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About FDA

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 1Group 2  Presentations Group 3
VOLUME II: RemarksGroup 4Presentations Group 5 

 

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