Agenda

2015 Advertising and Promotion Conference

October 1-2, 2015

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


*Agenda subject to change


Day 1:

7:30-8:15 AM 

Registration and Continental Breakfast

8:15-8:30 AM 

FDLI Welcome and Announcements 

Amy Comstock Rick, President and CEO, FDLI

8:30-9:30 AM 

Updates from the FDA Centers | Download Slides

Representatives from FDA’s Medical Products Centers will provide updates on enforcement and policy developments related to the advertising and promotion of drug, biologic, medical device, and veterinary medicine products. This session lays the foundation for the conference by presenting an overview of recent enforcement actions and policy changes, and insights into the future of FDA’s oversight activities. 

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

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

Sonny Saini, Senior Regulatory Operations Officer, Advertising and Promotional Labeling Branch, Division of Case Management, 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

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

9:30-10:15 AM 

Highlights of Recent FDA Guidances | Download Slides

FDA draft guidances have been published recently all of which impact the compliance policies of regulated companies.  Take advantage of this opportunity to hear an analysis of the latest guidances directly from their authors. 

Julie Chronis, Regulatory Consel, Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA

Roberta SzydloSenior Regulatory Review Officer, Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA

Moderated by Michael Sauers, Staff Supervisor, Office of Prescrption Drug Promotion, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA

10:15-10:45 AM 

Networking Break 

10:45-11:15 AM 

The Impact of 21st Century Cures 

An important update from congressional representatives on the ways in which 21st Century Cures will affect the promotional practices of drug and device companies.

11:15-12:15 PM 

Mobile Medical Applications: FDA & FTC Issues  | Download Slides

Because the definition of a medical device depends on its intended use, which is established through labeling, advertising, and statements by the manufacturer, it is critical that companies exercise care when promoting products. Even if a device is low risk, the FTC retains the authority to take enforcement action for false or misleading claims. In this session, panelists will discuss the special considerations posed by the availability and promotion of mobile medical applications. 

Michele Buenafe, Partner-Elect, Morgan Lewis & Bockius LLP 

Jeffrey N. Gibbs, Shareholder, Hyman, Phelps & McNamara, P.C., and Secretary and General Counsel, FDLI Board 

Karen Mandel, Attorney, Division of Advertising Practices, Bureau of Consumer Protection, FTC

Bradley Merrill Thompson, Member of the Firm, Epstein Becker & Green, P.C.

Moderated by Vernessa Pollard, Partner, Arnold & Porter LLP

12:15-1:45 PM 

Luncheon Address

Douglas H. Hallward-Driemeier, Partner, Ropes & Gray LLP
Mr. Hallward-Driemeier discusses the recent District Court decision, Amarin v. FDA, and its implications for medical product marketing using truthful off-label claims.

1:45-2:45 PM 

Navigating Advertising and Promotion through Social Media | Download Slides

Drug and device companies continue to expand their presence in social media, and would like to engage even more widely.  FDA recently issued six warning letters related to Facebook marketing and has issued a number of draft guidances describing its policies. This session will address what industry must bear in mind when using social media – what will and won’t FDA regard as acceptable.

Jennifer De Camara, Assistant General Counsel, Johnson & Johnson

Dale Cooke, Owner, PhillyCooke Consulting

Anne Maher, Partner, Kleinfeld, Kaplan & Becker LLP

Moderated by John Kamp, Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein LLP

2:45-3:15 PM 

Networking Break

3:15-4:15 PM 

DOJ – OIG Update 

This session will discuss recent enforcement activity 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?

Jill Furman, Deputy Director, Consumer Protection Branch, DOJ 

Mary Riordan, Senior Counsel, Office of Inspector General

Moderated by Jennifer L. Bragg, Partner, Skadden Arps LLP

4:15-5:00 PM 

Question and Answer Session Regarding FDA Guidances  

FDA Center representatives and the authors of the guidance documents respond to questions you have submitted throughout the day.

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

Deborah Wolf, Regulatory Counsel, Office of Compliance, Center for Devices and Radiological Health, Office of Medical Products and Tobacco, 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 

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

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

5:00-6:30 PM 

Reception


Day 2:

8:00-8:30 AM 

Registration & Continental Breakfast

8:30-9:45 AM 

Industry Perspective on FDA Guidances | Download Slides

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 day-to-day basis.

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

Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic 

Geoffrey M. Levitt, Senior Vice President & Associate General Counsel, Regulatory & Policy, Pfizer, Inc.

Moderated by Iris Gibbs, Associate Director, Advertising and Promotions, Regeneron Pharmaceuticals, Inc. 

9:45-10:15 AM 

Networking Break

10:15-11:45 AM Concurrent Breakout Sessions 1

1. Promotion of Biosimilars |Download Slides

FDA approved its first biosimilar this year, but it has yet to define any rules and policies governing biosimilar promotion. In this discussion, panelists will offer their insights into how the Agency is likely to proceed with respect to a variety of key issues, such as what terms can be used to claim interchangeability, and provide companies with practical recommendations as to how to proceed as they develop biosimilars. 

Sheldon Bradshaw, Partner, Hunton & Williams LLP

Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals, Inc.

Andrew N. Papas, Vice President, Regulatory Affairs, NSF Health Sciences Pharma Biotech Consulting

Jur Strobos, Of Counsel, Olsson Frank Weeda Terman Matz PC

Moderated by Susan Lee, Senior Associate, Hogan Lovells LLP

2. Update from FTC on Regulation of OTC Product Promotion | Download Slides

Speakers will provide updates on the FTC’s regulation of the advertising of over-the-counter medications and medical devices. 

Gregory W. Fortsch, Senior Attorney, Division of Advertising Practices, Bureau of Consumer Protection, FTC 

Jonathan Cohn, Partner, Sidley Austin

Ivan Wasserman, Partner, Manatt, Phelps & Phillips, LLP

Moderated by David Vladeck, Professor of Law, Georgetown University Law Center

3. Speaker Programs and Practices | Download Slides

This session will explore the current enforcement environment around speaker programs, identify key risks associated with speaker programs, and examine the additional controls that companies should consider implementing to ensure that promotional speaker programs are compliant from an FDA, anti-kickback, and transparency perspective.

Edward Berg, Vice President & Associate General Counsel, Sanofi-Aventis 
Stefanie Doebler, Special Counsel, Covington & Burling LLP
Lauren Roth, Assistant General Counsel, PhRMA

Moderated by Joy J. Liu, Partner, Ropes & Gray LLP, and Director, FDLI Board


11:45-1:00 PM 
Luncheon Address | Download Slides
Sally Greenberg, Executive Director, National Consumers League 

Sally, an expert on direct-to-consumer advertising, will explore her concerns about the sometimes misleading nature of print and television advertisements and discuss the critical issue of medication adherence.    

1:00-2:30 PM
Concurrent Breakout Sessions 2

1. The First Amendment, the False Claims Act, and the Implications of Amarin | Download Slides
The Caronia decision, and now this August’s Amarin decision, found that restrictions on truthful, non-misleading promotion raised fundamental First Amendment issues. Can similar arguments be made with respect to False Claims Act cases involving company representatives who “caused” a false claim to be submitted for reimbursement through, for example, dissemination of truthful medical literature that mentions an off-label use for a product? Panelists will consider the merits and vulnerabilities of such cases.

Scott Liebman, Partner, Loeb & Loeb LLP
Linda Pissott Reig, Shareholder, Buchanan Ingersoll & Rooney P.C.
Ralph Hall, Professor of Practice, University of Minnesota Law School

Moderated by Richard Samp, Chief Counsel, Washington Legal Foundation


2. Innovation in Training of Field and Sales Forces | Download Slides
FDA and OIG expect companies to execute and document employee training. In this discussion, speakers will address best practices regarding the training and specifically the e-training of field and sales forces, as well as the training essential to ensuring proper implementation of Corporate Integrity Agreements.

Michele Sharp, Senior Director Regulatory Affairs, Eli Lilly and Company
Kirsten Morasco, Owner, KLM Consulting
Jim Flaherty, Associate General Counsel, Fresenius Medical Care
Kimberly Belsky, Executive Director, OneSource Regulatory
Moderated by Ilyssa Levins, President, Center for Communication Compliance

3.  Pre-approval Communications to Patient and Other Groups | Download Slides
Patient groups are increasingly involved in the drug development process and the FDA encourages that engagement, but they require information before taking a position. Do pre-approval communications raise promotional issues. What can and can’t be said during the development stages of a drug or biologic to patient organizations engaged in the process?

Ryan M. Hohman, Managing Director, Policy & Public Affairs, Friends of Cancer Research
Dara K. Levy, Director, Hyman, Phelps & McNamara, P.C.
Julie Tibbets, Partner, Alston & Bird LLP
Moderated by Tammara Lewis, Senior Director Head of Promotional Regulatory Affairs, Endo Pharmeceuticals

 
2:30-2:45 PM 
Networking Break


2:45-4:00 PM 
Challenging Hypotheticals – What Would You Do? | Download Slides
In this session, panelists will present a host of difficult but practical hypothetical scenarios faced by companies every day. The audience, using interactive technology, will be able to join in.


Joy J. Liu, Partner, Ropes & Gray LLP, and Director, FDLI Board

Kai Peters, Partner, Gordon & Rees

Moderated by Colleen Heisey, Partner, Jones Day