Prescription Drug User Fee Act

What is the Prescription Drug User Fee Act (PDUFA)?

The Prescription Drug User Fee Act (PDUFA) was legislation first passed by Congress in 1992 most known for allowing the FDA to collect fees from companies in order to review new drug applications (NDAs). PDUFA is credited with speeding up review times as it allowed the FDA to scale up resourcing (including hiring of additional reviews) based on the number of drugs under review. Prior to its passage, FDA was often limited with a more static budget regardless of how many new drug applications came in for review. PDUFA has to be reauthorized every five years, so it is currently several iterations in, with various scope changes made over time for FDA as technology has progressed and as new challenges have surfaced. PDUFA is generally considered a great example of public policy that was a win-win for both public and private sectors (the latter which had more certainty on review timelines and shorter timelines compared to the pre-PDUFA era), although detractors suggest it may have led to some level of regulatory capture, by which FDA may have some perverse incentives in carrying out its primary function of regulating drug products.