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Our Buddies at the FDA

Another question I’ve had posed to me is whether the FDA standards for drug approval are too tight (no one who writes to me seems to worry that they might be too loose, although you can find groups who’d argue just that.)

Overall, I don’t think so. There are really two sets of standards, for safety and for efficacy, and neither are really set in stone. From drug to drug and disease to disease, things can slide around – which is how it should be. Safety is an open-ended problem that has to be addressed by closed-ended regulatory solutions, and as time goes one, the bar is raised. We know a lot more that we used to about, say, QT-interval prolongation as a cardiac side effect, and that means that we have to test for it instead of crossing our fingers. If this weren’t getting harder, neither the drug companies nor the FDA would be doing their jobs.

As for efficacy, I see the suggestion every so often that this requirement be done away with. I’m firmly opposed to that idea. It would open the door to even more Miraculous Herbal Tonics than we have already – all you’d need to do to get past the safety requirement is make sure your snake-oil doesn’t have anything active in it. Honestly, you’d have people springing up selling powdered drink mix at $5 the glass to cleanse your liver, grow new hair, and make your genitalia go out in the morning and fetch the newspaper. What? You say we have that already? Well, now they’d be “FDA-approved” on top of it.

No, I’m all for making companies show that their drugs actually do something. In fact, I’m all for making sure that any medicine entering a served market is tested head-to-head with the competition. Of course, this is often mandated already. And companies often do it themselves so they’ll have an edge in marketing – exceptwhen it’s a patent extension of one of their own drugs. As I mentioned a while back, I’d make Astra-Zeneca test Nexium against Prilosec, for example, and we’d see who’s fooling whom.

There’s no doubt that the FDA’s gotten pickier in the last couple of years, and all of us in the industry are feeling it. But it hasn’t gotten to the point where I think they’re stepping over the line.