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FDA unveils user-fee schemes for generics and biosimilars

Adds structure for a biosimilar approval pathway in the US

The FDA has published details of its user-fee programme for generic and biosimilar medicines for consideration by the US Congress, paving the way for hundreds of millions of dollars in additional funding for the agency.

The programme has been agreed with industry and should help the FDA bolster the resources needed to plough through a backlog of more than 2,000 generic drug applications, according to the Generic Pharmaceutical Association (GPhA).

Meanwhile, it adds structure to the Biologics Price Competition and Innovation Act (BPCI), which effectively created a biosimilar approval pathway in the US, and gives the FDA the resources it needs to help biosimilar developers bring their products to market.

FDA Commissioner Margaret Hamburg unveiled the schemes as part of the latest version of the Prescription Drug User Fee Act (PDUFA), now in its fifth incarnation. The generic drug fees alone could raise in the region of $300m a year over the next five years.

Since 1992, prescription drug manufacturers have paid fees to help fund a portion of the FDA's drug review activities in return for commitments by the agency to meet certain performance goals, such as reviewing a certain percentage of applications within a particular timeframe.

Most new medicines are reviewed by the FDA within 10 months, but for generics lack of capacity has meant that dossiers can face waiting times of up to 30 months.

In a statement, the FDA said that the new programme would support "continued timely review of critical prescription drugs, as well as advance the development of drugs for rare diseases and provide for enhanced communication with small or emerging companies".

The agency also said the latest PDUFA would increase the use of standardised electronic data to improve quality and efficiency, and foster the use of new clinical endpoints to improve drug development times.

The FDA receives 800 to 900 new generic-drug-related applications annually, and these are becoming increasingly complex, often involving products manufactured outside the US.  Additional revenue from user fees will help the agency increase its monitoring of overseas production sites.

The increased funding could help the agency clear the backlog at a rate of around 750 dossiers a year, and work towards a 10-month review time for generic drug applications.

16th January 2012

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