Summary
Teva should try to comply with the FDA requirements for the full new drug application of the generic version of COPAXONE and not rely on citizen petitions.
Analysis
This is an area outside my standard area of expertise, so my comments will be very sparse. But my mother, the late Rachel Silk, was involved with a number of new drug approval reviews as an analytical chemist covering neuropharmacogological drugs for many years with FDA. So I believe I have fairly good judgement of the way the politics of the approval works for the agency.
First, for those interested, a nice article on the development of COPAXONE (not the generic version) is at
http://molinterv.aspetjournals.org/cgi/reprint/4/1/6
The argument TEVA is making is that the efficacy of the generic version of COPAXONE can't be tested without clinical trials. TEVA has not yet responded in detail to the FDA rejection of its petition to, in essence, avoid the standard form of the New Drug Application (NDA) procedure for the generic version. (There is a statement that this is a minor setback on the Israeli business new site, Globes.)
TEVA does report on an EU Member study which includes clinical trials on the site
http://www.biospace.com/news_story.aspx?NewsEntityId=124967.
FDA has approved an "expanded indication for use" based on the European study of COPAXONE proper; see the story at
http://www.tradingmarkets.com/.site/news/Stock%20News/2214363/.
My own guess is that this is as far as FDA is likely to go under the current circumstances. I would expect that TEVA would be wasting its time trying to present any more petitions or pursue other actions other than trying to comply fully, as difficult and aggravating as it may be, with the full requirements of another New Drug Application for the generic version.
It is not possible in this forum to go into a comparison of the efficacy of the competing drugs, in particular, Elan and Biogen's Antegren. But I would point out that Biogen is a US-based company, in a way Teva is not. I believe it is the case that the system of review of new drugs is not politically compromised at FDA. But in a case like this one, where there is not overwhelming political cover for TEVA, and caution against the petition TEVA brought has scientific justification, politics may be some guide to regulatory decisions.
We can imagine that the Obama Administration would be able to present judgements against TEVA to Iran or countries that it is trying to reach out to as evidence of even-handedness in its treatment of Israel. I don't think the decision necessarily has anything to do with this, and it is most likely the case that the Obama Administration won't do any such thing. I would just point out that if they did, any such statement would be positively received by regimes like that of Iran. Given this, and given that such a decision could be argued to preserve U.S. jobs, you can draw the lines for yourself, even if, as I stress, they really aren't there.
