For Industry

Generic Drug User Fee Amendments of 2012

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In anticipation of the reauthorization of the Generic Drug User Fee Amendment (known as GDUFA II), the Food and Drug Administration (FDA) has begun taking steps to ensure efficient administration of GDUFA for fiscal year (FY) 2018. It is projected that the GDUFA II legislation will include an annual program fee for which holders of approved abbreviated new drug application (ANDA) will be responsible.

Under GDUFA II, it is anticipated that affiliated companies will be grouped together and counted as a single entity for purposes of assessing the program fee. The term “affiliate” is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has the power to control, both of the business entities.

The program fee will be allocated among three tiers of application holders:

  • Large (companies with 20 or more approved ANDAs);
  • Medium (companies with between 6 and 19 approved ANDAs); and,
  • Small (companies with 5 or fewer approved ANDAs).

To enable timely invoicing of FY 2018 GDUFA Fees, FDA has begun an inventory of all approved ANDAs, and has assembled a spreadsheet that lists all ANDA holders and the number of ANDAs associated with each entity. The current spreadsheet and instructions on how to use the list are available in the downloadable excel file located below.

The spreadsheet provided below is the subject of a Federal Register Notice. You may submit any comments about the spreadsheet by following the instructions provided in the Federal Register Notice, located at the Federal Register website: https://www.regulations.gov/document?D=FDA-2016-N-4508-0001.

FDA anticipates making available a revised spreadsheet based on the comments provided in the public docket of the Federal Register Notice. FDA plans to seek comment on the revised spreadsheet before compiling the final information that will be used as the basis for determining and assessing FY 2018 program fees.


To achieve GDUFA II commitments, FDA must increase the overall capacity and capabilities of the generic drug application review program through a user fee structure that provides stable, predictable funding, is efficient in design and feasible to execute. FDA and industry agreed to jointly recommend these proposed changes for GDUFA II.


On October 28, 2016, CDER hosted a webinar titled "Overview of GDUFA II and Implementation of GDUFA II User Fees". The webinar provided a brief overview of upcoming changes to the user fee structure and described how CDER and Industry can best prepare for GDUFA II.

GDUFA, an historic first: Providing user fees for FDA to ensure timely review of applications for generic drugs

 

The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.

GDUFA is designed to build on the success of the Prescription Drug User Fee Act (PDUFA).  Over the past 20 years, PDUFA has ensured a more predictable, consistent, and streamlined premarket program for industry and helped speed access to new, safe and effective prescription drugs for patients.  GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify.

The current legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. More information on recent developments related to the reauthorization of GDUFA is available at the GDUFA Reauthorization Website.

FY17 GDUFA Fees Table

ANDA$70,480
PAS$35,240
DMF$51,140
FacilityDomestic API$44,234
Foreign API$59,234
Domestic FDF$258,646
Foreign FDF$273,646
BacklogN/A

 

GDUFA Legislation

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This new law includes the Generic Drug User Fee Amendments of 2012 (GDUFA) which is designed to speed access to safe and effective generic drugs to the public. GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.

Page Last Updated: 01/18/2017
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