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Negotiations on generic drug user fees Posted 25/03/2011

Things seem to be finally moving ahead with the FDA’s long-awaited attempt to create a system of user fees for assessing generic drugs. The US Agency [FDA], which has a backlog of more than 2,000 products to review and has been short of funds for years, will launch negotiations with generic drug manufacturers by the end of February 2011.

The number of new and foreign generic applicants has been growing in recent years, and generic applications are increasingly including more complex dosage forms. Brand-name manufacturers currently pay user fees to the FDA under a programme designed to move experimental drugs along, however there is currently no such system in place for generics.

The FDA sees imposing generic user fees as fair, since both brand drug and medical-device makers are already a part of such a scheme, and is urging the industry to accept user fees as a solution to the problem of the current backlog.

Generics’ manufacturers were initially opponents to the fees, but are now reconsidering if it can help to alleviate some of the backlog, especially with some of the biggest brand-name drugs in history coming off patent in late 2011 and in 2012.

The US Generic Pharmaceutical Association (GPhA) stated it ‘has long supported a workable and meaningful generic drug user fee programme” in order “to assure the timely approval of generic drugs’ and added that ‘The Office of Generic Drugs cannot keep pace with its workload without additional resources. GPhA is delighted that the President included generic drug user fees in his budget request and we are anxious to work with the Agency to make user fees a reality’.

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FDA user fees for assessing generic drugs

Source: GPhA, Wall Street Journal

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