Regulatory Focus™ > News Articles > FDA Presentation Highlights Dramatic Need for GDUFA Legislation

FDA Presentation Highlights Dramatic Need for GDUFA Legislation

Posted 12 April 2012 | By

An official from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science (OPS) provided a presentation on the state of the proposed Generic Drug User Fee Act(GDUFA), which provides deep insight into the troubling state of the generic drugs inside FDA.

OPS Science Coordinator Russell Wesdyk's presentation to the Drug, Chemical & Associated Technologies Association covers a variety of points, including:

  • generic drugs have provided consumers $931 billion in savings from 2001-2010
  • program funding for generics reviews has remained flat since 2001
  • submission Abbreviated New Drug Applications(ANDAs) up to over 1,000-was roughly 300 in 2001
  • submission of drug master files up 100% since 2001 as well
  • backlog of generics at nearly 2,700, up from just 1,400 in 2006
  • foreign inspections have increased dramatically and surpassed domestic inspections for ANDAs

All of these facts lead to the need for the GDUFA legislation, said Wesdyk in his presentation. GDUFA will allow FDA to collect user fees, establish different types of fees, and allow FDA to provide the resources necessary to inspect more foreign establishments and clear its sizeable backlogs of ANDAs.


Read more:

Generic Drug User Fees Agreement: Overview for DCAT


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