Speaking of the Reigel case, which is actually less definitive than Levine and concerns device preemption rather than drugs, NEJM concludes that the case has “major, even momentous, implications for health care” and that the decision “will be critical for patients’ rights and have enormous impact on manufacters’ responsibilities and the safety of medical devices.” (NEJM 358:1, p. 77)

As posted in an earlier thread (I’ll find it if need be), the FDCA regulations are unambiguous that, if a company finds reason to strengthen a warning, they are not only free to do so, they are _obliged_ to do so. And they do not need to wait for FDA approval to take that action.

The FDA’s recent announcement that it wants to change the rule on that - and make it harder for companies to make such changes - is obviously the foyer into preemption. Otherwise, the doctrine is without ethical or logical foundation, however finely spun and suitably arcane are the arguments are the arguments preemptors invent.

As also noted earlier, changing a warning is _not_ equivalent to changing a label. There have been numerous cases in which companies have opted to strengthen a warning - say, via a “Dear Healthcare provider” message - with no expectation that the label would change. The relevant adverse was often already on the label. The point was to underline its significance more forcefully. People of integrity within the industry - and there are many more such than not - have often pushed for exactly such an additional warning, and pushed to be as certain as possible that physicians and the public got the word.

Thus, the preemptors’ recurring argument that “only the FDA can change the label” is irrelevant. It is one more red rerring of the kind you learn to fish for in law school. (Since I never attended law school, I’ve had to learn that through reading and listening to those who have. That’s an education in itself.)

But the really important point is this. FDA preemption presents us with what I believe is the most serious public health crisis we face. Imagine a drug safety issue that dwarfs Vioxx in size (say, a problem involving the statins), which the FDA does not catch for the hundred reasons they don’t catch such things (passive-aggressive compliance, company camoflage, delayed reporting, suppressed internal studies, intimidating researchers etc., etc., etc.), all in the context of no civil liability - and thus no genuine accountability - whatsoever. How will we all respond then?

Far beyond those who are washed away when the levees break are what remains of public trust in the FDA and the industry itself. That trust is already fragile enough; this would destroy it.

In the long run, which may not be far away, FDA preemption will take down botht the FDA and the industry. In the meantime, preemption is a Direct-to-Consumer Advertisement that says: “WE NEED THIS SHIELD BECAUSE WE SIMPLY CANNOT BE TRUSTED.”

The time wil come when their lawyer pals will not look like their pals anymore.