*Reputation and Power*, a new theory of the FDA

The subtitle is Organizational Image and Pharmaceutical Regulation at the FDA and the author is Daniel Carpenter.  Here is the book's home page but I don't yet see an Amazon listing.  Here is a Barnes&Noble listing, note the price discount.

Where to start?  It exhausts me to even write about this book, which is the most comprehensive and most detailed study of a regulatory agency written — ever – to the best of my knowledge.  It supplements and overturns all existing work on its subject and it will prove a model for future investigations.  It's not short!

The starting point is the notion of reputational capital and the claim that the FDA seeks to preserve and extend its reputation, for a variety of political reasons.  One implication of this is that the FDA is sometimes too loose and other times too strict but that both biases are possible.  The framework is then used to address numerous questions, including the following:

1. Why the U.S. has the most bureaucratically intensive drug regulation in the world.

2. Why the 1962 amendments were passed.

3. Why FDA regulation is so often treated as de facto irreversible.

4. Why the tenure of a division director matters for how the decisions of that division are treated.

5. Why there is so much judicial deference to the FDA.

6. Why the FDA has been so influential on a global scale.

7. How public attention affects the speed of FDA procedures.

The author makes a strong case that the FDA is one of the most powerful and most important regulatory agencies in the world and one of the most important extensions of state power.  Everyone interested in the economics of regulation should read this book, just be prepared to be a little overwhelmed.  I would also note that this is not mainly a partisan book in one direction or the other, though on net I read the author as wishing to see a stronger FDA.  (On p.379, for instance, I read Carpenter as overly dismissive of the "drug lag" argument.)

Here is Carpenter's previous book, which I have not read.  For the pointer to this work I thank Steve Teles.

Comments

Tyler, What I like about this blog is that sometimes you bring information to an audience that might be hostile to the message.

That shows more objectivity in a complex world than one typically sees in a blog that has a certain compositional makeup.

Hasn't judicial deference to the FDA been significantly compromised in light of the SCOTUS ruling last year in Wyeth v. Levine?

Hi Tyler - Can you say more about your point 7. please?

thanks

The FDA is a crime against humanity. 3,000 Americans suffer and die needlessly every day because of this evil bureaucracy. I really wish that the nutjob who flew his airplane into the IRS building in Texas had targeted the FDA instead.

re mdb's comment, it always strikes me as odd when people (especially a scientist) say they won't read a book or watch a movie or ingest some other source of information because it doesn't fit their current world view. IMHO, this behavior is the sign of a closed mind and is a good example of the kind of behavior that goes on at the FDA and other hidebound institutions. Perhaps I generalize, but I have found that conservatives exhibit this willful ignorance of possible facts (I dislike labeling people in general, but people who do like having a label tend to exhibit common behaviors).

Any information is good information, you can always dismiss it, but there might be a nugget of truth buried in the data. Why dismiss it out of hand because it doesn't fit your paradigms or sociopolitical leanings?

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