Slide 1

ADUFA Background

Comments by Steven D. Vaughn, D.V.M.
Director, Office of New Animal Drug Evaluation
Rockville, Maryland
April 24, 2007

Slide 2

ADUFA Background

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.

Slide 3

ADUFA Background

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.

Slide 4

ADUFA Background

This means:

1. Protecting the public health which includes human, animal and environmental health
2. Employing applicable science to make high quality decisions
3. Understanding the economics of the animal health industry

Slide 5

ADUFA Background

• Efficiently conducting quality reviews
• Keeping unsafe and ineffective drugs off of the market
• Expeditiously approving those drugs that are safe and effective

Slide 6

ADUFA Background

• 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

Slide 7

ADUFA Background

ADUFA is a program of fees to provide:

1. an enhanced and predictable review performance that meets industry, Congressional, and public expectations
2. 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
3. a stable revenue stream through the implementation of four fees, each generating the same level of income in a given fiscal year