It’s not about the future of my opinions. It’s about the future of us all.

The most important next case, Levine, is scheduled to be argued in October, and probably decided a few months after that. That’s drugs.

The Kent case, which will be argued next week, has been much misreported because it involves a rather arcane aspect of our Michigan law. It is not about preemption in general, but preempting whether state courts can find fraud on FDA. This would impact punitive damages in other states (like one of the NJ Vioxx decisions).

I was rather suprised that the verdict was 8-1. I expected a 4-5 split one way or the other. That doesn’t seem to bode well for your opinions in the upcoming cases. When are they supposed to hear them?

For those of us who believe preemption is disastrous policy, it is good to hear that Kennedy and Waxman intend to respond in the legislature. Still, everyone knew this was coming. Why didn’t they act earlier?

The FDAAA provided an explicit opportunity to do so: that is, to state Congressional intent re: preemption. The relevant sentence was, in fact, removed. If Kennedy and Waxman believe what they say, they will not wait for the Court to drop its next bomb, as it assuredly will.

I also believe it is, indeed, asking too much. 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. Further, the very people who have pushed for preemption are precisely those who have worked to weaken the FDA before they captured it during the present administration. All their rhetoric to the contrary, it would be foolish to think their essential goals have changed. And those goals are not, centrally, about the public good or the public health.

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.

That is one reason I have been arguing for several years that preemption has never been in industry’s own 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, in our hearts, we know to be true: 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, many of you, have told me.

However, this statement implies that the alternative is a “low regulation, high litigation” environment. However, we all know that isn’t take case. The current status of the system is “high regulation, high litigation”. One or the other should be lowered. I’d prefer that regulations be lowered, but litigation being lowered is a close second….