By Jeffrey H. Brochin, J.D.
The FDA has issued guidance intended to provide information regarding the FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI). Because PDUFA VI created changes to the user fee program, the guidance explains the new fee structure created by the statute, the types of fees for which entities are responsible, including user fees authorized by PDUFA VI, the process for submitting payments to the FDA, the consequences for failing to pay application fees or prescription drug program fees, and the process for requesting a reconsideration of a user fee assessment. The guidance also describes how the FDA determines which products are subject to a fee and discusses certain changes to the FDA’s policies under the new law (Notice, 83 FR 19564, May 3, 2018).
Changes to the structure of the PDUFA User Fee Program. PDUFA VI authorizes the collection of two types of fees: (1) human drug application fees, which are collected at the time certain human drug applications are submitted; and (2) prescription drug program fees, which are collected annually for certain prescription drug products.
Previously, Section 736 of the FDC Act authorized the FDA to collect (1) human drug application and supplement fees, (2) prescription drug establishment fees, and (3) prescription drug product fees. PDUFA VI eliminates fees for supplements as well as for establishments. Applicants will now be assessed annual prescription drug program fees for prescription drug products rather than the prescription drug product fee assessed under PDUFA V. In addition, PDUFA VI eliminates a provision under which applicants could apply for a waiver or refund of user fees on the basis that the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, also known as the "the fees-exceed-costs waiver."
Human drug application fees. Under PDUFA VI, each person that submits a human drug application beginning in FY 2018 is assessed an application fee under PDUFA VI, which is due when the application is submitted, as follows:
- A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee.
- A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval is assessed one-half of a full fee.
Prescription drug program fees. In general, each person named as the applicant in a human drug application and that, after September 1, 1992, had pending with the FDA a human drug application or supplement is required to pay the annual prescription drug program fee for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. An applicant may not be assessed more than five prescription drug program fees for a fiscal year for prescription drug products identified in a single approved application.
Prescription drug program fees are due on the later of the first business day on or after October 1 of each fiscal year, or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under section VI of the guidance.
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