Monday, July 2, 2012
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.
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.