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Public Statements

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

Floor Speech

Location: Washington, DC


Mr. PITTS. I rise today in support of the reauthorization of two successful programs--the Animal Drug User Fee Act, ADUFA, and the Animal Generic Drug User Fee Act, AGDUFA.

The bill we have before us today originated in the Senate and was approved by unanimous consent on May 8, 2013; and I urge my colleagues in the House to support this legislation as well.

In 2003, the first ADUFA was authorized to help the Food and Drug Administration's review of animal drugs. Similar to the Prescription Drug User Fee for human drugs, under ADUFA, FDA collected funds to help expedite the new animal drug approval process, to reduce application backlog, and to improve communications with drug sponsors. The program was authorized for 5 years, and Congress renewed the program for an additional 5 years in ADUFA II in 2008. In 2012, FDA completed 747 ADUFA reviews; and, according to FDA, the agency has exceeded all performance goals outlined in ADUFA I and ADUFA II. However, absent congressional action, FDA's ability to collect these user fees will expire on September 30, 2013.

AGDUFA I, ADUFA's generic cousin, was first authorized in 2008 for 5 years in order to improve the review of abbreviated new animal drug applications, eliminate application backlogs, and reduce review times.

To date, according to FDA, the agency has exceeded all performance goals but one from AGDUFA I. This program also expires September 30, 2013, unless it is reauthorized and FDA and industry have negotiated an agreement for AGDUFA II. These programs are extremely important not only for our animals and livestock on our farms and ranches, but for our pets' health and well-being as well.

I want to thank my colleagues, Representative John Shimkus and Representative Cory Gardner, for their outstanding work on this legislation, and I urge my colleagues to support this important legislation.


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