US law requires the pharmaceutical industry to pay fees to supplement the costs of reviewing applications for generic drugs and inspecting manufacturing facilities. These fees are covered by FDA’s Generic Drug User Fee Amendments (GDUFA), designed to accelerate public access to safe and effective generics. Not only relevant to the US, this system helps to ensure the safety of the global supply chain by requiring that all generic drug facilities across the world self-identify as such.

The most recent changes to GDUFA, announced by FDA in July 2016, could benefit generic drug manufacturers. The changes include reduced fees for ANDAs – applications for a generic version of an existing drug, and PAS – which must be submitted when a major change is made to a drug, which could affect its safety or effectiveness for example.

However, all other rates – including those for drug master files, which contain information on how drugs are manufactured, and facility fees, which must be paid by anyone that owns a facility identified in a generic drug submission – will increase.

Fees will rise for all facilities, including producers of active pharmaceutical ingredients and complete drug products, both in the US and abroad.

For the 2017 financial year, the fees will be:

Abbreviated new drug application: US$70,480, down from US$76,030 (a US$5,550 cut).

Prior approval supplement: US$35,240, down from US$38,020 (a US$2,780 cut).

Drug master files: US$51,140, up from US$42,170 (a US$8,970 increase).

Domestic active pharmaceutical ingredient (APIs) facility: US$44,234, up from US$40,867 (a US$3367 increase).

Foreign API facility: US$59,234, up from US$55,867(also a US$3367 increase).

Domestic finished dose formulation (FDF) facility: US$258,646, up from US$243,905 (a US$14,741 increase).

Foreign FDF facility: US$273,646, up from US$258,905 (also a US$14,741 increase).

FDA says its ANDA and PAS fees will decrease due to an expected increase in submissions. In total, they expect 891 new ANDAs and 439 PASs in 2017. However, the administration expects a decrease in the number of drug master files and facilities self-identifying as being involved in a generic drug submission, which explains the increase in these fees. More information on the changes can be found on the FDA website.

The fees outlined above will remain in place until 30 September 2017. This is the last year the current iteration of GDUFA (which was created in 2012) will be in use, with the next version currently under development. FDA held a public meeting on the changes in June 2015 and requested input from stakeholders, prompting generics producers to call for lower user fees and a more transparent review process [1]. More information on the upcoming changes to GDUFA is available on the official reauthorization website.

Related articles
Industry calls for generics user fees to be reduced

GDUFA regulatory priorities for 2016 include complex drugs

FDA to hold public meeting on GDUFA

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Industry calls for generics user fees to be reduced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 2]. Available from: www.gabionline.net/Policies-Legislation/Industry-calls-for-generics-user-fees-to-be-reduced

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