Each speaker has 10 minutes, but some -- like myself -- were given two 10-minute slots. As you may know, I will present results from the survey I have been hosting (see here). Why some of us got two slots, I don't know. I plan to address several questions put forward by the FDA and requested 15-20 minutes (see my proposal (pdf) here). I thought they would say 10 minutes and that's all you get! Instead, FDA gave me two 10-minute time slots. Nice of them.
Fabio Gratton (@skypen) of Ignite Health, a marketing communications agency, sent me a spreadsheet that listed all the 55 unique presenters and characterized the services offered by each presenter's organization. I simplified Fabio's schema into the following 7 categories (the number in parentheses represents the number of speakers in each category):
- Search Engine (2)
- Trade Media (2)
- Pharma Company (4)
- Consumer Advocate (5)
- Industry Advocate (6)
- Health Website (8)
- Industry Service Provider (28)
[NOTE: a few "Health Websites" may also represent the consumer and/or patient point of view. These include PatientsLikeMe and WEGO. Putting those two sites into the "Consumer Advocate" bin would increase the consumer slice of the pie to 13% vs. 9%.]
This distribution of speakers may be typical of FDA public hearings. After all, the FDA is not paying for speakers' expenses. Money talks because nobody walks to these things. Unfortunately, that means that consumers are under-represented.
Consumers, however, can submit written comments to the docket (see here). I have yet to see ANY submitted comments and I don't know if this is because there are none, or the FDA is keeping comments hidden from public view even though they promised otherwise. It would be a travesty if consumers do not have a voice in this process.
I think the preparations for this hearing have been pretty disorganized and hasty. It appears that not much planning has gone into it and I'm afraid that the whole experience will be anti-climatic. A series of 10-minute presentations one after another without dialogue seems quite numbing and UNEDUCATIONAL. FDA may be doing this more out of formality than necessity. Reading between those lines leads me to believe that FDA already has some draft guidelines on the drawing board and really doesn't need any public input.