Back to School with PDUFA

A version of this post also appeared on our LillyPad blog

It's back-to-school season. As families stock up on school supplies and dust off the lunch boxes, I thought it would be a perfect opportunity for a lesson on the Prescription Drug User Fee Act (PDUFA).

Congress passed the Prescription Drug User Fee Act in 1992 to solve the dilemma of extended waiting periods for important medicines. Since then, PDUFA has provided the Food and Drug Administration with the additional resources it needs to expedite its drug approval process. In 2014, the FDA took in nearly $800 million in user fees, which went to hiring more staff, shortening review times and increasing the amount of quality medications available to the public.

Every few years, Congress reviews PDUFA to keep it effective and up to date. Various versions of the law have included important tools such as benefit/risk analysis, patient recorded outcomes and the Patient Focused Drug Development (PFDD) program. The next version, PDUFA VI, will be up for renewal in 2017.

Learn how PDUFA is improving medical discovery and public health in our infographic:


If you want stay involved in the PDUFA discussion, follow LillyPad (@LillyPad) and CMM (@ModernMeds) on Twitter.