The Court reins in the FDA


The Supreme Court made news yesterday with its decision in Wyeth v. Levine, a case that brought up the possibility that if a drug (and its warning labels) had been approved by the FDA, that state-level court decisions couldn't alter them or open the door to lawsuits regarding them. This idea (pre-emption) is not unknown. It exists in some forms for medical devices, but the court thoroughly rejected the idea that it applies to prescription drugs. Stevens, Kennedy, Souter, Ginsberg, Breyer and Thomas (with an interesting concurrence) came down in the majority. Some take-away lessons from the decision are:

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. 

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Derek Lowe

Derek Lowe is a drug discovery chemist with 20 years of experience in the pharmaceutical industry, which is still very much his day job. He's worked on projects targeted at Alzheimer's, cancer, diabetes, infectious diseases, and other areas, but like most discovery scientists in the business, he has yet to produce a marketed drug. Explaining how and why this happens is what led to the launch of his blog, "In the Pipeline", in 2002, and the explaining continues. . .
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