Generic API makers to pay 20% of GDUFA fee

By Gareth MacDonald

- Last updated on GMT

API manufacturers will contribute a fraction of the annual fee paid to the US FDA if the proposed generic drug user fee act (GDUFA) is passed by Congress next year

Generic active pharmaceutical ingredient (API) makers will pay 20 per cent of the $300m a year charge with finished dosage manufacturers stumping up the rest according to European Fine Chemicals Group (EFCG) board member Guy Villax who spoke about the plan at CPhI this week.

Villax, CEO of Portugal-based API maker Hovione, said just under a third of the generic API sector’s contribution will come from annual inspection fees paid for manufacturing plants although, as yet, the amount per facility has not been set.

Nobody knows the [level of the] fee[s]​,” he said, explaining that “the FDA is unable to tell you how many sites supply the US, therefore the precise amount to be paid by each facility is unclear. We will only find out when we find out.”

Despite this, Villax reiterated his belief that the GDUFA will be good for the generic API industry and the FDA and set out some of the potential benefits.

After five years the EFCG expects the agency to reduce abbreviated new drug application (ANDA) review times from their current 31 month timescale to around 10 months​” he said, adding too that the EFCG predicts the FDA will have worked through its current 1,000-strong* ANDA backlog by 2017.

Villax also said that the GDUFA would allow overseas generic API makers, which supply 80 per cent of all those sold in the US, to achieve parity with their US counterparts in terms of inspection frequency and rigour.

He explained that: “At present foreign [ex-US] suppliers are only ever [re]inspected if they submit a new filing​,” adding that “[GDUFA] will move the FDA from a pre-approval approach to a continuous surveillance approach.

“The FDA sees GDUFA as an element of its efforts to cope with globalisation​,” Villax added.

Bio-equivalence a ‘weak link’

But, despite strongly endorsing the GDUFA, the EFCG does have some minor concerns according to Villax.

One weak link in the proposals remains those organisations and sites that provide vital bio-equivalence data, which will not be inspected under GDUFA​.”

He also raised the problem of duplicate inspections as a shortcoming of the proposed GDUFA.

Why does the FDA continue to inspect in Europe?”​ he asked, adding that “there is no reason why European inspections cannot be recognised in the US and vice versa, which would allow budgets to be redirected to other areas.”

However, despite these ‘tiny details,’ Villax reiterated his organisation’s belief that GDUFA is good for generic API makers. He predicted that it would be published in the US federal register this year and is on track to “get passed next summer.”

*The EFCG contacted after the press conference at CPhI and updated this figure to 2,700 ANDAs.

Related topics: Regulatory & Safety

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