FDA gives details of generic drug user fees

Home/Policies & Legislation | Posted 01/02/2013 post-comment0 Post your comment

FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012 (GDUFA).

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Legislation allowing FDA to collect several user fees under the GDUFA was approved by the US Congress on 21 September 2012 [1]. The fees are a supplement to funding FDA already receives from Congress. It is hoped that the additional fees will enable FDA’s Office of Generic Drugs to reduce its current backlog of pending applications, cut the average time required to review generic drug applications for safety and increase the number of plant inspections the agency carries out.

The fiscal year 2013 fees for finished drug formulation (FDF) and API facilities for US and foreign manufacturers, which are due on 4 March 2013, are:
Domestic FDF facility:  US$175,389
Foreign FDF facility:  US$190,389
Domestic API facility:  US$26,458
Foreign API facility:  US$41,458

This means that non-US manufacturers will end up paying US$15,000 more than domestic facilities to cover the higher costs of inspecting foreign facilities.

FDF fees are higher than originally anticipated, due to the lower than expected amount of facilities that self-identified and will now share the costs. FDA previously predicted the fee for API facilities would be roughly US$35,000 and the fee for FDF facilities would be roughly US$150,000.

FDA warns that failure to pay the fees within the 20-day deadline will result in FDA refusing to accept any new generic drug submission referencing the facility and that imports of their products will be denied entry into the US.

For 2014–2017 FDA expects to publish the GDUFA fee rates 60 days before the start of the fiscal year, with fees being due on the first business day on or after 1 October of each fiscal year.

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Generic and biosimilar user fee recommendations sent to Congress

Twenty per cent of generic drug user fees to come from API manufacturers


1.  GaBI Online - Generics and Biosimilars Initiative. Generic drug user fees come into effect [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 1]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect

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Source: FDA, Federal Register

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