Thursday, October 05, 2006

Dirty Davey: Once More, With Feeling

DD had some more thoughts on my screed from yesterday. It seems only minimally fair to post those thoughts without further commentary from me....DD in roman, my earlier gripes in italics, earlier still in bold/ital.

Oh, please. Stone-faced Joe's main job is to delay new drugs
to protect the profits of existing drugs.

I don't know that this is consistent with how the FDA works. Most importantly, the FDA approval process takes place AFTER the "patent clock" has started ticking. Quicker approval means a longer period without generic competitors.

Other branded/patented products represent much less of a threat to a drug than do the generics, so speed of approval is something the pharma companies really care about. (I am in pharma these days, so I have some notion whereof I speak.)

In fact, the entire concept of "intellectual property" is one
of government intervention in the market process... And yet
IP regulation is generally seen as an essential component of
a market which encourages innovation.

If you think enforcing property rights is the same as
"regulation," then you think that having speed limits is the
same as having a cop drive your car.

By ignoring the word "intellectual" you changed my entire meaning. INTELLECTUAL property regulation is in fact government intervention in the market process... and is not "enforcing property rights" in the classic sense. IP protection would be the law telling me I had to take the main road and not the shortcut through the neighborhood because someone else had discovered the shortcut first.

It seems to me that regulation of commerce here can be seen
as an alternative to...
(1) Very strict regulation of commercial speech and
advertising to enable informed consumer decision-making
(2) A chaotic world in which liability lawsuits are the
primary response to bad behavior in the market

You don't think #1 involves the courts?

Oh no--both (1) and (2) involve the courts.

What I'm saying is that having a regulation saying "you must get FDA approval to sell X to treat condition Y" is an alternative to...

(1) Requiring the seller of X to provide consumers with precise clinical data on the safety of X and its efficacy in treating Y, plus possible side effects and their likelihood, plus enumeration of which advertising or marketing claims constitute contractual obligation on the part of the seller,


(2) Lawsuits from many buyers for whom X does not resolve Y, or for whom X produces unacceptable or unexpected side effects, claiming that the understood conditions of the sale make the seller liable for the product's failure to perform, or that the information provided by the seller was false, incomplete, or misleading.

One could in fact argue that--unless we say "caveat emptor" and say the seller has no contractual obligation whatsoever--the liability risk of selling drugs in a non-FDA world (or unapproved drugs in an FDA-optional world) would be so high that no one would rationally enter the business or push the frontiers of research.

(And pure "caveat emptor" would be a return to snake oil salesmen--nothing could be really trusted to have any positive medical effect.)