Reauthorization of Generic Drug User Fee Seen As A Win For Consumers

With the October 1, 2017 reauthorization, the U.S. Food and Drug Administration (FDA) sees the continuation of the Generic Drug User Fee Amendments (GDUFA) as a victory for public health. GDUFA fees provide funding that advances the review and approval of applications for generic drugs.

Initially approved by Congress in 2012 and required to be reauthorized every five years, GDUFA fees are levied against drug manufacturing companies and their affiliates based on the number of abbreviated new drug applications (ANDAs) in their portfolios. According to the FDA, generic medications account for almost 90% of prescriptions filled in the U.S. and have saved Americans $1.7 trillion in the past decade. GDUFA gives the FDA an additional funding source beyond their usual budget appropriations, allowing them to hire additional staff to help with the review process. In FY 2013, the FDA approved 440 applications for generic drugs, and in FY 2017, the number of approved applications increased to 763.

The FDA reports that 25% of all generic drugs currently available in the U.S. received approval during the first five years of GDUFA and hope to build on this success with the reauthorization. In addition to dedicated staff, the user fees cover inspection of facilities that make generic drugs, IT infrastructure to improve efficiency and transparency while managing the increased workload, and regulatory research that is the foundation for product assessment. With the reauthorization, the FDA put a system in place to fast-track applications that are considered public health priorities and will continue to work towards two primary objectives: increasing the number of generic drugs approved annually and reducing the time it takes for a generic drug application to be approved.