Regulatory Focus™ > News Articles > FDA Tries to Clear ANDA Backlog before User Fee Assessment

FDA Tries to Clear ANDA Backlog before User Fee Assessment

Posted 23 August 2012 | By Alexander Gaffney, RAC 

Sponsors of so-called "backlogged" abbreviated new drug applications (ANDAs) should withdraw the applications before 1 October 2012 if they do not wish to pay a fee, the US Food and Drug Administration (FDA) said in a Federal Register notice.

The notice relates to new fee established by the Generic Drug User Fee Amendments to the FDA Safety and Innovation Act-a massive piece of FDA reform legislation passed into law on 9 July 2012. Among its many provisions is one aimed at reducing a large and growing backlog of ANDA applications, which are typically used by companies looking to receive approval for a generic drug product.


Over the last decade, FDA has been faced with a growing backlog of ANDA applications as applications to the Office of Generic Drugs surged by more than 300% and submissions of drug master files (DMFs) increased more than 100%. As FDA resources for the office remained flat, the backlog of ANDA applications grew from approximately 1,400 in 2006 to approximately 2,700 by 2011.

The agency has already started advance work to clear the backlog through administrative means before the 1 October deadline. A June 2012 Federal Register announcement by the agency indicated it was looking to disregard 364 applications that have languished at the agency since before July 1991. FDA said it deemed the applications to be abandoned, but explained it did not have the statutory authority to label them as "voluntarily withdrawn." Many of the applications were for companies that have since been merged into other companies, have undergone corporate restructuring or no longer exist.

Approximate Fees

For applications that remain in the backlog on 1 October, FDA said it will assess an as-to-be-determined fee on the sponsors of the ANDAs. The formula for the fee will be the total amount negotiated under the law-$50 million-divided by the number of applications. Assuming approximately 2,500 applications remain in the backlog, the fee for each application would be $20,000.

FDA said it must receive notice of withdrawal by 28 September 2012, and preferably before 15 September in order to expedite the process.

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