Updated 9/21
Monday, October 1
7:30 a.m.
Registration and Networking Breakfast (Presidential Foyer and Senate)
8:25-8:30 a.m.
FDLI Welcome (Presidential Ballroom)
Susan C. Winckler, RPh, Esq, President & CEO, FDLI
Introduction of All Plenary Sessions on October 1:
Geoffrey M. Levitt, Senior VP & Associate General Counsel, Regulatory & Policy, Pfizer Inc. and Chair, FDLI Board of Directors
8:30-10:30 a.m.
Policy Updates and Enforcement Developments from FDA’s Medical Product Centers (Presidential Ballroom)
Representatives from FDA’s Medical Product Centers will provide updates on policy developments related to advertising and promotion activities (including direct to consumer marketing) of drug, biologic, medical device, and veterinary medicine products. This session lays the foundation for the conference by presenting an overview of the current regulations, enforcement actions, recent developments, perspective on comments submitted to the Agency, and insights on the future of FDA's advertising and promotion oversight.
In addition to the question-and-answer portion of this session, the conference concludes with a 45-minute question and answer session on the afternoon of October 2. Attendees may submit questions anytime during the conference.
CBER
Lisa L. Stockbridge, PhD, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA
CDER
Thomas W. Abrams, RPh, Director, Office of Prescription Drug Promotion, Office of Medical Policy, CDER, FDA
CVM
Thomas J. Moskal, DVM, Dipl. ACLAM, Office of Surveillance and Compliance, CVM, FDA
Moderated by Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide
10:30-11:00 a.m.
Networking Break (Senate Room)
11:00 a.m.-12:30 p.m.
Trends and Priorities in Enforcement: U.S. Department of Health and Human Services and the U.S. Department of Justice Activity (Presidential Ballroom)
What can be learned from recent settlements involving medical product advertising and promotion? Speakers from the DOJ will present a summary of recent settlements, Corporate Integrity Agreements, and whistleblower rule changes; and provide updates on other issues, such as “online pharmacy advertising” (Google Inc.), Sorrell v. IMS Health, and the states that are imposing marketing restrictions on medical device manufacturers.
Mary E. Riordan, Senior Counsel, Office of Counsel, Office of the Inspector General, Department of Health & Human Services
Jeffrey K. Francer, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America
Joan D. Humes, Vice President and Deputy General Counsel, Litigation and Investigations, Medtronic, Inc.
Joy J. Liu, Partner, Ropes & Gray LLP
Eugene M. Thirolf, Jr., Consultant
Moderated by Anne K. Walsh, Of Counsel, Hyman, Phelps & McNamara PC
12:30-1:50 p.m.
Lunch (Congressional and Senate Rooms)
2:00-3:15 p.m.
Updates on FDA Guidances (Presidential Ballroom)
An FDA panel will discuss recent and emerging guidances that significantly impact advertising and promotion of medical products.
Jean-Ah Kang, PharmD, Special Assistant, OPDP, CDER, FDA
Marci C. Kiester, Associate Director of Operations, OPDP, CDER, FDA
Lisa L. Stockbridge, PhD, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA
Ernest S. Voyard, Senior Regulatory Counsel, OPDP, CDER, FDA
Moderated by Mark Gaydos, Vice President, U.S. Regulatory Affairs Marketed Products, Sanofi-Aventis
3:15-3:40 p.m.
Networking Break (Senate Room)
3:45-5:00 p.m.
Concurrent Breakout Sessions: Hot Issues
1. Substantial Evidence & Other Standards for Support of Promotional Claims (Presidential Ballroom)
Elaine Hu Cunningham, PharmD, Senior Regulatory Review Officer, OPDP, CDER, FDA
Mark S. Hirsch, MD, Medical Team Leader, CDER, FDA
James P. Stansbury, PhD, MPh, Consumer Safety Officer, SEALD Study Endpoints, Office of New Drugs, CDER, FDA
Eugene J. Sullivan, MD, Principal, EJS Consulting, Inc.
Moderated by Michele M. Hardy, Executive Director, Regulatory Advertising and Promotion Policy, GlaxoSmithKline
2. 1st Amendment: Legal Developments in Case Law (Federal A Room)
Vicki W. Girard, Professor, Georgetown University Law Center
William M. Janssen, Professor, Charleston School of Law
Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Moderated by Ralph F. Hall, Professor of Practice, University of Minnesota Law School
3. Defining “Scientific Exchange” (Federal B Room)
Tracy L. Acker, PharmD, President and Owner, The Acker Group, LLC
Diane E. Dorman, Vice President, Public Policy, National Organization for Rare Disorders
Daniel J. O'Connor, Vice President and General Counsel, Bracco Diagnostics, Inc.
Michael D. Petty, Partner, King & Spalding
Moderated by Marc J. Scheineson, Partner, Alston & Bird LLP
5:00-6:00 p.m.
Networking Reception, Sponsored by Epstein Becker Green (Senate Room)
All conference attendees are invited to the networking reception. Reconnect with colleagues and meet other members of the food and drug law and regulation community.
Tuesday, October 2
7:30 a.m.
Networking Breakfast (Senate Room)
8:30-10:15 a.m.
Concurrent Breakout Sessions: Compliance Issues
Each breakout session will explore product specific examples and obligations of complying with advertising and promotion oversight. Attend one of the breakouts to gain practical information through interactive exercises and discussion.
Following the breakout sessions, all conference attendees will gather in the main meeting room at 10:45 a.m.
1. Animal Health and Veterinary Medicine (Federal A Room)
Dorothy R. McAdams, VMD, Team Leader, Post-Approval Review Team, Division of Surveillance, OSC, CVM, FDA
Thomas J. Moskal, DVM, Dipl. ACLAM, Veterinary Medical Officer, Division of Surveillance, Office of Surveillance and Compliance, CVM, FDA
Thomas R. Schriemer, Director of Regulatory Affairs, Pfizer, Inc.
Tracey L. Ward, Director, Surveillance and Compliance Regulatory, Elanco
Moderated by Neal Bataller, DVM, Director, Division of Surveillance, OSC, CVM, FDA
2. Drugs and Biologics (Presidential Ballroom)
Sheila K. Ryan, PharmD, Team Leader, Office of Prescription Drug Promotion, CDER
Bryant Godfrey, Senior Lead Regulatory Counsel, Office of Prescription Drug Promotion, CDER
Lisa L. Stockbridge, PhD, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA
Sandra Kerr, RPh, Head, Office of Promotion and Advertising Review, Merck
Moderated by Thomas Casola, Vice President, Regulatory Affairs, Advertising and Promotion, Shire Specialty Pharmaceuticals
3. Medical Devices and Diagnostics (Federal B Room)
Terri T. Garvin, Regulatory Counsel, Office of Compliance, CDRH, FDA
Deborah A. Wolf, Regulatory Counsel, Office of Compliance, CDRH, FDA
Casper E. Uldriks, Counsel, Olsson Frank Weeda PC
Moderated by Lynn C. Deutsch, Associate Director, Regulatory Affairs, Abbott Vascular
10:15-10:45 a.m.
Networking Break (Senate Room)
Introduction of All Plenary Sessions on October 2:
Minnie V. Baylor-Henry, Worldwide VP for Regulatory Affairs, Johnson & Johnson Medical Devices & Diagnostics and Immediate Past Chair, FDLI Board of Directors
10:45a.m.-12:00 p.m.
Comparative Effectiveness: Communicating Research Results to Make a Difference (Presidential Ballroom)
This session will provide a high-level discussion of comparative effectiveness research. Panelists will discuss the views of FDA on the scientific support necessary to demonstrate product efficacy, and how those views influence CER standards developed under the Patient-Center Outcomes Research Institute.
Peter Neumann, ScD, Director, Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center; Professor of Medicine, Tufts University School of Medicine
Kimberly Westrich, Director, Health Services Research, National Pharmaceutical Council
Moderated by Coleen Klasmeier, Global Coordinator; Food, Drug and Medical Device Regulatory Practice, Sidley Austin LLP
12:00-1:20 p.m.
Luncheon Address: What to Expect from FTC in 2013 (Congressional and Senate Rooms)
Heather Hippsley, Assistant Director for Advertising Practices, Federal Trade Commission
1:30-2:30 p.m.
Instilling Quality in Promotional Communications from Start to Finish: Effective Collaboration With Marketing and Media Companies (Presidential Ballroom)
How can marketing, public relations, and media vendors effectively communicate with regulatory departments to ensure that FDA rules are met? This panel will provide advice and examples for how to achieve effective collaboration in order to create quality promotions.
Alan Bergstrom, Senior Director, Commercial Regulatory Affairs, Daiichi Sankyo, Inc.
Ilyssa Levins, President and Founder, Center for Communication Compliance
Hamish Miller, Director of US Operations, Zinc Ahead, LTD
Preeti I. Pinto, President, Preeti Pinto and Associates, LLC
Moderated by John J. Seng, President & CEO, Spectrum
2:30-3:30 p.m.
Social Media in Medical Product Companies: Using Emerging Technology to Communicate about Products (Presidential Ballroom)
This session will explore the most effective social media websites and how they can be leveraged by the medical products industry. Speakers will provide step-by-step instructions for how to incorporate the latest social media technology into successful communications and marketing plans.
Dale Cooke, Vice President/Group Director, Regulatory Review, Digitas Health
Mark S. Senak, Senior Vice President, Fleishman-Hillard
Brian J. Winterfeldt, Partner, Steptoe & Johnson LLP
Moderated by Bradley Merrill Thompson, Member, Health Care and Life Sciences Practice, Epstein Becker & Green, PC
3:30-3:45 p.m.
Networking Break (Senate Room)
3:45-5:00 p.m.
Question and Answer Session with FDA’s Medical Product Center Representatives (Presidential Ballroom)
CBER
Lisa L. Stockbridge, PhD, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA
CDER
Thomas W. Abrams, RPh, Director, Office of Prescription Drug Promotion, Office of Medical Policy, CDER, FDA
CDRH
Deborah A. Wolf, Regulatory Counsel, Office of Compliance, CDRH, FDA
CVM
Thomas J. Moskal, DVM, Dipl. ACLAM, Office of Surveillance and Compliance, CVM, FDA
Moderated by Janet L. “Lucy” Rose, President, Lucy Rose & Associates, LLC