Sunday, 3 March 2013


History and background of GDUFA:
  • The one hundred twelfth congress of the United States of America at the second session on 3rd January,  2012, amended the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars and for other purposes.
  •  This act may be cited as the “Food and Drug Administration Safety and Innovation Act”.
  •  The amendment is referred to as Generic Drug User Fee Amendments of 2012 (GDUFA).
  •  On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. 
  •  On Oct. 1, 2012, FDA implemented the Generic Drug User Fee Amendments of 2012 (GDUFA) 

What is GDUFA and why was it implemented by FDA?
  • GDUFA is Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA was implemented to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry.
  • Under GDUFA, certain facilities, sites, and organizations must self-identify and may be Subject to user fees.
  • GDUFA requires industry to pay user fees, which will supplement the costs of reviewing generic drug applications and inspecting facilities.
  • The money earned by FDA through GDUFA will help FDA 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. 

Self-Identification:  All the facilities which manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both are required to self-identify. Under GDUFA, Self-identification is necessary to determine the universe of facilities required to pay user fees, and is a central component of an effort to promote global supply chain transparency. This information will enable quick, accurate, and reliable surveillance of generic drugs and facilitate inspections and compliance.

The Facilities/ Entities/Sites/ Organizations which are not required to pay annual facility fee -
  • Generic entities that solely manufacture positron emission tomography (PET) drugs
  • Clinical bioequivalence or bioavailability study sites
  • In vitro bioequivalence testing or bioanalytical testing sites
  • Active pharmaceutical ingredient (API)/finished dosage form (FDF) analytical testing sites
  • Packagers and repackagers.

Penalty for failure to self-identify: All FDFs (Finished dosage forms) or APIs (Active Pharmaceutical Ingredients) manufactured in the facility, and all FDFs containing APIs manufactured in the facility will be deemed misbranded. This means that it will be a violation of federal law to ship these products in interstate commerce or to import them into the United States.

As stated in the earlier section of this post, user fees have to be paid by the industry to supplement costs of reviewing generic drug applications and inspecting facilities.

The various types of GDUFA fees, which were effective on October 1st 2012, are listed below-
Back log Fee- The ANDA, that has not been withdrawn, which has been under review, got tentative approval, that was submitted as on September 28th, 2012 is considered for back log fee. The FDA calculated the fee as $17,434.

DMF Fee- The Type II active pharmaceutical ingredient (API) DMF that is referenced, on or after Oct. 1, 2012, in a generic drug submission by an initial letter of authorization (LOA) is considered for DMF fee. The DMF fee For Year 2013 is calculated as $21,340. It is a one-time fee for each individual DMF, incurred on first reference of the DMF on or after Oct. 1, 2012..

ANDA and PAS Fee- The ANDA which is filed with FDA on or after October 1st, 2012 is considered for ANDA fee. The ANDA fee for year 2013 is calculated as $51,520. PAS fee is considered for any approved ANDA for which Prior Approval Supplement (PAS) [PAS is filed to notify and seek approval of FDA for any major change in an approved ANDA] is filed. The PAS fee for year 2013 is calculated as $25,760. The PAS fee is half the fee of new ANDA

FDA’s Refuse to File Policy with respect to GDUFA
  • GDUFA adds a new requirement to FDA’s existing refuse to receive policy with respect to payment of fees and the time of receipt of an ANDA.
  •  Failure to pay an ANDA fee within 20 calendar days of the applicable due date will result in the ANDA not being received.
  • Failure to pay the fee for a DMF referenced in the ANDA within 20 calendar days of the date that FDA provides notification of that failure will result in the ANDA not being received.
  • Failure to pay a facility fee for any facility referenced in the ANDA within 20 calendar days of the date that FDA provides notification of that failure will result in the ANDA not being received.
  • If an application is substantially complete except for failure to pay the ANDA fee, or the failure to pay the facility fee within 20 days of notification, the application will be deemed received as of the date the fee is paid.

My Take on GDUFA:
The landmark Hatch and Waxman act paved the way for fast track approval of generics in USA, which resulted in large scale entry of generic players into the market over a period of time.  The presence of generics was kind of, win-win situation for Government, Insurance companies and patients alike, as generics resulted in saving billions of dollars to them.

The numbers of ANDAs filed are rapidly growing, which were around 900 in the year 2011. The numbers of ANDAs pending for review were about 2600 in the year 2011. So, obviously it made the job tough for FDA. Hence, the fees earned will help the FDA to increase its resources and expedite the approval process of ANDAs.

The GDUFA may superficially seem to be burdensome for generic companies. However, for the generic companies which are serious to have their ANDA approval in the fact track and gain market share as soon as possible, the GDUFA is positive news.

Five years down the line after implementation of GDUFA, the FDA has given commitment that, it will review and act on 90 percent of complete electronic ANDAs within 10 months after the date of submission. This is fantastic news, as the generic companies could get their ANDAs approved within 10 months of their filing for conventional generic drugs.

References –

Rajesh Yelugoila


  1. Hi Rajesh
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    Great Job!!
    As this post came out lately, i thought you are weaving something big and important is and sooo... it is. Liked it Rajesh. Thanks for this interesting post where it says importance to know how much valuable when we are filing an application or variation and making it right for the first time.

    paralleled it's much important to the authorities as well to make the product get market approval and helping the needy in time.

    Kudos once again
    Looking forward for more

    Long way to go..

    It became very usual of me that, i am referring this blog with out any second one in my mind to everyone who wanted to come into regulatory field and also who are already working in.......really "Regulatory One" deserves.


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