PDUFA V Begins With Relatively Modest Changes to User Fee Rates

By Kurt R. Karst –      

In two Federal Register notices (here and here) scheduled for publication on August 1st, FDA will announce the Fiscal Year (“FY”) 2013 user fee rates pursuant to the fifth iteration of the Prescription Drug User Fee Act (“PDUFA”) and pursuant to the first iteration of the Biosimilar User Fee Act (“BsUFA”).  (In separate notices, FDA will announce – or has already announced – the FY 2013 user fee rates for animal drugs, animal generic drugs, medical devices, and fees under the Food Safety Modernization Act domestic for foreign facility reinspections, recall, and importer reinspection.)  Later this year, FDA should announce the FY 2013 user fee rates established pursuant to the Generic Drug User Fee Amendments (“GDUFA”).  Among other things, the FDA Safety and Innovation Act (“FDASIA”), Pub. L. No. 112-144, 126 Stat. 993 (2012) (see our summary here), reauthorized and amended several several existing user fee statutes that were scheduled to sunset and established new user fee statutes for generic drugs (GDUFA) and biosimilars (BsUFA).

The FY 2013 PDUFA application user fee rate is set at $1,958,800 for an application requiring “clinical data,” and one-half of a full application fee ($979,400) for an application not requiring “clinical data” and a supplement requiring “clinical data.”  (The term “clinical data” for PDUFA user fee purposes is explained in an FDA guidance document available here.)  These figures reflect FDA’s estimate of 122.3 fee-paying full application equivalents – an average of the number of full applications that paid fees over the lateset 3 years.  Annual establishment and product fees have been set at $526,500 and $98,380, respectively, and are based on estimates of 455 establishments and 2,435 products. 

The FY 2013 fees go into effect on October 1, 2012 and represent a modest change vis-à-vis FY 2012 user fee rates.  All BsUFA user fees – i.e., the initial and annual biosimilar biological product development fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees – are keyed to PDUFA user fees.

As we have done in past years, we provide tables (below) showing the increase/decrease in PDUFA user fee rates since the previous FY for each fee type (and in this case for each of the five FYs under PDUFA IV).  The first set of tables should be used with the table from our previous post, which tracks user fees rates since the inception of PDUFA.  The next set of tables illustrate the historical trend for each PDUFA user fee.