Generics makers to self-identify for FY2014 generics fees

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Generics makers to self-identify for FY2014 generics fees

Home/Policies & Legislation | Posted 10/05/2013 0 Post your comment

FDA has informed generics and active pharmaceutical ingredient (API) manufacturers that they will have one month to self-identify for the generics drug user fees for fiscal year (FY) 2014.

The agency announced on 16 April 2013 that generics drug facilities will be required to self-identify during the period from 1 May 2013 to 1 June 2013, so that FDA can calculate the user fees to be paid for FY 2014.

Legislation to allow FDA to collect user fees from industry was passed by US Congress in September 2012 [1]. Generics drug facilities, certain sites and organizations identified in a generic drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update or reconfirm identification information to FDA annually.

The agency collected its first user fees as part of the GDUFA for FY 2013. These were higher than expected due to the relatively low number of facilities self-identifying (1,643). This led to fees for domestic finished drug formulation facilities of US$175,389 and API facilities of US$26,458, while non-US facilities paid US$15,000 more than domestic facilities to cover the extra costs of inspecting foreign facilities [2].

As part of the president’s FY 2014 budget, FDA is requesting a budget of US$4.7 billion to protect and promote the public health. Industry user fees would fund 94% of the proposed budget increase.

The generics user fees for FY 2014 are due to be paid on the first business day on or after 1 October 2013 and FDA expects to publish the GDUFA fee rates 60 days before the start of the fiscal year. The FY 2014 covers the period from 1 October 2013 through 30 September 2014.

References

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 May 10]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect

2. GaBI Online - Generics and Biosimilars Initiative. FDA gives details of generic drug user fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Policies-Legislation/FDA-gives-details-of-generic-drug-user-fees

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: FDA