Tomorrow, the FDA is holding a hearing on transparency here in Washington, D.C and have issued their ground rules for participation. The event is certainly a noble gesture and one does not have reason to expect that this time around, FDA is anything less than serious about the effort. The FDA Transparency Blog has also opened up to take questions. I have to admit, I have been so consumed with work and the blog that I haven't had time to enter a question to the Blog about transparency.
But as you may guess, my question would focus on why FDA's DDMAC issued untitled letters against 14 companies, about 45 brands, but (i) did not signal ahead of time any regulatory parameters for the action taken; (ii) has steadfastly refused to issue such parameters about emerging media; and (iii) refuses to discuss the matter and open the agency up to reasonable questions about same?
The Internet has evolved considerably. Why won't the FDA?
So that would be my question. Sadly, I won't be there. But I hope others ask something along these lines of reasonable question.
Good luck FDA and all who attend.