Congress has minimal influence in this process... FDA has significant deference in these matters. Interesting that TEVA decided to go public in this way... I suspect the behind the scenes intimidation tactics by the Joe Barton's of the world yielded no results so they felt they had no choice. Didn't TEVA learn from Amphastar/Watson ... the FDA doesn't like being bullied into approvals. This smells of desperation.
This may be the catalyst we have been looking for to shed the TEVA overhang.
Joe "we owe BP an apology" Barton is fast becoming a true standard bearer for downtrodden big companies with inferior technology.
The ridiculous side of this article is that 81 people in the US died and numerous others were sickened by the contaminated heparin. How long would it have taken to solve this public health crisis if FDA did not ask for MNTA's assistance? If Mr. Barton was so concerned about tainting FDA impartiality he could have offered to throw up a couple Chinese walls between FDA and MNTA when they were working to solve the contaminated heparin issue. Perhaps TEVA hadn't yet cried on his shoulder to appraise him of how this little company was beating them to the punch.
I'm beginning to wonder whether the objective here is to try to push FDA into approving other Lovenox generics or whether they are trying to put FDA into a defensive position when reviewing other MNTA applications (i.e., copaxone).
Market Data 
Markets 
AI
