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Transcript of Internet Public Meeting: Advertising and Promotion of Medical Products, October 16-17, 1996, Silver Spring, MD.

  

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

FDA AND THE INTERNET

ADVERTISING AND PROMOTION OF MEDICAL PRODUCTS

October 16-17, 1996

Quality Hotel
8727 Colesville Road
Silver Spring, Maryland 20910


 

Wednesday, October 16, 1996
8:35 a.m.
Volume I


C O N T E N T S

Opening Remarks: William B. Schultz
World Wide Web 101: Sandy Desautels

DISCUSSION GROUP 1

Investigational Use and "In the Pipeline"

Moderator: Wayne Pines

 

DISCUSSANTS

Wendy Borow, Com-Med Interactive--Medicus New Media
Larry Carrier, Telectronics Pacing Systems
Louis Castelli, Rittenhouse Communications
Mario Cavallini, Slack, Inc.
Becky Cleavenger, AMGEN
Sandra Eskin, AARP
Renardo Hicks, Deputy Attorney General, Pennsylvania
Priya Jambhekar, Ohmeda Pharmaceutical Products
Janis Kelly, Medical Journalist
Kiyoshi Kuromiya, Critical Path AIDS Project
Thomas Merchant, SmithKline Beecham
Peter Reichertz, Arent, Fox
Al Rusch, Securities Exchange Commission
Patricia Shrader, Becton Dickinson Microbiology Systems
David Vance, Glaxo Wellcome, Inc.
Pam Weagraff, Hewlett Packard
Robert Whitaker, Center Watch
Tom Willer, Abbott Labs
Sidney Wolfe, Public Citizen Health Research Group
  FDA
Ilisa Bernstein, Pharm.D., J.D.
Jerome A. Donlon, M.D., Ph.D.
William C. Keller, D.V.M.
Melissa M. Moncavage, M.P.H.
Louis A. Morris, Ph.D.
William B. Schultz, Esq.
Toni M. Stifano
Byron Tart
Robert Temple, M.D.


DISCUSSION GROUP 2

Chat Rooms and News groups

Moderator: Linda Golodner

 

DISCUSSANTS

Wendy Borow, Com-Med Interactive--Medicus New Media
Mark Boulding, Fox, Bennett and Turner
Loren Buhle, SmithKline Beecham
James Burke, Frontier Media Group
Janet Carlson, J. Carlson & Associates
Sandra Eskin, AARP
Larry Ganslaw, American College of Cardiology
Carol Gillespie, Liposome Co.
Neil Gray, Medical Forum, Inc.
Mark Grebenau, Sandoz
Sandy Kline, Fujisawa Medical Information
John Lee, Unimed Pharmaceuticals
Lawrence Liberti, Pharmaceutical Information Associates
William McClymont, HTN, Inc.
Michael Pozsgai, Eli Lilly
Larry Sasich, Public Citizen Health Research Group John Scheffel, Physicians Online
John Shannon, Glaxo Wellcome
Sara Stein, Stanford Department of Psychiatry
   FDA
Ilisa Bernstein, Pharm.D., J.D.
Cathy E. Conn
Jerome A. Donlon, M.D., Ph.D.
Melissa M. Moncavage, M.P.H.
Nancy M. Ostrove, Ph.D.
William B. Schultz, Esq.
Edward L. Spenser, M.S., D.V.M.
Deborah Wolf


Presentations

Lee Peeler, Esq.
Renardo Hicks, Esq.

 

 

DISCUSSION GROUP 3

General Regulatory Issues

Moderator: Dan McKillen

 

DISCUSSANTS

Michael Altmann, Medical Forum, Inc.
Mark Boulding, Fox, Bennett and Turner
Thomas Chen, Genetics Institute
Jim Czaban, Venable, Baetijer
Allen Douma, Health Response Ability System
Tim Fallon, MedScape, Inc.
Elizabeth Toni Guarino, Drinker, Biddle & Reath
Renardo Hicks, Deputy Attorney General. Pennsylvania
Janis Kelly, Medical Journalist
Michael Manzagol, New Millennium Interactive
Thomas Merchant, SmithKline Beecham
Phil McKee, National Consumers League
Dan Mjolsness, American Medical Association
Lee Peeler, FTC
Michael Scott, CoMed Communications
David Vance, Glaxo Wellcome
Mary Wallace, American Society of Health System Pharmacists
Steven Zatz, Physicians Online
Edward Zimney, Immunex Corporation
Bruce Grant, Frontier Media
   FDA
Minnie Baylor-Henry, R.Ph, J.D.
Cathy E. Conn
Rebecca Devine, Ph.D.
Roma J. Egli
William C. Keller, D.V.M.
William B. Schulz, Esq.
Byron Tart
Donald J. Vasbinder
Judy D. Wilkenfeld, Esq.
Ann H. Wion, Esq.

 


 

Thursday, October 17, 1996

8:30 a.m.

Volume II


 

C O N T E N T S

Remarks: Stuart Nightingale, M.D.

 

DISCUSSION GROUP 4

Website Links

Moderator: George Lundberg, M.D.

 

DISCUSSANTS

Tom Buford, Intermedics Orthopedics, Inc.

Jack Calfee, American Enterprise Institute
Dave Vance, Glaxo Wellcome, Inc.
Becky Cleavenger, AMGEN
Mark Deitch, Bioscience Communications
Craig Douglas, Frontier Media Group
Allen Douma, Health Response Ability
Edward Fotsch, Net Source Communications
Lawrence Ganslaw, American College of Cardiology
Linda Golodner, National Consumer League
Mark Grebenau, Sandoz
Susan Hamet, Knoll Pharmaceutical
Tom Jones, Family Internet
Kiyoshi Kuromiya, Critical Path AIDS Project
Karen Lancaster, PR Newswire
Paul Leuhr, Federal Trade Commission
John Mack, VirSci Corp
Jamie Marks, Body Health Resources Corporation
Matthew Naythons, NetHealth
Sara Stein, Stanford Department of Psychiatry
 
   FDA
Ilisa Bernstein, Pharm.D., J.D.
Melissa M. Moncavage, M.P.H.
Patrick O'Brien, Pharm.D., J.D.
William V. Purvis
Edward L. Spenser, M.S., D.V.M.
Robert Temple, M.D.
Deborah Wolf

 

Presentations

J. Idanpaan-Heikkila, M.D.
Cedric Allenou
Manuel Montenegro
Bob Treherne
Heather Simmonds

        

DISCUSSION GROUP 5

International Issues

Moderator: J. Idanpaan-Heikkila, M.D.

 

DISCUSSANTS

Cedric Allenou, Embassy of France
Jeffrey Blander, SSI Health Systems
Jack Calfee, American Enterprise Institute
Michael Evers, National Health Care
Lawrence Ganslaw, American College of Cardiology
Elizabeth Toni Guarino, Drinker, Biddle & Reath
Robert Klepinski, Medtronic, Inc.
Douglas McCormick, SmithKline Beecham
John Rothschild, Federal Trade Commission
Heather Simmonds, Prescription Medical Code of Practice Authority
Henk Van Der Berg, Net Result/Eurotransplant**?
   FDA
Minnie Baylor-Henry, R. Ph., J.D.
Ilisa Bernstein, Pharm.D., J.D.
Rebecca Devine, Ph.D.
Roma J. Egli
William C. Keller, D.V.M.
Melissa M. Moncavage, M.P.H.
Stuart L. Nightingale, M.D.
Toni M. Stifano
Byron Tart

 


Contents
VOLUME I: Remarks   WWW 101   Group 1 Group 2   Presentations  Group 3
VOLUME II: Remarks Group 4 Presentations  Group 5