FDA issues first warning letter for unpaid generics user fees

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FDA issues first warning letter for unpaid generics user fees

INICIO/Políticas y legislación | Posted 18/10/2013 0 Post your comment

In what appears to be the first of its kind, FDA has warned CPM Contract Pharma (CPM) for failing to self identify and pay its generic drug user fees.

FDA issued a warning letter to the German pharmaceuticals manufacturer on 17 September 2013, with a 15-day deadline to self identify and a 20-day deadline to pay the outstanding fees.

The agency has been collecting fees since legislation was passed by the US Congress on 21 September 2012 [1]. The Generic Drug User Fee Amendments (GDUFA) of 2012 requires that all generic drug facilities, as well as certain sites and organizations identified in a generic drug submission, to self identify and pay fees to FDA annually.

FDA points out in its warning letter to CPM that the deadline for identifying itself for 2013 was December 2012 and that the fees should have been paid by 4 March 2013. The deadline for registering for 2014 was 1 June 2013. CPM has missed all of these deadlines.

FDA warns that any generic drug submissions from the company will be refused and that imported drugs may also be seized if CPM fails to pay the fees. FDA further states that the company will be placed on a public arrears list. The FDA list aims to publicly shame facilities that have failed to submit their annual facility fee required under the GDUFA and thus encourage compliance. The 9 October 2013 FDA list, however, still contains 39 companies, including ophthalmic specialist Allergan.

The FDA list also still includes CPM, which we can only presume means that the company has missed the FDA deadline to correct the violations and will mean that the company will be subject to FDA sanctions.

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Reference

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 Oct 18]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect

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Source: FDA