Wednesday, September 29, 2010

The FDA, Transparency, and Reality

As we have stated in this blog many times, transparency, as in nearly all matters, can be a good thing.

So by all means -- a 21-gun salute for the FDA’s 21 proposals that allow the public a better view at what transpires between the agency and industry, including summary safety and efficacy data from pre-approval and marketing applications.

Why the touch of tone? Because what the FDA wants to do will cost money and eat up valuable time. And skeptics might ask: Will these new rules really improve the public's health?

We actually think so! But, industry insiders may not be looking at it that way. In our view, transparency will uncover those issues in which the agency and industry have differences -- now, those problems will get thrashed out, but usually during the time compressed approval process, when conflict avoidance is the word of the day and if conflict occurs is usually not a positive outcome.

We all know consensus is not reached without significant debate -- and that typically does not happen quickly. Why does industry panic?  Is it because these business constraints seem to happen only at critical moments in their business cycle?  It seems like the age old going to the gym argument. Maybe if we went to the gym and worked out before we needed to desperately do it, maybe the change would not be so hard. 

Because we live in a sound-bite world, a full explanation of these problems will rarely be published, digested, and carefully considered, and most likely will be misconstrued. Does this help improve public health? Not likely, because again the presumption is that medicines are generally safe and people may not care until after the fact. 

No man-made system works perfectly – who isn’t shocked when something goes off without a hitch?

While it seems like each party should fight for its point of view, people just want their various afflictions solved.

We just think this transparency issue needs to be moved forward. These 21 proposals are not perfect, but they do begin that process. Please engage in discussing the solutions.  

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