As most of you know, in a couple of weeks (November 12-13), the FDA is holding a public hearing on the use of social media by pharma and medical device companies (and others). Officially, the title of the hearing is: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001).

Catchy, right?

In any event, since this is a public hearing, people were allowed to request both a seat to attend the meeting and also to speak at the meeting. If you haven’t already applied for a spot, forget it, as the deadline has passed and all the seats are gone. Apparently, there were more than 800 requests for the 300 or so seats (John Mack has a nice recap of all this). We also knew that around 60 people would be speaking over the two days.

The meeting has been broken up into two parts. November 12 and the afternoon of November 13 will tackle the first four questions in the FDA’s announcement. The fifth question in the announcement deals with the handling of adverse events (AEs), which even the FDA recognizes as the major stumbling block for companies in dealing with social media. The morning of November 13 will deal exclusively with the AE question, so there is a great deal of attention being paid to it. Those requesting to speak (or who were invited) could request to speak on any of the questions. Those who wanted to cover question five and another question (and who were accepted as speakers) were given two speaking spots.

The speaking times have been limited to between 5-15 minutes, but it appears that most are around 10 minutes. How do I know all of this? I have the privilege of being one of the speakers and I will be one of the people who covers question five and another (question 3), so you’ll get to hear me twice. For those who can’t attend, the FDA has set up a webcast to watch it live.

So, you probably want to know who’s speaking. Here’s the list with a link at the end to download a PDF copy of the draft agenda. This agenda is subject to change (according to FDA) based on speaker confirmation and availability, but this is this first release of names and tentative times. I’ve removed the times from my list below, but they are included in the PDF at the end of the list. You’ll see a company name and then a person(s) representing the company here. Again, some names you’ll see twice because they are speaking twice and covering different issues.

November 12

Pew Prescription Project/The Pew Charitable Trusts-Alan Coukell

Coalition for Healthcare Communication-John Kamp

Eli Lilly and Company-Michele Sharp

AdvaMed Advertising and Promotion Working Group-Tony Blank

Center for Medicine in the Public Interest-Peter J. Pitts

Ogilvy 360 Digital Influence-Rohit Bhargava

PhRMA-Jeffrey K. Francer

Pharma Marketing News-John Mack

The Advertising Coalition-James H. Davidson

Arnold I. Friede & Associates-Arnold I. Friede

Integrated Media Solutions/The Sandino Group/Caleco Pharma Corp-James A. Sandino

Interactive Advertising Bureau-David G. Adams

National Research Center for Women & Families-Diana Zuckerman

VuMedi, Inc.-Robert Winder

WebMD-Wayne Gattinella

WEGO Health-Jack Barrette, Bob Brooks, and Marie Connelly

Consensus Interactive

Global Prairie Integrated Marketing-Alex Vandevere

sanofi-aventis-Craig M. Audet

Social Media Working Group-Mark Gaydos

Yahoo!-David Zinman

Waterfront Media Inc.-Ben Wolin

Johnson & Johnson Family of Companies-Philomena McArthur and Elizabeth Forminard

Manhattan Research-Mark Bard

Acsys Interactive-Stan Valencis

comScore-John Mangano

Envision Solutions, LLC-Fard Johnmar

MISI Company-Kathleen Fourte, Alejandra Diaz, and Jerilyn MacLaren-Hall

Compass Healthcare Communications-Peter Nalen and Maureen Miller

Euro RSCG Life 4D-Lawrence Mickelberg

McCann Healthcare Worldwide-W. John Reeves

Google-Mary Ann Belliveau and Amy Cowan

November 13

(morning session on AEs)

AdvaMed Advertising and Promotion Working Group-Tony Blank

Individual Consumer-Kim Witczak

Consumers Union-Steven Findlay

LehmanMillet-David A. Saggio

HealthCentral-Christopher M. Schroeder

Semantelli Corporation-Shaleen Gupta

PhRMA-Jeffrey K. Francer

Ogilvy 360 Digital Influence-Rohit Bhargava

The Advertising Coalition-James H. Davidson

Arnold I. Friede & Associates-Arnold I. Friede

GolinHarris-Rick Wion

Heartbeat Digital-Bill Drummy and MK Tantum

National Research Center for Women & Families-Diana Zuckerman

PatientsLikeMe-James Allen Heywood

Pharma Marketing News-John Mack

Sermo-Daniel Palestrant

TGaS Advisors-Donna Wray

VeoMed-Aaron Krinsky and Kay Metis

v-Fluence Interactive-Jay Byrne

WCI Consulting Ltd.-Tara M. Churik

WEGO Health-Jack Barrette, Bob Brooks, and Marie Connelly

Word of Mouth Marketing Association-John Bell and Melissa Davies

Bridge Worldwide/Dose of Digital-Jonathan Richman

Accelerated Medical Ventures-Zen Chu

(afternoon session, non-AE related questions)

Individual Consumer-Kim Witczak

Consumers Union-Steven Findlay

PatientsLikeMe-James Allen Heywood

Bulletin News/Custom Briefings-Paul Roellig

ORC Guideline, Inc.-Morris Whitcup

HealthCentral-Christopher M. Schroeder

LehmanMillet-David A. Saggio

Heartbeat Digital-Bill Drummy and MK Tantum

Semantelli Corporation-Shaleen Gupta

Sermo-Daniel Palestrant

TGaS Advisors-Donna Wray

VeoMed-Aaron Krinsky and Kay Metis

Bridge Worldwide/Dose of Digital-Jonathan Richman

Ignite Health-Fabio Gratton

imc2 health and wellness-Hensley Evans

RAPP-Robert Grammatica

Rosetta-Jamie Peck

W2 Group, Inc.-Larry Weber

Word of Mouth Marketing Association-John Bell and Melissa Davies

Digitas Health-Bruce Grant

Cadient Group-Jim Walker

Intouch Solutions-Wendy Blackburn

Pfizer-Freda C. Lewis-Hall and Clifford Thumma

Here is the PDF with the times: Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools Draft Agenda (617 downloads)

Remember, you can still submit your comments until February, so do it if you’ve got something to say. I’ll be sharing my slides for the meeting sometime next week (you get a sneak preview). Of course, I’ll be tweeting like crazy from the meeting and will do a full recap afterwards, but do tune into the webcast if you can.

Possibly related posts (auto-generated):

1. A Sneak Preview of My FDA Social Media Hearing Testimony
2. Patients WILL Have the Final Say on Pharma Social Media
3. Three Things I Learned at the FDA Social Media Hearings and Three I Wish I Had