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.”