Thursday, November 2
Christine Simmon, President & CEO, FDLI
Mark Gardner, Directing Attorney, Gardner Law, PLLC, and 2023 FDLI A&P Conference Co-Chair
Arun G. Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, DOJ
Serena Viswanathan, Associate Director, Division of Advertising Practices, FTC
Lauren Roth, Associate Commissioner for Policy, Office of the Commissioner, FDA
Moderated by Christine M. Simmon, President & CEO, FDLI
FDA panelists will provide updates on regulatory advancements and address frequently asked questions about medical product 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
11:00–11:30 AM | Networking and Refreshment Break
This session will distinguish between legally sharing valuable insights and engaging in illicit FDA pre-approval communications for business gain. Panelists will illustrate the dos and don’ts of information exchange and address how rules differ when information is shared globally over virtual platforms and data repositories.
Danielle C. Humphrey, VP, Compliance Officer & Chief Regulatory Counsel, Becton Dickenson
Peter Pitts, President, Center for Medicine in the Public Interest
Elisabethann Wright, Partner, Cooley LLP
Moderated by Matthew Hegreness, Partner, Covington & Burling LLP
12:30–1:30 PM | Networking Luncheon
1:45–2:45 PM | Concurrent Breakout Sessions
Concerns about consumer privacy have intensified since the Dobbs decision and rise of data-capturing technologies. This year, FTC proposed amendments to address these concerns by fortifying the Health Breach Notification Rule (HBNR). Under this proposal, the HBNR would broaden the concept of a health data “breach” and cover sensitive health data drawn from health apps and devices not covered under HIPAA. On the enforcement side, FTC brought several cases against HBNR violators. Panelists will address the HBNR, HHS tracking technology guidance, and ambiguities concerning health data used to demonstrate when and how personal health data may be meaningfully and legally used.
Lyra Correa, Health Information Privacy Specialist, Office for Civil Rights, HHS
Elisa Jillson, Attorney, Bureau of Consumer Protection, Division of Privacy and Identity Protection, FTC
Nancy Perkins, Counsel, Arnold & Porter LLP
Moderated by Dale Cooke, President, PhillyCooke Consulting
FDA recently released a guidance on presenting quantitative efficacy and risk information in Direct-to-Consumer (DTC) promotional labeling and advertisements. This update provides an opportunity for industry to reexamine practices for developing and presenting consumer-directed content. Panelists will provide best practices to conduct these internal reviews and address questions concerning the guidance. This session will explore what the guidance means for industry, provide best practices to conduct internal review, and address questions, including whether firms are required to use quantitative information in their promotional communications?
Helen W. Sullivan, Social Science Analyst, Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, FDA
Amy Muhlberg, Deputy Director, Division of Promotion Policy, Research and Operations, Center for Drug Evaluation and Research, FDA
Elizabeth Mulkey, Senior Associate, Goodwin Procter LLP
Moderated by Erin Carducci, Senior Director, Regulatory Advertising & Promotion, Novartis Pharmaceuticals Corporation, FDLI A&P Conference Co-Chair
This session will provide a legal and regulatory landscape surrounding veterinary drug advertising. Panelists will clarify when organizations should use the new animal drug approval process, explore CVM’s draft GFI concerning human user safety, and provide guidance on next steps after receiving a warning letter based on promotional claims.
Elizabeth Butterworth Stutts, Principal, Elizabeth Butterworth Stutts, Esq, PLLC
Patrick C. Gallagher, Partner, Duane Morris LLP
Moderated by Jeannie M. Perron, Partner, Covington & Burling LLP
2:45–3:00 PM | Networking and Refreshment Break
FTC’s recent enforcement activities, trends, and FDA collaboration efforts demonstrate the agency’s commitment to protecting patients and consumers from advertising falsehoods. This year FTC issued hundreds of warning letters indicating that it will pursue civil penalties for first-time substantiation offenses through its penalty offense authority. Panelists will discuss these developments, updates to FTC’s Health Products Compliance guidance, and provide best practices when presenting information to patients and complying with FTC investigations.
Christine Lee DeLorme, Attorney, Division of Advertising Practices, FTC
Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman, P.C.
Melissa B. Runsten, Associate, Debevoise & Plimpton, LLP
Moderated by Sharon Bradley, Principal, Sharon Bradley Law PLLC
When an influencer, endorser, patient ambassador, caregiver, patient, or employee uses social media platforms to promote products, are they acting as an agent on behalf of an organization? What can industry do to mitigate risk? This session demonstrates best practices in social media advertising, including developing influencer agreements, monitoring social media content, and educating employees on proper social media use.
Kellie B. Combs, Partner, Ropes & Gray LLP
Lynn Deutsch, Director, Regulatory Affairs & Legal Compliance, Imperative Care, Inc.
Jae Kim, Senior Associate, DLA Piper LLP (US)
Michael Ostheimer, Senior Staff Attorney, Division of Advertising Practices, FTC
Moderated by Abraham Gitterman, Senior Associate, Arnold & Porter LLP
5:00–6:00 PM | Networking Reception (In-Person Only)
Friday, November 3
Lauren-Caroline Tadros Potter, Assistant Director, FDLI
Erin Carducci, Senior Director, Regulatory Advertising & Promotion Novartis Pharmaceuticals Corporation, 2023 FDLI A&P Conference Co-Chair
This session will provide recommendations on interpreting the 2018 “consistent with FDA-required labeling” (CFL) guidance and warning letters concerning CFL data. Panelists will share best practices and case studies to demonstrate practical considerations when implementing the guidance using real-world data, and engaging in “medical, legal, and regulatory affairs review” to ensure accurate, truthful, non-misleading, and statistically sound advertising and promotional materials.
Torrey Cope, Partner, Sidley Austin LLP
Jaimi Gaffe, Vice President, Regulatory Law, MedTech, Johnson & Johnson
Wyatt Kernell, Associate, Cooley LLP
Moderated by Timothy Candy, Principal Consultant, Regulatory Affairs, Opus Regulatory, Inc.
10:15–10:30 AM | Networking and Refreshment Break
Advertising globalization through social media has led to greater challenges in DTC compliance across countries with different requirements. Panelists will address how social media promotion is conducted in other countries, explore differences between the US and EU, and demonstrate what industry can do to reduce risk where boundary-less promotional messaging is concerned.
Suzanne Cadden, Vice-President, Global Regulatory Affairs – Advertising & Promotion, Alcon
Dara Katcher Levy, Director, Hyman, Phelps & McNamara, PC
Alexander Roussanov, Partner, Life Sciences & Healthcare Regulatory, Arnold & Porter LLP
11:30 AM–12:30 PM | Lunch with Facilitated Table Topic Discussions
12:45–1:45 PM | Concurrent Breakout Sessions
Using artificial intelligence (AI) in marketing is a response to the demands of patient needs and industry expansion. This session will provide a regulatory foundation followed by a question-driven discussion concerning product liability, bias-perpetuating health inequities, and enforcement activity, balanced with benefits and future innovation.
Kyle Y. Faget, Partner, Foley & Lardner LLP
Andrew Hasty, Attorney, Division of Privacy and Identity Protection, FTC
Charlotte Tschider, Associate Professor, Loyola University – Chicago
Moderated by Mark Gardner, Directing Attorney, Gardner Law, PLLC, and Co-Chair, 2023 FDLI A&P Conference
According to FDA statistics, over 7,000 rare diseases affect more than 30 million people in the US. The collective number of diseases is large, but the number of patients affected by each disease is small, resulting in smaller clinical datasets and unique challenges. This interactive session will discuss the role of advertising and promotion in engaging with informed consumers and health care providers seeking treatments, while opining on the legal and regulatory challenges industry and sponsors face. Panelists will explore questions about implementing meaningful disease campaigns, communications with patient advocacy groups, enforcement risks, and more.
Bryant M. Godfrey, Partner, Foley Hoag LLP
Analise Johnian, Director, Commercial and Regulatory Counsel, Mitsubishi Tanabe Pharma America, Inc.
Dominick Paul DiSabatino, Partner, Sheppard Mullin Richter & Hampton LLP
Moderated by Mark Gaydos, Vice President & Global Head, Advertising & Promotion, Global Regulatory Affairs, Sanofi
Under 21 CFR § 314.550, applicants must submit all promotional materials to FDA, including ones for dissemination or publication. This session will provide guidance on structuring a promotional regulatory strategy when seeking accelerated approval pathways. Panelists will share best practices from pre-submission through post-approval, including collaboration with marketing.
Anthony Genovese, Group Leader, Regulatory Advertising and Promotion Johnson & Johnson
Geoffrey M. Levitt, Of Counsel, DLA Piper
Upasana Marwah, Director, Regeneron
Moderated by Eva Temkin, Partner, King & Spalding LLP
This session will join representatives from industry, DOJ, and the National Advertising Division to present on tools and resources used to counter illegal activities and unethical practices concerning advertising and promotion. Panelists will highlight enforcement activity and litigation trends, illustrate questionable advertisements, and provide insights on particular claims, including ESG.
Katherine Armstrong, Deputy Director, National Advertising Division
Alan G. Minsk, Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP
Gabriel Scannapieco, Assistant Director, Consumer Protection Branch, DOJ
Moderated by Colleen M. Heisey, Partner, Jones Day
3:00 PM | Closing Remarks and Conference Adjournment
