveillance Advertising Act of 2022–on digital advertising and access to promotional material about healthcare treatments and outreach.

10:30–11:30 AM
Digital Marketing: Regulating Social Media, Health Sources, and Wellness Applications
Madhavi Bellamkonda, Director Regulatory Intelligence & Policy, Global leader for Advertising & Promotion, Intuitive Surgical Inc.
Dale Cooke, President, PhillyCooke Consulting
Nathan C. Sheers, Partner, Paul Hastings, LLP
Moderated by Marc J. Scheineson, Partner, Alston & Bird LLP 

Medical product promotion now encompasses social media, wellness applications, data collection technology, and other novel tools. This session will clarify which agency guidances apply to innovative marketing, address recent enforcement actions, provide a global perspective to the current advertising space, and highlight data privacy risks in use of digital marketing. Panelists will engage in a discussion forecasting the future state of digital marketing given the rapid growth in technological development.

11:30–11:45 AM
Networking & Refreshment Break

11:45 AM–12:45 PM
The New Faces of Campaigns: Regulatory Challenges in Influencer, Patient Ambassador, and Peer-Mentor Brand Advertising
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Erin Carducci, Director, Regulatory Advertising & Promotion, Digital Strategy & Innovation, Novartis Pharmaceuticals Corporation
Elizabeth Mulkey, Senior Associate, Goodwin Procter LLP
Moderated by John Caruso, Associate Director, Global Regulatory Affairs, Otsuka Pharmaceutical Development & Commercialization

Social media advertising has enabled a network of influencers, patient ambassadors, and peer ambassadors and mentors to serve as remote campaigners for products and services. However, ensuring these third parties comply with regulatory requirements while navigating evolving policies of social media platforms is complex and challenging. This session will cover FTC enforcement and contracting considerations, as well as FDA guidance on the promotion of FDA-regulated medical products utilizing remote campaigners. Speakers will also address how to prevent false claims and deceptive advertising while demonstrating corporate responsibility in managing third-party communications.

12:45–1:45 PM
Luncheon & Facilitated Table Topic Discussions

Led by FDLI-member experts, these informal facilitated discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on a hot topic in food and drug law. Attendees have the option to choose from one of the many topics or enjoy open seating during lunch.

2:00–3:00 PM
Concurrent Breakout Sessions

  • Regulatory Compliance in Advertising Digital Health Software
    Kyle Y. Faget, Partner, Foley & Lardner LLP
    Sonia W. Nath, Partner, Cooley LLP
    Moderated by Fred Medick, Assistant General Counsel, Healthcare Law Group, Genentech, Inc.

Rising use of software as a medical device (SaMD), telehealth, and other digital health software presents questions about regulatory compliance. This session will provide a framework for understanding software classification and address new FDA guidance on clinical decision support software and mobile medical applications. Panelists will examine intended use analysis and opine on the current and future state of product development and enforcement.

  • Preventing and Addressing Fraudulent Marketing and Abuse
    Philomena McArthur, Sr. Counsel Regulatory Law, Johnson & Johnson
    Krysten Rosen Moller, Partner, Covington & Burling LLP
    Carolina M. Wirth, Of Counsel, Hall, Render, Killian, Heath & Lyman P.C.
    Moderated by Markham C. Luke, Director, Division of Therapeutic Performance, Center for Drug Evaluation and Research, FDA

The risk of garnering fraudulent marketing claims under the False Claims Act and Civil Monetary Penalties Law, as well as violations under the Anti-Kickback Statute, may be reduced through corporate compliance programs and practices to ensure lawful marketing. Panelists will examine the roots of how unintentional fraudulent activity in an industry begins and provide best practices through practical examples to prevent such activity. This session will additionally address recent caselaw and trends related to fraudulent marketing and abuse to highlight the importance of developing a culture of compliance in industry.

3:00–3:15 PM
Break

3:15–4:15 PM
Recent Trends in Enforcement and Practical Examples to Ensure Compliance
Gus W. Eyler, Director, Consumer Protection Branch, DOJ
Colleen M. Heisey, Partner, Jones Day
Raqiyyah R. Pippins, Partner, Arnold & Porter LLP
Zheng Wang, Attorney, National Advertising Division
Moderated by Matthew Hegreness, Partner, Covington & Burling LLP and Co-Chair FDLI Advertising & Promotion for Medical Products Conference

This session will explore the evolving landscape of advertising enforcement through the lens of FDA, DOJ, FTC, and NAD enforcement tools, resources, priorities, while discussing recommendations for best practices in navigating the increasingly complex world of advertising. Join our panelists as they address recent regulatory actions; illustrate case studies to demonstrate advertising compliance; and provide an enforcement perspective on first amendment violations, Covid-19 claims, and subject-matter addressed throughout the conference.

4:15 PM
Closing Remarks and Conference Adjournment