Nov 12, 2009
Day 1 of the hearings is over and I think we are hearing loud and clear the position from pharma, the industry, and the agencies.
But what about FDA?
FDA has asked a few good questions, but not explored any in detail. In my opinion, I believe this is because the presenters did not have the data at their fingertips to further the conversation.
Remember, FDA is science and data driven. Period.
I encourage all presenters who FDA probed to follow up with additional data to do so before the 30-day cut-off. This is our chance to really USE this meeting for the benefit of patients, caregivers, HCPs and really open up new opportunities for how health care is provided in the US. After all, isn't this a major charter of Obama and the White House?
Ideas shared in the last few presentations.
Everything from framework layouts and wireframes (we all got it, but FDA seemed to start to nod off) to more data and reinforcement of the 1-click rule seemed to dominate the late afternoon.
A few different key points from 2 presentations did stand out:
- The recent FDA warning letters actually are confusing consumers (evidenced by decreased CTR and bounce rates) I talked about this a little in a past blog.
- These same warning letters create less transparency (opposite of intended effect).
- Watch the trends and stay current FDA. It's our best chance at improving health care and patient literacy.
- Provide regular guidance (not every 10 years)
- Define social media guidelines now. Get us started...just like you did with print and TV.
- Allow sites to pull content from FDA's own website (what more credible content can you get than that?)
And with that...Day 1 has come to a conclusion. Rather than boil the ocean and be repetitive, Day 2 summaries will focus on new information and we'll leave the repetition to the transcripts.
See you in the morning.