Thursday, February 21, 2008

A Riegel View From a Nonlawyer?

Some serious gloating (and teeth gnashing) going on all over the net today as a result of Reigel. At a blog discussing drugs and devices, there is commentary on blog posts today.

You can find a good roundup of posts on the New York Personal Injury Law Blog.

Back to the device blog -- taking one set of comments at face value, this poster (with a reference to the Pharmalot blog) writes:

"Everything we have learned about industry, FDA, and their relationship over the past decade (and much longer) tells us that they will not step up to the plate. On the FDA side, they simply do not have the means to do the kind of job you describe.

I believe it a certainty, therefore, that disaster will occur, and it will be on a scale much larger and more devastating than anything we have seen because most of it will happen in the dark. When the levee breaks, it will entail more than burying the bodies and hoping for a Congressional fix. Trust in the FDA and the industry will be shattered for a very, very long time. And that itself will result in both economic and public health disaster. We will have a lot of dead people. And a lot of dead companies. So I agree - the situation will be profoundly worse for the industry, and all of us, than it is now.

That is one reason I have been arguing for several years that preemption has never been in industry’s interest. Entirely, the opposite. And the disapproval rates one sees now will be looked back upon as very good days compared to what is to come.

I am sorry to be so negative. Trust me, this is not a political statement. And it is precisely the opposite of anti-industry. It is looking a policy in the face - the policy of preemption - and simply saying what cannot be blinked away: it is logically, practically, and ethically bankrupt. It is a preemptive strike that will cost more, in both lives and treasure, than the preemptive strike on Iraq. It is an avoidable disaster (in the drug arena), but one that will almost certainly not be avoided.

And, sad to say, those who are on the inside of the industry know this best of all. And many of them have told me this, just as I am sure, in one way or another, they have told you. "

Source here.

I'd like to welcome back to reality anyone who rationally thinks that the FDA is doing a good job now.