First if you think that the responsibility for labeling drugs rests finally with the FDA, think again. It's with the manufacturer. The FDA vets the language, and provides a "floor" to what the label has to say, but if a drug can later be found to have needed a stronger warning on it (for example), that's not the agency's problem.
Next, in the same manner, a state-level verdict can indeed find an existing drug label inadequate. Lawsuits at the state level are supposed to be part of the drug safety process - the FDA cannot be presumed to have done a perfect job of evaluating the risks and benefits of a given drug. If Congress had wanted to pre-empt this, it could have done so any time in the last 70 years. Legally, Congressional intent is key here, and the intent seems clear.
Now, you can argue that Congress is disproportionately full of lawyers, who aren't going to rush to restrict drug liability lawsuits, but the constitutional law response to that argument is: "Elect a different Congress, if you can, get them to pass a new law, and we'll talk". An agency recommendation with the force of law can override state requirements, but the FDA doesn't have it yet, no matter what it might at times assert. Congress hasn't given it the power.
To that point, the FDA, in the court's opinion, really went off the rails in a preamble to a 2006 regulation the agency issued on prescription drug labeling. That included statements that the agency can indeed pre-empt state law, that they provided not only a floor to such labeling language but a ceiling as well, and so on. Wyeth seems to have relied heavily on this preamble - "Hey, it's the FDA telling us these things" was the general tone - but the court has responded by slapping the FDA back down, which left Wyeth's case without much to stand on.
So this decision might look like a whack at the drug industry, but it's actually a case of a federal agency being told that its powers aren't as broad as it occasionally seems to think. You wouldn't necessarily guess it to see that way the justices lined up in this case, but the verdict looks like a real endorsement of federalism. And in the same way, you might not guess it, but the drug companies would probably like for the FDA to be that powerful, actually - that way, some of the responsibility could be offloaded, and there would be a single place to go for regulatory clarity. (Or a single place to go to exert influence, if you want to look at it that way). But that's not going to happen.
This article available online at: