PDUFA IV Recommendations from FDA

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The FDA is between a rock and a hard place when it comes to PDUFA.  The Prescription Drug User Fee Act provides a great deal of funding by which the agency can afford to engage in a wide range of activities to protect public health.  User fees are charged to companies bringing new products for consideration and applied to provide important staffing for benefit-risk assessment and the like.  User fees are not uncommon in federal government – other agencies charge them to the industry that is being regulated.  And in Europe, the EMEA budget is 75% derived from user fees, as is 100% f the U.K. drug enforcement budget.

The current PDUFA set up (PDUFA III) expires on September 30. 

The user fees charged by the FDA, however, are a great source of concern for many who see this as an intrusion of industry influence over the process that regulates it.  No real evidence that I can see supports either point of view on that issue – that there is undue influence or not. 

PDUFA IV, the latest iteration, has been submitted by FDA.  It will bring an extra $87.4 million to FDA coffers, $29.3 million of which is to be applied to hiring new staff to support post-marketing surveillance.  The rub there, of course, is that post-marketing surveillance in the U.S. is generally considered weak because of the way it is performed – something not addressed by adding new staff.   

I don’t think the real question for PDUFA IV is  whether or not user fees are a good idea – I think it is obvious they are here to stay – but whether so much of the funds derived from PDUFA IV can effectively be applied to bring staff to a regulatory area where the agency is working with an adverse event reporting system that so many consider inadequate.  The question isn’t whether PDUFA funds should exist, but how to best apply them.

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