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Industry calls for generics user fees to be reduced Posted 27/05/2016

Generics makers and industry groups have commented on the Generic Drug User Fee Amendments (GDUFA) reauthorization, calling for lower user fees and greater transparency in the review process.

The current legislative authority for the GDUFA expires at the end of September 2017. Therefore, the US Food and Drug Administration (FDA) is looking to introduce new legislation in order to continue to collect generic drug user fees for future fiscal years.

FDA held a public meeting on 5 June 2015, during which the agency requested input from stakeholders on their assessment of the overall performance of the GDUFA programme to date and what aspects of the GDUFA should be retained, changed, or discontinued to further strengthen and improve the programme. The comment period for the GDUFA public meeting docket was open from 21 April 2015 until 15 July 2015 [1].

The agency received 22 comments from pharmaceutical companies and associations. The comments generally expressed their support of the GDUFA. However, some of the changes requested for the next version of the GDUFA included:
• Bring greater predictability and timeliness in the review process for abbreviated new drug applications (ANDAs)
• Improve FDA’s communications and feedback with industry in order to expedite product access
• Reduce fees and base them on business size to create a more level playing field

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, and which representing the US domestic Active Pharmaceutical Ingredients (API) industry, asked FDA to ‘consider several changes to performance goals and the fee payment schedule’. The BPTF, although recognizing the benefit of the GDUFA to generics makers, said that it ‘is concerned the increase in foreign inspections has been at the expense of domestic inspections’. ‘To help level the playing field’, the BPTF also asked that FDA ‘consider a fee reduction for small businesses during GDUFA II negotiations’.

In addition, the BPTF believes ‘the original baseline cost estimate for GDUFA of US$299 million was too high, based on user fee carryover of US$277.5 million at the end of Year 2 of the program’. Thus, the BPTF is asking that ‘user fees under GDUFA II be reduced to better align with actual needs of the agreed program’.

The Generic Pharmaceutical Association (GPhA), on the other hand, stressed ‘the importance of safety, access and transparency for all ANDAs’. The association states that ‘as it has been reported by several sources, approximately 3,000 ANDAs that are not subject to performance metrics are currently pending action by FDA’. They add that ‘the average approval times are edging towards 40 months with little to no communication from the FDA with regards to the status of these pending applications’. The GPhA concluded that ‘the motto for GDUFA implementation should be, “no application (ANDA) left behind”’.

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FDA calls for comment on generics user fees guidelines

1. GaBI Online - Generics and Biosimilars Initiative. FDA to hold public meeting on GDUFA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 27]. Available from: www.gabionline.net/Guidelines/FDA-to-hold-public-meeting-on-GDUFA

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