Is the Problem Too Much Regulation?

 So, after I wrote this blog entry, I came home and pulled out my USP from 1990 (translation, its been obsolete for 12 years - however I doubt that the heparin monographs have changed).  The release tests for Heparin Calcium are, as follows:

Identification of Calcium (so any powder with calcium would pass here)

Pyrogenicity test - making sure it won't cause fevers in rabbits

pH - not too specific

Loss on Drying - how much water is present.

Nitrogen content

Protein Content

Heavy Metals

Anti-factor Xa Activity

So, nothing to specifically look at the structure of the molecule in question.  As long as the molecular weight is similar, and it is active against Factor X, and it has Calcium, your good.  So, if you close your eyes, you can hear the response from Baxter's attorneys:

"We were following the required USP testing"

"We are operating under an approved ANDA/NDA, and we can't just change tests"

"If the FDA was more active in monitoring China..."

The second statement being the one I think we'll hear.  Current regulations do make it expensive to change a testing strategy.  There is much lab work required, comparability studies, etc.  Then you have to file the changes with the FDA and go through the approval process.  Its expensive and time consuming, and will cut into profits.  In other words, why would you bother?  The regulations have caused stagnation.  I can't put my hands on it, but back in 2003 there was an article in the Wall Street Journal pointing out that the technology used to make pharmaceutical products was far more primitive than that used to make other consumer products, like your Nike's.  This is because of the regulatory hurdles that make it less competitive to improve.