Animal Drug User Fee Act; Public Meeting

April 11, 2008 Dr. Bernadette Dunham Director, Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place Rockville, MD 20855 [Docket No. FDA-2008-N-0082] Animal Drug User Fee Act: Request for Comments Dear Dr. Dunham, The AVMA believes there is an urgent need for the efficient review of new animal drugs, and we support the reauthorization of the Animal Drug User Fee Act (ADUFA). Since first enacted in 2003, ADUFA has provided FDA's Center for Veterinary Medicine (CVM) with resources essential to enabling its timely review of new animal health drugs. CVM performance goals, established by ADUFA in exchange for base funds of $43 million over five years, helped eliminate a backlog of new drug submissions and allowed the agency to better meet animal health needs. An effective and efficient animal drug approval process is crucial to both the health and well-being of animals and to public health, as evidenced by ongoing threats of zoonotic diseases. Additionally, animal health directly impacts food safety, and medicines remain a vital tool in ensuring the safety of our food supply. The review process supported by ADUFA helps make available new and innovative products to meet these challenges and encourages animal health companies to continue investing in the research and development of new drugs. Those investments totaled $664 million in 2006. The AVMA recognizes the demands of balancing the need to efficiently bring new animal drugs to market with the necessity of ensuring safety through rigorous science-based regulatory review. ADUFA meets these demands by providing additional resources to strengthen the agency and enhance CVM's ability to meet its public health and animal health mandates. The CVM and the animal health industry have agreed on a reauthorization proposal that provides $98 million in fees over the next five years and specifies timelines and improvements to ensure timely decisions on an animal drug submission. Given the immediate impact of inaction on public and animal health, we encourage reauthorization of the Animal Drug User Fee Act in 2008. Sincerely, W. Ron DeHaven Executive Vice President American Veterinary Medical Association

April 11, 2008 Dr. Bernadette Dunham Director, Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place Rockville, MD 20855 [Docket No. FDA-2008-N-0082] Animal Drug User Fee Act: Request for Comments Dear Dr. Dunham, The AVMA believes there is an urgent need for the efficient review of new animal drugs, and we support the reauthorization of the Animal Drug User Fee Act (ADUFA). Since first enacted in 2003, ADUFA has provided FDA's Center for Veterinary Medicine (CVM) with resources essential to enabling its timely review of new animal health drugs. CVM performance goals, established by ADUFA in exchange for base funds of $43 million over five years, helped eliminate a backlog of new drug submissions and allowed the agency to better meet animal health needs. An effective and efficient animal drug approval process is crucial to both the health and well-being of animals and to public health, as evidenced by ongoing threats of zoonotic diseases. Additionally, animal health directly impacts food safety, and medicines remain a vital tool in ensuring the safety of our food supply. The review process supported by ADUFA helps make available new and innovative products to meet these challenges and encourages animal health companies to continue investing in the research and development of new drugs. Those investments totaled $664 million in 2006. The AVMA recognizes the demands of balancing the need to efficiently bring new animal drugs to market with the necessity of ensuring safety through rigorous science-based regulatory review. ADUFA meets these demands by providing additional resources to strengthen the agency and enhance CVM's ability to meet its public health and animal health mandates. The CVM and the animal health industry have agreed on a reauthorization proposal that provides $98 million in fees over the next five years and specifies timelines and improvements to ensure timely decisions on an animal drug submission. Given the immediate impact of inaction on public and animal health, we encourage reauthorization of the Animal Drug User Fee Act in 2008. Sincerely, W. Ron DeHaven Executive Vice President American Veterinary Medical Association