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December 2, 2011
Not Just FDA-Bashing?
There have been a lot of complaints about the FDA over the years, from all sorts of people. Many of these complaints are, well, incompatible: there are those who feel that the agency is letting too many bad compounds through, and not keeping a close enough eye on drug companies and their marketing departments. Then there's another vocal contingent that think that the agency is stifling innovation with overbearing regulations. Those can't both be right.
I'm at neither end of this spectrum. I think that we need an FDA, and that its purview should be roughly what it is now. That is, I think that the agency should require proof of safety and efficacy for marketed drugs, and that this proof should include rigorous clinical trials. I think that it should, in fact, make sure that drug companies don't go too far in their efforts to market their compounds, with "too far" to be determined (as it is now) by continuous wrangling. But I don't mean to suggest that the agency is doing all of its jobs optimally, or that it couldn't think of new ways to fulfill its mission.
Here's an example, a column in Bio-IT World that (at first glance) comes across as just more FDA-hammering. But there are some interesting ideas, once you get past the boilerplate. Such as:
While wholesale FDA reform is needed, doing it right would entail a monumental effort that could take years. But there are modest steps we can take in the meantime. How about carving out one or more FDA-free Enterprise Zones where doctors, scientists, and volunteer patients can make their own decisions unfettered by the heavy hand of regulators? Imagine an experimental terminal-illness wing of the Cleveland Clinic where informed consent was the only law. How hard would it be to draft enabling legislation?
Defenders of the FDA’s prerogatives would fight such proposals tooth and nail. But what kind of nanny state arguments can be made against conducting such a policy experiment when anyone who objects doesn’t have to be treated? Breakthroughs that emerge would still have to pass through the FDA gantlet before they would be generally available. The difference is that researchers could continue making improvements while treating volunteers during this long process.
Now, it's fair to ask how heavy the hand of regulation is in the case of terminal illnesses. We already have an awful lot of unusual therapies being tried in such situations. But could we accomplish more under these proposed conditions? Should we? I invite debate in the comments.
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