Animal Generic Drug User Fee Act will Speed Approval Process

Earlier this year, President Bush signed legislation reauthorizing the Animal Drug User Fee Act (ADUFA) and authorizing the Animal Generic Drug User Fee Act (AGDUFA), which will provide for additional funds and resources to review generic animal medications. User fees are to be paid by drug sponsors during the FDA application process.

"The AGDUFA is the first ever generic drug user fee program," said Laura Alvey, deputy director of the communications staff at the FDA's Center for Veterinary Medicine. "The program will provide consumers with multiple sources of animal drugs, better ensuring an adequate supply of animal drugs. The proposed user fees will enable enhanced, predictable, and sustainable performance-driven programs that maintain high standards for product safety and efficacy. Both AGDUFA and ADUFA will facilitate more efficient development of safe and effective products available for veterinarians and animal producers, thereby improving public health."

Before AGDUFA, there were very few generic medications available for animals. According to a press release from the Generic Animal Drug Alliance (GADA), an independent organization representing the interests of generic animal health companies before Federal regulatory agencies and Congress, application review times for generic animal drugs took about four times longer than new medications.

According to GADA, the more efficient review process provided for through AGDUFA will save money for owners of horses and other animals by encouraging more generic drugs to enter the market, more quickly than before the legislation was enacted.

ADUFA was first enacted in 2003 to ensure the safety and effectiveness of new animal drugs.

About the Author

Jennifer Walker

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