Comments by Steven D. Vaughn, D.V.M.
Director, Office of New Animal Drug Evaluation
April 24, 2007
FDA/CVM is committed to a sustainable world class pre-market review organization ensuring safe and effective new animal drugs to meet therapeutic and production needs.
FDA/CVM protects the public health by ensuring an adequate amount of safe and effective new animal drugs to meet the therapeutic and production needs of animals.
- Protecting the public health which includes human, animal and environmental health
- Employing applicable science to make high quality decisions
- Understanding the economics of the animal health industry
- Efficiently conducting quality reviews
- Keeping unsafe and ineffective drugs off of the market
- Expeditiously approving those drugs that are safe and effective
- ADUFA was developed to fill a need created by a continued flat line budgets and decreasing resources in the face of increasing workload demands
- ADUFA Authorization Legislation became law on November 18, 2003
- The first Appropriation Legislation was passed on January 23, 2004
ADUFA is a program of fees to provide:
- an enhanced and predictable review performance that meets industry, Congressional, and public expectations
- revenue collections over a five-year period would increase from $5 million in FY 2004 to $8 million in FY 2005, and to $10 million in the third through fifth and final year of the program
- a stable revenue stream through the implementation of four fees, each generating the same level of income in a given fiscal year