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Twenty per cent of generic drug user fees to come from API manufacturers Posted 02/12/2011

In a presentation by the European Fine Chemicals Group (EFCG) at CPhI Worldwide, Frankfurt, Germany, on 25 October 2011, data was presented showing that generic active pharmaceutical ingredient (API) manufacturers are expected to contribute only a small proportion towards generic drug user fees.

The proposal by FDA, according to the EFCG, is that generic API manufacturers pay US$60 million, or around 20%, of the US$300 million generics budget being proposed by the agency to increase staff and facilitate faster turnaround times for review of abbreviated new drug applications (ANDAs).

In return for the fees FDA is promising that after five years, primary review times for ANDAs should be reduced from the current 31 months to 10 months and that there will be parity between foreign (non-US) and US compliance inspections for good manufacturing practices.

FDA gave its main reason for introduction of the fees as being to reduce the agency’s current backlog of more than 2,000 generic applications which are still awaiting review. However, there is still much speculation in the generics industry as to how large the fees would be, with estimates ranging from US$20,000–US$100,000 per ANDA [1].

Member of the EFCG Board, Mr Guy Villax, who gave the presentation, said that the ‘EFCG looked to negotiate savings by avoiding FDA inspections in Europe through a mechanism of mutual recognition. However, the EFCG [was] unable to convince FDA to seek efficiencies by collaborating with other agencies in order to pool knowledge and share the burden of inspections.’ This is a shame, if FDA could only accept European inspections by EMA as being valid it would free up considerable budget which could be used elsewhere.

Despite this the EFCG supports generic drug user fees as ‘a major step forward’ and ‘possibly the most significant step since Waxman Hatch Act’.

Although FDA held its meeting with industry to discuss the fees back in February 2011 there has been no news from FDA as to when and how these user fees will be implemented [1]. However, the Chairman of the Senate Health, Education, Labor and Pensions Committee, Mr Tom Harkin, is pushing for the reauthorisation bill, which includes user fees for brand-name prescription drugs, generics and biosimilars, to be passed by March 2012.

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Biosimilars user fees as high as brand-name fees


1. GaBI Online - Generics and Biosimilars Initiative. Still no word from FDA on generic user fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 02]. Available from: www.gabionline.net/Policies-Legislation/Still-no-word-from-FDA-on-generic-user-fees

Source: EFCG, FDAnews, US Senate Committee on Health, Education, Labor, and Pensions

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