During the meeting in February, which was attended by the trade organisations US Generic Pharmaceutical Association (GPhA), the European Fine Chemicals Group and the Society of Chemical Manufacturers and Affiliates, the FDA presented its case for generic user fees. The agency 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.

There is 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 abbreviated new drug application. This could especially have an impact on smaller companies with limited resources. When exactly the fees will come into force is another topic of discussion. Speculation ranges from the second quarter of 2011 to sometime in 2012.

Perhaps the most important issue for generics’ manufacturers is how the fees would impact approval timelines. The consensus seems to be that an 18 month target would be ideal. Although in their presentation on the 23 February 2011 the FDA said that the ‘user fee is additive to budget appropriation’, industry is still concerned that the fees will be used to replace some of the Federal Government’s funding for the Office of Generic Drugs (OGD). This fear has been further justified by the recent announcement by US Congress that it intends to cut the OGD budget. The worry is that if the user fees replace even part of the Federal Government funding nothing will change. This view was echoed by the GPhA, which said that budget cuts at the OGD ‘would further slow generic approvals at the very time we need more, not fewer affordable medicines on the market’.

The only thing that does not seem to be in question is whether or not the fees will happen.

Editor’s Comment

It certainly seems that generic user fees are now inevitable. All that is needed now is a proposal from the FDA outlining costs, timelines and when they will be implemented.

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on generic user fees? How do you think that they will affect the generics industry?

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Source: Custopharm, FDA, GPhA