FDA has collected more than $255 million in generic drug user fees

Memo sent to staff marks Generic Drug User Fee Amendments' one-year anniversary

NEW YORK — The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

In addition, the agency has hired 165 new CDER staff members, helped to make it easier to accurately calculate fees and made "significant strides" in reducing the backlog of generic drug approval applications.

"As we approach the one-year anniversary of the Generic Drug User Fee Amendments of 2012 (GDUFA), I would like to recognize the important accomplishments of those who have worked to launch this program," Woodcock wrote. "This has been a cross-cutting Center and Agency-wide effort led by Mary Beth Clarke, and involving staff and managers from the Office of Regulatory Affairs and most of CDER's offices."

Woodcock wrote that the program would transition to a new project and governance structure similar to PDUFA, led by a new steering committee and focusing on enhancing the program and transforming the generic drug application review process.


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