Generic Drug User Fees

About Generic Drug User Fees (GDUF)

An important responsibility of FDA is to assess generic drug applications. Generic drugs currently are used to fill more than two-thirds of all prescriptions dispensed in the United States and they provide important cost-effective alternatives to the American public. Nonetheless, despite increasing productivity on the part of FDA's Office of Generic Drugs, the number of applications awaiting FDA action has been steadily increasing, and the median time for review of such applications has grown.

Similar to user fees for brand name human drugs, animal drugs, generic animal drugs, and medical devices, the intent of a generic drug user fee program would be to provide additional revenues so that FDA can hire more staff and improve systems to support the generic drug review process. FDA believes the supplementary revenues from generic drug user fees would allow the Agency to review generic drug applications in a timely manner and will provide flexibility, adequacy, and predictability in the funding of FDA's review of generic drug applications.

Although the last several administration budgets contain a generic drug user fee program, new legislation would be needed to put such fees into place. At this time, generic drugs for humans are the largest category of preapproval products regulated by FDA and generic drug applicants do not currently pay any type of user fee. FDA believes that the predictability, flexibility, and adequacy of a funding stream from user fees and the accompanying ability to more efficiently review generic drug applications would benefit the public health, FDA, and the generic drug industry.