I've got a little list, I've got a little list
Of healthcare regulators who PDUFA doth confound
With deadlines often dissed, they never would be missed.
I believe it was former US Senator, Everett Dirkson who first said, “When I feel the heat I see the light.”
Now it’s time for folks at the FDA to repeat it. Repeat it, in fact, as a mantra.
As you’ve surely heard, House Approps has FDA on its little list of cuts to 70 accounts that will be included in the CR. And included on that list is a $220 million cut to FDA. (The list does not specify how those cuts are to be allocated but, if enacted, would be implemented over the final seven months of the current fiscal year - -which ends on March 4th.)
The general sense is that the Appropriations Committee will not hold a markup, rather the bill is expected to be brought to the floor next week under an open rule. That means the number of amendments to be filed could reach into the thousands, so where things end up is anybody’s guess.
What is pretty clear is that FDA is, indeed and as predicted, in the Congressional crosshairs.
Repeat after me, “When I feel the heat I see the light. Om.”
Remember, that $220 million won’t come from PDUFA fees but rather from that piece of the FDA budget largely allocated for staff and school supplies. And there’s no fat there. None. (Note: Despite the dearth of new obesity medications, this is most certainly NOT a good thing. Indeed – it is a dangerous thing. Very.)
But this proposed cut is, in many ways, tied to the PDUFA debate. The current deliberation surrounding PDUFA reauthorization, at its core, is a discussion of first principles – of predictability, consistency, transparency, and cooperation.
When I feel the heat, I see the light.
Perhaps the best way for the FDA to counter the very unfair and perilous call for bone-deep budget cuts is for FDA Commissioner Hamburg to raise go in front of the committee, raise her right hand and say, “I want a more accountable FDA.”
