Regulatory Focus™ > News Articles > FDA Releases Generic Drug User Fee Schedule, Backlog Fees

FDA Releases Generic Drug User Fee Schedule, Backlog Fees

Posted 24 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released the last of its user fees for pharmaceutical products, disclosing the user fees payable to the agency for the submission of abbreviated new drug applications (ANDAs), prior approval supplements (PASs), drug master files (DMFs) and for the clearance of a backlog of ANDA submissions.

Since the signing of the FDA Safety and Innovation Act by President Obama in July 2012, FDA has been steadily releasing guidance documents regarding the exact user fees for various product types and the deadlines they must adhere to.

A 1 October 2012 guidance released by FDA, for instance, established which facilities involved in the manufacture of generic drug products-submitted to FDA under an ANDA-must register with the agency and when. Similar guidance released on 23 August 2012 established what those facilities need to disclose to FDA.

Now the agency has revealed what it expects sponsors of ANDAs, PASs, and DMFs to pay as well. Fees payable to the agency will total $299 million in fiscal year 2013. Less $50 million set aside for the clearance for a backlog of ANDAs, this comes to $249 million.

Sponsors of ANDAs will be charged a per-application fee of $51,520, while a submission of a PAS will cost exactly half that ($25,760) and a DMF will cost ($21,340). These fees are effective retroactive to 1 October 2012, and will be assessed until 30 September 2013, at which time they will be increased.

FDA said it estimates it will receive approximately 576 ANDA during the 2012 fiscal year based on the receipts during the last fiscal year, while another 584 will come in the form of PASs and DMFs.

Backlog at 2,868, Set to Fall

Each sponsor of an existing ANDA will also be required to pay a one-time fee of $17,434 as a way to generate enough resources to process the backlog of ANDAs that have piled up at FDA. The number of backlogged applications numbered approximately 2,700 in 2011 according to some estimates, and FDA has been working in advance of the user fee assessment to clear the backlog through administrative measures.

FDASIA established that FDA would be allowed to assess a fee of no more than $50 million, and that fee paid equally by all current applicants. Based on Regulatory Focus' calculations, that means FDA currently has an exact backlog of 2,868 ANDA applications.

The fee will be payable to FDA within 30 days (24 November 2012 deadline) of the guidance's publication in the Federal Register, which is set for 25 October.

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