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Generic Drug User Fee Amendments (GDUFA)

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By: DAVID SAVASTANO

Contributing Editor, Coatings World and Ink World, Coatings World and Ink World Magazine

A user fee model for generic drugs, passed by Congress and insituted by FDA in 2012, "to speed access to safe and effective generic drugs to the public and reduce costs to industry," according to FDA. GDUFA requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. With boosted resources, the FDA intends to reduce its backlog of pending generic applications, reduce the average time required to review ANDAs for safety, and increase risk-based inspections. The structure of GDUFA's funding, particularly its Facility Fees, have led to some controversy.

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