Preemption, at core, is not about whether the FDA sets “optimal” guidelines. It is about whether they had the information that would have enabled them to do so. And, if not, what can be done, and by whom?

This statement should be true, but the recent lack of disclosure to the FDA of known risks of certain drugs makes this a moot point.

Until the FDA sets in place a system of obtaining and evaluating ALL the information that a drug company has about a drug, then they cannot be considered the final word on a drugs safety.

We are far from that situation.

I thought they did a great job of distilling the debate down to two sentences: “Do the F.D.A. and other federal regulators set minimum safety standards that states are free to augment? Or do they make judgments about the optimal balance between risks and benefits that states must follow?”

Obviously I lean towards the latter. They also quoted the dissenting opinion from the Vermont supream court. Again, an interesting statement that I agree with: “No drug is without risks. The F.D.A. balances the risks of a drug against its benefits to maximize the availability of beneficial treatments. A jury does not engage in a measured and multifaceted policy analysis. Rather, a jury views the safety of the drug through the lens of a single patient who has already been catastrophically injured.”

Re: the FDA, if the situation is as bad as some posters have recently described, they are grim indeed. But compensating Diana Levine is not the answer to cleaning house there either. That said, Salmon makes interesting points re: citizens’ petitions, etc.. If one followed Catherine Sharkey’s viewpoint, FDA would have to show (to a judge) - and not simply assert - that it reviewed whatever relevant risk in an appropriate way in order for preemption to kick in.

Sidelight - the one place the reply brief veers off point is a footnote in which NEJM’s analysis of the fen-phen (Wyeth’s Pondimin/Redux) case is rejected.

I agree that this was really no one’s fault. But sometimes sh*t happens in life and we learn to deal with the hand that life gives us — even if we don’t like it. Bad things happen all the time that aren’t really anyone’s fault. Do they get compensated?