The DDL guys (understandably given their clients) blame the “plaintiffs’ lobby” for this legislation. However, precisely this remedy was suggested in the January editorial in NEJM which was as strong a condemnation of FDA preemption as you’ll find. I don’t think the NEJM editorial board view themselves as spokespeople for the trial lawyers!

Second, the same language as the Pallone bill was inserted - and then removed, in compromise - in last year’s FDAAA bill. So it is not at all clear whether a further amendment to the FDCA would not impact preemption in the drug, as in the device, arena. Almost certainly, we will see that debate in the future.

Finally, I say again, that no jury decision has _ever_ “trumped” - or was intended to “trump” - FDA regulation. All decisions about warnings, labels, withdrawal or not are solely within the purview of FDA, and always have been.

What juries decide is whether - given what they knew, when they knew it, what they did - companies ought to be held liable. Not all potentially relevant delinquencies are within the purview of FDA oversight, and some may have occurred entirely outside FDA’s knowledge. Either way, no jury has ever withdrawn a drug or changed a label. (On the other hand, FDA has sometimes done either one _because_ litigation uncovered new facts that the agency had not known).

Once again, then, that’s why FDA itself has alwaysw argued that - in this world of imperfect folks and institutions - having both systems of consumer protection is better than either one alone. The “only FDA” argument (preemption) is a creature of the Bush FDA.