PDUFA IV: Putting the Public Health First: An Opportunity to Ensure Safety and Effectiveness are Prioritized in the Drug Approval Process

While there are some benefits resulting from the agency getting increased funds to speed
review of new, life-saving drugs, we believe the overall result of PDUFA has been to undercut the
independence and objectivity of the agency due to its reliance on industry funding. In turn, this
undercuts public trust in the FDA’s primary mission of protecting our nation’s health and welfare. By
shifting resources to speeding drug approval without a concomitant increase in drug safety, PDUFA
has created a lopsided agenda in the agency that, in part, has resulted in the kinds of drug safety
tragedies we’ve seen play out over the last several years.