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Brooks Schuelke
Brooks Schuelke
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Is The FDA Even Opposed To Complete Immunity Preemption?

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Regular readers know that we’ve been looking at complete immunity preemption issues this month. In looking at these preemption issues, we’ve already seen how doctors are opposed to FDA preemption of drug litigation. But now it appears that even the FDA may be opposed to preemption.

Yesterday, a congressional report on preemption was released, and included among report were several memos from senior FDA officials who opposed preemption. John Jenkins, the top official in the FDA drug approval sections, wrote about preemption in 2003:

Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis.

Regular readers will recognize that this is one of my (many) complaints against preemption. I have argued here and here that regulators aren’t nimble enough to provide up-to-date protections for consumers.

The report that included the preemption memos concludes:

FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, the internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. This is a serious abuse of the agency’s publich health authorities.

One other story notes that the memos were forwarded to the FDA’s chief counsel, who is now the general counsel for pharmaceutical giant Glaxo-Smith-Kline. That type of close relationship between the regulating body and the industry being regulated, which is all too common, should give us all pause.