I applaud Merck's "twin wins," here -- but I also imagine that this development just puts these candidates on about the "pre-shutdown" timeframe for "normal" review, from this point, forward. Thanks again, Tea Partiers! FierceBiotech here, reporting:
. . . . Merck's beleaguered R&D group picked up another breakthrough therapy designation from the FDA. On the heels of a BTD for MK-3475, the pharma giant's closely watched cancer immunotherapy, Merck now has boasting rights for a combo therapy for hepatitis C, MK-5172 and MK-8742. . . .
So it goes. But. . . Kudos, just the same! [One of these, MK-3475, is the science nerds' naming playfulness -- lambrolizumab. Hah!]
Drug reviews should not be effected by the shutdown.
ReplyDeleteReviews are paid for by user fees and employees performing reviews or otherwise paid out of user fees don't need to stop working due to the government shutdown.
Well, I know that was the theory.
ReplyDeleteIn fact, I'm willing to bet you a donut and coffee that. . .
When we look back at the 12 months starting from October 1, 2013, we will notice a statistically-significant decrease in new drug approvals, compared to 2012. And we already know that 2012 was down slightly from 2011 levels.
I do hear you, but I'm told that CDER was helping cover other duties during the shutdown, unofficially and off-the-record.
And, if you know more than a little bit about how the NDA process works, you know that all those user-fee supported staff rely to a great degree on teh help of the non-user fee covered FDA staff.
True enough, 55 percent of the FDA stayed on during the shutdown, but if an NDA was awaiting an analysis of some basic science interp (as to a study data set), it likely was put to the side for the full 16 days.
As I say, we will know, about this time next year.
I do hear you -- I just think common sense, and human experience, dictate that the shutdown affected approvals -- and did so in a material way.
We shall now wait and see.
Namsste, and do stop back!
Actually the science would definitely be covered by the user fees.
ReplyDeleteTo consult to a basic scientist doing lab work is almost never done.
Support staff functions such as loading supplement submitted information onto computers or forwarding the information that it has arrived to the correct review could be effected. But I'm sure FDA management could easily justify using the user fees for this too.
If an application was already in house then it was loaded onto computers within a few days and it available to review staff.
So -- I take it you'll accept my wager. One year from now, on Nov 15, 2014, I'll post the year over year NDA/ANDA approvals data.
ReplyDeleteAnd I'll glad you buy you coffee and a donut if I am in error.
We shall see -- humans staff and run all of FDA, afterall.
Namaste, new friend!
Your wager assumes correlation means causation which every scientist should know does not hold. Any such decrease could be entirely independent of the shutdown. Approval numbers bounce around a lot and all statistics regress towards the mean. Since 2012 numbers were more than 50% higher than the historical mean a decrease in 2013 is almost assured regardless of the shutdown.
ReplyDeleteOh Salmon --
ReplyDeleteIf I say (as I know you are, based on your history!) "You are right!". . .
Will you accept my wager, in a genuine offer of friendship?
Hah! Enjoy Halloween, man!