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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 | ||
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