Monday, August 23, 2004

FDA Smackdown

Recently I wrote a post citing an editorial from the journal, The Lancet. In that post, I commented that The Lancet  is a fairly conservative journal, as most medical journals are. Yet, in that same issue, there was a blistering critique of the Bush Administration, in a different editorial, about a different topic:

Ejecting the FDA from the courtroom
The Lancet, Volume 364, Number 9435, 21 August 2004

Despite a traditional Republican belief in limited government, the administration of US President George Bush seems curiously tilted towards increasing governmental intrusion into health affairs. Its fixation on the doctrine of separation of powers among the three branches of government (witness the White House's initial refusal to allow the National Security Advisor, Condoleezza Rice, to testify before the 9/11 commission; it argued that the legislative branch cannot coerce the executive) is apparently a flexible one. The Food and Drug Administration (FDA), a part of the executive branch, is now taking an activist role in judicial matters. [...]

A BeefeaterTheir use of the term "activist," in this context, contains a certain understated irony; it's a good example of classic British humor. It's a serious matter, though. If, indeed, the Administration wants to reserve the right to be critical of the judicial branch, on account of alleged "activism," then they need to clean their own (glass) house first. Of course, if they had their way entirely, it would not be a glass house: transparency would be a thing of the past.

Rant tangents aside, what is the beef that they are getting on about.?

It turns out that the editors of The Lancet  have noticed a peculiar trend in behavior at the US FDA.  Our Food and Drug Administration is taking it upon themselves to file briefs in medical liability cases.  The Editorial notes that, in the past, the FDA would file such a brief only in response to a request by the court.  Now, though, it appears that they are doing this spontaneously. 

Personally, I wonder just how spontaneous it really is.  That is, I suspect that they are acting upon requests, not from the courts, but from the pharmaceutical companies that have a stake in the outcome of the cases.  I do not have any direct evidence of this, but the Editorial points out some circumstantial evidence:

The agency has to contend with a serious conflict of interest. Its chief counsel, Daniel Troy, who has been leading the charge in preemptive filings since his appointment in 2001, came to the FDA from a Washington law firm, where he represented the interests of pharmaceutical companies, such as Pfizer.
I mean, really, how is the FDA even going to know about these cases?  Do they monitor court dockets around the country, looking for tort cases in which pharmaceutical products have been alleged to be the cause of harm?  That would take a lot of time and money, and it seems doubtful that the FDA has people all around the country going into courthouses to look for such cases.  No, it is far more likely that legal firms have an inside connection at the FDA.  A case comes up, they call their buddy a the FDA, and, sort of like magic, the Federal Government  -- acting at taxpayer expense -- writes up a brief that is highly advantageous for the defense. 

The Editorial mentions Pfizer specifically.  I have nothing against Pfizer.  They make some great products.  And I tend to be skeptical of cases against such companies.  Indeed, the Editorial states:

Certainly, a great number of liability cases are filed each year in the USA. And juries sometimes award payouts that clearly exceed appropriate compensation for the harm done. Reform of the tort system, often championed by doctors' groups, insurance companies, and conservative organisations, has long been high on the political agenda--more so on the part of Republicans than Democrats, though many in both parties agree that some change is in order.

There are two problems with the FDA's "activist" stance, though.  One is that it is not the proper role of the Administrative Branch of the government to interfere with the Judicial Branch.  The second is that this is being done with public funds.  Both would appear to be at variance with traditional conservative values.  Unless you count good ol' boy cronyism as a traditional conservative value. 

Note: the opinions expressed here are those of the Corpus Callosum.  They are not necessarily congruent with the opinions of the editorial board at The Lancet. 

(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
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