Ask Cato: PDUFA V: A Funny Sounding Name for a Very Important Bill

Can you say PDUFA (pŭ-dōō-fŭ)?  The United States Senate can.  A very partisan Senate showed uncharacteristically bipartisan support for the Prescription Drug and User Fee Act (PDUFA) V, voting on 24 May 2012 to reauthorize PDUFA by a 96 to 1 vote.  This reauthorization allows for a 6% increase in fees paid by drug and medical device manufacturers to fund the FDA’s approval process.  PDUFA IV expires on 30 September 2012, and PDUFA V, if passed by the House and signed into law, will allow the FDA to collect user fees for the review of human drug and device applications for fiscal years 2013 through 2017.

PDUFA was first passed in 1992.  It mandated that manufacturers of new drugs pay a fee upon submitting a New Drug Application (NDA).  The increase in revenue to the FDA from these fees was used to decrease the time between a NDA submission and a FDA decision.  Indeed, review times did decrease, and PFUFA II was passed in 1997, III in 2002, and IV in 2007.  Each reauthorization of PDUFA implemented fees to modernize and accelerate processes for drug and medical device approval.

To find more information please use the below mentioned weblink 

http://www.ask-cato.com/2012/05/pdufa-v-a-funny-sounding-name-for-a-very-important-bill/?utm_source=rss&utm_medium=rss&utm_campaign=pdufa-v-a-funny-sounding-name-for-a-very-important-bill