Whoever is Commish, there are a series of positions on down that will be harder to change. My limited study of FDA - like other large organizations - suggests that there is only so much a Commish can do to impact the organizational culture as a whole. But whatever that leader does, it has to be clear, definitive, and deadly serious. “Shmoozing around” will get us nowhere.

Some have proposed Howard Dean as a follow up to Dr. Eschenbach’s charade. It will be interesting to see how quickly the FDA’s crooked culture can be turned around. And whether everyone there now in an appointed position gets off scott free.

The problem that Congress will have, should this cross-the-board preemption be upheld, has to do with the relationship between agency rule-making and Congressional oversight. Thus, even a very large majority in Congress against these directions would not have an easy time, as Ed’s summary suggests.

In my view, the most important first step of a President and Congress concerned with maintaining civil liability would be to replace the top management of every regulatory agency involved. This often happens with new administrations in any event.

I would then follow with hearings featuring representatives of those agencies, and some in industry, who have the experience and competence to describe what the realities of the regulatory process are.

Michigan has not been able to rescind its 1995 Drug Immunity Law that stripped citizens of their basic civil right of due process in claims against drug manufacturers, even though a 2007 House bill was passed to do so.

The FDA and civil liability carried on for many years with no problems with over alleged “conflicting standards.” In the drug arena, that is because it remains the exclusive province of FDA to change labeling, approve or withdraw a drug, etc..

There are rare instances - and Levine may be one - in which a state court directly challenges FDA’s determinations. In the vast majority of instances, however, the issue is not what FDA did or did not do. It is whether a company acted such that FDA _could_ do its regulatory job and that FDA _did_ review the relevant risk at issue.

So it’s not about conflicting standards. It is about actual regulation on one side, and the presence of absence of negligence - from mild to felonious - on the other.