Why Attend

Agenda

CLE

Agenda Subject to Change. 
All Times are Eastern Time.

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

While biologics hold immense therapeutic promise, FDA and FTC must ensure fair and competitive markets to reduce costs and increase patient access. This panel will examine FDA’s partnership with the FTC to prioritize enforcement against innovator and biosimilar manufacturers that have attempted to inhibit competition through false or misleading superiority claims. The panel will review FDA’s February 2020 draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers.” Speakers will then discuss recent enforcement actions taken and compare innovator/biosimilar superiority claims to those used for innovator/generic drugs.

  • 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

During this session, speakers will discuss practical aspects of pre-approval interactions with payors. The panel will address how companies have adapted their pre-approval communications with payors pursuant to FDA’s 2018 “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers” final guidance. The panel will also examine industry questions related to the Academy of Managed Care Pharmacy’s updated Format for Formulary Submissions 4.1 Unapproved Product and Unapproved Use Dossiers.

  • 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

In light of the many Emergency Use Authorizations (EUAs) granted to medical products targeted to address the COVID-19 pandemic, a common question has been how to promote such products under the Federal Food, Drug, and Cosmetic Act. Can sponsors say that such products are safe and effective? How can promotions remain “on-label” with an EUA, and are there any disclaimers that FDA favors for products authorized under an EUA? This panel will also discuss other products cleared under special circumstances.

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

Medical Science Liaisons (MSLs) have evolved into a bridge between medical and commercial teams, becoming increasingly sophisticated through vehicles such as on-demand systems. What are the boundaries of MSLs? This panel will explore MSL best practices through a hypothetical case study involving scientific exchange and safe harbor provisions. The session will also explore how COVID-19 has affected MSL activities.

  • 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

As the number of specialty drugs has grown over the last decade, so has the need to develop a patient-centric approach to market access while navigating the many compliance pitfalls associated with specialized patient support programs. Pharmaceutical manufacturers’ use of “hubs,” or third-party patient and reimbursement support services, has become a standard industry approach to bridging the legally mandated gaps between manufacturers, patients, health care providers, and coverage providers. This session will discuss how hubs work and explore manufacturers’ potential federal and state liability.

  • 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

This panel will examine the evolving landscape of promotional submission requirements for accelerated approval drugs and biologics. The panel will differentiate between the various programs (Breakthrough Therapy, Priority Review, Accelerated Approval, Fast Track). Speakers will then discuss the preapproval submission requirements for accelerated approval products specified in the “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” guidance. Real world applications of presubmission requirements for these products will also be discussed, including the varying approaches of CDER’s Office of Prescription Drug Promotion and CBER’s Advertising and Promotional Labeling Branch.

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

This session will cover a variety of hot topics in pre-approval communications, with an emphasis on how to stay compliant despite legal gray areas. Speakers will discuss specific pre-approval communications, including scientific exchange and investor communications. Unbranded disease-awareness communications, such as content considerations and method of communication, will also be discussed.

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

This interactive panel will look at trends in formal and informal enforcement from the past year, as well as across the past decade, through anonymous attendee polling and speaker analysis of these trends. Topics will include correspondence from competitors and FDA, boxed warning products, conference booths, scrutiny of investigational drugs, areas of OPDP research, OPDP enforcement letters triggered by reports submitted to the Bad Ad Program, oral statements by sales representatives, and social media platforms. Other themes to explore include repeat offenders, women’s health products, and spokespersons/testimonials.

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

Even prior to COVID-19, a fundamental shift from in-person to online medical care and associated advertising had occurred, presenting new opportunities and risks related to online promotion through vehicles such as telehealth, electronic health records (EHRs), and online one-stop doctors/pharmacies. The panel will explore best practices for online promotion, as well as recent litigation involving EHRs. Hypotheticals involving contracts with pharmacies and partnering through sponsorship will also be discussed.    

3:55 PM
Closing Remarks and Adjournment