This annual event brings together the regulated industries and the regulators responsible for overseeing the advertising and promotion of prescription drugs, medical devices, biological products and animal drugs. Hear directly from FDA leadership to gather insight into timely issues facing these regulated industries. Breakout sessions offer an opportunity for practical application. FDA Centers' representatives participate in a questions and answers session. By attending this conference, participants emerge with a clearer understanding of the regulatory and legal environment for the marketing of medical products.

Agenda

September 20

7:30 a.m.
Registration and Continental Breakfast

8:30 a.m.
I. FDLI Welcome and Announcements and Overview of Program
(Presidential Ballroom)
Susan C. Winckler, RPh, JD, President & CEO, FDLI

II. Policy and Guidance Updates and Enforcement Trends and Actions
from FDA's Medical Products Centers (Presidential Ballroom)

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

Speakers
CBER: Lisa L. Stockbridge, PhD, Acting Branch Chief, Advertising and Promotional Labeling Branch (APLB), Division of Case Management (DCM), Office of Compliance and Biologics Quality (OCBQ)

CDER: Thomas W. Abrams, RPh, MBA, Director, Division of Drug Marketing, Advertising, and Communications (DDMAC), Office of Medical Policy (OMP)

CDRH: Deborah A. Wolf, JD, Regulatory Counsel, Office of Compliance

CVM: Dorothy R. McAdams, VMD, Team Leader, Post-Approval Review Team, Division of Surveillance, Office of Surveillance and Compliance

Refreshment and Networking Break (Congressional Room)

III. Advertising and Promotion: Point/Counterpoint
(Presidential Ballroom)

Moderator
Susan C. Winckler, RPh, JD, FDLI

Speakers
Martin H. Redish, Professor of Law and Public Policy,
Northwestern University School of Law, and, Senior Counsel,
Sidley Austin LLP
Allison M. Zieve, JD, Director, Public Citizen Litigation Group

11:45 a.m.-1:00 p.m.
Lunch (Congressional and Senate Rooms)

1:00 p.m.
IV. Roundtable Discussion on Product Communication Issues: 510(k) Issues, Scientific Exchange, Solicited vs. Unsolicited, Medical Science Liaisons, Promotion vs. Communication, REMS, Allergan, Social Media, Publications, Speaker Programs (Presidential Ballroom)

Moderator
Minnie V. Baylor-Henry, JD, Regulatory & Capital Markets Consulting, Deloitte & Touche LLP

Speakers
Richard M. Cooper, Partner, Williams & Connolly LLP
Sheila M. Hemeon-Heyer, JD, RAC, Vice President, Global Regulatory Affairs, Boston Scientific Corporation Inc.
Freda C. Lewis-Hall, MD, Chief Medical Officer, Senior Vice President, Pfizer, Inc.
James C. Shehan, Vice President and General Counsel, Legal, Government and Quality Affairs, Novo Nordisk Inc.

Refreshment and Networking Break (Congressional Room)

V. FDA Updates: Direct-to-Consumer Promotion, DDMAC Research,
and the Use of Social and Electronic Media (Presidential Ballroom)

Moderator
Thomas W. Abrams, RPh, MBA, CDER, FDA

Speakers
Barbara S. Chong, PharmD, Team Leader, DDMAC, OMP, CDER, FDA
Maryann R. Gallagher, Regulatory Reviewer, APLB, DCM, OCBQ, CBER. FDA
Michael A. Sauers, Group Leader, Direct-to-Consumer Review Group I, DDMAC, OMP, CDER, FDA
Toni M. Stifano, Consumer Safety Officer, Office of Compliance, CDRH, FDA
Helen W. Sullivan, PhD, MPH, Social Science Analyst, Direct-to-Consumer Review Group, Research Team, DDMAC, OMP, CDER, FDA

VI. Other Influencers Relating to Advertising and Promotion
(Presidential Ballroom)

Moderator
Tammara M. Lewis, Director, Regulatory Affairs, Advertising and Promotional Labeling Group, Genzyme Corporation

A. Academic Medical Centers
Jann T. Balmer, PhD, RN, Associate Professor, Director of Continuing Medical Education, University of Virginia School of Medicine, and, President, Alliance for CME

B. Continuing Medical Education Providers
Lewis A. Miller, Principal, WentzMiller & Associates LLC

VII. Blue Skies and User Fees: What Should Change Legislatively?
(Presidential Ballroom)

Moderator
James N. Czaban, Partner, Wiley Rein LLP

Speakers
Diane E. Dorman, Vice President of Public Policy, National Organization for Rare Disorders (NORD)
Norman A. Drezin, RPh, JD, President, Drezin Consultants, LLC
Steven E. Irizarry, Senior Vice President, Capitol Hill Consulting Group

6:00 p.m.
Adjournment for the Day

6:00-7:00 p.m.
Networking Reception, and, Mingling with Using Social Media in FDA-Regulated Industries Authors (Congressional Room)

September 21

8:00 a.m.
Continental Breakfast (Congressional Room)

8:30-10:30 a.m.
VIII. Concurrent Breakout Sessions

Please report to your respective breakout meeting room by 8:30 a.m. Following the morning refreshment break, you will join your colleagues in the Presidential Ballroom.

Drugs/Biologics (Presidential Ballroom)

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

Panelists
Thomas Casola, Vice President, Regulatory Affairs, Advertising and Promotion, Shire Specialty Pharmaceuticals
Sue E. Duvall, Director, Global Regulatory and Safety, Amgen Inc.
Sheila K. Ryan, PharmD, Group Leader, Professional Review Group IV, DDMAC, OMP, CDER, FDA
Lisa L. Stockbridge, PhD, APLB, CBER, FDA

Medical Devices/Diagnostics (Federal B Room)

Moderator
Jennifer A. Henderson, JD, MPH, Attorney, Hogan Lovells LLP

Panelists
David E. Chadwick, PhD, Regulatory Scientist, Regulatory Affairs, Cook Group Incorporated
Terri T. Garvin, Regulatory Counsel, Office of Compliance, CDRH, FDA

Veterinary Medicine (Federal A Room)

Panelists
David P. Jones, Legal Director, Intervet/Schering-Plough Animal Health
Jeannie M. Perron, JD, DVM, Of Counsel, Covington & Burling LLP

Refreshment and Networking Break (Congressional Room)

10:45 a.m.
IX. First Amendment and Advertising and Promotion (Presidential Ballroom)

A. Tobacco – Implications for FDA's Other Centers?
B. Social Marketing and Media
C. Case Law; Other Developments and Assessments

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

Speakers
Ralph F. Hall, Distinguished Professor and Practitioner, University of Minnesota Law School
Mark S. Senak, Senior Vice President and Partner, Fleishman-Hillard, and, Editor, Eye on FDA blog
Jeffrey M. Senger, Partner, Food, Drug and Medical Device Regulatory and Enforcement Practices, Sidley Austin LLP

12 Noon-1:30 p.m.
Lunch with Speaker: How the Healthcare Reform Legislation Applies
to Advertising and Promotion (Congressional and Senate Rooms)

Speaker
Michael K. Loucks, Partner, Skadden, Arps, Slate, Meagher & Flom, former Acting U.S. Attorney, District of Massachusetts, U.S. Department of Justice

1:30 p.m.
X. Roles and Activities of Other Parties (Presidential Ballroom)

Moderator
Ladd A. Wiley, JD, Consultant, Akin Gump Strauss Hauer & Feld LLP

A. Federal Trade Commission
Karen Jagielski, Senior Attorney, Division of Advertising Practices, Federal Trade Commission

B. Veterans Affairs
Jonathan I. Gurland, Attorney, Office of the Chief Counsel, U.S. Department of Veterans Affairs
Louis E. Cobuzzi, RPh, MS, Associate Chief Consultant, Policy Development and Program Analysis, Pharmacy Benefits Management Services, Veterans Health Administration

C. The States
James G. Sheehan, Inspector General, Office of Medicaid, State of New York

Refreshment and Networking Break (Congressional Room)

XI. Updates from the Office of the Inspector General (OIG), U.S. Department of Health and Human Services, and the U.S. Department of Justice
(Presidential Ballroom)

A. Off Label Issues; Settlements
B. Corporate Integrity Agreements – New Provisions

Moderator
Daniel Meron, Partner, Latham & Watkins LLP

Speakers
Ann M. Ravel, Deputy Assistant Attorney General, Torts Branch and Office of Consumer Litigation, Civil Division, U.S. Department of Justice
Mary E. Riordan, Senior Counsel, Administrative & Civil Remedies Branch, Office of the Inspector General, U.S. Department of Health & Human Services

XII. Questions and Answers with FDA's Medical Products Centers Representatives
(Presidential Ballroom)

Moderator
Janet Lucy Rose, President, Lucy Rose Associates

Panelists
Thomas W. Abrams, RPh, MBA, DDMAC, CDER, FDA
Dorothy R. McAdams, VMD, OSC, CVM, FDA
Lisa L. Stockbridge, PhD, APLB, CBER, FDA
Deborah A. Wolf, JD, O ce of Compliance, CDRH, FDA

5:00 p.m.
Closing Remarks and Adjournment

Who Should Attend?

Attendance at this conference is appropriate for advanced and experienced regulatory, legal, public relations, marketing and management professionals working in or representing pharmaceutical, medical device, biological and veterinary medicine companies and organizations, as well as consultants in the areas of advertising, public relations, sales, legal and marketing communications.