Why Attend

Agenda

subject to change
All times are in Eastern Daylight Time

CLE

Wednesday, October 13

10:55 – 11:10 AM
Technology and Connection Support Session

11:15 – 11:30 AM
FDLI Welcome and Introduction 
Amy Comstock Rick, President & CEO, FDLI
Madhavi Bellamkonda, Director, Regulatory Intelligence & Integration Management, Intuitive Surgical Inc. and Co-Chair, 2021 FDLI Advertising & Promotion for Medical Products Conference

11:30 AM – 12:15 PM
Keynote Address
Lauren K. Roth, Associate Commissioner for Policy, Office of the Commissioner, FDA

12:15  – 1:15 PM
Closed Doors Lead to Open Windows: Emerging Trends in Virtual Sales Force Tools
Dale Cooke, President, PhillyCooke Consulting
Adam Falkowitz, Head of Legal, North America, Getinge
Virginia Foley, Head of Marketing and Strategic Business Development, Opus Regulatory, Inc.
Colleen M. Heisey, Partner, Jones Day

During the pandemic, pharmaceutical and medical device companies implemented creative ways to keep their field-based teams engaged with physicians and support patient access. These adaptations, such as conference call product demos, interactive medical affairs portals, and advancements in digital marketing collateral, have the potential to remain.  This session explores the legal and regulatory hurdles in implementing these digital sales tools and how to successfully incorporate more digital sales and field teams in the long term.

1:30 – 2:30 PM
Concurrent Breakouts

  • Best Practices for Globalizing Promotional Review
    Mark Gaydos, Vice President & Global Head, Advertising, Promotion & Labeling, US Advertising & Promotion, Global Regulatory Affairs, Sanofi
    Victoria Tamarkin, President, Principal Consultant, Tamarkin Consulting LLC
    Moderated by Kellie B. Combs, Partner, Ropes & Gray LLP

What are the best ways to approach internal promotional review when entering global markets? Should a company selling its products across different international markets, internally review its marketing materials in a centralized or decentralized fashion? This session will explore the tension between ensuring compliance with various labeling and claims substantiation requirements versus the need for a unified brand and messaging. 

  • Drug and Device Uses of Digital Health Tools: Considerations for Advertising and Promotion
    Robert J. Berlin, Senior Director and Head, US Regulatory, GlaxoSmithKline
    Schevon Gaylord Salmon, Director, Corporate Counsel, Otsuka America Pharmaceutical, Inc.
    Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC
    Moderated by Eva Temkin, Partner, King & Spalding LLP

Digital health tools, including software apps, other digital mechanisms for tracking prescription drug use, and digital therapeutics, are increasingly becoming part of the medical product landscape. How should firms approach labeling and other promotional materials for these products, and what pitfalls should they consider?

2:30 – 3:00 PM
Break

 

3:00 – 4:00 PM
Planning for Launch: Navigating the Office of Prescription Drug Promotion’s Core Launch Review Process
Christine O’Neill, Corporate Counsel, Legal Affairs, Otsuka America Pharmaceutical, Inc.
Kevin Wright, Director of Regulatory Affairs, Advertising & Promotion (Oncology), Takeda Pharmaceuticals
Moderated by Bryant M. Godfrey, Partner, Foley Hoag LLP and Co-Chair, 2021 FDLI Advertising and Promotion for Medical Products Conference

 

FDA recently released recommendations on core launch material preparation and submission to inform company expectations for this process. What does FDA look for in core launch materials? When should a core launch advisory submission include analysis of the three factors described in the “Medical Product Communications That Are Consistent with the FDA-Required Labeling — Questions and Answers Guidance for Industry” guidance? This panel will focus on preparing for and navigating the core launch material preparation process and best practices.

4:15 – 5:30 PM
Inter-Agency Enforcement Updates and Priorities
Donald D. Ashley, Director, Office of Compliance, CDER, FDA
John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP
Moderated by Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC 

What enforcement tools have FDA, the Federal Trade Commission (FTC), and the U.S. Department of Justice (DOJ) used in the past year, and which authorities are in flux? This panel will explore how the COVID-19 Consumer Protection Act has been used against unsupported COVID-19 claims; how medical product manufacturers’ public statements are assessed as nuanced means of promotion; and the impact of the U.S. Supreme Court’s decision in AMG Capital Management LLC v. FTC, which held that the FTC does not have the authority to seek equitable monetary relief in federal court.

Thursday, October 14

11:30 – 11:45 AM
Technology and Connection Support Session

12:00 – 12:10 PM
FDLI Welcome and Introduction
Laura Brown, Director, Educational Programs, FDLI
Bryant M. Godfrey, Partner, Foley Hoag LLP and Co-Chair, 2021 FDLI Advertising and Promotion for Medical Products Conference

12:15 –1:15 PM
Clinical Trial Recruitment and Preapproval Communications for Underrepresented Groups and Underserved Disease States
Kenita Barrow, Deputy General Counsel, Otsuka America Pharmaceutical, Inc.
Mahnu Davar, Partner, Arnold & Porter LLP
Jovonni R. Spinner, Associate Director, Outreach and Communications, Office of Minority Health and Health Equity, Office of the Commissioner, FDA
Moderated by Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP

On November 9, 2020, FDA issued the final guidance, “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs.” This guidance aims to ensure that both demographic (e.g., age, gender, race, location) and non-demographic (e.g., patients with comorbid conditions or rare diseases) characteristics of study populations are more representative of the population that will eventually be taking the drug. While these changes can improve patient care, the resulting data may also provide important information for promotional purposes. This panel will discuss how companies can use this data effectively and responsibly.

1:15 – 1:45 PM
Break

1:45 – 2:45 PM
Concurrent Breakout Sessions

  • Case Study: Best Practices in Drug Promotion
    Rebecca Burnett, Executive Director, Framework Solutions
    Kathryn C. Harr-Sponsler, Associate General Counsel – Global Commercial, Spark Therapeutics, Inc.
    Matthew Hegreness, Special Counsel, Covington & Burling LLP

This interactive case study will explore a fictional drug company’s promotional materials. The session will identify issues that could have been avoided or mitigated, as well as discuss alternative best practices.

  • Case Study: Compliance Risks in Medical Device Advertising
    Joni Anderson , Vice President, Regulatory Affairs, Becton Dickinson (BD)
    Michael A. Swit, Sr. Corporate Counsel, Regulatory Affairs, Varian Medical Systems
    Deborah A. Wolf, Regulatory Counsel, Office of Product Evaluation and Quality, Regulations, Policy and Guidance Staff, CDRH, FDA
    Moderated by Gregory Levine, Partner, Ropes & Gray LLP

Medical devices present advertising challenges for industry that can differ markedly from those faced by drug/biologics firms. This session will explore issues such as navigating “research use only” versus approved/cleared diagnostic claims, promotion of pre-clearance/pre-approval “works in progress,” and advertising implications of the now fully implemented EU MDR. Speakers will also discuss how evolving views on “intended use” impact device claims.

  • Case Study: Dos and Don’ts in Veterinary Medicine Advertising and Promotion
    Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP
    Ann Randall, Senior Director and Senior Counsel Regulatory and Government Affairs, Covetrus, Inc.
    Elizabeth Butterworth Stutts, Principal, Elizabeth Butterworth Stutts, Esq, PLLC

This interactive panel will focus on common errors in the label, labeling, and advertising and promotion of veterinary medical products. The session will present condensed narratives of fictional animal products together with examples of product labels, labeling, websites, and social media posts, based on violations identified in FDA and FTC warning letters, untitled letters, and CVM guidance documents. Examples will include promotional issues unique to veterinary products and also reinforce human medical product regulations.

3:00 – 3:45 PM
The Current State of Unbranded Promotion and Disease Awareness
Mary Ellen Dronitsky, Assistant Teaching Professor, School of Professional Studies, Northeastern University
Ashley Zborowsky, Principal Legal Counsel, Medtronic
Moderated by Scott S. Liebman, Partner, Loeb & Loeb

Traditionally, companies could utilize institutional advertising in a preapproval setting. This trend grew to become somewhat synonymous with disease awareness, whether preapproval or post-approval. More recently, the scope of disease awareness communications has evolved, and preapproval versus post-approval distinctions must be made depending on the company’s objectives. A newer category of unbranded product promotion has also emerged in the form of sponsored links and digital ads, which does not necessarily fit the definitions of disease awareness or express product promotion. This session will explore the regulatory history, policy, and enforcement related to these types of communications and current industry practices.

4:00 – 5:15 PM
Navigating Social Media and Influencer Developments 
Madhavi Bellamkonda, Director, Regulatory Intelligence & Integration Management, Intuitive Surgical Inc. and Co-Chair, 2021 FDLI Advertising and Promotion for Medical Products Conference
Erin Carducci, Director, Regulatory Ad/Promo Digital Strategy & Innovation, Regulatory Advertising & Promotion, Novartis Pharmaceutical Corporation
Jason Gordon, Partner, Reed Smith LLP
Moderated by Gillian M. Russell, Counsel, King & Spalding LLP

 

As social media evolves, advertisers are quick to expand their online presence. While these new sites present opportunities to reach existing and fresh audiences, brands should use caution when diving into emerging platforms. Use of influencers, including patient ambassadors and peer mentors, presents specific considerations such as vetting, contracts, managing comments, and training. This panel will discuss practical areas of consideration in the use of social media and influencers, best practices, and lessons learned.

Friday, October 15

10:30–11:00 AM
FDLI Student Member Debrief

The FDLI Student Member Debrief will feature a space for student members to discuss the ongoing conference, network with other FDLI student members, and hear about other opportunities for those new to the food and drug law field.

11:40 – 11:55 AM
Technology and Connection Support Session

12:00 – 1:00 PM
FDLI Welcome
Laura Brown, Director, Educational Programs, FDLI

Risk Reduction in a New Generation of TV Ads – Saving Time and Increasing Consumer Comprehension
Julie B. Chronis, Senior Counsel II, Gilead Sciences, Inc.
Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman, P.C.
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

The “major statement”— FDA’s recommendations for the presentation of risk information in broadcast television ads — has remained largely unchanged over the last decade. Yet, during the same timeframe, streaming TV has emerged as a completely different option. FDA has completed several research studies that provide insight into what an improved, and potentially shorter, TV major statement would be. This session will provide companies with the tools they need to improve the communication of risk information in both traditional and streaming TV ads.

1:15 – 2:15 PM
Concurrent Breakout Sessions

  • Advertising and Promotion of Reference and Biosimilar Products — Where Are We Now?
    Karin Hessler, Deputy General Counsel, Association for Accessible Medicine
    Rachel Turow, Associate General Counsel, Regulatory Law & Policy, TEVA Pharmaceuticals USA, Inc., and Member, FDLI Board of Directors
    Moderated by Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

It has been more than a year since FDA published guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry” and held a joint public workshop with FTC on the subject. This session will examine how the guidance has impacted industry’s decision-making around entering the reference and biosimilar product markets. The panel will also gauge how interchangeable-specific issues are playing out and whether additional solutions may be needed.

  • Industry Impact from FDA’s New “Intended Use” Rule
    Jeffrey B. Chasnow
    , Senior Vice President and Associate General Counsel, Pfizer Inc.
    Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP
    Kelly F. Goldberg, Vice President, Law/Senior Counsel for Biopharmaceutical Regulation, PhRMA
    Moderated by James (Jim) N. Czaban, Partner, Loeb & Loeb

In August 2021, FDA issued new regulations regarding “Intended Uses.” This final rule describes the types of evidence the agency will consider when determining whether a product is intended for use as a drug or device. This panel will examine the rule’s impact on industry, as well as previous litigation that led to the rule in its current state. Speakers will also discuss whether First and Fifth Amendment challenges to the rule are likely. 

  • Tailoring Marketing and Claims to the Post-Emergency Use Authorizations Era
    Suzanne Levy Friedman, Senior Associate, Hogan Lovells US LLP
    Lav Patel, Senior Specialist, Office of Promotion and Advertising Review, Merck & Co., Inc.
    Elizabeth Richards, Partner, Latham & Watkins LLP

This session will focus on how medical product companies can manage their business’s advertising and promotion activity when the status of their product changes post-COVID. The panel will first provide a brief history of expanded access leading up to today’s EUAs. Speakers will then discuss best practices for communicating information about products under an EUA and products transitioning out of an EUA, using real-world industry examples.

2:30 – 3:30 PM
The Impact of Telehealth on Advertising and Promotion
Ritu Kaur Cooper, Attorney, Hall, Render, Killian, Heath & Lyman P.C.
Stephen Evans, Assistant General Counsel, Healthcare Law Group, Genentech, Inc.
Kyle Thomson, Senior Legislative Counsel, American Medical Association
Moderated by Serra J. Schlanger, Director, Hyman, Phelps & McNamara, PC

Patients’ need for remote medical care during the COVID-19 pandemic has accelerated the use of digital technologies, including telehealth portals and wearables that measure and track physiological signals that can help inform medical treatments. Industry is likely to continue to build on the inroads made during COVID-19, and virtual healthcare is likely to continue to accelerate. This panel will explore marketing issues and opportunities associated with virtual health care.

3:30 PM
Closing Remarks and Adjournment