September 1, 2012

In a Congressional cycle paralyzed by partisan gridlock, early reauthorization of PDUFA — the user fee act for drugs — was hailed as a triumph for the current Congress. Not only did the law pass with bipartisan support, it passed ahead of schedule. So why was this particular piece of “must-pass” legislation able to garner the nearly unanimous support of Congress, the FDA, Big Pharma, and lobbyists alike?

NAI’s article, @BeginLink@PDUFA V – A Step in the Right Direction@EndLink@, published in FierceBiotech September 26, 2012, examines this law. NAI President Rita E. Numerof, Ph.D., and Senior Consultant, Raj Riswadker, M.S., M.B.A., explore the elements of the law, what’s changed, and what will need to happen to ensure success of the FDA’s efforts to avoid being a chokepoint for innovation.