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# GDUFA Reauthorization Aids Public Health: FDA Execs
- URL: https://www.fdaweb.com/gdufa-reauthorization-aids-public-health-fda-execs/
- Published: 2017-10-17T12:00:00.000Z
- Updated: 2026-09-14T22:56:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139891

CDER Office of Generic Drugs director **Kathleen Uhl** and Office of Pharmaceutical Quality director **Michael Kopcha** say the recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) is a “victory for public health. Increasing consumer access to safe, high-quality, and affordable generic drugs is a top priority at FDA.” Writing in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/10/generic-drug-user-fees-reauthorization-a-victory-for-public-health/?ref=fdaweb.com), the two CDER directors say that when FDA approves more than one generic version of a drug, it spurs competition and facilitates affordable options for consumers.

When GDUFA was first approved for a five-year term in 2012, they write, the additional source of funding for an extended period of time beyond the traditional congressional budget appropriations allowed the agency to hire additional staff and better allocate its review activities. As a result, the post says, FDA has approved record numbers of generic drug applications.

“In fact,” Uhl and Kopcha write, “25% of all generic drug currently approved were approved during the first five years of GDUFA. In the last two years of GDUFA, FDA approved more generic drugs each year than in any other year in the history of the generic drug program. The reauthorization of GDUFA will help us build on this success.”

The post says that user fees support the FDA staff who review generic drug applications and who inspect the facilities that make generic drugs. They also provide funds for important IT infrastructure that helps the agency manage its increasing workload, improves efficiency, and increases transparency. The fees also fund regulatory research that helps clarify and improve the scientific and clinical understanding that is the foundation for generic drug assessment, the two write.

“Our experience in GDUFA allowed us to improve review processes and implement best practices for communicating with industry and consumers,” Uhl and Kopcha conclude. “The reauthorization of GDUFA builds on the successes during the first five years. We look forward to the next five years of helping the American public gain even greater access to affordable, high-quality generic drugs.”