Monday, February 15, 2016

Merck Gets A "No" From FDA -- On Latest Label Expansion From IMPROVE-IT Data

A few weeks ago, I mentioned that this proposed new indication was voted down by the Advisory Committee at FDA -- and wondered aloud whether an ex-Merck officer's new role as Senior Counsel to the Commissioner might lead to mischief, in the form of an approval at the full Commission level.

I can safely report that it has not.

The full Commission has voted not to grant the label expansion. I'd guess that just cost Kenilworth about an annual $50 million in sales in the US. Immaterial, but a strange end to a twisted ten year tale.

So it goes.



Anonymous said...

It would be a wonderful world if we could all trust- with certainty -that each of our lives and end-health were guarded from the interests of individuals with bottomless pockets. What a world to imagine!

Smiling for now...

Comdor said...

Indeed -- but sadly that world sails the far horizon, from where I sit... Still there are so many reasons to smile! Great comment!

Namaste -- do stop back by...