Drug safety is getting even harder


After a brief mysterious disappearance that I didn’t catch, I finally put Eye on FDA back into my blog aggregator. Though Senak considers issues that I only marginally consider (for sake of time, really), every once in a while he comes up with something I really have to pay attention to. And here it is for today:

At the very long 3 days worth of advisory committee meetings held on
the COX-2 safety issue, several AC [advisory committee – jj] members stated more than once that the “paradigm” on safety had shifted. Clinical trials, it was said,
would have to be larger. They would have to be longer. They would be more expensive. But there were no specifics given, only general indications that what had been acceptable before was no longer the ideal.

So the public demand for “the safe drug” is trickling up to the FDA advisory committees (and I think that’s a good thing). However, I really do wonder if there is a better paradigm. One hypothesized effect of this greater demand is the delay of new drugs on the market because companies are getting more and more approvable letters (i.e. “looks good so far, but we need to see more before it goes on the market”). With only one recent notable exception — Cephalon (feel free to correct me if there are more recent instances of shares jumping on approvable letters) — it seems investors hate approvable letters.
At any rate, I fear a backlash against this line of thinking. Going to an extreme either way isn’t going to serve the public good.

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One Response

  1. In order to make sure of appropriate quality of drugs, they should be FDA approved, anyway, how you could be sure that you buy and use safe drugs?

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