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FDA user fees for assessing generic drugs Posted 12/11/2010

The FDA is beginning a long-awaited attempt to create a system of user fees for assessing generic drugs. The US agency has a backlog of more than 2,000 products to review and has been short of funds for years. But things are never straightforward…

As far back as February 2008 President Bush was trying to get the FDA up to speed with a scheme for fees for assessing animal generics. It regulates products ranging from pharmaceuticals and medical devices to food and cosmetics, which account for a quarter of every dollar spent in the US. Even then, the FDA faced criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Part of the problem is a complex relationship with the legislators. It is an enormous organisation that is requesting a budget of US$ 4 billion (Euros 2.8 billion) from Congress for 2011, as well as charging fees.

Conflicts of interest

Today, the number of new and foreign generic applicants has grown, and generic applications are increasingly including “more complex dosage forms.” However, the backlog appears to be less of a priority to the agency than having funds to conduct overseas plant inspections. The industry is increasingly sourcing active pharmaceutical ingredients from outside the US and safety of the supply chain is in everyone’s interests. However, asking domestic generics companies to pay for foreign inspections is not entirely logical.

The position of generics manufacturers is not straightforward either. Teva Pharmaceuticals, Apotex Inc., Hospira Inc., and Perrigo Laboratories have left the Generic Pharmaceutical Association (GPhA) and are teaming up as the Generic Drug User Fee Coalition. Mylan is taking an independent view, and most other generics companies are still represented by the GPhA.

The third conundrum is patent litigation. Mylan, which received approval to sell atomoxetine in November 2009, still is not marketing its generic because of patent litigation. Companies are not interested in paying big fees and getting faster review times if their products still can not get to market.

So, it will take a while before the time taken to to get a generic approved by the FDA falls below two years.


FDA. User Fees. Animal Generic Drug User Fee Act (AGDUFA) [monograph on the Internet]. USA: FDA [last updated 2010 August 3; cited 2010 October 14]

FDA News and Events. President's FY 2010 Budget Request [monograph on the Internet]. USA: FDA [last updated 2009 November 2; cited 2010 October 14]

Silverman E. Will There Be Generic User Fees? Ramsey Explains. Pharmalot. 23 September 2010

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