Nov 12, 2009
FDA Social Meeting Day 1 Early PM Summary
The resounding theme today is "transparency." Pharma and agencies alike are proposing and preaching it, now will industry uphold its own recommendations? And, if most do, will the select few renegades spoil all of the effort and ideas to date. THAT is left to be seen.
If you've been over on the twitter feed today you've seen a lot of repetition of the same points. So, for the blog, I'll try and focus on new items and information that gets everyone thinking about new possibilities (or obstacles we may have to overcome).
Change in format for this one...quick hit bullets...
Sanofi Aventis
- Suggests company owned or sponsored websites should have clear terms and check boxes that users MUST check to confirm they understand what they can and cannot do
- Terms MUST advise that UGC and discussion is for branded indication only and off-label comments/discussion will be removed
- Suggests that site alerts be placed with links so users can appropriately report AEs or problems
Yahoo!
- Primarily a sales pitch (sorry Yahoo! but it's true)
- Lobbied that rich media, with ISI scrolls satisfy present criteria (which I agree with)
- Presently testing clickable logos and video embedded into paid search results
FDA Question: Are you testing technology feasibility? Or consumer learning?
Answer: Yahoo! is testing user "interaction". (Face it. They sell ads. But now they will have the data to project learning based on clicks).
Johnson & Johnson
- Great presentation
- Social media communicates/connects people where and when they are
- Responsibility differs based on who is talking, what they are saying, and where they are posting
- Companies are not responsible for the entire Internet (love that!)
- Also not responsible for content superimposed over their content without permission
- Digital media is here to stay. We want to engage online responsibly
FDA Question: How do you suggest companies ensure the immediacy of the Internet does not adversely affect the consumer's ability to easily access the PI and safety information? And, What can FDA do to encourage consumer behavior (Hello? We'd all kill to get asked part 2 to this question).
Answer: Use scrolling ISI and 1-click rule to link to the PI and safety information. And for part two, FDA should keep doing what its doing. Hold more hearings and meetings.
I don't know about you, but part 2 of FDA's question to J&J was the perfect opportunity to ACTUALLY provide guidance and tell FDA what they can do to help us. This was a missed golden opportunity.
J&J put so many excellent stakes in the ground in their presentation...all the things we want to say, but shiver at actually saying them at the hearing...only to end on a whimper. Sorry, but it's true.
Headed back downstairs for the last session of the day.
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