Nov 13, 2009

FDA Social Meeting Day 2 Afternoon Takeaways

A decent part of the afternoon sounded more like sales pitches than anything else, which is a shame given we might not get this opportunity again for...another 10 years?

It's been a long 2 days, so we'll keep this one short and not only provide takeaways, but also a couple of great quotes.

Best quote of the day goes to Jamie Peck at Rosetta:
"The Plavix site has been hijacked through Sidewiki!"

Funny, but true. Unauthorized content, off-label comments, you name it..and FDA should send Google a warning letter!

Truest quote of the day goes to Hensley Evans:
"Today was more of a monologue than a dialogue"

Not funny, but true. Without a 'conversation' how will things ever change? Here's a thought...remove any redundancy, cut the presentations down by 75%, and spend 2 days generating conversations that form a catalyst for change.

Now for some interesting data.

Digitas Health
Performed research with 1,000 users testing various display ad formats for benefit and risk recall. Scoring was based on a 4 point scale (0= no recall, 4 = 100% recall).

  • 0.78/4 score for present-day ad format
  • 1.94/4 score for 50/50 split between benefit and risk
  • 1.94/4 score for 65/35 (benefit/risk), but higher consumer preference to this format
  • 2.03/4 and highest consumer preference through combined benefit+contextually-relevant risk
What the Digitas data indicates is that there can be a balance of risk and benefit that consumers actually prefer and respond to (better health literacy anyone?), however, fear of receiving a warning letter from FDA is causing companies not to engage in this form of advertising.

Cadient
It is estimated that 30 million Americans are health illiterate (no this is not a typo). Research has shown the education levels required to understand and comprehend the average ISI and PI:
  • ISI requires some college education
  • PI requires post-graduate level education
If FDA is truly interested in ensuring patients are receiving balanced and correct information, we need to radically simplify the language contained within the consumer versions of these two documents.

For additional summaries and takeaways, hit the previous blog posts. For more blow-by-blow commentary, hit the twitter feed
@roskadigital.

And special thanks to
Fabio Gratton for setting up the #FDASM site. Great job Fabio.

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