The Food and Drug Administration (FDA) recently issued a draft guideline for Generic Drug User Fee Amendments (GDUFA) to the Prescription Drug User Fee Act (PDUFA). The agency's website features documents including guidance for generics-makers on self-identification of generic-drug sites, organizations and facilities, as well as questions and answers about the guideline.
The FDA Draft Guidance Document entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers,” will be open for comment until October 26, 2012. Comments should reference Docket No. FDA-2012-D-0880.
Background
As we noted back in July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which contained the reauthorization of several “user fee acts,” which authorize FDA every five years to collect funds from industry in order to, among other things, speed up the time for drug and device review. FDASIA, however, also created to new user fee programs, GDUFA and a program for biologics—the Biosimilars User Fee Act (BsUFA).
The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA also requires that generic drug facilities, sites, and organizations located around the world provide identification information annually to FDA.
FDA’s Draft Guidance
FDA’s guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA.
GDUFA establishes fees for abbreviated new drug applications (ANDAs), prior approval supplements (PASs) to ANDAs, and drug master files (DMFs), annual facility fees, and a one-time fee for original ANDAs pending with FDA on October 1, 2012 (backlog fees). Fees will be incurred for ANDAs and PASs submitted on or after October 1, 2012. An application fee will also be incurred the first time a DMF is referenced in an ANDA or PAS submitted on or after October 1, 2012.
FDA plans to publish the fee amounts for ANDAs, PASs, DMFs, and the backlog fee in the Federal Register on or before October 31, 2012.
The amount of the annual user fees for generic drug facilities will be determined after GDUFA program launch. Under GDUFA, facilities, sites, and organizations are first required to self-identify. Fees will be determined after the self-identification process has been completed, providing FDA information about the number of facilities that will be required to pay user fees. These include facilities manufacturing, or intending to manufacture, active pharmaceutical ingredients of human generic drugs and/or finished dosage form human generic drugs.