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Statement of Senator Tom Harkin (D-IA) At the HELP Committee Hearing: “Animal Drug User Fee Agreements: Advancing Animal Health for the Public Health”

*As Prepared for Delivery*

“We have convened this hearing to examine the animal drug and animal generic drug user fee agreements that are due to be reauthorized this year.  The Animal Drug User Fee Agreement (ADUFA) and Animal Generic Drug User Fee Agreement (AGDUFA) programs mirror the fee programs for human medical products that this Committee shepherded through the Senate last Congress as part of the FDA Safety and Innovation Act.  ADUFA and AGDUFA allow FDA to collect user fees from sponsors of animal drug and animal generic drug applications, and the agency uses those fees to help fund the review of animal drug applications. 

“At today’s hearing, we will discuss the history and the purpose of these agreements between FDA and the animal drug industries that it regulates.  We will delve into the agreements themselves, to better understand the revenue that the fees provide and the performance standards that will benefit the industries paying them.  We will also learn about the importance of animal drug user fees to ensuring that both pioneer and generic animal drugs are approved in a timely way.  Fast, predictable approval of animal drugs, and their generic equivalents, benefits both the animals themselves and the people who depend on them. 

“As was true of the user fees for human medical products, ADUFA and AGDUFA are negotiated between FDA and the industries subject to the fees.  We will hear today from the parties involved in those negotiations.

“On our first panel, we will hear from Dr. Bernadette Dunham, the Director of FDA’s Center for Veterinary Medicine (CVM).  Dr. Dunham will discuss the critical role that the ADUFA and AGDUFA fees play in helping CVM ensure that animal drugs are safe and effective and that they are made available as quickly as possible. 

“On our second panel, we will hear from the organizations that negotiated with FDA to reach the ADUFA and AGDUFA agreements we are considering.  In the negotiations with FDA, the pioneer animal drug industry was primarily represented by the Animal Health Institute (AHI).  On our second panel, Dr. Richard Carnevale, AHI’s Vice-President for Regulatory, Scientific, and International Affairs, will discuss the past successes of the ADUFA program and the features of the new ADUFA agreement.  He will be joined on the second panel by Ms. Jennifer Johansson, the Vice-Chair of the Generic Animal Drug Alliance (GADA).  GADA represented the generic animal drug industry during the AGDUFA negotiations.  Ms. Johansson will talk to us about her industry’s experience with the AGDUFA program and about the new AGDUFA agreement.

“The testimony of today’s witnesses will reflect consensus that the animal drug user fee programs are essential to FDA’s timely review of pioneer and generic animal drugs.  The agreements were carefully negotiated, and it is important that we pass them.”