A few thoughts on PDUFA V before we settle in for the holiday break.
Two Teams. As negotiations proceed, it becomes increasingly obvious there’s an emerging duality – the FDA’s Part B “asks” and industry’s legitimate worries over what was promised, but not delivered, from PDUFA IV.
Perhaps both agency and industry should create two teams so that both sets of issues can be addressed in a timely and comprehensive manner. Special teams, as they say, win ballgames.
Carrots and Sticks. Everyone wants to be rewarded for promises delivered – but perhaps its time for some hurt to be written into the system for promises unfulfilled. PDUFA is a partnership and partnerships are built on mutual respect and understanding. When one side rewrites the rules while the game is in play, that’s not partnership – it’s a thorny thicket of unintended consequences. Not to put too fine a point on it, but predictable timing for first cycle decisions count.
When the agency can “stop the clock,” PDUFA dates lose all meaning. It’s the same argument used in Inherit the Wind to dispute the length of Earth’s “first day.” After all, since the Sun hadn’t been created yet, the first day could have been 24 hours or 24 billion years long. Sometimes a review feels just like that.
And finally …
First Principles. It’s time to remember why PDUFA exists in the first place. And that reason is predictability. PDUFA V will either provide more predictability or more excuses. The latter is not an acceptable choice for industry – nor will it be tolerated by the 112th Congress.
For all concerned – and particularly for patients – PDUFA V needs more resonant cowbell.
