FDA’s Proposed PDUFA IV Recommendations Would Eliminate the 505(b)(2) Application User Fee Exception

FDA’s highly anticipated PDUFA IV proposal, if enacted by Congress, would eliminate any possibility that a 505(b)(2) application might not be an application subject to PDUFA user fees. 

Among various technical changes included in the Agency’s PDUFA IV proposal, FDA recommends that Congress “[s]implify the definition of ‘human drug application’ to include all new drug applications under section 505(b) of the [FDC Act].”  Currently, FDA collects user fees for each “human drug application.”  This term is defined to mean, with respect to 505(b)(2) applications, either an application requesting approval of a new molecular entity or a new “indication for a use” of a previously approved drug.  In a guidance document issued in February 2007, FDA finalized its interpretation of a new “indication for a use.”  In that document, FDA articulates a broad interpretation of that term:

[B]ecause only certain 505(b)(2) applications are exempt [from user fees], it is important that potential applicants who do not want to be assessed fees be advised to . . . not seek any new indications for a use.  It is particularly important that they strictly follow the approved labeling for the individual ingredients.  If, for example, applicants seek a different use of the drug, a different dosing regimen or route of administration, use in a new population, or if they compare their product to others in the labeling, they will not qualify for the 505(b)(2) exemption from fees.

FDA’s interpretation of a new “indication for a use” has been criticized as overbroad and contrary to Congressional intent.  Such criticism will disappear, however, if Congress implements FDA’s PDUFA IV recommendation to treat all applications as “human drug applications.”