2012 Prescription Drug User Fees Announced

In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.

The fees are calculated using the fee base revenue amount for fiscal year (FY) 2008 published in the Federal Register of Oct. 12, 2007 (72 FR 58103) adjusted for the FY 2009, FY 2010, FY 2011, and FY 2012 drug-safety increases, for inflation, for workload, for excess collections through FY 2011, and for a final-year adjustment. Rates for 2011 and 2012 are listed below:

• For applications requiring clinical data, the FY 2011 fees were $1,542,000. FY 2012 fees will be $1,841,500, a 19.42% increase.
• For applications that do not require clinical data, the FY 2011 fees were $771,000. FY 2012 fees will be $920,750, a 19.42% increase.
• For supplements requiring clinical data, the FY 2011 fees were $771,000. FY 2012 fees will be $920,750, a 19.42% increase.
• Establishment fees for FY 2011 were $497,200. FY 2012 fees will be $520,100, a 4.6% increase.
• Product fees for FY 2011 were $86.520. FY 2012 fees will be $98,970, a 14.3% increase.

These fees are effective on Oct. 1, 2011, and will remain in effect through Sept. 30, 2012.

For related stories see:

FDA Issues Draft Guidance on User-Fee Waivers, Reductions, and Refunds

FDA Holds Public Meeting on Prescription Drug User Fee Act