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Updated 10/2

Monday, October 1 

8:30-10:30 a.m.

Policy Updates and Enforcement Developments from FDA’s Medical Product Centers

CBER

Lisa L. Stockbridge, PhD, Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA | Slides

CDER

Thomas W. Abrams, RPh, Director, Office of Prescription Drug Promotion, Office of Medical Policy, CDER, FDA | Slides

CDRH

Toni M. Stifano, Consumer Safety Officer, Office of Compliance, CDRH, FDA

CVM

Thomas J. Moskal, DVM, Dipl. ACLAM, Veterinary Medical Officer, Division of Surveillance, Office of Surveillance and Compliance, CVM, FDA | Slides

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

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

Jeffrey K. Francer, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America | Slides

Mary E. Riordan, Senior Counsel, Office of Counsel, Office of the Inspector General, Department of Health & Human Services | Slides

Joan D. Humes, Vice President and Deputy General Counsel, Litigation and Investigations, Medtronic, Inc. | Slides

Joy J. Liu, Partner, Ropes & Gray LLP | Slides

Eugene M. Thirolf, Jr., Consultant | Slides

Moderated by Anne K. Walsh, Of Counsel, Hyman, Phelps & McNamara PC   

Updates on FDA Guidances  

Jean-Ah Kang, PharmD, Special Assistant, OPDP, CDER, FDA | Slides 

Marci C. Kiester, Associate Director of Operations, OPDP, CDER, FDA | Slides

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 | Slides 

Moderated by Mark Gaydos, Vice President, U.S. Regulatory Affairs Marketed Products, Sanofi-Aventis

Concurrent Breakout Sessions: Hot Issues

1. Substantial Evidence & Other Standards for Support of Promotional Claims

Elaine Hu Cunningham, PharmD, Senior Regulatory Review Officer, OPDP, CDER, FDA | Slides

Mark S. Hirsch, MD, Medical Team Leader, CDER, FDA  

James P. Stansbury, PhD, Consumer Safety Officer, SEALD, ONDIO, CDER, FDA

Eugene J. Sullivan, MD, Principal, EJS Consulting, Inc.

Moderated by Michele M. Hardy, Executive Director, Regulatory Advertising and Promotion Policy, GlaxoSmithKline

2. 1^st Amendment: Legal Developments in Case Law

Vicki W. Girard, Professor, Georgetown University Law Center

William M. Janssen, Professor, Charleston School of Law | Slides

Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC | Slides

Moderated by Ralph F. Hall, Professor of Practice, University of Minnesota Law School | Slides

Tracy L. Acker, PharmD, President and Owner, The Acker Group, LLC | Slides

Diane E. Dorman, Vice President, Public Policy, National Organization for Rare Disorders | Slides

Daniel J. O'Connor, Vice President and General Counsel, Bracco Diagnostics, Inc. | Slides

Michael D. Petty, Partner, King & Spalding | Slides - Social Media | Slides - How Companies Decide

Moderated by Marc J. Scheineson, Partner, Alston & Bird LLP | Social Media Best Practices

8:30-10:15 a.m.

Concurrent Breakout Sessions: Compliance Issues

1. Animal Health and Veterinary Medicine

Dorothy R. McAdams, VMD, Team Leader, Post-Approval Review Team, Division of Surveillance, OSC, CVM, FDA

Thomas J. Moskal, DVM, Dipl. ACLAM, 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 | Slides

Moderated by Neal Bataller, DVM, Director, Division of Surveillance, OSC, CVM, FDA 

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 | Handout - Excerpt | Handout - Brochure

Moderated by Thomas Casola, Vice President, Regulatory Affairs, Advertising and Promotion, Shire Specialty Pharmaceuticals| Panel Slides

3. Medical Devices and Diagnostics

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 | Panel Handout

10:45a.m.-12:00 p.m.

Comparative Effectiveness: Communicating Research Results to Make a Difference

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 | Slides

Kimberly Westrich, Director, Health Services Research, National Pharmaceutical Council | Slides

Moderated by Coleen Klasmeier, Global Coordinator; Food, Drug and Medical  Device Regulatory Practice, Sidley Austin LLP | Slides | Handout 

12:00-1:30 p.m.

Lunch Address: What to Expect from FTC in 2013 

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   

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 | Panel Slides

2:30-3:30 p.m.

Social Media in Medical Product Companies: Using Emerging Technology to Communicate about Products 

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 | Panel Slides

 3:45-5:00 p.m.

Question and Answer Session with FDA’s Medical Product Center Representatives

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