Wednesday, October 28
10:55–11:10 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.
11:15 – 11:30 AM
FDLI Welcome and Introduction
Amy Comstock Rick, President & CEO, Food and Drug Law Institute (FDLI)
Dolores M. Shank-Samiec, Executive Director, Office of Promotion and Advertising and Review, Merck & Co., Inc., and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee
11:30 AM – 12:00 PM
Fireside Chat with Grail Sipes, Deputy Center Director, CDER, FDA
Moderated by Dolores M. Shank-Samiec, Executive Director, Office of Promotion and Advertising and Review, Merck & Co., Inc., and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee
12:15–1:00 PM
Navigating Remote Promotion Through COVID-19 and Beyond
Madhavi Bellamkonda, Global Regulatory Advertising & Promotion Leader, Abbott Laboratories
Edgar Donohoe, North America Compliance Lead, Pfizer, Inc.
Moderated by Mahnu Davar, Partner, Arnold & Porter LLP
Even prior to COVID-19, industry access to healthcare professionals had begun a fundamental shift to a remote setting, a trend which will likely continue long after the public health emergency is over. Medical product companies must continue to engage prescribers and product users virtually in a meaningful and compliant manner. However, the general rules, guidance, and codes governing such interactions were not necessarily written with remote interactions in mind. Thus, enforcement risks may emerge in the absence of careful planning and strong safeguards. This session will identify the potential legal, regulatory and compliance risks associated with specific areas of remote promotion, such as meals, educational programs, provision of samples, virtual booths, remote sponsorships, and sales team outreach. Panelists will also explore fair balance, anti-kickback, and privacy considerations.
1:05 – 1:45 PM
Concurrent Breakouts: Practical Considerations for Successful Remote-Based Marketing and Compliance Strategies
- Health Care Provider Access and Sales Training
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
Colleen M. Heisey, Partner, Jones Day
- Adapting Practices/Culture to Virtual Space
John Paul Benitez, Assistant General Counsel – Immunology Brand Attorney, Eli Lilly and Company
John F. Johnson III, Of Counsel, Shook, Hardy & Bacon LLP
- Messaging During COVID
Virginia Foley, Principal Consultant, Opus Regulatory, Inc
Heidi Gertner, Partner, Hogan Lovells US LLP
- Virtual Speaker Programs/Meals
Jason J. Olin, Chief Privacy Officer & Assistant General Counsel, Avanir Pharmaceuticals
Betty C. Pang, Counsel, Latham & Watkins LLP
- Monitoring Controls
Mahnu Davar, Partner, Arnold & Porter LLP
Edgar H. Donohoe, North America Compliance Lead, Pfizer, Inc.
- Social Media Apps and Other Technology/Global Issues
Heather Banuelos, Counsel, King & Spalding LLP, and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee
Madhavi Bellamkonda, Global Regulatory Advertising & Promotion Leader, Abbott Laboratories
Building from the prior presentation, these breakout sessions will provide discussion of practical considerations for successful remote-based marketing strategies and updated compliance programs. Attendees will be able to share experiences through face-to-face facilitated discussions.
1:45 – 2:15 PM
Sponsor Virtual Exhibit Hall
Visit the virtual sponsor booths and meet live with company representatives
2:15–3:15 PM
Inter-Agency Enforcement Against COVID Claims
Donald D. Ashley, Director, Office of Compliance, CDER, FDA
Bryan Benesch, Senior Policy Advisor, Office of Product Evaluation and Quality, CDRH, FDA
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Shannon Pedersen, Trial Attorney, U.S. DOJ
Moderated by Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Since the onset of COVID-19, thousands of products have touted scientifically unsupported claims about preventing, mitigating, treating, diagnosing, or curing COVID-19. This onslaught of claims has resulted in an unprecedented degree of collaboration between FDA, the Federal Trade Commission, and the US Department of Justice, leading to the issuance of hundreds of warning letters, as well as seizures, injunctions, and criminal prosecutions. This panel will explore the agencies’ efforts to protect consumers from these unsubstantiated claims and the impact of COVID claims enforcement on other agency priorities.
3:30 – 4:30 PM
Concurrent Breakout Sessions
- FDA-FTC Biologics Promotion Enforcement
Julie Grimaldi, Associate Director, Regulatory Affairs, Biogen, Inc.
Blythe Buchanan, Senior Director, Regulatory Affairs, Biogen, Inc.
Scott M. Lassman, Principal, Lassman Law + Policy
Moderated by Marc J. Scheineson, Partner, Alston & Bird LLP
- Pre-Approval Communications with Payors
Cynthia Reilly, COO, Academy of Managed Care Pharmacy (AMCP)
Kevin Stark, Director, Reg Affairs, Merck & Co., Inc.
Moderated by Dara Katcher Levy, Director, Hyman, Phelps & McNamara, PC
- Promotion Under Exceptions/Exemptions
Danielle C. Humphrey, Associate General Counsel, Regulatory Law and Compliance Officer – Life Sciences, Becton Dickinson (BD)
David L. Riggs, Senior Director, Global Regulatory Affairs, Eli Lilly and Company
Moderated by Chad Jennings, Associate, Latham & Watkins LLP
4:45–5:30 PM
Minimizing Product and Promotional Digital Health/ Artificial Intelligence Liability Issues
Stephen Evans, Assistant General Counsel, Genentech, Inc.
Bakul Patel, Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Vernessa T. Pollard, Partner, McDermott Will & Emery
Digital health technologies, including tools incorporating artificial intelligence, are rapidly becoming an important part of drug development and marketing strategies, as well as part of the pharmacovigilance, marketing, and disease diagnosis processes. These tools, which range from relatively simple mobile apps to highly sophisticated systems generating their own hypotheses and suggested solutions, present important opportunities to improve patient care. However, they also introduce new liability risks given the potential for inaccuracies and quality problems, limitations on the ability to step-in as AI systems evolve new capabilities, weaknesses that may skew AI machine learning and data, and the impact on the role of the “learned intermediary.” This panel will examine how to minimize future product and promotional liability issues based on these technologies.
Thursday, October 29
10:45–11:15 AM
Connect with FDLI: Learn More About FDLI Membership and Engagement
Wondering how to take full advantage of your FDLI membership or how to speak at an FDLI event? Stop by to get those, and any other questions, answered by the FDLI membership team prior to the start of the formal program. Attendees are encouraged to join at any time throughout the 30 minute session, as there is no set agenda.
11:00–11:15 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.
11:20 – 11:30 PM
FDLI Welcome and Introduction
Laura A. Brown, Director, Educational Programs, FDLI
Heather Banuelos, Counsel, King & Spalding LLP, and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee
11:35–11:50 AM
Group Tribute to Thomas W. Abrams, Director, Office of Prescription Drug Promotion (Retired), FDA
Presented by: Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Chair, FDLI Board of Directors; Catherine B. Gray, Acting Director, Office of Prescription Drug Promotion, CDER, FDA;
Jean-Ah Kang, Special Assistant to the Director, Office of Prescription Drug Promotion, CDER, FDA; Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide; Amy Comstock Rick, President & CEO, FDLI; and Melissa S. Scales, Assistant Director, Educational Programs, FDLI
11:55 AM–12:55 PM
FDA Compliance Actions and Priorities
Catherine B. Gray, Acting Director, Office of Prescription Drug Promotion, CDER, FDA
Dorothy McAdams, Supervisory Veterinary Medical Officer, CVM, FDA
Lisa L. Stockbridge, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, CBER, FDA
Deborah A. Wolf, Regulatory Counsel, Office of Product Evaluation and Quality, CDRH, FDA
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Chair, FDLI Board of Directors
FDA officials from the agency’s medical product centers – CDER, CBER, CDRH, and CVM – will discuss recent compliance actions taken by their offices, the importance of these actions for companies, and enforcement priorities.
12:55 – 1:25 PM
Sponsor Virtual Exhibit Hall
Visit the virtual sponsor booths and meet live with company representatives
1:25–2:25 PM
Social Media Platform Policies and Emerging Issues
Eric DeLange, Senior Manager, Government & Health, Snap Inc.
Dawn Lacallade, Chief of Social Strategies, VP of Account Services, LiveWorld
Donnelly McDowell, Special Counsel, Kelley Drye & Warren LLP
Moderated by Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP
With the increased visibility provided by interactive social media platforms comes the responsibility of understanding how to navigate advertising on social media platforms while adhering to regulatory guidelines. This session will feature social media and other representatives who grapple with medical product advertising and promotion on social media. Speakers will discuss how companies are leveraging social media, features of various social media platforms, and how to stay compliant while using content such as influencers.
2:40 – 3:40 PM
Concurrent Breakout Sessions
- Medical Science Liaisons: Emerging Technology and Current Practices
Trish Dring, Associate General Counsel, Aurinia Pharmaceuticals
Julie K. Tibbets, Partner, Goodwin Procter LLP
Moderated by Katie Graham, Managing Director, Trajet Consulting
- Beyond the Hubs: Promotional Compliance Considerations for the Use of Patient Support Representatives
Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi
Savaria B. Harris, Senior Counsel, Regulatory Law, Johnson & Johnson
Moderated by Scott S. Liebman, Partner, Loeb & Loeb LLP
- End-to-End Promotional Management for Accelerated Approval Products
Renee Ambrosio, Director, Office of Promotion & Advertising Review, Merck & Co., Inc.
Jason Cober, Lead Project Manager, Office of Prescription Drug Promotion, CDER, FDA
Moderated by Marian J. Lee, Partner, Gibson Dunn & Crutcher LLP
3:55 – 4:55 PM
Hot Topics in Pre-Approval Communications
Kellie B. Combs, Partner, Ropes & Gray LLP
Sarah diFrancesca, Partner, Dinsmore & Shohl LLP
Cassie Scherer, Senior Principal Legal Counsel, Medtronic
Moderated by Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide
Friday, October 30
10:25–10:55 AM
Connect with FDLI: Learn More About FDLI Membership and Engagement
Wondering how to take full advantage of your FDLI membership or how to speak at an FDLI event? Stop by to get those, and any other questions, answered by the FDLI membership team prior to the start of the formal program. Attendees are encouraged to join at any time throughout the 30 minute session, as there is no set agenda.
10:40–10:55 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.
11:00 – 11:10 AM
FDLI Welcome
Melissa S. Scales, Assistant Director, Educational Programs, FDLI
11:10 – 12:10 PM
Industry Benchmarking: Trends in Formal and Informal Enforcement Trends
Sharon M. Bradley, Senior Counsel, Advertising & Promotion, Mylan Pharmaceuticals, Inc.
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
Mary Ellen Dronitsky, Head of Regulatory Labeling Advertising and Promotion, Arena Pharmaceuticals
Moderated by Gillian M. Russell, Counsel, King & Spalding LLP
12:10 – 12:40 PM
Sponsor Virtual Exhibit Hall
Visit the virtual sponsor booths and meet live with company representatives
12:40 – 1:40 PM
Concurrent Breakout Sessions
- Rise of Docfluencers/Nursefluencers – Are ‘Docfluencers’ the New Key Opinion Leaders?
Lauren A. Miller, Corporate Counsel, Otsuka America Pharmaceutical, Inc.
Lee Rosebush, Partner, BakerHostetler
Moderated by Serra J. Schlanger, Director, Hyman, Phelps & McNamara, PC
Medical product development and promotion is increasingly utilizing physicians and other healthcare providers as opinion leaders. The panel will discuss FTC transparency considerations for sponsored content by HCPs, FDA rules and enforcement related to physician spokespeople, and risks of engaging an Instagram doctor. The session will also examine HIPAA, state privacy law, use of health influencers for clinical trial recruitment, and state practice of medicine law considerations.
- Before and Beyond Advertising: Healthy Partnerships with Disease and Patient Experts
Kathryn Harr-Sponsler, Associate General Counsel, Global Commercial, Spark Therapeutics
Niquette Hunt, President and CEO, Candesant Biomedical
Jennifer Romanski, Principal, Porzio, Bromberg & Newman, P.C.
Michael Thomas, Chief Innovation Officer, Upstream 360
Moderated by Lisa Pieretti, Executive Director, International Hyperhidrosis Society
Most brand teams engage with patient groups and disease advocates after product commercialization. However, owever, there is significant value to developing these relationships early in the product development and conceptualization phase, especially with rare diseases and those with an established advocacy community. In this session, we will explore the resource ecosystem, illustrate the unique contributions of patient groups that can enrich the experience for all stakeholders, and discuss potential legal pitfalls, such as undisclosed financial relationships.
- FDA’s Framework for Drug-Use Software: Is This the Future?
Schevon Gaylord Salmon, Corporate Attorney, Otsuka America Pharmaceutical, Inc.
Kyle Thomson, Senior Attorney, American Medical Association
Rachel Turow, Associate General Counsel, Regulatory Law & Policy, TEVA Pharmaceuticals USA, Inc., and Member, FDLI Board of Directors
Moderated by Meredith Manning, Partner, Hogan Lovells US LLP
In 2018, FDA published a framework for the regulatory status of prescription drug-use software, or software designed to be used in conjunction with prescription drugs. COVID-19 has caused digital devices and mobile apps to become even more necessary tools in healthcare, requiring an understanding the nuances of FDA’s regulatory framework for both the underlying devices that convey drug information and the output of those devices. This session will discuss how FDA might regulate certain devices that deliver guidance or instruction to drug users, and how companies can evaluate and implement FDA’s 2018 proposed framework.
1:55 – 2:55 PM
Concurrent Breakout Sessions
- Trends in Veterinary Medicine Promotion
Elizabeth B. Stutts, Principal, Elizabeth Butterworth Stutts, Esq, PLLC, and Of Counsel, Hancock, Daniel & Johnson, PC
This session will provide updates on advertising and promotion issues for animal health products. We will discuss labeling and other approval requirements for animal drugs, including how they differ from those applicable to human drugs, review misbranding claims raised in recent warning letters, and consider website marketing and social media trends, among other issues.
- Case Study: Best Practices in Drug Sales and Marketing
Jennifer Beachell, VP of Global Commercial Strategy, Momenta Pharmaceuticals, Inc.
Rebecca Burnett, Executive Director, Framework Solutions
Christopher Primiano, EVP, Chief Business Officer and General Counsel, Karyopharm Therapeutics
Moderated by Matthew Keenan, Partner, Shook, Hardy & Bacon LLP
This drug-focused case study will explore a fictional company that encounters post-approval adverse events, leading to several label changes and a competing drug with a lower risk profile. These events lead to litigation and other resulting complications.
- Case Study: Device Promotion Compliance Risks
Kristin R. Davenport, Of Counsel, Covington & Burling LLP
Lynn Deutsch, President, Regulatory Promo, LLC
Kristi Schrode Travers, Assistant General Counsel, Johnson & Johnson
Moderated by Lynn Deutsch, President, Regulatory Promo, LLC
This case study will review a hypothetical medical device company’s advertising strategy, including press releases and social media posts, that is relevant to today’s compliance environment. Attendees will identify actions that present potential promotional violations, comment on areas where FDA might have concerns, identify promotional violations, and find actions that do not present any promotional compliance issues.
3:10 – 3:55 PM
Promotional Opportunities and Risks in Telehealth and Other Online DTC Advertising
Ritu Kaur Cooper, Shareholder, Hall, Render, Killian, Heath & Lyman P.C.
Kimberly Maney, Assistant General Counsel, GlaxoSmithKline
Allison Shuren, Partner, Arnold & Porter LLP
Moderated by Dale Cooke, President, PhillyCooke Consulting
3:55 PM
Closing Remarks and Adjournment