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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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May 9, 2007

A New FDA?

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Posted by Derek

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.

Comments (5) + TrackBacks (0) | Category: Toxicology


1. Still Scared of Dinosaurs on May 9, 2007 9:44 PM writes...

My favorite little tidbit about drug safety came from one of the most highly paid collections of morons in the world, the editorial board of the Wall Street Journal. They said that much of the clinical testing required by FDA was unnecessary because, while large trials are sometimes needed to prove efficacy, safety is already proven in Phase 1.


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2. Timothy on May 10, 2007 11:40 AM writes...

I think this could make the FDA even more risk-averse, which would slow down approval of new drugs. Which is bad, but as for the underlying data, you're exactly right Derek.

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3. MTK on May 10, 2007 12:53 PM writes...

I'm usually against more government, but at the same time I believe that some is good and that the FDA may be one of the most successful of US government agencies in terms of fulfilling it's mission, but...

Instead of increasing the FDA's post-approval powers, would we not be better served as a population with separate agencies responsible for approval and another responsible post-approval? In many ways, the FDA being in charge both before and after approval would be like having courts hear both the trial and the appeal.

Of course, from an industry perspective, that would really raise the bar for approval, since it's conceivable the pre-approval agency would become very cautious then.

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4. biohombre on May 11, 2007 11:39 AM writes...

Derek, I agree with your assessment. In addition, as a society we should consider how we assess success in our quest for "drug safety". The press, as well as congressional responses leave me with the impression that 100% safety is the target. Safety is appropriately paramount, but do we as a society expect that any medical treatment, not just drugs, should come to use completely free of risk?

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5. DEL on May 12, 2007 12:17 AM writes...

As one who works in the industry in drug safety, I think the compromise, in which the people doing new drug applications remain the same ones doing the post-marketing assessments is a mistake. Rare is the medical officer with the requisite experience or expertise to deal with post-marketing data. That's partly how the current mess started. Whether it's a separate agency, as MTK suggests, or within the common agency of the FDA really doesn't matter so much. It's much more a function of the expertise of the medical officers making the initial judgement and the degree to which those judgements are insulated from political pressures (which I don't think they are at the moment).

That said, there's been precious little said about the qualifications of drug safety personnel in the industry--this is an area ripe for some improvement--and the need for federal support of drug safety training programs, of which there is practically none now. Is it any wonder no one can find individuals with the requisite training and experience. Finding a pharmacoepidemiologist is very difficult these days.

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