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August 19, 2004
Yesterday I was writing about a proposal to encourage new antibiotics, partly by not putting so much effort into discouraging the use of the current ones. The economist who's advocating this, Paul Rubin, also would like for the FDA to consider accelerating the approval process (and at the very least, not making it even harder than for other classes of drugs.)
I like the sound of that part, as you'd guess, though always with a nervous look up in the sky for the circling silhouettes of the product-liability attorneys, whose razory talons were the subject of yesterday's post. But there's another problem with just stepping out of the way of the new antibiotics: there aren't very many coming through.
Many companies have been scaling back their anti-infectives research over the last few years, and I don't think that the regulatory environment is the main reason. The whole therapeutic area is rather target-poor. We've exploited the obvious vulnerabilities of bacteria, thus the -cillins and -sporins, the fluoroquinolones and the erythromycins. Extended searching hasn't turned up many more modes of attack, at least not of that quality. The most recent new class of antibiotics that I can think of are the oxazolidinones, but resistance to the first one is already showing up.
Here's a rundown of newer antibiotics (the situation hasn't changed much since this appeared.) Note that most of the things on this list have been known for a long time and are being re-examined, or are improved versions of things we already have.
I know where Rubin is coming from - drug resistance wouldn't be as much of a problem if we had a steadier stream of new antibiotics with new mechanisms of action. But I don't know if we can hold up our end. Providing incentives by loosening regulatory requirements could persuade some companies to get into the hunt (or stay in it), but the hunt itself is the real limiting factor. It's not a good situation, and I think that we in the industry are kind of at a loss as to what to do about it. . .
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