Update: FDA’s Proposed Generic Drug User Fee Program

September 16, 2011

Update: FDA’s Proposed Generic Drug User Fee Program

On August 25th, the FDA hosted a public meeting to provide an update to ongoing negotiations to establish a generic drug user fee program.  FDA indicated that they had received many comments and 90% of these were supportive of the program overall, though differed in suggested approach.  While there were not a large number of requests for specific exemptions, FDA did state that a good many were received to specifically ask for exemptions for PET drugs.  Peter Beckerman, FDA Office of Policy, explained to those in attendance that FDA recognized the unique nature of PET drugs and understood why PET manufacturers enjoyed exemptions under PDUFA and therefore there will be no fees for PET drugs under the GDUFA legislation.

FDA is planning on sending the generic user fee program proposal to the Hill in January, when PDUFA and MDUFA legislation will go up for reenactment.  We will continue to monitor the GDUFA legislation to ensure the exemptions are in fact included. 

Slides from the August 25thmeeting can be viewed at:  http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM270566.pdf

Transcripts of the August 25thmeeting, when available, will be posted at: http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm270507.htm