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Generic Drug User Fee Amendments of 2012

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In anticipation of the enactment and implementation of the reauthorization of the Generic Drug User Fee Amendment of 2018 (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 applications (ANDAs) 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 for download below.  

FDA is seeking general feedback on whether the information in this spreadsheet is accurate and complete.  FDA is particularly interested in information that could be relevant to assessing whether two or more companies that are currently listed separately are considered to be affiliated for purposes of assessing the anticipated program fee.

After receiving feedback and comments about this list, FDA anticipates making a revised spreadsheet available.  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. 

All comments may be sent to CDERCollections@fda.hhs.gov.

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: 12/08/2016
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