All four podcasts can be downloaded here: http://downloads.pharmalive.com/
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All four podcasts can be downloaded here: http://downloads.pharmalive.com/
All four podcasts can be downloaded here: http://downloads.pharmalive.com/
The first is on the defeated but still looming ad tax bill. The second is an overview and analysis of the "New FDA".
You can download them here: http://downloads.pharmalive.com/
Med Ad News plans to present three more podcasts in this series.
For background information, read:
Fabio Gratton's Ignite Blog
Mark Marmur's December 10th Presentation - Update on the FDA's Social Media Hearings
Marmur-FDASMUpdate_Dec10_09.pdf
and visit the Coalition's Overview page
If you want to join this Working Group, click here. You'll receive email updates and announcements of future meetings.
Coalition Message on Social Media Hearings
By John Kamp, Executive Director
Analysis of the issues
Paper on FDA Public Hearing on the Internet and Social Media
By Peter Pitts, Center for Medicine in the Public Interest
Documentation, timeline, analysis
Highlights of FDA Public Hearing on the Internet and Social Media
By Mark Marmur, Markovsky + Company
Summary of each item of testimony for both days
Click to view.
Comments are invited.
"Adverse event generation is the real bĂȘte noire of social media.
"Should companies actively avoid participation - even to the degree of monitoring - lest they uncover an adverse experience? Shouldn't companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn't companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it's not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don't want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn't look good on Page One or sound very good in front of a congressional subcommittee. "In compliance" and "in the best interest of the public health" must not be mutually exclusive propositions."
Read the rest of Friday's summary on DrugWonks.com. We want to hear your comments here.
In his Drug Wonks blog Peter Pitts, founder of the Center for Medicine in the Public Interest (CMPI) comments on all the testimony of the first day of the FDA's Part 15 Hearing on Social Media.
About John Kamp's testimony on behalf of the Coalition and the 4As, he wrote:
He also commented in a positive way on presentations by representatives of EURO RSG, McCann, and Google.
To view the entire Drug Wonk blog post, visit www.drugwonks.com.
We will post more information, links and summaries on Monday. Meanwhile, we welcome your comments.
At the November 12th FDA Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, John Kamp, the Coalition's Executive Director, will present testimony on behalf of the Coalition and the American Association of Advertising Agencies. The testimony offers FDA a regulatory pathway to advance the public health by enabling robust marketing by regulated companies and at the same time coordinating effective enforcement against health fraud on the Internet. The Coalition/AAAA presentation will be delivered early on the first day of the hearing and lay the groundwork for testimony by other industry leaders.
View the slide presentation: CHC_FDA_SM_Forum_Nov09.pdf
We invite your comments!




