Post on 14-Dec-2014
description
Three Things I Learned at the FDA Hearings and Three I Wish I Had
Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital@jonmrich
Yes, I was there...
...along with 60+ of my close friends
Two themes
What I learned What I didn’t(but wish I had)
What I learned
The FDA gets itMedWatch is deadConsumers might actually want us there
(a serious AE, BTW)
What I didn’t
FDA’s plan for keeping upThe end of red herringsWhat pharma REALLY wants to do
What I learned
The FDA gets itMedWatch is deadConsumers might actually want us there
The FDA gets it
The FDA gets it
“Since the 1996 public meeting, there has been a massive expansion of new tools and technologies, such as blogs, microblogs, podcasts, social network sites (‘social networks’) and online communities, video sharing, widgets, and wikis...”
The FDA gets it
1. For what online communications is pharma accountable?
2. How can pharma follow the rules in using tools with space limitations and real-time comms?
3. What rules apply to the posting of corrective info on websites controlled by third parties?
4. When is the use of links appropriate? 5. Questions specific to Internet adverse event
reporting
MedWatch is dead
MedWatch is dead
Courtesy of Ignite Health
MedWatch is dead
Consumers might actually want us there
AGREE that healthcare companies’ use of social media...
...provides important updates on products and services – 79%
...brings accurate information into conversations about drugs or devices – 73%
...addresses frequently asked questions about products and services – 66%
...adds valuable professional expertise to the conversation – 62%
Good News
Consumers might actually want us there
If I double the dose, would the blisters go away faster?If I double the dose, would the blisters go away faster?
Double your dose and see what happens, but I wouldn’t hold my breath.Double your dose and see what happens, but I wouldn’t hold my breath.
Consumers might actually want us there
AGREE healthcare companies... ...should monitor and correct misperceptions or
misinformation when that info can be harmful – 90% ...should be responsible for policing any unauthorized
versions of their content – 64%
Bad News
Consumers might actually want us there
In short...
To whom much is given, much is expected.
What I didn’t
FDA’s plan for keeping upThe end of the red herringsWhat pharma REALLY wants to do
FDA’s plan for keeping up
FDA’s plan for keeping up
FDA’s plan for keeping up
FDA’s plan for keeping up
FDA’s plan for keeping up
19962022
2009
FDA Technology-RelatedHearings Schedule
FDA’s plan for keeping up
19962022
2009
FDA Technology-RelatedHearings Schedule
The end of red herrings
Only 1 in 500 posts qualifies as a “reportable adverse event”
The end of red herrings
Source: Nielsen BuzzMetrics, Personal Communications
Nielsen BuzzMetrics total Healthcare discussions (~1,350 sites):
82,697 per day
Percentage of posts with a reportable adverse event:
0.2%
Number of reportable adverse events for the ENTIRE INDUSTRY:
166 per day
The end of red herrings
Adverse event reportingOff label discussionsPersonal identifying informationMonitoring volume and resourcesFTC regulationsTechnology integrationNo clear precedentsLack of internal expertise
The end of red herrings
What pharma REALLY wants to do
?
What pharma really wants to do
?
?
What pharma really wants to do
What pharma really wants to do
?
What pharma really wants to do
?
What pharma really wants to do
1. For what online communications is pharma accountable?
2. How can pharma follow the rules in using tools with space limitations and real-time comms?
3. What rules apply to the posting of corrective info on websites controlled by third parties?
4. When is the use of links appropriate? 5. Questions specific to Internet adverse event
reporting
What pharma really wants to do
Does allowing additional leeway for pharma to participate in social media improve or harm public health?
Three Things I Learned at the FDA Hearings and Three I Wish I Had
Contact Me
Text Healthcare to 50500
Jonathan Richman513.253.1295j.richman@bridgeworldwide.comTwitter: @jonmrichThis presentation: http://bit.ly/dodfda
http://www.doseofdigital.com http://www.bridgeworldwide.com
Contact Me