Agenda & Speakers Slides

Day 1: Agenda & Speaker Slides
Day 2: Agenda & Speakers Slides
Print Agenda (PDF)
Attendee List (PDF)
Speaker Biographies (PDF)

Friday, October 18

8:30 – 8:55 AM 

Registration and Continental Breakfast

8:55 – 9:00 AM 

Welcome and Announcements 
Laura Brown, Director, Educational Programs, FDLI
Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol-Myers Squibb Company, and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee

9:00 – 10:00 AM 

What are social media companies’ policies and approaches regarding industry engagement? This session will feature representatives who navigate social media platforms that grapple with medical product advertising and promotion issues on a daily basis. Speakers will discuss emerging issues, specifically focusing on policies regarding patient engagement, the role of influencers, and drug warnings.

Jason Gordon, Partner, Reed Smith LLP
Dawn H. Lacallade, Vice President, Healthcare, LiveWorld 
Tim Wisniewski, Senior Strategist, Wunderman Thompson
Moderated by Heather Banuelos, Counsel, King & Spalding LLP     

10:00 – 10:45 AM

This panel will discuss steps companies are increasingly taking to address concerns about competitor promotional activities regarding false or misleading statements. Speakers will explore recent developments in private advertising enforcement and litigation between companies under the Lanham Act, similar state false advertising and unfair trade practice laws, and product liability claims. The Better Business Bureau’s National Advertising Division (NAD) process for addressing competitor claims and how sales and marketing can influence a company’s ability to fairly defend the company in product liability disputes will also be addressed.

Susan Cook, Partner, Hogan Lovells US LLP
Hal Hodes, Senior Attorney, National Advertising Division
Kirke Weaver, Vice President, Office of General Counsel, Merck & Co., Inc.
Moderated by Lisa Molot Dwyer, Partner, King & Spalding LLP

10:45 – 11:00 AM

Coffee and Networking Break

11:00 AM – 12:00 PM 

Concurrent Breakout Sessions

This session will discuss FDA’s implementation of, and industry experiences with, the “Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs” guidance. FDA will answer questions that industry has about the implementation process.

Jason Cober, Project Manager Team Lead, Office of Prescription Drug Promotion, CDER, FDA
Moderated by Joanne Hathaway, Manager, Global Regulatory Affairs, Promotion Compliance, Otsuka America Pharmaceutical, Inc.

This panel will discuss advertising and promotion dilemmas with which medical product companies often wrestle: balancing marketing important and sometimes lifesaving products, satisfying stakeholders, and ensuring fair balance in claims. Speakers will cover mistakes companies have made in the past that have led to adverse jury verdicts and steps industry can take to lower risk.

Jodie Floyd, Assistant General Counsel, Eli Lilly and Company
Keren Tenenbaum, VP and Assistant General Counsel, Head of  Legal, Salix at Bausch Health
Moderated by Matthew Keenan, Law Partner, Shook, Hardy & Bacon LLP

What is “scientific exchange?” When is it appropriately used? Where is the line between scientific exchange and off-label promotion? This panel will discuss where these grey areas are and how to use scientific exchange effectively while still complying with regulatory requirements.

Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy
Kellie Combs, Partner, Ropes & Gray LLP
Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi
Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol-Myers Squibb Company and and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee

12:00 – 12:15 PM

Transition

12:15 – 1:15 PM

Luncheon and Facilitated Table Topic Discussions

1:15 – 2:15 PM 

Concurrent Breakout Sessions

During this panel speakers will discuss some of the challenges of making comparative claims when launching a new therapy into a therapeutic or pharmacological class with a variety of existing approved products. Although the general rule is that comparative claims require substantiating data from two head-to-head registration-quality studies demonstrating very significant differences, some statements about competing products that vary from this standard are expressly permitted by the agency, if properly executed. Speakers will examine how changes under the CFL guidance have affected the ability to make comparative claims, as well as practical strategies to manage risk.

Justin Drinkwine, Corporate Counsel, Jazz Pharmaceuticals, Inc.
Dara Katcher Levy, Director, Hyman, Phelps & McNamara, PC
Coleen E. Klasmeier, Partner, Sidley Austin LLP

In this era of bloggers and celebrity endorsements, this session will discuss how to work effectively with influencers to ensure actions taken and statements made are in compliance with FDA and Federal Trade Commission (FTC) regulations. Speakers will discuss specific issues to watch for when working with influencers in the social media space, how to stem the tide of inaccurate information, and recent enforcement examples.

Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Lauren Myers, Associate, Kelley Drye & Warren LLP
Moderated by Danielle Humphrey, Counsel, Hogan Lovells US LLP

This session will address how companies deal with common promotional challenges in the face of regulatory uncertainty, as well as associated risks. Issues addressed will include: whether it is “off-label” to make a specific claim when the device has a more general indication for use; how much safety information must be included in device advertisements and promotional labeling; implications of the CFL Guidance as applied to devices; promotion of combination drug/device products and restricted/Rx devices;  and preapproval/preclearance promotion.

Eitan Bernstein, Associate, Latham & Watkins LLP
Sarah Blankstein, Associate, Ropes & Gray LLP
Michele Buenafe, Partner, Morgan, Lewis & Bockius LLP
Moderated by Sarah Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson

2:15 – 2:20 PM 

Transition

2:20– 3:30 PM

Companies are increasingly using new technologies such as AI/ML, Alexa, disease monitoring apps that include a branded product, and digital advertising at the point of care, including on electronic health records, for promotional purposes. Speakers will discuss benefits and risks of using these technologies to better engage with doctors and patients on product information or disease education, develop precision messaging, probe real world data for development of healthcare economic models, speed access through coverage and reimbursement, identify patient adherence issues, engage with patients, and anticipate future prescribing trends. Speakers will address privacy issues as well as how to maintain regulatory compliance and ensure best practices.

M. Jason Brooke, Director, Life Sciences Regulatory, Quality & Patient Safety, Navigant Consulting, Inc.
Dale Cooke, President, PhillyCooke
Daniel Kracov, Partner, Arnold & Porter LLP, and Secretary and General Counsel, FDLI Board of Directors
John Vaughan, General Counsel and Chief Compliance Officer, Outcome Health

3:30 PM

Conference Adjournment