<<<I suppose it is technically inaccurate to say Sanofi did not seek a TRO but for all intents and purposes, in the telephonic status conference, they abandoned the request>>>
Which is the equivalent of Sanofi admitting the generic is not a danger to the public. 10,000 or more scripts since its been put on the market and no issues (I'm just using this as an example number, but more than 10,000 have had to have issued and been used to date - as I don't know the actual number) speaks bold and loud to any argument that the drug is dangerous.
I think Sanofi keeps putting the issue out there as PR and marketing material, and not for its legal case.
Its legal case really comes down to (1) irreparable harm, and (2) the FDA violated its statutory authority when it asked for immunogenicity information.
So it comes down to, does the FDA have the power to collect some information to insure manufacturing quality or does it not. I'm not going to hazard a guess other than to say, yes, that is a very narrow reading of the statute that Sanofi is trying to make, and unless the FDA is using the manufacturing rationale as a pre-text, it does not sound like a very plausible ruling to read the statute the way that Sanofi is requesting - at least from a Congressional intent, and practical real world perspective. Perhaps the judge prefers just to stay within the parameters of the specific and narrow text (which is not usual in matters like this, but not unheard of).
And as Dew presciently pointed out multiple times, with lovenox, where immunogenicity is not a great problem, there is little reason to do it other than to examine the manufacturing process. Given the 2008 heparin scare, the FDA could order Sanofi to test the immunogencity of its own product to insure the quality of its manufacturing process if the FDA had doubt about it.
Tinker
AI
