The GDUFA of 2012 requires that generics makers self-identify and pay appropriate generics fees. FDA has been collecting fees since legislation was passed by the US Congress on 21 September 2012 [1]. However, some generics makers, including India-based Marck Biosciences (now Amanta), have failed to pay their fees. Although Amanta self-identified for 2013 and 2014, it has not yet paid the 2013 or 2014 facility fee, according to a warning letter sent to the company on 26 August 2014.

FDA warns Amanta in its warning letter that failure to pay the fees promptly could result in the facility being placed on import alert, resulting in a ban of drug imports from the facility to the US.

The facility fee for foreign final dose manufacturers for fiscal year 2013 was US$190,389 and was due no later than 4 March 2013. For 2014, the fee was US$235,152 and was due no later than 18 October 2013 [2].

The first generics company to be warned about non-payment of generics fees was German-based CPM Contract Pharma (CPM) in September 2013 [3]. CPM does not appear on FDA’s 2014 arrears list, which we can only assume means that they have subsequently paid.

FDA has placed Amanta and 27 of its fellow generics makers on a publicly available GDUFA facility arrears list. A further 18 companies, including pharma giants AstraZeneca, Bristol-Myers Squibb, and F. Hoffman-La Roche appear on a second list of companies with outstanding facility fees.

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FDA releases new guidance outlining generics review goals

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 2014 Oct 24]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect 
2.   GaBI Online - Generics and Biosimilars Initiative. FDA increases generic user fees in 2014 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 24]. Available from: www.gabionline.net/Generics/General/FDA-increases-generic-drug-user-fees-in-2014
3.   GaBI Online - Generics and Biosimilars Initiative. FDA issues first warning letter for unpaid generics user fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 24]. Available from: www.gabionline.net/Policies-Legislation/FDA-issues-first-warning-letter-for-unpaid-generics-user-fees

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