Advertising & Promotion Conference

September 27-28, 2016

Renaissance Washington, DC Downtown Hotel
999 9th Street NW | Washington, DC 20001

*Agenda subject to change

Monday, September 26:

6:00 – 7:00 PM

Out-of-Towners Reception 

A casual reception for out-of-town attendees.

Tuesday, September 27:

8:00-8:45 AM 

Registration and Continental Breakfast

8:45-9:00 AM

FDLI Welcome and Announcements

Amy Comstock Rick, JD, President & CEO, Food and Drug Law Institute

9:00-10:30 AM

Updates from the FDA Centers

Representatives from FDA’s Medical Products Centers will provide updates on the latest policy developments, enforcement actions, and the future of FDA’s oversight activities related to the advertising and promotion of drug, biologic, medical device, and veterinary medicine products. This session will lay the foundation for the conference and provide FDA’s current thinking on important issues raised by industry.

Thomas W. Abrams, Director, Office of Prescription Drug Promotion, Office of Medical Policy, Center for Drug Evaluation and Research, FDA 

Thomas J. Moskal, Veterinary Medical Officer, Center for Veterinary Medicine, FDA 

CDR Oluchi Elekwachi, PharmD, MPH, Senior Regulatory Operations Officer, Advertising and Promotional Labeling Branch, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA

Toni Stifano, Consumer Safety Officer, Office of Compliance, Center for Devices and Radiological Health, FDA 

Kendra Y. Jones, Lead Consumer Safety Officer, Division of Premarket and Labeling Compliance, Office of Compliance, Center for Devices and Radiological Health, FDA 

Moderated by Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide

10:30-11:00 AM

Networking Break

11:00-12:00 PM

Communicating with Payers

What enforcement activities have we seen from FDA, DOJ or others regarding formulary communications? Are the rules different for pre-approval formulary communications versus off-label information? Do FDA policies on non-promotional scientific exchange apply to any formulary communications? This panel will explore the rules and practices that govern communicating drug information to payers and formulary committees in light of evolving FDA policies on scientific exchange, First Amendment case law, and proposed legislative changes to FDAMA 114.  

Michael S. Labson, Partner, Covington & Burling LLP

12:00-1:15 PM

Luncheon Address

Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission

1:15-1:45 PM

Networking Break

1:45-2:45 PM

DOJ – OIG Compliance Update and Recent Settlements

This session will discuss recent enforcement activities by the US Department of Justice and the US Department of Health and Human Services, Office of Inspector General, against the medical products industries. What lessons can be learned from the latest settlements and issues raised?

Mary Riordan, Senior Counsel, Office of Inspector General, HHS 

Michael S. Blume, Director, Consumer Protection Branch, Department of Justice 

Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP

2:45-3:15 PM

Networking Break

3:15-4:15 PM

Direct-to-Consumer Advertising

This panel will provide an update on recent FDA developments and legislative proposals relating to direct-to-consumer (DTC) advertising, along with the evolution of DTC advertising from an industry perspective. The issue of the current impact of DTC on the learned intermediary defense, the state of the law and trends in the decisions, and potential future developments will also be discussed.

Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP

Kai Peters, Partner, Gordon & Rees LLP

Heather E. Rennie, Managing Counsel, Merck & Co., Inc.

Moderated by Sonali P. Gunawardhana, Of Counsel, Wiley Rein LLP

4:15-4:30 PM


4:30-5:00 PM

Question & Answer Panel with FDA

FDA Center representatives will respond to questions you have submitted throughout the day. This is your opportunity to engage with FDA and learn valuable takeaways from the discussion.

Thomas W. Abrams, Director, Office of Prescription Drug Promotion, Office of Medical Policy, Center for Drug Evaluation and Research, FDA 

Dorothy McAdams, Supervisory Veterinary Medical Officer, Center for Veterinary Medicine, FDA 

Lisa Stockbridge, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA 

Deborah Wolf, Regulatory Counsel, Office of Compliance, Center for Devices and Radiological Health, FDA 

Kendra Y. Jones, Lead Consumer Safety Officer, Division of Premarket and Labeling Compliance, Office of Compliance, Center for Devices and Radiological Health, FDA 

Moderated by Lucy Rose, President, Lucy Rose & Associates, LLC

5:00-6:30 PM

Networking Reception

Wednesday, September 28:

8:30-9:00 AM

Registration and Continental Breakfast

9:00-10:00 AM

FDA Guidances: An Industry Perspective

Panelists from industry will explore issues they have faced in interpreting and implementing FDA guidances, focusing on the practical issues they deal with on a daily basis. 

Khatereh Calleja, Senior Vice President of Technology and Regulatory Affairs, AdvaMed

Monaya M. Krause, Senior Legal Director, Medtronic

Geoffrey M. Levitt, SVP & Associate General Counsel, Regulatory, Environmental and Global Supply, Pfizer Inc.

Moderated by Kellie B. Combs, Counsel, Ropes & Gray LLP

10:00-10:15 AM

Networking Break

10:15–11:30 AM

Commercial Speech: Key Cases and Their Practical Implications  

Industry has recently had a number of significant victories in criminal and civil off-label promotion cases. In this session, panelists will share key lessons learned, implications for future off-label promotion, and offer practical tips for how pharmaceutical and medical device companies can effectively navigate off-label communications. These favorable outcomes also demonstrate that litigation, both offensive and defensive, can be a powerful tool to shape off-label policy and to protect the rights of manufacturers. 

Joseph T. Kennedy, EVP, General Counsel Amarin Pharma, Inc. 

Lynn C. Tyler, Partner, Barnes & Thornburg LLP

Moderated by Lisa M. Dwyer, Partner, King & Spalding LLP

11:30–12:30 PM

Concurrent Breakout Sessions 1

1. Trends and Special Issues for Device Promotion

Because the definition of a medical device depends on its intended use, which is established through labeling, advertising, and statements by the manufacturer, it’s critical that companies exercise care when promoting products. This session will bring you up-to-speed on current trends and special issues for device promotion. 

Vernessa Pollard, Partner, McDermott Will & Emery LLP 

Jeffrey K. Shapiro, Partner, Hyman, Phelps & McNamara, PC 

2. Mobile Medical Apps 

There is a graveyard of well-intentioned mobile apps littering laptops and handheld devices. Although the industry has had high hopes for branded apps, there have been many regulatory hurdles to overcome such as fair balance, disclosure, privacy, 2253 submission, and medical device designation. With careful planning, deploying a successful mobile app is possible in order to help patients understand their condition, safely use their prescriptions, speed their start on drug therapy through request forms, and collect data for benchmarking and planning purposes. A panel of diverse speakers will share their experiences and best practices.

Shalu Bhambhani, Business Insights and Operations Manager, Genetic Disease Franchise, Shire

Peter Pitts, President, Center for Medicine in the Public Interest

Alexis Pone, Consultant, Digital Strategy and Healthcare Marketing

Moderated by Ilyssa Levins, President and Founder, Center for Communication Compliance

3. Precision Medicine, Diagnostics, and Laboratory-Developed Tests: Special Promotional Issues

This session will address the challenging promotional issues for Precision Medicine products and services, including new drug products, unapproved combinations of drugs, approved and unapproved diagnostic tests, and laboratory developed tests. Final guidance from FDA on its regulation of LDTs is forthcoming; however, many stakeholders are uncertain of the legality of FDA’s regulation. This breakout will explore these concerns. 

Kathleen M. Sanzo, Morgan, Lewis & Bockius LLP 

Michael A. Swit, Senior Director, Senior Director, Legal, Regulatory, Illumina, Inc. 

Moderated by James Czaban, Partner, DLA Piper LLP

12:30–1:30 PM

Luncheon Address

Floyd Abrams, Partner, Cahill Gordon & Reindel LLP 

1:30-2:00 PM

Networking Break

2:00-3:00 PM

Concurrent Breakout Sessions 2

1. Life after a Corporate Integrity Agreement 

Companies emerging from a Corporate Integrity Agreement (CIA) face many challenging issues even after spending years responding to regulatory obligations. Learn from those that have been under CIAs, how they have survived, and ways to proactively shift to a risk-mitigation model driven by company needs, current industry practices, and enforcement trends.

Mahnu Davar, Partner, Arnold & Porter LLP

Matthew Hill, Senior Corporate Counsel, Novo Nordisk Inc.

2. Making the Most of Social Media: Innovative Uses and Practical Experience

Drug and device companies continue to expand their presence using social media to connect with consumers and healthcare professionals. Get practical advice on how some of the industry’s leading companies are ensuring compliance with FDA regulatory requirements while applying draft guidance for social media use. 

Dale Cooke, Owner, PhillyCooke Consulting

Nancy M. Parsons, Counsel, Hogan Lovells LLP

Moderated by Jill Charbonneau, Director, RA-Ad/Prom, Product Launch & Labeling, Marathon Pharmaceuticals, LLC

3. Promotional Review Committees: Advanced Strategies

This session will discuss the promotional issues arising from drug and device companies’ use of promotional review committees (PRCs) and how PRCs can be used effectively to mitigate risk, as well as what pitfalls exist for companies employing them.

Colleen M. Heisey, Partner, Jones Day

Julie K. Tibbets, Partner, Alston & Bird LLP

Eileen Valenta, Vice President, Client Services, Validant

3:00–3:15 PM


3:15–4:30 PM

Challenging Hypotheticals – What Would You Do?

In this interactive session, panelists will present a host of difficult, but practical hypothetical scenarios faced by companies every day.

Laura Cooper, Senior Director, Global Regulatory Affairs, Sanofi-Aventis

Sue Duvall, Head, North America Advertising and Promotion, Mylan Pharmaceuticals, Inc.

Jeffrey M. Senger, Partner, Sidley Austin LLP

Moderated by Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman, P.C.

4:30 PM

Conference Adjournment