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May 9, 2007
A New FDA?
You'd think that I'd have more to say on the new bill giving the FDA a broader drug safety mandate. It's certainly all over the news as I write. But this seems (to me, anyway) to be a change in degree more than anything else. Congress is asking the agency to do what it does - monitor drug safety, change label wordings if necessary, etc. - but to do more of it. I don't have a problem with that, because this sort of thing will be all the execution, and we don't know how that's going to go yet.
And the other reason I'm not as revved-up as I could be about this is that I know that the raw material for everything the FDA does isn't changing a bit. By that I mean all the drugs that get sent in for approval, as well as the ones already on the market. Altering the way that data is collected isn't going to change the underlying data. I don't see how the pharmacopeia is going to be much safer (or much more dangerous) compared to how it is today. Perhaps some safety decisions will be made more quickly, but it's also possible that a flood of new information might obscure some things in the noise.
We know just as much about toxicology as we did yesterday - a lot, from one perspective, but not nearly enough, from another. People who believe that this regulatory change are more likely to believe that we know a lot about side effects and toxicity, and that if we just pay more attention we'll improve the situation greatly. But this isn't a view that I can endorse. As far as I can see, regulatory oversight isn't the limiting reagent here. It's knowledge, and that comes on slowly and in defiance of every lawmaker that ever was.
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