PDUFA: Now it's execution

FDA, the biopharma industry and patient advocates have performed a rare feat in gridlocked Washington, moving a major piece of legislation smoothly and quickly through both houses of Congress and onto the president's desk with barely a hint of partisan rancor. If implementation of PDUFA V approximates the success in negotiating and enacting the deal, it could lead to better, more rapid drug development.

Effective implementation, however, will be far more difficult than getting the agreement of 92 senators and the entire House of Representatives. It will require communicating policy changes to staff - and more critically, eliciting appropriate changes in behavior and culture - throughout FDA's drug and biologics centers...