Supreme Court on the FDA

NPR lays out the upcoming docket for the Supreme Court. There’s a theme in the cases highlighted: the executive branch should be able to do whatever it wants. Let’s look at the FDA case as an example.

You can’t sell a drug in the US unless you get federal approval from the FDA. I and others have pointed out many times that the process is arbitrary and harmful, especially since consumers are led to believe that FDA-approved drugs are de facto safe. On this point, I have to agree with Wyeth Pharmaceuticals’ lawyers: that the FDA approves the drug and the label, it is implied that the drug manufacturer is immune from wrongdoing.The bureaucrats at the FDA who do the approving have no stake in the outcome. They are not personally liable for mistakes or incompetence. The drug companies have, in the past, assumed all of the risk in addition to the burden of maneuvering through the FDA drug approval process.

But, unfortunately, the fate of the FDA is not at stake in this court case. Rather, it is the fate of the 10th Amendment, since the lawyers are really arguing for pre-emption:

The shield that drug companies argue protects them from suit is a legal doctrine called pre-emption — meaning that Congress can write laws that give the federal government the exclusive right to regulate in an area, barring states from getting into the act.

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9:24 am on October 6, 2008