Replies to post #664 on Momenta Pharmaceuticals, Inc. (MNTA)

[MTB]

As noted in the BV site earlier (now that I've had a chance to review it), the 63 pages aren't much.

The take home point is that when the FDA was faced with life-threatening crisis, they looked around the world -- and turned to MNTA for a simple reason: NO ONE ELSE COULD DO IT.

GAO recognizes FDA's need for relevant outside expertise and finds no fault with that.

GAO faults FDA for 1) not soliciting a simple letter specifying MNTA's 'outside experts' were not expecting to be paid (and so creating a potential obligation in excess of the funds granted them by Congress (this is why Joe cares), and 2) The FDA didn't formally run it through their legal office to help protect against the appearance of COI.

The FDA's response was even keeled. They did the right thing in a crisis.

The Journal's 'reporting' on this report was underwhelming.

Likelihood of MNTA remaining the sole generic Levonox simply keeps going up with data like this.

[go seek]

In summary, the FDA got a slap on the hand...

It is easy to criticize, when one is not in the 'fire'.
In this crisis, was the FDA to turn to an external entity in which they had little or no confidence? I hardly think so.

In its effort to do the right thing, the Gov't often loses sight of the goal... or the goal is never achieved.