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

March 14, 2007

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.”

Categories: Hatch-Waxman